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Paxil 60 mg: Uses, Dosage, Side Effects, Interactions, Warning

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Uses, Dosage, Side Effects, Interactions, Warning

SIDE EFFECTS

The following adverse reactions are included in more detail in other sections of the prescribing information:

  • Hypersensitivity reactions to paroxetine [see CONTRAINDICATIONS]
  • Suicidal Thoughts and Behaviors [see WARNINGS AND PRECAUTIONS]
  • Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
  • Embryofetal and Neonatal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS]
  • Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS]
  • Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Angle-closure Glaucoma [see WARNINGS AND PRECAUTIONS]
  • Hyponatremia [see WARNINGS AND PRECAUTIONS]
  • Bone Fracture [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data for PAXIL are from:

  • 6-week clinical trials in MDD patients who received PAXIL 20 mg to 50 mg once daily
  • 12-week clinical trials in OCD patients who received PAXIL 20 mg to 60 mg once daily
  • 10- to 12-week clinical trials in PD patients who received PAXIL 10 mg to 60 mg once daily
  • 12-week clinical trials in SAD patients who received PAXIL 20 mg to 50 mg once daily
  • 8-week clinical trials in GAD patients who received PAXIL 10 mg to 50 mg once daily
  • 12-week clinical trials in PTSD patients who received PAXIL 20 mg to 50 mg once daily
Adverse Reactions Leading To Discontinuation

Twenty percent (1,199/6,145) of patients treated with PAXIL in clinical trials in MDD and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), 10.7% (79/735), and 11.7% (79/676) of patients treated with PAXIL in clinical trials in SAD, OCD, PD, GAD, and PTSD, respectively, discontinued treatment due to an adverse reaction. The most common adverse reactions (≥1%) associated with discontinuation (i. e., those adverse reactions associated with dropout at a rate approximately twice or greater for PAXIL compared to placebo) are presented in Table 3:

Table 3: Adverse Reactions Reported as Leading to Discontinuation (≥1% of PAXIL-Treated Patients and Greater than Placebo) in MDD, OCD, PD, SAD, GAD, and PTSD Trials

MDD OCD PD SAD GAD PTSD
PAXIL
%
Placebo
%
PAXIL
%
Placebo
%
PAXIL
%
Placebo
%
PAXIL
%
Placebo
%
PAXIL
%
Placebo
%
PAXIL
%
Placebo
%
CNS
Somnolence 2.3 0.7 1. 9 0.3 3.4 0.3 2.0 0.2 2.8 0.6
Insomnia 1.7 0 1.3 0.3 3.1 0
Agitation 1.1 0.5
Tremor 1.1 0.3 1.7 0 1. 0 0.2
Anxiety 1.1 0
Dizziness 1.5 0 1.9 0 1.0 0.2
Gastrointestinal
Constipation 1. 1 0
Nausea 3.2 1.1 1.9 0 3.2 1.2 4.0 0.3 2.0 0.2 2.2 0.6
Diarrhea 1.0 0.3
Dry mouth 1.0 0.3
Vomiting 1. 0 0.3 1.0 0
Flatulence 1.0 0.3
Other
Asthenia 1.6 0.4 1.9 0.4 2. 5 0.6 1.8 0.2 1.6 0.2
Abnormal Ejaculationa 1.6 0 2.1 0 4.9 0.6 2.5 0.5
Sweating 1.0 0.3 1.1 0 1.1 0.2
Impotencea 1.5 0
Libido Decreased 1. 0 0
Where numbers are not provided the incidence of the adverse reactions in patients treated with PAXIL was not >1% or was not greater than or equal to 2 times the incidence of placebo.
a. Incidence corrected for gender.
Most Common Adverse Reactions

The most commonly observed adverse reactions associated with the use of PAXIL (incidence of 5% or greater and at least twice that for placebo) were:

MDD

Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

OCD

Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.

PD

Asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.

SAD

Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawn, abnormal ejaculation, female genital disorders, and impotence.

GAD

Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.

PTSD

Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence.

Adverse Reactions In Patients With MDD

Table 4 presents the adverse reactions that occurred at an incidence of 1% or more and greater than placebo in clinical trials of PAXIL-treated patients with MDD.

Table 4: Adverse Reactions (≥1% of PAXIL-Treated Patients and Greater than Placebo) in 6-Week Clinical Trials for MDD

Body System/Adverse Reaction PAXIL
(n = 421)
%
Placebo
(n = 421)
%
Body as a Whole
Headache 18 17
Asthenia 15 6
Cardiovascular
Palpitation 3 1
Vasodilation 3 1
Dermatologic
Sweating 11 2
Rash 2 1
Gastrointestinal
Nausea 26 9
Dry Mouth 18 12
Constipation 14 9
Diarrhea 12 8
Decreased Appetite 6 2
Flatulence 4 2
Oropharynx Disordera 2 0
Dyspepsia 2 1
Musculoskeletal
Myopathy 2 1
Myalgia 2 1
Myasthenia 1 0
Nervous System
Somnolence 23 9
Dizziness 13 6
Insomnia 13 6
Tremor 8 2
Nervousness 5 3
Anxiety 5 3
Paresthesia 4 2
Libido Decreased 3 0
Drugged Feeling 2 1
Confusion 1 0
Respiration
Yawn 4 0
Special Senses
Blurred Vision 4 1
Taste Perversion 2 0
Urogenital System
Ejaculatory Disturbanceb,c 13 0
Other Male Genital Disordersb,d 10 0
Urinary Frequency 3 1
Urination Disordere 3 0
Female Genital Disordersb,f 2 0
a. Includes mostly “lump in throat” and “tightness in throat.”
b. Percentage corrected for gender.
c. Mostly “ejaculatory delay.”
d. Includes “anorgasmia,” “erectile difficulties,” “delayed ejaculation/orgasm,” and “sexual dysfunction,” and “impotence.”
e. Includes mostly “difficulty with micturition” and “urinary hesitancy.”
f. Includes mostly “anorgasmia” and “difficulty reaching climax/orgasm.”
Adverse Reactions In Patients With OCD, PD, And SAD

Table 5 presents adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with OCD, PD, and SAD.

Table 5. Adverse Reactions (≥2% of PAXIL-Treated Patients and Greater than Placebo) in 10 to 12-Week Clinical Trials for OCD, PD, and SAD

Body System/ Preferred Term Obsessive Compulsive Disorder Panic Disorder Social Anxiety Disorder
PAXIL
(n = 542)
%
Placebo
(n = 265)
%
PAXIL
(n = 469)
%
Placebo
(n = 324)
%
PAXIL
(n = 425)
%
Placebo
(n = 339)
%
Body as a Whole
Asthenia 22 14 14 5 22 14
Abdominal Pain 4 3
Chest Pain 3 2
Back Pain 3 2
Chills 2 1 2 1
Trauma 3 1
Cardiovascular
Vasodilation 4 1
Palpitation 2 0
Dermatologic
Sweating 9 3 14 6 9 2
Rash 3 2
Gastrointestinal
Nausea 23 10 23 17 25 7
Dry Mouth 18 9 18 11 9 3
Constipation 16 6 8 5 5 2
Diarrhea 10 10 12 7 9 6
Decreased Appetite 9 3 7 3 8 2
Dyspepsia 4 2
Flatulence 4 2
Increased Appetite 4 3 2 1
Vomiting 2 1
Musculoskeletal
Myalgia 4 3
Nervous System
Insomnia 24 13 18 10 21 16
Somnolence 24 7 19 11 22 5
Dizziness 12 6 14 10 11 7
Tremor 11 1 9 1 9 1
Nervousness 9 8 8 7
Libido Decreased 7 4 9 1 12 1
Agitation 5 4 3 1
Anxiety 5 4 5 4
Abnormal Dreams 4 1
Concentration Impaired 3 2 4 1
Depersonalization 3 0
Myoclonus 3 0 3 2 2 1
Amnesia 2 1
Respiratory System
Rhinitis 3 0
Pharyngitis 4 2
Yawn 5 1
Special Senses
Abnormal Vision 4 2 4 1
Taste Perversion 2 0
Urogenital System
Abnormal Ejaculationa 23 1 21 1 28 1
Dysmenorrhea 5 4
Female Genital Disordera 3 0 9 1 9 1
Impotencea Urinary 8 1 5 0 5 1
Frequency 3 1 2 0
Urination Impaired 3 0
Urinary Tract Infection 2 1 2 1
a. Percentage corrected for gender.
Adverse Reactions In Patients With GAD And PTSD

Table 6 presents adverse reactions that occurred at a frequency of 2% or more in clinical trials in patients with GAD and PTSD.

Table 6. Adverse Reactions (≥2% of PAXIL-Treated Patients and Greater than Placebo) in 8- to 12-Week Clinical Trials for GAD and PTSDa

Body System/Preferred Term Generalized Anxiety Disorder Posttraumatic Stress Disorder
PAXIL
(n = 735)
%
Placebo
(n = 529)
%
PAXIL
(n = 676)
%
Placebo
(n = 504)
%
Body as a Whole
Asthenia 14 6 12 4
Headache 17 14
Infection 6 3 5 4
Abdominal Pain 4 3
Trauma 6 5
Cardiovascular
Vasodilation 3 1 2 1
Dermatologic
Sweating 6 2 5 1
Gastrointestinal
Nausea 20 5 19 8
Dry Mouth 11 5 10 5
Constipation 10 2 5 3
Diarrhea 9 7 11 5
Decreased Appetite 5 1 6 3
Vomiting 3 2 3 2
Dyspepsia 5 3
Nervous System 3
Insomnia 11 8 12 11
Somnolence 15 5 16 5
Dizziness 6 5 6 5
Tremor 5 1 4 1
Nervousness 4 3
Libido Decreased 9 2 5 2
Abnormal Dreams 3
Respiratory System
Respiratory Disorder 7 5
Sinusitis 4 3
Yawn 4 2 <1
Special Senses
Abnormal Vision 2 1 3 1
Urogenital System
Abnormal Ejaculationa 25 2 13 2
Female Genital Disordera 4 1 5 1
Impotencea 4 3 9 1
a. Percentage corrected for gender.
Dose Dependent Adverse Reactions
MDD

A comparison of adverse reaction rates in a fixed-dose study comparing PAXIL10 mg, 20 mg, 30 mg, and 40 mg once daily with placebo in the treatment of MDD revealed dose dependent adverse reactions, as shown in Table 7:

Table 7. Adverse Reactions (≥5% of PAXIL-Treated Patients and ≥ Twice the Rate of Placebo) (in a Dose-Comparison Trial in the Treatment of MDD

Body System/Preferred Term Placebo
n = 51
%
PAXIL
10 mg
n = 102
%
20 mg
n = 104
%
30 mg
n = 101
%
40 mg
n = 102
%
Body as a Whole
Asthenia 0.0 2.9 10.6 13.9 12.7
Dermatology
Sweating 2.0 1.0 6.7 8.9 11.8
Gastrointestinal
Constipation 5.9 4.9 7.7 9.9 12.7
Decreased Appetite 2.0 2.0 5.8 4.0 4.9
Diarrhea 7.8 9.8 19.2 7.9 14.7
Dry Mouth 2.0 10.8 18.3 15.8 20.6
Nausea 13.7 14.7 26.9 34.7 36.3
Nervous System
Anxiety 0.0 2.0 5.8 5.9 5.9
Dizziness 3.9 6.9 6.7 8.9 12.7
Nervousness 0.0 5.9 5.8 4.0 2.9
Paresthesia 0.0 2.9 1.0 5.0 5.9
Somnolence 7.8 12.7 18.3 20.8 21.6
Tremor 0.0 0.0 7.7 7.9 14.7
Special Senses
Blurred Vision 2.0 2.9 2.9 2.0 7.8
Urogenital System
Abnormal Ejaculation 0.0 5.8 6.5 10.6 13.0
Impotence 0.0 1.9 4.3 6.4 1.9
Male Genital Disorders 0.0 3.8 8.7 6.4 3.7
OCD

In a fixed-dose study comparing placebo and PAXIL 20 mg, 40 mg, and 60 mg in the treatment of OCD, there was no clear relationship between adverse reactions and the dose of PAXIL to which patients were assigned.

PD

In a fixed-dose study comparing placebo and PAXIL 10 mg, 20 mg, and 40 mg in the treatment of PD, the following adverse reactions were shown to be dose-dependent: asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation.

SAD

In a fixed-dose study comparing placebo and PAXIL 20 mg, 40 mg and 60 mg in the treatment of SAD, for most of the adverse reactions, there was no clear relationship between adverse reactions and the dose of PAXIL to which patients were assigned.

GAD

In a fixed-dose study comparing placebo and PAXIL 20 mg and 40 mg in the treatment of GAD, the following adverse reactions were shown to be dose-dependent: asthenia, constipation, and abnormal ejaculation.

PTSD

In a fixed-dose study comparing placebo and PAXIL 20 mg and 40 mg in the treatment of PTSD, the following adverse reactions were shown to be dose-dependent: impotence and abnormal ejaculation.

Male And Female Sexual Dysfunction

Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

The percentage of patients reporting symptoms of sexual dysfunction in males and females with MDD, OCD, PD, SAD, GAD, and PTSD are displayed in Table 8.

Table 8. Adverse Reactions Related to Sexual Dysfunction in Patients Treated with PAXIL in Clinical Trials of MDD, OCD, PD, SAD, GAD, and PTSD

PAXIL Placebo
n (males) 1446
%
1042
%
Decreased Libido 6 to15 0 to 5
Ejaculatory Disturbance 13 to 28 0 to 2
Impotence 2 to 9 0 to 3
n (females) 1822
%
1340
%
Decreased Libido 0 to 9 0 to 2
Orgasmic Disturbance 2 to 9 0 to 1

PAXIL treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.

Hallucinations

In pooled clinical trials of PAXIL, hallucinations were observed in 0.2% of PAXIL-treated patients compared to 0.1% of patients receiving placebo.

Less Common Adverse Reactions

The following adverse reactions occurred during the clinical studies of PAXIL and are not included elsewhere in the labeling.

Adverse reactions are categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse reactions are those occurring on 1 or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare adverse reactions are those occurring in fewer than 1/1,000 patients.

Body as a Whole

Infrequent: Allergic reaction, chills, face edema, malaise, neck pain; rare: Adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer.

Cardiovascular System

Frequent: Hypertension, tachycardia; infrequent: Bradycardia, hematoma, hypotension, migraine, postural hypotension, syncope; rare: Angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles.

Digestive System

Infrequent: Bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, abnormal liver function tests, rectal hemorrhage, ulcerative stomatitis; rare: Aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries.

Endocrine System

Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis.

Hemic and Lymphatic Systems

Infrequent: Anemia, leukopenia, lymphadenopathy, purpura; rare: Abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia.

Metabolic and Nutritional

Frequent: Weight gain; infrequent: Edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare: Alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased.

Musculoskeletal System

Frequent: Arthralgia; infrequent: Arthritis, arthrosis; rare: Bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany.

Nervous System

Frequent: Emotional lability, vertigo; infrequent: Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare: Abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome.

Respiratory System

Infrequent: Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare: Emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration.

Skin and Appendages

Frequent: Pruritus; infrequent: Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare: Angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis; herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.

Special Senses

Frequent: Tinnitus; infrequent: Abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare: Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect.

Urogenital System

Infrequent: Amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.

Postmarketing Experience

The following reactions have been identified during post approval use of PAXIL. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, syndrome of inappropriate ADH secretion, prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, oculogyric crisis which has been associated with concomitant use of pimozide; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), vasculitic syndromes (such as Henoch-Schönlein purpura), and premature births in pregnant women. There has been a case report of severe hypotension when PAXIL was added to chronic metoprolol treatment.

Paroxetine (Oral Route) Proper Use

Proper Use

Drug information provided by: IBM Micromedex

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Follow the instructions carefully. Ask your doctor if you have any questions.

Paroxetine may be taken with or without food.

You may have to take paroxetine for a month or longer before you begin to feel better.

If you are taking the oral suspension, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

Swallow the tablet or extended-release tablet whole. Do not crush, break, or chew it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (capsules):


    • For moderate to severe hot flashes caused by menopause:


      • Adults—7.5 milligrams (mg) once a day, at bedtime.

      • Children—Use is not recommended.

  • For oral dosage form (suspension):


    • For depression:


      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.

      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.

      • Children—Use and dose must be determined by your doctor.

    • For generalized anxiety disorder:


      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.

      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.

      • Children—Use and dose must be determined by your doctor.

    • For obsessive-compulsive disorder:


      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg (30 mL) per day.

      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.

      • Children—Use and dose must be determined by your doctor.

    • For panic disorder:


      • Adults—At first, 10 milligrams (mg) (5 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg (30 mL) per day.

      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg (20 mL) per day.

      • Children—Use and dose must be determined by your doctor.

    • For posttraumatic stress disorder:


      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg (25 mL) per day.

      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 40 mg (20 mL) per day.

      • Children—Use and dose must be determined by your doctor.

    • For social anxiety disorder:


      • Adults—At first, 20 milligrams (mg) (10 milliliters [mL]) once a day, usually taken in the morning.

      • Older adults—At first, 10 mg (5 mL) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 20 mg (10 mL) per day.

      • Children—Use and dose must be determined by your doctor.

  • For oral dosage form (tablets):


    • For depression:


      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.

      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.

      • Children—Use and dose must be determined by your doctor.

    • For generalized anxiety disorder:


      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.

      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 40 mg per day.

      • Children—Use and dose must be determined by your doctor.

    • For obsessive-compulsive disorder:


      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 60 mg per day.

      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.

      • Children—Use and dose must be determined by your doctor.

    • For panic disorder:


      • Adults—At first, 10 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.

      • Children—Use and dose must be determined by your doctor.

    • For posttraumatic stress disorder:


      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 50 mg per day.

      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.

      • Children—Use and dose must be determined by your doctor.

    • For social anxiety disorder:


      • Adults—At first, 20 milligrams (mg) once a day, usually taken in the morning.

      • Older adults—At first, 10 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.

      • Children—Use and dose must be determined by your doctor.

  • For oral dosage form (extended-release tablets):


    • For depression:


      • Adults—At first, 25 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 62.5 mg per day.

      • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.

      • Children—Use and dose must be determined by your doctor.

    • For panic disorder:


      • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose usually is not more than 75 mg per day.

      • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per day.

      • Children—Use and dose must be determined by your doctor.

    • For premenstrual dysphoric disorder:


      • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg per day.

      • Older adults and children—Use and dose must be determined by your doctor.

    • For social anxiety disorder:


      • Adults—At first, 12.5 milligrams (mg) once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 37.5 mg per day.

      • Older adults—At first, 12.5 mg once a day, usually taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 37.5 mg per day.

      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Portions of this document last updated: Sept. 01, 2021

Copyright © 2021 IBM Watson Health. All rights reserved. Information is for End User’s use only and may not be sold, redistributed or otherwise used for commercial purposes.


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Paxil Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

See also Warning section.

Nausea, drowsiness, dizziness, trouble sleeping, loss of appetite, weakness, dry mouth, sweating, blurred vision, and yawning may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: shaking (tremor), restlessness, inability to keep still, decreased interest in sex, changes in sexual ability, numbness/tingling, easy bruising/bleeding, fast/irregular heartbeat, muscle weakness/spasm, seizures.

Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night).

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Paxil – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Paroxetine belongs to the class of medications called selective serotonin reuptake inhibitors (SSRIs). It is used to treat depression, obsessive-compulsive disorder, panic disorder, social phobia (social anxiety disorder), generalized anxiety disorder, and post-traumatic stress disorder. It works by affecting the balance of chemicals in the brain that are associated with depression and anxiety disorders.

It may take several weeks before the full beneficial effects of this medication are felt. Continue taking the medication until you have consulted with your doctor, even if you feel your symptoms are not improving.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

10 mg
Each yellow, bisected, film-coated, oval, biconvex tablet, with the product name engraved on one side and the strength engraved on the other, contains paroxetine HCl equivalent to 10 mg of paroxetine free base. Nonmedicinal ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, and titanium dioxide.

20 mg
Each pink, bisected, film-coated, oval, biconvex tablet, with the product name engraved on one side and the strength engraved on the other, contains paroxetine HCl equivalent to 20 mg of paroxetine free base. Nonmedicinal ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, and titanium dioxide.

30 mg
Each blue, film-coated, oval, biconvex tablet, with the product name engraved on one side and the strength engraved on the other, contains paroxetine HCl equivalent to 30 mg of paroxetine free base. Nonmedicinal ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, and titanium dioxide.

The 10 mg, 20 mg, and 30 mg tablets also contain one or more of the following: D&C Red No. 30 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake.

How should I use this medication?

For adults being treated for depression, the recommended starting dose is 20 mg taken once daily. This is also the dose that most people find effective. If necessary, your doctor may suggest you increase the dose slowly to a maximum of 50 mg daily.

For people being treated for obsessive-compulsive disorder, the usual starting dose of paroxetine is 20 mg taken once daily. Gradually, your doctor will have you increase the dose to the recommended dose of 40 mg daily. If necessary, the dose may be increased to a maximum of 60 mg daily.

For people being treated for panic disorder, the usual starting dose is 10 mg once daily. It should then be slowly increased to the recommended dose of 40 mg daily. If necessary, the dose may be increased to a maximum of 60 mg daily.

For social phobia (social anxiety disorder), generalized anxiety disorder and post traumatic stress disorder, the starting dose is 20 mg taken once daily. The maximum dose for treating any of these conditions is 50 mg daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way that you are taking the medication without consulting your doctor.

In all cases, this medication is usually taken first thing in the morning. It may be taken with or without food. Swallow the tablet whole – do not chew or crush it.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take paroxetine if you:

  • are allergic to paroxetine or any ingredients of the medication
  • are taking an MAO inhibitor (e.g., phenelzine, tranylcypromine, moclobemide) or have taken a MAO inhibitor within the past 2 weeks (do not start treatment with an MAO inhibitor until at least 2 weeks after stopping paroxetine treatment)
  • take the medication pimozide
  • take the medication thioridazine

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • decreased appetite
  • decreased sexual desire or ability
  • diarrhea
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • increased sweating
  • increased sensitivity to sun
  • menstrual period changes
  • nausea
  • nervousness
  • nightmares
  • tremor
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • agitation
  • blurred vision
  • feeling restless
  • hallucinations (seeing or hearing things that aren’t there)
  • increased cholesterol levels
  • low blood pressure (dizziness or fainting when rising from a sitting or lying position)
  • new or worsening signs of depression (such as feeling sad, losing interest in things you used to enjoy, weight changes, changes in sleep habits, feelings of guilt or worthlessness, thoughts of suicide)
  • problems with urination
  • restless legs syndrome (irresistible urge to move the legs)
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • skin rash
  • symptoms of glaucoma (e.g., eye pain, blurred vision)
  • symptoms of low blood sodium (confusion, seizures, drowsiness, dryness of mouth, increased thirst, lack of energy)
  • talking, feeling, and acting with excitement and activity you cannot control
  • uncontrollable movements of the body or face

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizure or convulsions
  • serotonin syndrome (signs include agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, twitching)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • thoughts of suicide or hurting yourself

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal bleeding: Paroxetine, like other similar medications, may cause abnormal bleeding, including bleeding in the stomach or intestines. People who have or have had a history of bleeding disorders should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report any unusual bruising or bleeding to your doctor, especially if you are taking other medications that affect blood clotting. These medications include acetylsalicylic acid (ASA), clopidogrel, dipyridamole, nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen or naproxen), other anticoagulant medications (e.g., warfarin), and certain antipsychotic medications.

Bone fracture: This medication may increase the risk of bone fractures (breaks) when taking this medication. If you have osteoporosis or any other illness that increases your risk for breaking bones, or are at risk for developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Although paroxetine is not known to cause drowsiness, it is advisable to avoid driving or operating hazardous machinery until you determine how paroxetine affects your ability to do these things safely.

Glaucoma: Paroxetine can cause an increase in the pressure in the eye, making symptoms of glaucoma worse. If you have narrow-angle glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: If you have heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: People with kidney disease may need lower doses of this medication. If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Mania: Paroxetine may cause symptoms of mania to worsen or return. If you have a history of mania or bipolar disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: There have been occasional reports of seizures occurring with paroxetine. If you have a history of seizures discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Anyone who develops seizures should seek immediate medical attention.

Serotonin syndrome: Severe reactions are possible when paroxetine is combined with other medications that act on serotonin, such as tricyclic antidepressants, “triptan” medications for migraine and some medications to treat nausea due to chemotherapy. These combinations should be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking other medications that affect serotonin, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Stopping this medication suddenly may lead to side effects such as dizziness, abnormal dreams, numbness or tingling sensations, agitation, anxiety, nausea, vomiting, sweating, or other symptoms. If you are thinking of stopping the medication, check with your doctor first. Your doctor may want you to decrease the dose of the medication gradually when it is time to stop taking paroxetine.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These behavioural changes may be more likely to occur in children and adolescents, however they are possible for all age groups that use this medication. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Paroxetine has been reported to cause an increase in birth defects, primarily of the heart, in babies born to women who have taken it in the first trimester. It has also been reported that babies born to women who took medications of this kind during the last trimester of their pregnancy may experience adverse effects (such as breathing problems, seizures, trouble feeding, vomiting, low blood sugar, shaking, jitteriness, irritability, and constant crying) that result in an increase in the length of hospital stay. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking paroxetine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of paroxetine for those less than 18 years of age have not been established. The use of this medication by children and adolescents less than 18 years old may cause behavioural and emotional changes, such as suicidal thoughts and behaviour.

Seniors: Seniors may need lower doses of this medication, and they should be closely monitored by their doctor when taking paroxetine.

What other drugs could interact with this medication?

There may be an interaction between paroxetine and any of the following:

  • abiraterone
  • acetylsalicylic acid (ASA)
  • alcohol
  • alfuzosin
  • alteplase
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine, methamphetamine)
  • antihistamines (e.g., diphenhydramine, hydroxyzine)
  • antipsychotic medications (e.g., chlorpromazine, haloperidol, olanzapine, quetiapine, risperidone)
  • apixaban
  • atomoxetine
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • beta-blockers (e.g., carvedilol, metoprolol, propranolol)
  • bromocriptine
  • bupropion
  • buspirone
  • cabergoline
  • captopril
  • celecoxib
  • certain antiarrhythmic medications (e.g., disopyramide, flecainide, propafenone)
  • chloral hydrate
  • chloroquine
  • cimetidine
  • cinacalcet
  • clopidogrel
  • cobicistat
  • cyclophosphamide
  • dabigatran
  • darifenacin
  • dasatinib
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • desmopressin
  • dextromethorphan
  • dipyridamole
  • dofetilide
  • domperidone
  • doxorubicin
  • dronedarone
  • efavirenz
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • galantamine
  • general anesthetics (medications used to put people to sleep before surgery)
  • glucosamine
  • heparin
  • herbal products that affect blood clotting (e.g., cat’s claw, chamomile, fenugreek, evening primrose, feverfew, garlic, ginger, ginseng, turmeric)
  • ifosfamide
  • irinotecan
  • ketoconazole
  • levothyroxine
  • linezolid
  • lithium
  • losartan
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • MAO inhibitors (e.g., linezolid, moclobemide, phenelzine, selegiline, tranylcypromine)
  • methadone
  • methylene blue
  • metoclopramide
  • metyrosine
  • mexiletine
  • mifepristone
  • mirabegron
  • mirtazapine
  • multivitamins/minerals
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine, tizanidine)
  • narcotic pain relievers (e.g., codeine, fentanyl, methadone, morphine, oxycodone)
  • nefazodone
  • nilotinib
  • nonsteroidal anti-inflammatory medications (NSAIDs; diclofenac, ibuprofen, naproxen)
  • omega-3 fatty acids
  • olopatadine
  • peginterferon Alfa-2b
  • pentoxifylline
  • pimozide
  • pravastatin
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., levofloxacin, moxifloxacin)
  • rasagiline
  • ritonavir
  • rivaroxaban
  • scopolamine
  • seizure medications (e.g., carbamazepine, clobazam,  felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs e.g., desvenlafaxine, duloxetine, venlafaxine)
  • other selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, sertraline)
  • 5-HT3 antagonists (e.g., granisetron, ondansetron)
  • St. John’s wort
  • tamoxifen
  • tamsulosin
  • tapentadol
  • terbinafine
  • tetrabenazine
  • thiazide diuretics (e.g., hydrochlorothiazide, indapamide)
  • ticagrelor
  • ticlopidine
  • tolterodine
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., nortriptyline, amitriptyline, imipramine, desipramine)
  • “triptan” migraine medications (e.g., sumatriptan, zolmitriptan, rizatriptan)
  • tryptophan
  • tyrosine kinase inhbitors (e.g., imatinib, lapatinib, pazopanib, sunitinib)
  • vitamin E
  • warfarin
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Paxil

Paroxetine (Paxil) – Side Effects, Interactions, Uses, Dosage, Warnings

You should not use this medicine if you are allergic to paroxetine, or if you are also taking pimozide or thioridazine.

Do not use an MAO inhibitor within 14 days before or 14 days after you take paroxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking paroxetine you must wait at least 14 days before you start taking an MAO inhibitor.

Tell your doctor if you have ever had:

  • heart disease, high blood pressure, or a stroke;
  • liver or kidney disease;
  • a bleeding or blood clotting disorder;
  • seizures or epilepsy;
  • bipolar disorder (manic depression), drug addiction, or suicidal thoughts;
  • narrow-angle glaucoma; or
  • low levels of sodium in your blood.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with paroxetine and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine without your doctor’s advice.

Do not use Brisdelle if you are pregnant.

You should not breastfeed while using this medicine.

Paroxetine is not approved for use by anyone younger than 18 years old.

Uses, Side Effects, Dosage, and More

Anxiety disorders and depression are estimated to affect approximately 60 millions adults in the United States. People who suffer from severe forms of anxiety and depression may be able to improve their symptoms by making certain lifestyle changes, such as cutting stress out of their lives and increasing their amount of exercise, but prescription drugs like Paxil can help to further reduce symptoms. 

Paxil is a prescription antidepressant that is commonly used for the treatment of many different mental health disorders. Paxil is available in the generic form under the name of its active ingredient, paroxetine, and the medication is only used in adults. Paxil is used to treat a wide range of medical conditions. 

What is Paxil?

Paxil is a prescription antidepressant medication that is part of a class of drugs called selective serotonin reuptake inhibitors (SSRIs). 

SSRIs represent a newer class of antidepressants that were first introduced in the mid-1980s with the intention of replacing older antidepressants like MAOIs and tricyclic antidepressants. SSRIs are commonly associated with fewer side effects than older classes of antidepressants and are better tolerated by most patients. 

Sold under the generic name paroxetine, Paxil is approved by the U.S. Food and Drug Administration (FDA) for the treatment of many different common mental health conditions.

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What conditions are treated with Paxil?

Paxil is an effective treatment option for some of the most common mental health conditions, including major depressive disorder (also known as clinical depression), premenstrual dysphoric disorder (PMDD) and multiple types of anxiety disorders. Some of the types of anxiety disorders treated with Paxil include obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder, post-traumatic stress disorder (PTSD),and generalized anxiety disorder. Paxil can also be combined with other drugs for the treatment of other mental health disorders that are not specified above. 

How much does Paxil cost?

Paxil is a brand name medication that is typically more expensive than its generic version, paroxetine. The following table compares the costs of a 30-day supply of Paxil and paroxetine.

Costs of a 30-Day Supply of Paxil and Paxil HCL

 

 

10 mg oral tablets

20 mg oral tablets

Paxil

$226.60

$236.20

Paroxetine HCL

$19.90

$29.20

 

Regardless of whether patients choose to use Paxil or paroxetine, they can save on the cost of Paxil or Paxil regardless of their insured status with a free pharmacy discount card from USA Rx. 

How do I know which dose of Paxil to take?

Several different factors influence which dose of Paxil you should take. While your doctor will prescribe the best starting dose of the medication for you, the decision will be made based on several factors, including: 

  • The age of the patient
  • The mental health condition being treated
  • The severity of the patient’s condition
  • How the patient responds to the first few doses of the drug
  • Other medical conditions that could affect how the drug is absorbed. 

Every person will respond to Paxil differently, so it is best not to compare your dose to the dose of someone else that you know who is taking the same drug. Also, your doctor may adjust your dose several times before settling on the right dose of the medication for you. 

When taken for major depressive disorder, adults under the age of 65 will typically start at a dose of 20 mg per day of the immediate release version of Paxil or 25 mg per day for the extended release dose of the drug. Your dose of the medication can be incrementally increased at your doctor’s discretion by 10 mg per day per week until reaching a maximum dosage of 50 mg per day for the immediate release version of the drug and by 12.5 mg per day to a maximum dose of 62.5 mg per day for the extended release version of the medication. 

Adults taking Paxil for social anxiety disorder typically start at a dose of 20 mg per day with a maximum dose of 60 mg per day for the immediate release form of the drug. When using the extended release version of Paxil, the starting dose is 12.5 mg per day with a maximum dose of 37.5 mg per day.

Post-traumatic stress disorder is only treated with the immediate-release version of Paxil. The starting dose of the medication for social anxiety disorder is 20 mg per day with a maximum dose of 50 mg per day.

Similarly, generalized anxiety disorder is also treated with only the immediate release version of Paxil. The starting dose is 20 mg per day with a maximum dose of 50 mg per day.

Panic disorder can be treated with either the immediate release or extended release version of Paxil. When using the immediate release tablet, adults under the age of 65 aim for a target dose of 40 mg per day and a maximum dose of 60 mg per day. When using the extended-release tablet, the starting dose is typically 12.5 mg per day with a maximum dose of 75 mg per day. 

Premenstrual dysphoric disorder is treated with the extended release version of Paxil. The typical starting dose is 12.5 mg per day, typically taken in the morning. The maximum dose for the treatment of premenstrual dysphoric disorder is 25 mg per day.

What are the side effects associated with Paxil?

Antidepressant SSRIs like Paxil are associated with a lengthy list of possible side effects due to their effects on the chemical balance in the brain. The side effects associated with Paxil are typically classified as either common and serious.

Common side effects of Paxil usually do not require medical attention. These side effects include: 

  • Dizziness
  • Nausea
  • Weakness
  • Sleepiness
  • Decreased sexual desire
  • Sexual dysfunction
  • Constipation
  • Infection
  • Impotence
  • Sweating
  • Delayed ejaculation
  • Decreased appetite
  • Dry mouth
  • Shaking
  • Anxiousness or sleeplessness
  • Yawning

If you experience mild side effects from Paxil, as noted above, your symptoms will likely disappear over the course of a few days or weeks as your body starts to adjust to the effects of the medication. If you experience side effects over an extended period of time or your side effects start to feel severe, you should contact your doctor or pharmacist and consider seeking medical attention. 

Paxil is associated with potentially serious or life-threatening side effects in some patients. If you experience any of the following serious side effects, make sure to contact your doctor or call 911 and seek medical attention from a healthcare professional if you feel like you are experiencing a medical emergency. 

Serious side effects of Paxil include: 

  • Changes in mood, anxiety or behavior, as evidenced by:
    • New or worsened depression
    • Sleeplessness
    • Acting on dangerous impulses
    • New or worsening anxiety or panic attacks
    • Agitation, restlessness, anger, or irritability
    • Thoughts of suicide or dying
    • Attempts to commit suicide
    • Acting aggressive or violent
    • Increase in activity or talking more than what is normal for you
  • Increased risk of serotonin syndrome, which most commonly occurs when the medication is taken with other drugs that influence the amount of serotonin in the brain. Symptoms of serotonin syndrome include: 
    • Coordination problems or muscle twitching (overactive reflexes)
    • Racing heartbeat
    • Fever
    • Sweating
    • High or low blood pressure, including hypertension
    • Agitation, confusion, hallucinations, coma, and trouble thinking
    • Muscle rigidity
    • Nausea, vomiting, or diarrhea
  • Eye problems, such as:
    • Swelling or redness in or around your eyes
    • Changes in vision
    • Eye pain
  • Severe allergic reactions. Symptoms can include:
    • Hives (itchy welts)
    • Blisters
    • Trouble breathing
    • Joint pain
    • Fever
    • Rash
    • Swelling of your face, tongue, eyes, or mouth
  • Seizures or convulsions
  • Manic episodes. Symptoms can include:
    • Reckless behavior
    • Severe trouble sleeping
    • Excessive happiness or irritability
    • Greatly increased energy
    • Unusually grand ideas
    • Racing thoughts
    • Talking more or faster than usual
  • Changes in appetite or weight (either weight loss, loss of appetite, or weight gain)
  • Abnormal bleeding
  • Low sodium levels, as evidenced by:
    • Headache
    • Weakness or feeling unsteady
    • Confusion 
    • Memory problems
    • Problems concentrating or thinking
  • Increased risk of bone fracture, as indicated by:
    • Swelling
    • Unexplained bone pain
    • Tenderness
    • Bruising

Are there any risks associated with Paxil?

Paxil is associated with several serious warnings and has been assigned a black box warning from the FDA. Black box warnings are the strongest warning given by the FDA for medications and are intended to provide doctors and patients with information about the potentially serious effects of the drug.  

One of the most significant risks associated with the use of Paxil is the increased risk of suicidal thoughts or behaviors, especially in young adults. Patients are most likely to experience these adverse effects of paroxetine when they first begin treatment with Paxil or when they increase their dose of the medication. Adults ages 24 and younger, as well as teenagers and children, are particularly susceptible to experiencing suicidal thoughts and behaviors while taking Paxil.

Serotonin syndrome is a potentially life-threatening condition that can occur when levels of serotonin in the brain become elevated at a level that the body cannot tolerate. When combined with other medications that impact the levels of serotonin in the brain, Paxil can cause serotonin syndrome, but Paxil can also cause serotonin syndrome on its own.  People experiencing serotonin syndrome may experience symptoms like coma, muscle twitching, hallucinations, agitation, confusion, trouble thinking, and coordination problems.

Patients who are using Paxil for the treatment of major depressive disorder may find that use of the drug exacerbates their symptoms. Make sure to pay attention to your symptoms and let a friend, family member, or your healthcare provider know if they change. If you notice symptoms like extreme mood swings, restlessness, anxiety,  aggressiveness, panic attacks, irritability, acting on dangerous impulses, sleeplessness, or suicidal thoughts or behaviors, call your doctor.

Like many other types of antidepressants, Paxil can cause withdrawal symptoms due to its effects on the chemistry of the brain. Patients who have been taking Paxil for four weeks or more and who desire to stop or reduce their dose of the drug should not do so without first consulting a doctor. 

Withdrawal symptoms of Paxil include:

  • Headache
  • Nausea
  • Sweating
  • Dizziness
  • Shaking
  • Anxiety
  • Restlessness
  • Irritability
  • Changes in sleep habits
  • Confusion

What drugs interact with Paxil?

Paxil can cause a number of different drug interactions. Some drug interactions can be potentially dangerous, while others can cause an increased risk of side effects or reduced effectiveness of both medications. 

Paxil should not be taken with any of the following medications under any circumstances:

  • Thioridazine
  • Linezolid and intravenous methylene blue
  • Pimozide
  • Tryptophan (when found in dietary supplements)
  • Monoamine oxidase inhibitors (MAOIs) including isocarboxazid, phenelzine, and tranylcypromine

When Paxil is taken with certain other medications, it can increase the risk of patients experiencing certain side effects. These medications include:

  • Lithium
  • Amphetamines
  • Theophylline
  • Cimetidine
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) like Aleve, Aspirin, and Advil
  • Risperidone
  • Antiarrhythmics
  • Serotonergic drugs, including tramadol, fentanyl, and St. John’s wort
  • Tricyclic antidepressants
  • Triptans, including sumatriptan
  • Phenothiazines
  • Quinidine
  • SNRIs

Some medications can interact with Paxil in a way that makes both medications less effective. These include:

  • Tamoxifen
  • Phenytoin
  • Digoxin
  • Protease inhibitors like ritonavir and fosamprenavir
  • Phenobarbital

Summary

Paxil is a popular prescription SSRI antidepressant that is also sold under the brand name paroxetine. The drug is FDA-approved for the treatment of many common mental health conditions, including major depressive disorder, premenstrual dysphoric disorder, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. 

Side effects of Paxil most commonly include sleepiness, difficulty thinking clearly, difficulty making decisions, slowed reaction times, and nausea. Paxil is also associated with a long list of other common and serious side effects, including an increased risk of suicidal thoughts and behaviors. 

Seek medical advice to determine whether Paxil is right for you. 

Paxil is thought to be safe for breastfeeding mothers, despite being detected in breast milk. Pregnant women should consult with their doctor before starting Paxil, as it may be linked to heart defects in newborns.

Generic brand paroxetine hydrochloride can be sold as the short-term Paxil or in the long-acting Paxil CR. You can save significantly on the cost of your medication by choosing the generic drug. 

Regardless of whether or not your health insurance covers Paxil, you can save on the cost of your prescription with a pharmacy discount card from USA Rx. 

Sources:

https://www.healthline.com/health/paroxetine-oral-tablet 

https://www.webmd.com/drugs/2/drug-6969-9095/paroxetine-oral/paroxetine-oral/details 

https://medlineplus.gov/druginfo/meds/a698032.html 

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Paxil (Paroxetine) Patient Information | HealthyPlace

Find out why Paxil is prescribed, side effects of Paxil, Paxil warnings, effects of Paxil during pregnancy, more – in plain English.

Generic name: Paroxetine hydrochloride

Brand name: Paxil

Pronounced: PACKS-ill

Paroxetine Full Prescription Information
Paxil Medication Guide

Why is Paxil prescribed?

Paxil relieves a variety of emotional problems. It can be prescribed for serious, continuing depression that interferes with your ability to function. Symptoms of this type of depression often include changes in appetite and sleep patterns, a persistent low mood, loss of interest in people and activities, decreased sex drive, feelings of guilt or worthlessness, suicidal thoughts, difficulty concentrating, and slowed thinking.

Paxil is also used to treat obsessive-compulsive disorder (OCD), a disease marked by unwanted, but stubbornly persistent thoughts, or unreasonable rituals you feel compelled to repeat.

In addition, Paxil is prescribed for panic disorder, a crippling emotional problem characterized by sudden attacks of at least four of the following symptoms: palpitations, sweating, shaking, numbness, chills or hot flashes, shortness of breath, a feeling of choking, chest pain, nausea or abdominal distress, dizziness or faintness, feelings of unreality or detachment, fear of losing control, or fear of dying.

Paxil can be prescribed for generalized anxiety disorder, a disease marked by excessive anxiety and worry that persists for at least 6 months and can’t be easily controlled. True cases of generalized anxiety disorder are accompanied by at least three of the following symptoms: restlessness or a keyed-up or on-edge feeling, a tendency to tire easily, difficulty concentrating or spells when the mind goes blank, irritability, muscle tension, or sleep disturbance.

Paxil can be used in the treatment of social anxiety disorder (also known as social phobia), a condition marked by shyness or stage fright so intense that it interferes with an individual’s work and social life.

Paxil is also prescribed for posttraumatic stress disorder–a crippling condition that sometimes develops in reaction to a disastrous or horrifying experience. Symptoms, which stubbornly refuse to abate, include unwanted memories and dreams, intense distress when confronted with reminders of the event, a general numbing of interest and enjoyment, jumpiness, irritability, poor sleep, and loss of concentration.

 

Most important fact about Paxil

Your symptoms may seem to improve within 1 to 4 weeks after beginning treatment with Paxil. Even if you feel better, continue to take the medication as long as your doctor tells you to do so.


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How should you take Paxil?

Paxil is taken once a day, with or without food, usually in the morning. Inform your doctor if you are taking or plan to take any prescription or over-the-counter drugs, since they may interact unfavorably with Paxil.

Shake the oral suspension well before using.

–If you miss a dose…

Skip the forgotten dose and go back to your regular schedule with the next dose. Do not take a double dose to make up for the one you missed.

–Storage instructions…

Paxil tablets and suspension can be stored at room temperature.

What side effects may occur with Paxil?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine whether it is safe for you to continue taking this medication.

Over a 4 to 6 week period, you may find some side effects less troublesome (nausea and dizziness, for example) than others (dry mouth, drowsiness, and weakness).

  • More common side effects may include: Abnormal ejaculation, abnormal orgasm, constipation, decreased appetite, decreased sex drive, diarrhea, dizziness, drowsiness, dry mouth, gas, impotence, male and female genital disorders, nausea, nervousness, sleeplessness, sweating, tremor, weakness, vertigo

  • Less common side effects of Paxil may include: Abdominal pain, abnormal dreams, abnormal vision, agitation, altered taste sensation, blurred vision, burning or tingling sensation, drugged feeling, emotional instability, headache, increased appetite, infection, itching, joint pain, muscle tenderness or weakness, pounding heartbeat, rash, ringing in ears, sinus inflammation, tightness in throat, twitching, upset stomach, urinary disorders, vomiting, weight gain, vertigo, yawning

  • Rare side effects may include: Abnormal thinking, acne, alcohol abuse, allergic reaction, asthma, belching, blood and lymph abnormalities, breast pain, bronchitis, chills, colitis, difficulty swallowing, dry skin, ear pain, exaggerated sense of well-being, eye pain or inflammation, face swelling, fainting, generally ill feeling, hair loss, hallucinations, heart and circulation problems, high blood pressure, hostility, hyperventilation, increased salivation, increased sex drive, inflamed gums, inflamed mouth or tongue, lack of emotions, menstrual problems, migraine, movement disorders, neck pain, nosebleeds, paranoid and manic reactions, poor coordination, respiratory infections, sensation disorders, shortness of breath, skin disorders, stomach inflammation, swelling, teeth grinding, thirst, urinary disorders, vaginal inflammation, vision problems, weight loss

Why should Paxil not be prescribed?

Dangerous and even fatal reactions are possible when Paxil is combined with thioridazine (Mellaril) or drugs classified as monoamine oxidase (MAO) inhibitors, such as the antidepressants Nardil and Parnate. Never take Paxil with any of these medications, or within 2 weeks of starting or stopping use of an MAO inhibitor. You’ll also need to avoid Paxil if it gives you an allergic reaction.

Special warnings about Paxil

Paxil should be used cautiously by people with a history of manic disorders and those with high pressure in the eyes (glaucoma).

If you have a history of seizures, make sure your doctor knows about it. Paxil should be used with caution in this situation. If you develop seizures once therapy has begun, the drug should be discontinued.

If you have a disease or condition that affects your metabolism or blood circulation, make sure your doctor is aware of it. Paxil should be used cautiously in this situation.

Paxil may impair your judgment, thinking, or motor skills. Do not drive, operate dangerous machinery, or participate in any hazardous activity that requires full mental alertness until you are sure the medication is not affecting you in this way.

It’s best to avoid an abrupt discontinuation of Paxil therapy. It can lead to symptoms such as dizziness, abnormal dreams, and tingling sensations. To prevent such problems, your doctor will reduce your dose gradually.

Possible food and drug interactions when taking Paxil

Remember that Paxil must never be combined with Mellaril or MAO inhibitors such as Nardil and Parnate.

If Paxil is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Paxil with any of the following:

Alcohol Antidepressants such as Elavil, Tofranil, Norpramin, Pamelor, Prozac
Cimetidine (Tagamet)
Diazepam (Valium)
Digoxin (Lanoxin)
Flecainide (Tambocor)
Lithium (Eskalith)
Phenobarbital Phenytoin (Dilantin)
Procyclidine (Kemadrin)
Propafenone (Rythmol)
Propranolol (Inderal, Inderide)
Quinidine (Quinaglute)
Sumatriptan (Imitrex)
Tryptophan
Warfarin (Coumadin)

Special information if you are pregnant or breastfeeding

The effects of Paxil during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Paxil appears in breast milk and could affect a nursing infant. If this medication is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment with Paxil is finished.

Recommended dosage for Paxil

DEPRESSION

The usual starting dose is 20 milligrams a day, taken as a single dose, usually in the morning. At intervals of at least 1 week, your physician may increase your dosage by 10 milligrams a day, up to a maximum of 50 milligrams a day.

OBSESSIVE-COMPULSIVE DISORDER

The usual starting dose is 20 milligrams a day, typically taken in the morning. At intervals of at least 1 week, your doctor may increase the dosage by 10 milligrams a day. The recommended long-term dosage is 40 milligrams daily. The maximum is 60 milligrams a day.

PANIC DISORDER

The usual starting dose is 10 milligrams a day, taken in the morning. At intervals of 1 week or more, the doctor may increase the dose by 10 milligrams a day. The target dose is 40 milligrams daily; dosage should never exceed 60 milligrams.

GENERALIZED ANXIETY DISORDER

The recommended dose is 20 milligrams taken once a day, usually in the morning.

SOCIAL ANXIETY DISORDER

The recommended dose is 20 milligrams taken once a day, usually in the morning. For older adults, the weak, and those with severe kidney or liver disease, starting doses are reduced to 10 milligrams daily, and later doses are limited to no more than 40 milligrams a day. Safety and effectiveness in children have not been established.

POSTTRAUMATIC STRESS DISORDER

The recommended dose is 20 milligrams taken once a day, usually in the morning.

Overdosage of Paxil

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

The symptoms of Paxil overdose may include: Coma, dizziness, drowsiness, facial flushing, nausea, sweating, tremor, vomiting

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Paroxetine Full Prescription Information
Paxil Medication Guide

Detailed Info on Signs, Symptoms, Causes, Treatments of Depression

Detailed Info on Signs, Symptoms, Causes, Treatments of OCD

Detailed Info on Signs, Symptoms, Causes, Treatments of Anxiety Disorders

back to: Psychiatric Medication Patient Information Index

PAXIL 0.02 N30 TABLE P / PLEN / SHELL

Absorption

After oral administration, paroxetine is well absorbed from the gastrointestinal tract. Food intake does not affect absorption.

Distribution

Css is set by 7-14 days from the start of therapy. The clinical effects of paroxetine (side effects and efficacy) do not correlate with its plasma concentration.

Paroxetine is extensively distributed in tissues, and pharmacokinetic calculations show that only 1% of it is present in plasma, and at therapeutic concentrations 95% is in protein bound form.

It has been established that paroxetine in small amounts is excreted in breast milk, and also penetrates the placental barrier.

Metabolism

The main metabolites of paroxetine are polar and conjugated products of oxidation and methylation. Due to the low pharmacological activity of metabolites, their effect on the therapeutic efficacy of the drug is unlikely.

Since the metabolism of paroxetine includes the stage of “first pass” through the liver, its amount determined in the systemic circulation is less than that absorbed from the gastrointestinal tract.With an increase in the dose of paroxetine or with repeated dosing, when the load on the body increases, there is a partial absorption of the effect of the “first pass” through the liver and a decrease in the plasma clearance of paroxetine. As a result, an increase in the concentration of paroxetine in plasma and fluctuations in pharmacokinetic parameters are possible, which can be observed only in those patients in whom, when taking low doses, low plasma levels of the drug are achieved.

Excretion

It is excreted in the urine (unchanged – less than 2% of the dose and in the form of metabolites – 64%) or with bile (unchanged – 1%, in the form of metabolites – 36%).

T1 / 2 varies, but averages 16-24 hours.

The elimination of paroxetine is biphasic, including primary metabolism (first phase) and subsequent systemic elimination.

With long-term continuous administration of the drug, pharmacokinetic parameters do not change.

Pharmacokinetics in special clinical situations

In elderly patients, the plasma concentration of paroxetine is increased, and the range of plasma concentrations in them almost coincides with the range of healthy adult volunteers.

In patients with severely impaired renal function (CC less than 30 ml / min) and in patients with impaired liver function, the plasma concentration of paroxetine is increased.

instructions for use, analogs, composition, indications

Treatment with paroxetine should be started with caution 2 weeks after discontinuation of irreversible MAO inhibitors, or 24 hours after discontinuation of reversible MAO inhibitors. The dose of paroxetine should be increased gradually until an optimal response to treatment is achieved (see section 4.4).sections “Contraindications” and “Interaction with other drugs and other types of interactions”).

Use in children and adolescents (under 18 years of age)

Paroxetine should not be used in children and adolescents under 18 years of age.

In clinical studies, adverse events associated with suicidal attempts and suicidal thoughts, hostility (mainly aggression, deviant behavior and anger) were more often observed in children and adolescents who received antidepressants than in patients of this age group who received placebo.If, based on clinical need, a decision on treatment is nevertheless made, patients should be carefully monitored for the occurrence of suicidal symptoms. There are currently no data on the long-term safety of paroxetine in children and adolescents regarding the effects of this drug on growth, maturation, cognitive and behavioral development.

Clinical deterioration and suicidal risk in adults

Patients with depression are at increased risk of suicidal ideation, suicidal behavior and self-harm.This risk persists until significant remission is achieved. Improvement in the patient’s condition may be absent in the first weeks of treatment or more, and therefore the patient must be closely monitored until the condition improves. Clinical experience with all antidepressants shows that the risk of suicide may increase in the early stages of recovery.

Other psychiatric disorders treated with paroxetine may also be associated with an increased risk of suicidal behavior.In addition, these disorders can be comorbid conditions accompanying major depressive disorder. Therefore, the same precautions should be followed when treating patients with other psychiatric disorders as when treating major depressive disorder.

Patients with a history of suicidal behavior or suicidal thoughts and those with severe suicidal thoughts prior to starting treatment are at greatest risk for suicidal thoughts or attempts, and therefore all need to be given special attention during treatment.A meta-analysis of placebo-controlled studies in adults with mental illness shows an increase in the incidence of suicidal behavior in young patients under the age of 25 while taking antidepressants compared with placebo.

Treatment of patients, and especially patients at high risk, should be closely monitored, especially at the beginning of treatment and when changing the dose of the drug. Patients (and their caregivers) should be warned about the need to watch for signs of worsening clinical condition, occurrence of suicidal thoughts / suicidal behavior, unusual changes in behavior.If you experience these symptoms, you should seek immediate medical attention.

Akatizia / psychomotor agitation

The use of paroxetine may be accompanied by the occurrence of akathisia, which is manifested by a feeling of internal anxiety and psychomotor agitation, when the patient cannot sit or stand still, which is usually associated with subjective discomfort. The likelihood of developing akathisia is highest in the first few weeks of treatment.If these symptoms occur, increasing the dose may worsen the condition.

Serotonin Syndrome / Neuroleptic Malignant Syndrome

In rare cases, during treatment with paroxetine, serotonin syndrome or symptoms similar to neuroleptic malignant syndrome may occur, especially if paroxetine is used in combination with other serotonergic drugs and / or antipsychotics.These syndromes pose a potential threat to life, and therefore treatment with paroxetine should be discontinued if these phenomena occur (they are characterized by groups of symptoms such as hyperthermia, muscle rigidity, myoclonus; autonomic disorders with possible rapid changes in vital signs; changes in mental status, including confusion , irritability, extremely severe agitation, progressing to delirium and coma) start supportive symptomatic therapy.Paroxetine should not be prescribed in combination with serotonin precursors (such as L-tryptophan, oxytriptan) due to the risk of developing serotonergic syndrome (see sections “Contraindications” and “Interaction with other medicinal products and other forms of interaction”).

Mania

As with other antidepressants, paroxetine should be used with caution in patients with a history of mania. Paroxetine should be discontinued in any patient entering the manic phase.

Renal or liver dysfunction

Caution is advised when treating with paroxetine in patients with severe renal impairment and in patients with impaired liver function.

Diabetes

In patients with diabetes mellitus, the use of SSRIs can lead to a change in glycemic control. Dose adjustment of insulin and / or oral hypoglycemic agents may be required. In addition, some studies suggest that the combined use of paroxetine and pravastine may lead to an increase in blood glucose levels (see.section “Interaction with other medicinal products and other types of interactions).

Epilepsy

Like other antidepressants, paroxetine should be used with caution in patients with epilepsy.

Seizures

The incidence of seizures in patients taking paroxetine is less than 0.1%. If a seizure occurs, treatment with paroxetine should be discontinued.

Electroconvulsive therapy

There is limited clinical experience with the concomitant use of paroxetine and electroconvulsive therapy.

Glaucoma

Like other SSRIs, paroxetine can cause mydriasis and should be used with caution in patients with angle-closure glaucoma or a history of glaucoma.

Heart disease

Normal precautions should be followed when treating patients with heart disease.

Hyponatremia

In rare cases of the use of paroxetine, mainly in elderly patients, the development of hyponatremia has been reported.Caution should also be observed in patients at increased risk of hyponatremia due to concomitant medications and in patients with cirrhosis. Hyponatremia usually disappears after discontinuation of paroxetine.

Bleeding

There are reports of hemorrhages in the skin and mucous membranes (such as ecchymosis and purpura), as well as gastrointestinal and gynecological bleeding in patients using SSRIs. Elderly patients may be at increased risk of developing non-menstrual bleeding.

Therefore, paroxetine should be used with caution in patients who are simultaneously receiving oral anticoagulants, drugs that affect platelet function, or other drugs that increase the risk of bleeding (atypical antipsychotics such as clozapine, phenothiazines, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, inhibitors of CO 2, most tricyclic antidepressants), as well as in patients with a history of bleeding and in patients with bleeding predisposing diseases (see.section “Side effects”).

Interactions with tamoxifen

The use of paroxetine, a potent inhibitor of CYP2D6, may decrease the concentration of endoxifen, one of the most important active metabolites of tamoxifen. Therefore, if possible, the use of paroxetine should be avoided during treatment with tamoxifen.

Symptoms that may occur upon discontinuation of paroxetine treatment

When treatment with paroxetine is discontinued, especially when abruptly discontinued, withdrawal symptoms often occur.In clinical studies, the incidence of adverse events with paroxetine withdrawal was 30%, while the incidence of adverse events in the placebo group was 20%. The onset of withdrawal symptoms does not mean that the drug is abused or addictive.

The risk of withdrawal symptoms depends on various factors, including the duration of treatment, the dose of the drug taken, and the rate of dose reduction.

Withdrawal symptoms described as dizziness, sensory disturbances (including paresthesias, electric shock and tinnitus), sleep disturbances (including vivid dreams), agitation or anxiety, nausea, tremors, confusion, sweating, headaches, diarrhea , heart palpitations, irritability, emotional lability, visual disturbances.These symptoms are usually mild to moderate, but in some patients they can be severe. They usually occur in the first few days after stopping treatment, but there are very rare reports of their occurrence in patients who inadvertently skipped the drug. Typically, these symptoms resolve spontaneously and disappear within two weeks, but in some patients they may last longer (two to three months or more). It is recommended that the dose of paroxetine be reduced gradually over several weeks or months, depending on the needs of the individual patient.

Bone fractures

Based on the results of epidemiological studies of the risk of bone fractures, an association of this risk with the use of antidepressants, including the SSRI group, has been revealed. The risk occurs during the course of antidepressant treatment and is greatest during the initial stages. The possibility of bone fractures should be considered when prescribing paroxetine.

Interaction with other medicinal products and other types interactions

Serotonergic drugs:

The use of paroxetine, like other drugs of the SSRI group, simultaneously with serotonergic drugs can cause effects associated with 5-HT (serotonin syndrome).When using serotonergic drugs (including L-tryptophan, triptans, tramadol, linezolid, methylthioninium chloride (methylene blue), SSRI drugs, pethidine, lithium and herbal remedies containing St. John’s wort) in combination with paroxetine, care must be taken and careful clinical monitoring … Caution should be exercised when combined with fentanyl, used in general anesthesia or in the treatment of chronic pain. The use of paroxetine with MAO inhibitors is contraindicated due to the risk of serotonin syndrome.

Pimozide:

In a study of the combined use of paroxetine (at a dose of 60 mg) and pimozide at a low dose (2 mg once), an increase in the level of pimozide was recorded, on average by 2.5 times. This fact is explained by the known property of paroxetine to inhibit CYP2D6. Due to the narrow therapeutic index of pimozide and its known ability to prolong the QT interval, the concomitant use of pimozide and paroxetine is contraindicated.

Enzymes involved in the metabolism of drugs: The metabolism and pharmacokinetics of paroxetine can be altered by the induction or inhibition of enzymes involved in its metabolism.

When paroxetine is used concomitantly with a known inhibitor of such enzymes, the use of paroxetine at doses in the lower end of the therapeutic dose range should be considered. The initial dose does not need to be adjusted if it is used concomitantly with which is a known enzyme inducer (eg, carbamazepine, rifampicin, phenobarbital, phenytoin), or with fosamprenavir / ritonavir. Any dose adjustment of paroxetine (after starting or stopping the intake of an enzyme inducer) should be determined by its clinical effects (tolerance and efficacy).

Neuromuscular blockers:

Preparations of the SSRI group can reduce the activity of cholinesterase in plasma, which leads to a longer neuromuscular blocking activity of mivacuria and suxamethonium.

Fosamprenavir / ritonavir:

Concomitant use of fosamprenavir / ritonavir 700/100 mg twice daily with paroxetine 20 mg / day in healthy volunteers for 10 days resulted in a significant decrease in the plasma concentration of paroxetine by approximately 55%, while the plasma levels of fosamprenavir / ritonavir were similar to values ​​observed in other studies, indicating that paroxetine did not significantly affect fosamprenavir / ritonavir metabolism.There are no data on long-term (more than 10 days) co-administration of paroxetine and fosamprenavir / ritonavir.

Procyclidine:

Daily administration of paroxetine significantly increases plasma concentrations of procyclidine. If anticholinergic effects occur, the dose of procyclidine should be reduced.

Anticonvulsants: The simultaneous use of paroxetine and carbamazepine, phenytoin or sodium valproate does not affect their pharmacokinetics and pharmacodynamics in patients with epilepsy.

The ability of paroxetine to inhibit the enzyme CYP2D6

Like other antidepressants, including other SSRIs, paroxetine inhibits the hepatic enzyme CYP2D6, which belongs to the cytochrome P450 system. Inhibition of the CYP2D6 enzyme can lead to an increase in plasma concentrations of simultaneously used drugs that are metabolized by this enzyme. These drugs include tricyclic antidepressants (for example, clomipramine, nortriptyline, and desipramine), phenothiazine antipsychotics (perphenazine and thioridazine), risperidone, atomoxetine, some class 1c antiarrhythmics (for example, propafenone and flecainide.) And metoprololide.It is not recommended to use paroxetine simultaneously with metoprolol in heart failure due to the narrow therapeutic index of metoprolol when used for this indication.

The literature reported a pharmacokinetic interaction between CYP2D6 inhibitors and tamoxifen, which led to a decrease in plasma levels of one of the more active forms of tamoxifen, endoxifen, by 65-75%. A decrease in the effectiveness of tamoxifen has been reported when used together with some antidepressants of the SSRI group.Since the possibility of a decrease in the effectiveness of tamoxifen cannot be ruled out, its combined use with potent inhibitors of CYP2D6 (including paroxetine) should be avoided whenever possible.

Alcohol

As with other psychotropic drugs, patients receiving paroxetine should be warned to avoid alcohol.

Oral anticoagulant s

There is a potential for pharmacodynamic interaction between paroxetine and oral anticoagulants.The concomitant administration of paroxetine and oral anticoagulants can lead to an increase in the anticoagulant activity of the blood and an increased risk of bleeding. Therefore, paroxentin should be used with caution in patients treated with oral anticoagulants.

Non-steroidal anti-inflammatory drugs NSAIDs and Acetylsalicylic acid, other antiplatelet agents

There is a possibility of a pharmacodynamic interaction between paroxetine and NSAIDs / acetylsalicylic acid.Concomitant use of paroxetine and NSAIDs / acetylsalicylic acid may increase the risk of bleeding. SSRI drugs should be used with caution in patients who are simultaneously receiving oral anticoagulants, drugs that affect platelet function or increase the risk of bleeding (atypical antipsychotics such as clozapine, phenothiazines, acetylsalicylic acid, NSAIDs, COX-2 inhibitors, most tricyclic antidepressants) , as well as in patients with a history of bleeding disorders or other conditions that predispose to bleeding.

Pravastatin

In the course of studies, an interaction was observed between paroxetine and pravastatin, suggesting that the combined use of these drugs may lead to an increase in blood glucose levels. In patients with diabetes mellitus receiving paroxetine and pravastatin, dose adjustment of oral hypoglycemic agent and / or insulin may be required (see section “Precautions”).

Use during pregnancy and lactation

Several epidemiological studies have found an increased risk of congenital anomalies, in particular of the cardiovascular system (eg, ventricular and atrial septal defects), associated with paroxetine intake during the first trimester of pregnancy.The mechanism is not known. According to the data, the incidence of defects of the cardiovascular system with the use of paroxetine during pregnancy is less than 2/100, while the expected incidence of such defects in the general population is approximately equal to 1/100 of newborns.

Paroxetine should be used during pregnancy only if strictly indicated. The attending physician should consider alternative treatment for women who are pregnant or planning to become pregnant. Abrupt withdrawal of paroxetine should be avoided during pregnancy.

It is necessary to carefully monitor the health of those newborns whose mothers took paroxetine late in pregnancy, in particular, in the third trimester.

When mothers take paroxetine in late stages of pregnancy, newborns may experience the following symptoms: respiratory distress syndrome, cyanosis, apnea, seizures, temperature instability, feeding difficulties, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremor, nervous irritability, irritability, lethargy, constant crying, drowsiness, and trouble sleeping.Symptoms can be caused by serotonergic effects or be a manifestation of withdrawal symptoms. In most cases, the described complications occurred immediately after childbirth or shortly after them (

According to epidemiological studies, taking SSRI drugs during pregnancy, in particular in late pregnancy, is associated with an increased risk of persistent pulmonary hypertension in newborns. The observed risk was approximately 5 per 1000 pregnancies.In the general population, the risk is 1-2 per 1000 pregnancies.

Animal studies have shown reproductive toxicity of paroxetine, but have not shown any adverse effects on pregnancy, embryonic / fetal development, childbirth or postpartum development.

Small amounts of paroxetine pass into breast milk. According to published studies, serum paroxetine concentrations have not been determined in breastfed infants (

Animal studies have shown that paroxetine can affect semen quality.Data from in vitro studies of human material indicate a possible effect on sperm quality, but reports from several SSRIs (including paroxetine) indicate that the effect on sperm quality is reversible.

No effect on human fertility has been observed to date.

Influence on the ability to drive a car and / or other mechanisms

Clinical experience with paroxetine shows that it does not impair cognitive and psychomotor functions.However, as in the treatment of any other psychotropic drugs, patients should be especially careful when driving a car and working with mechanisms.

Despite the fact that paroxetine does not increase the negative effects of alcohol on thinking and psychomotor functions, the simultaneous use of paroxetine and alcohol is not recommended.

Form of issue

10 tablets in PVC / aluminum foil / paper blisters. 3 blisters, together with instructions for use, are placed in a cardboard box.

Expiry date Expiration date

3 years. Do not use after the expiration date stated on the package.

instructions, reviews, price in the Pharmacy NTs

Composition

active ingredient: paroxetine.

1 tablet contains paroxetine (in the form of hemihydrate hydrochloride) 20 mg

excipients: calcium phosphate dibasic (dihydrate), sodium starch (type A), magnesium stearate, Opadry White YS-1R-7003 (hypromellose, titanium dioxide (E 171), polyethylene glycol 400, polysorbate 80).

Dosage form.

Film-coated tablets.

Basic physical and chemical properties: white, film-coated, oval biconvex tablets marked “20” on one side and a distribution line on the other.

Pharmacological group.

Antidepressants.

ATX code N06A B05.

Pharmacological properties.

Pharmacodynamics

Paxil is a potent selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) reuptake.Its antidepressant effect and efficacy in the treatment of obsessive-compulsive and panic disorders is due to the specific inhibition of the uptake of 5-hydroxytryptamine by brain neurons. In its chemical structure, Paxil differs from tricyclic, tetracyclic and other known antidepressants.

The drug has a low affinity for muscarinic cholinergic receptors. He, in contrast to tricyclic antidepressants, has a slight relationship with alpha 1 -, alpha 2 – and beta-adrenergic receptors, dopamine (D 2), 5-HT 1 shaped, 5-HT 2 – and histamine (H 1 -) receptors; does not affect psychomotor function and does not enhance the depressive effect of ethanol.

Paxil does not affect the activity of the cardiovascular system; does not cause clinically significant changes in blood pressure, heart rate and ECG parameters.

Paxil, in contrast to antidepressants, which inhibit the uptake of norepinephrine, to a much lesser extent affects the hypotensive effect of guanethidine.

Pharmacokinetics

After administration, it is rapidly absorbed and undergoes transformation in the liver.

The main metabolites of the active substance Paxil (paroxetine) are polar and conjugated products of oxidation and methylation, which are rapidly excreted from the body.

Approximately 64% of the paroxetine dose is excreted in the urine, while the amount of paroxetine excreted unchanged is less than 2%. Approximately 36% of the dose of paroxetine taken is excreted in the feces as metabolites.

Paroxetine metabolites are excreted in two stages – first by first pass metabolism through the liver, and then by systemic excretion of paroxetine.

The half-life on average is approximately 1 day.

A constant blood concentration is achieved 7-14 days after the start of treatment, and during the subsequent long-term treatment, the pharmacokinetics of the drug almost does not change.

No correlation was found between the plasma concentration of paroxetine and the clinical effect (efficacy and adverse reactions).

Due to the disintegration of the drug in the liver, the amount of paroxetine circulating in the blood is less than the amount absorbed in the gastrointestinal tract. With an increase in a single dose or with multiple dosing, the effect of partial saturation of the metabolic pathway of the first passage through the liver occurs and a decrease in clearance is observed. This leads to a disproportionate increase in the concentration of paroxetine in blood plasma and changes in pharmacokinetic parameters with the appearance of a non-linear relationship.However, this nonlinearity of the part is insignificant and is observed only in patients in whom, when using low doses, a small concentration in the blood plasma is achieved.

Paroxetine is widely distributed in body tissues. The value of the calculated pharmacokinetic parameters indicate that only 1% of the dose taken remains in the blood plasma.

When used in therapeutic concentrations, approximately 95% of paroxetine binds to plasma proteins.

In elderly patients and patients with renal or hepatic insufficiency, an increase in the concentration of paroxetine in the blood plasma is observed, but it does not go beyond the concentration fluctuations in healthy adults.

Indications

Adults

Major depressive disorder. Treatment of major depressive disorder.

Obsessive-compulsive disorder. Treating symptoms and preventing relapse of obsessive-compulsive disorder.

Panic disorder. Treating symptoms and preventing recurrence of panic disorder, with or without concomitant agoraphobia.

Social phobias / social anxiety disorders. Treatment of social phobias / social anxiety conditions.

Generalized anxiety disorder. Treating symptoms and preventing recurrence of generalized anxiety disorder.

Post-traumatic stress disorder. Treatment of PTSD.

Contraindications

Hypersensitivity to paroxetine or to any other component of the drug.

Paxil should not be administered concurrently with MAO inhibitors (MAO), including linezolid – an antibiotic, is an inverse non-selective MAO inhibitor and methylthionine chloride (methylene blue), and earlier than 2 weeks after stopping treatment with MAO inhibitors.Similarly, MAO inhibitors can be used no earlier than 2 weeks after discontinuation of Paxil treatment (see Section “Interaction with other medicinal products and other types of interactions”).

The drug should not be used in combination with thioridazine, because, like other drugs that suppress the hepatic enzyme CYP450 2D6, Paxil can increase the level of thioridazine (see Section “Interaction with other drugs and other forms of interaction”). The use of thioridazine can cause prolongation of the QT interval with associated severe ventricular arrhythmias (eg torsades de pointes) and sudden death.Paxil should not be administered in combination with pimozide (see Section “Interaction with other medicinal products and other forms of interaction”).

Interaction with other drugs and other forms of interaction

Serotonergic drugs

As with the use of other selective serotonin reuptake inhibitors, combined use with serotonergic drugs can lead to a 5-HT-associated effect (serotonin syndrome).

Paxil should be used with serotonergic drugs such as L-tryptophan, triptans, tramadol, other serotonin reuptake inhibitors, lithium, fentanyl, and the herb Hypericum perforatum, St. John’s wort, with caution and with mandatory careful monitoring of the patient’s clinical condition. Concomitant use of paroxetine and MAO inhibitors (including linezolid, an antibiotic, an inverse non-selective MAO inhibitor, and methylthionine chloride (methylene blue)) is contraindicated (see.”Contraindications”).

Pimozide

According to a study on the combined use of a single low dose of pimozide (2 mg) and paroxetine, an increase in the level of pimozide was recorded. This was explained by the known CYP2D6 inhibitory properties of paroxetine. Due to the narrow therapeutic index of pimozide and its ability to lengthen the QT interval, the combined use of pimozide and paroxetine is contraindicated (see “Contraindications”).

Enzymes involved in drug metabolism

The metabolism and pharmacokinetics of paroxetine can be altered by induction or inhibition of enzymes involved in drug metabolism.

With the simultaneous use of paroxetine with drugs that inhibit enzymes, it is recommended to prescribe the smallest effective dose. When used together with drugs that induce enzymes (carbamazepine, rifampicin, phenobarbital, phenytoin), there is no need to change the initial dose of paroxetine. It is necessary to change the dose during subsequent treatment in accordance with the clinical effect (tolerance and efficacy).

Muscle relaxants

Selective serotonin reuptake inhibitors can reduce the activity of plasma cholinesterase, which leads to an increase in the neuromuscular blockade effect of mivacurium and suxamethonium.

Fosam converting / ritonavir

Combining fosamprenavir / ritonavir with paroxetine significantly reduces the plasma level of paroxetine. It is necessary to change the dose during subsequent treatment depending on the clinical effect (tolerance and efficacy).

Procyclidine

Daily use of paroxetine significantly increases the level of procyclidine in the blood serum. In the event of anticholinergic effects, the dose of procyclidine should be reduced.

Anticonvulsants

Carbamazepine, phenytoin, sodium valproate. When used together with these drugs, there is no effect on the pharmacokinetics / pharmacodynamics of the drug in patients with epilepsy.

The ability of paroxetine to suppress the CYP2D6 enzyme

Paxil, like other antidepressants, are inhibitors of serotonin reuptake, slows down the activity of the CYP2D6 enzyme of the cytochrome P450 system. Inhibition of CYP2D6 can lead to an increase in the plasma concentration of simultaneously administered drugs metabolized by this enzyme.These drugs include some tricyclic antidepressants (for example, amitriptyline, nortriptyline, imipramine, and desipramine), phenothiazine antipsychotics (for example, perphenazine and thioridazine), risperidone, atomoxetine, and some type 1c antiarrhythmics (for example, propafenone and metopecainide).

Tamoxifen has an important active metabolite endoxifen produced by CYP2D6 and is an important part of the effectiveness of tamoxifen. Irreversible inhibition of CYP2D6 with paroxetine leads to a decrease in the concentration of endoxifen in blood plasma (see.Section “Features of application”).

CYP3A4

In in vivo experiments, the combined use of Paxil and terfenadine, a substrate for the CYP3A4 enzyme, when a constant blood concentration was reached, was not accompanied by the effect of Paxil on the pharmacokinetics of terfenadine. A similar in vivo study of the interaction did not reveal any effect of the drug on the pharmacokinetics of alprazolam and vice versa. The simultaneous administration of Paxil and terfenadine, alprozalam and other drugs that are substrates for CYP3A4 cannot be dangerous.

During clinical studies, it was found that the absorption or pharmacokinetics of Paxil are not affected or hardly affected (that is, do not require a change in dosage) by the following factors: food, antacids, digoxin, propranolol, alcohol.

Paxil does not increase the disturbances of mental and motor reactions caused by alcohol, however, it is not recommended to consume alcoholic beverages during Paxil treatment.

Oral anticoagulants.

With the combined use of oral anticoagulants and paroxetine, pharmacodynamic interaction is possible, it can cause an increase in anticoagulant activity and the risk of bleeding.Therefore, paroxetine should be used with caution in patients treated with oral anticoagulants.

Nonsteroidal anti-inflammatory drugs, acetylsalicylic acid and antiplatelet agents.

With the combined use of non-steroidal anti-inflammatory drugs / acetylsalicylic acid and paroxetine, pharmacodynamic interaction may occur, which may increase the risk of bleeding. Paroxetine should be used with caution in conjunction with drugs that affect platelet function or increase the risk of bleeding.

Pravastatin.

Interaction between paroxetine and pravastatin, which has been observed in studies, suggests that the simultaneous use of paroxetine and pravastatin can lead to an increase in blood glucose levels. Patients with diabetes mellitus receiving both paroxetine and pravastatin may need to adjust the dose of oral antidiabetic agents and / or insulin (see section “Peculiarities of use”).

Application features

Children and adolescents.

Treatment with antidepressants is associated with an increased risk of suicidal behavior and thoughts in children and adolescents with severe depressive and other mental disorders. According to clinical studies, side effects associated with suicidality (attempted suicide and suicidal thoughts) and hostility (predominantly aggressive, opposing behavior and irritability) were observed in the treatment of children and adolescents with Paxil more often compared with the placebo group (see.Section “Adverse Reactions”). There are no results of studying the safety of the drug for children and adolescents in terms of height, development, cognitive and behavioral characteristics.

Deterioration of the clinical condition and the risk of suicide in adults.

Young adults, especially those with severe depressive disorders, may have an increased risk of suicidal behavior during Paxil treatment. An analysis of placebo-controlled clinical trials involving adults with mental disorders showed that young adults (approximately 18-24 years old) had a greater risk of developing suicidal behavior than patients with placebo groups (17 of 776 (2, 19%) compared to 5 from 542 (0.92%)), although this difference is not statistically significant.In the group of older patients (25-64 years old and over 65 years old), such an increase in risk was not found. In patients with severe depressive disorders (of any age), Paxil was used, there was a statistically significant increase in the incidence of suicidal behavior compared with the placebo group (11 out of 3455 (0.32%) compared with 1 since 1978 (0.05%) , all these cases were suicide attempts). However, most of these attempts (8 out of 11) in the treatment of Paxil occurred in young adult patients aged 18-30 years.These data on the treatment of major depressive disorders suggest that the high risk of these complications, which was observed in the group of young patients with mental disorders, may be extended to patients aged 24 years and older.

Patients with depressive disorders may have exacerbated symptoms of depression and / or develop suicidal thinking and behavior (suicidality), regardless of whether they are taking antidepressants or not. This risk persists until significant remission occurs.A common clinical experience with all antidepressant courses is that the risk of suicide may increase in the early stages of recovery.

Other mental disorders for which Paxil is prescribed may be associated with an increased risk of suicidal behavior, and such disorders may also be associated with major depressive disorders. In addition, patients with suicidal behavior and corresponding intentions in the past, young patients and patients with a persistent suicidal mood before the start of treatment are a group at increased risk of suicidal attempts and suicidal thoughts.All patients should be closely monitored for deterioration of the clinical condition (including the development of new symptoms) and suicidality during treatment, especially at the beginning of the course of treatment or when the dosage is changed (both increase and decrease).

Patients (and their caregivers) should be warned about the need for constant monitoring of any exacerbation of the patient’s condition (including the development of new symptoms) and / or the appearance of suicidal intentions / behavior or thoughts of self-harm and immediately seek medical help in if they appear.It should be understood that the onset of certain symptoms, such as agitation, akathisia or mania, may be associated with both the course of the disease and the course of treatment (see “Akathisia”, “Mania and bipolar disorder” below, section “Adverse reactions”) …

The possibility of changing the therapeutic regimen, including discontinuation of the drug, should be considered for patients with clinical worsening of the condition (including the development of new symptoms) and / or the appearance of suicidal intentions / behavior, especially if these symptoms are severe, occur suddenly or are not part of the previous symptom complex this patient.

Akathisia.

Rarely, the use of Paxil or other selective serotonin reuptake inhibitors may be associated with the development of akathisia, a condition characterized by feelings of internal anxiety and psychomotor agitation, such as the inability to sit or stand still, combined with a subjective feeling of discomfort. This is most likely to occur during the first weeks of treatment.

Serotonin syndrome / neuroleptic malignant syndrome.

In rare cases, Paxil treatment may be associated with the development of serotonin syndrome or symptoms characteristic of neuroleptic malignant syndrome, especially when used together with other serotonergic and / or neuroleptic drugs. Since these syndromes can cause life-threatening conditions, Paxil treatment should be discontinued if such phenomena appear (characterized by a combination of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid changes in the main indicators of the functional state of the body, changes in mental status, including confusion , irritability, extreme agitation with progression to delirium and coma) and prescribe supportive symptomatic therapy.Paxil should not be used in combination with serotonin precursors (such as L-tryptophan,

Mania and bipolar disorder.

Major depressive episode may be the initial manifestation of bipolar disorder. episodes with antidepressant medication alone may increase the likelihood of accelerating the onset of mixed / manic episodes in patients at increased risk of developing bipolar disorder.Before starting treatment with antidepressants, patients should be carefully evaluated to identify any risk of bipolar disorder. This examination should include a detailed examination of the patient’s medical history, including the presence of suicidal attempts, bipolar disorder, and depression in family members. Please note that Paxil is not approved for the treatment of depression in bipolar disorder. Like other antidepressants, Paxil should be used with caution in patients,

Tamoxifen

According to some studies, it has been found that the effectiveness of tamoxifen, as measured by the risk of breast cancer recurrence / death, can be reduced when used together with Paxil, because paroxetine is an irreversible inhibitor of CYP2D6 (see.Section “Interaction with other medicinal products and other types of interactions”). This risk increases with the duration of joint use. When treating breast cancer with tamoxifen, the patient is prescribed an alternative antidepressant with little or no inhibition of CYP2D6.

Bone fractures

According to epidemiological studies on the risk of bone fractures, with the use of certain antidepressants, including selective serotonin reuptake inhibitors, an association with fractures has been reported.The risk arises during treatment and is greatest in the initial stages of therapy. When treating patients with Paxil, the possibility of bone fractures should be weighed.

Monoamine oxidase inhibitors.

Treatment with Paxil should be started with caution, no earlier than 2 weeks after stopping the administration of MAO inhibitors; the dose should be increased gradually until an optimal response is achieved.

Renal / hepatic failure.

Recommended for use with caution in patients with severe renal or hepatic impairment.

Diabetes mellitus.

In diabetic patients, treatment with serotonin reuptake inhibitors can alter the glycemic profile, therefore the dose of insulin and / or oral antidiabetic drugs should be adjusted. Additionally, clinical studies indicate that an increase in blood glucose levels can be observed with concomitant treatment with paroxetine and pravastatin.

Epilepsy.

Paxil, like other antidepressants, should be used with caution in the treatment of patients with epilepsy.

Attacks.

In patients treated with Paxil, the overall frequency of seizures is less than 0.1%.

If a patient develops seizures, Paxil should be discontinued.

Electroconvulsive therapy.

There is little clinical experience with the use of Paxil in combination with electroconvulsive therapy.

Glaucoma.

Paxil, like other serotonin reuptake inhibitors, can cause mydriasis, so it should be used with caution in patients with angle-closure glaucoma.

Hyponatremia.

Sometimes there have been cases of hyponatremia, mainly in elderly patients. After discontinuation of Paxil, the signs of hyponatremia generally subsided.

Hemorrhages.

After treatment with Paxil, hemorrhages in the skin and mucous membranes (including gastrointestinal and gynecological bleeding) were observed. Therefore, Paxil should be used with caution in the treatment of patients who are simultaneously prescribed drugs that increase the risk of bleeding, as well as patients with frequent bleeding or with a predisposition to them.Elderly patients may have an increased risk of bleeding that is not associated with menstruation.

Heart disease.

The usual precautions should be followed when treating patients with underlying heart disease.

Symptoms observed in adults when Paxil is discontinued.

According to clinical studies, in adults, adverse reactions with discontinuation of Paxil treatment occurred in 30% of patients compared with 20% of patients who received placebo.The onset of symptoms when a drug is discontinued is not similar to a situation where addiction or dependence on the drug occurs when it is abused.

Symptoms have been reported such as dizziness, sensory disturbances (including paresthesias, electric shock and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremors, confusion, excessive sweating, headache, diarrhea … In general, these symptoms are mild or moderate, although they may be more intense in some patients.They usually occur within the first few days after discontinuation of the drug, but there have been isolated cases of these symptoms in patients who accidentally missed a single dose. Usually these symptoms go away on their own within 2 weeks, although in some patients this process can be long (2-3 months or longer). Therefore, it is recommended that when Paxil is discontinued, the dose should be reduced gradually, over several weeks or months,

Symptoms observed in children and adolescents when Paxil is discontinued.

According to clinical studies, in children and adolescents, adverse reactions with discontinuation of Paxil treatment occurred in 32% of patients compared with 24% of patients who received placebo. After discontinuation of Paxil, the following side effects occurred (with a frequency of at least 2% of patients, with a frequency of occurrence twice as high as compared with the placebo group): emotional lability (including suicidal intentions, suicide attempts, mood changes and tearfulness), nervousness , dizziness, nausea and abdominal pain (see.section “Adverse reactions”).

Application during pregnancy or lactation

Fertility.

Several clinical studies have shown that selective serotonin reuptake inhibitors, including Paxil, can affect sperm quality. It is believed that these phenomena disappear after discontinuation of treatment. Changes in sperm quality can affect fertility in some men.

Pregnancy.

According to animal studies, no teratogenic or embryotoxic effect was found.

According to epidemiological studies monitoring the results of pregnancy in women treated with antidepressants in the first trimester of pregnancy, an increased risk of congenital developmental disorders, mainly cardiovascular (for example, atrial or interventricular septal defect) associated with taking paroxetine, has been reported. According to these data, it can be assumed that the risk of having an infant with a cardiovascular defect in a woman treated with paroxetine during pregnancy is about 1 in 50, compared with the expected risk of such a defect in the general population, is about 1 in 100.

The physician should consider the possibility of using alternative treatment for a pregnant woman or a woman who plans to become pregnant, and prescribe paroxetine only when the expected benefit to the mother outweighs the potential risk to the fetus. If a decision is made to discontinue treatment for a pregnant woman, for additional information, refer to the appropriate sections of the Instructions for medical use of the drug, which describe the doses and symptoms that occur when discontinuing treatment with paroxetine (see.Sections “Dosage and Administration” and “Application Features”).

There are reports of premature birth of children in women treated with Paxil or other selective serotonin reuptake inhibitors, although a causal relationship with the drug intake has not been established.

Neonates should be examined if the pregnant woman continued to take Paxil in the third trimester of pregnancy, as there are reports of the development of complications in newborns when the mother is treated with Paxil or other selective serotonin reuptake inhibitors during this period, although a causal relationship with the drug intake has not been established.The following effects have been reported: respiratory distress, cyanosis, apnea, seizures, temperature fluctuations, difficulty feeding, vomiting, hypoglycemia, hypertension, hypotension, hyperreflexia, tremors, tremors, excitability, lethargy, constant crying and drowsiness. In some reports, symptoms have been described as neonatal withdrawal symptoms. In most cases, they occur immediately or shortly (<24 hours) after delivery.

According to epidemiological studies, the use of selective serotonin reuptake inhibitors (including paroxetine) in pregnant women, especially in late pregnancy, was associated with an increased risk of persistent pulmonary hypertension in newborns.In women taking serotonin reuptake inhibitors in late pregnancy, this risk increased 4-5 times compared with the general group of patients (1-2 cases per 1000 pregnant women in the general group of patients).

Breastfeeding.

A small amount of Paxil is excreted in breast milk. No signs of the effect of the drug on newborns were found, however, Paxil should not be used during breastfeeding, unless the expected benefit to the mother outweighs the possible risk to the child.

The ability to influence the reaction rate when driving vehicles or other mechanisms

The experience of using Paxil in clinical practice indicates that this drug does not affect cognitive functions or psychomotor reactions. However, as with the use of other psychoactive drugs, patients should be warned of a possible impairment of the ability to drive vehicles or other mechanisms during treatment.

Paxil does NOT increase the disturbances of mental and motor reactions caused by alcohol, however, the combined use of Paxil and alcohol is not recommended.

Dosage and administration

General recommendations.

The drug is intended for oral administration, it is recommended to take it once a day – in the morning with meals. The tablet should be swallowed without chewing. The tablet has a break line, which allows a dose of 10 mg to be obtained if necessary.

As with all other antidepressants, the dose must be carefully selected individually during the first 2-3 weeks of treatment, and then adjusted depending on the clinical manifestations.

The course of treatment should be long enough to ensure that symptoms are relieved. This period can last several months for major depressive disorder, and even longer for obsessive-compulsive disorder and panic disorder. As with other drugs for the treatment of mental disorders, sudden discontinuation of the drug should be avoided.

Major depressive disorder. The recommended dose is 20 mg per day. For some patients, an increase in dose may be required.This should be done gradually, increasing the dose by 10 mg (up to a maximum of 50 mg per day), depending on the clinical effectiveness of the treatment.

Obsessive-compulsive disorder. The recommended dose is 40 mg per day. Treatment should be started with a dose of 20 mg per day, and then weekly increased by 10 mg per day. In some patients, improvement is observed only with a maximum dose of 60 mg per day.

Panic disorder. The recommended dose is 40 mg per day.Treatment should be started with a dose of 10 mg per day, and then weekly increased by 10 mg, depending on the clinical effect. In some patients, improvement is observed only with a maximum dose of 60 mg per day.

To reduce the risk of a possible increase in the symptoms of panic disorder, which is often observed at the beginning of treatment for this disease, it is recommended to start treatment with a low dose of the drug.

Social anxiety disorders / social phobias.The recommended dose is 20 mg per day. For some patients, the dose can be gradually increased by 10 mg per day, depending on the clinical effect of the treatment, up to 50 mg per day. The interval between dose increases should be at least 1 week.

Generalized anxiety disorder. The recommended dose is 20 mg per day. For some patients for whom 20 mg is not effective enough, the dose can be gradually increased by 10 mg per day, depending on the clinical effect, up to 50 mg per day.

Post-traumatic stress disorder. The recommended dose is 20 mg per day. For some patients for whom 20 mg is not effective enough, the dose can be gradually increased by 10 mg per day, depending on the clinical effect, up to 50 mg per day.

Cancel Paxil.

As with other drugs for the treatment of mental illness, sudden discontinuation of the drug should be avoided. During clinical studies, a gradual dose reduction regimen was used, which included a decrease in the daily dose by 10 mg per day with an interval of 1 month.After reaching the dosage regimen of 20 mg, the patients took the drug at this dose for another week before completely canceling it. If severe symptoms appear during dose reduction or after discontinuation of treatment, it is necessary to decide whether to resume treatment at the previous dose. Later, you can continue to reduce the dose, but more slowly.

Elderly patients. Treatment begins with the usual starting dose for adults, which can then be gradually increased to 40 mg per day.There have been cases of increased plasma concentrations of paroxetine in elderly patients, but the concentration range in this group of patients coincides with the corresponding range in younger patients.

Children. Paxil is not indicated for the treatment of children.

Renal and hepatic failure. In patients with severe renal failure (creatinine clearance less than 30 ml / min) or liver failure, an increase in the concentration of paroxetine in the blood plasma is observed.Therefore, for such patients, the dose should be reduced to the lower end of the dosage range.

Children

Paxil is not indicated for the treatment of children.

According to the results of controlled clinical studies, no efficacy was noted and no supporting data were obtained regarding the use of Paxil in children with depression. The safety and efficacy of the drug for children under 7 years of age has not been studied.

Overdose

In case of an overdose of Paxil, in addition to the symptoms indicated in the “Adverse reactions” section, there was an increase in body temperature, changes in blood pressure, involuntary muscle contractions, anxiety and tachycardia.

All these effects in patients mostly disappeared without serious consequences even after using a dose of 2000 mg. Sometimes coma or changes in ECG parameters were observed, deaths were very rarely noted, but mainly in such cases, Paxil was taken together with other psychotropic drugs and sometimes with alcohol.

No specific antidote known.

Treatment of overdose should include general therapeutic measures, the same as for overdose with other antidepressants.It is shown carrying out supportive treatment with control of vital signs and careful monitoring of the patient’s condition.

Adverse reactions

The side effects listed below are classified by organs and systems and by frequency of occurrence. Frequency is determined: very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10000, <1/1000) , very rare (<1/10000), including isolated cases.

Blood and lymphatic system.

Rare: increased bleeding, mainly of the skin and mucous membranes (including ecchymosis and gynecological bleeding).

Very rare: thrombocytopenia.

Immune system.

Very rare: severe and potentially fatal allergic reactions (including anaphylactoid reactions and angioedema).

Endocrine system.

Very rare: a syndrome caused by insufficient secretion of ADH.

Metabolism and digestive disorders.

Often: increased cholesterol levels, decreased appetite.

Rarely: there is information about an altered glycemic profile in patients with diabetes mellitus (see section “Peculiarities of use”).

Rare: hyponatremia. Hyponatremia is mainly observed in elderly patients and is sometimes associated with a syndrome caused by insufficient secretion of ADH.

Mental disorders.

Often: drowsiness, insomnia, agitation, abnormal dreams (including nightmares).

Rare: confusion of consciousness, hallucinations.

Rare: manic reactions, anxiety, depersonalization, panic attacks, akathisia.

Frequency unknown: suicidal ideation, suicidal behavior and aggression.

These symptoms may also be due to an underlying disease.

Nervous system.

Often: dizziness, tremors, headache.

Rare: extrapyramidal disorders.

Rare: convulsions, akathisia, restless legs syndrome.

Very rare: serotonin syndrome (may include agitation, confusion, hyperhidrosis, hallucinations, hyperreflexia, myoclonus, tachycardia and tremor).

Extrapyramidal disorders, including orofacial dystonia, are observed in patients with movement disorders or in patients treated with antipsychotics.

Organs of vision.

Often: blurred vision.

Rarely: mydriasis (see Section “Peculiarities of use”).

Very rare: acute glaucoma.

organs of hearing

Frequency unknown: ringing in the ears.

Cardiovascular system.

Rare: sinus tachycardia, postural hypotension, transient increase or decrease in blood pressure.

Rare: bradycardia.

Respiratory system.

Often: yawning.

Gastrointestinal tract.

Very common: nausea.

Often: constipation, diarrhea, vomiting, dry mouth.

Very rare: gastrointestinal bleeding.

Hepatobiliary system.

Rare: increased levels of liver enzymes.

Very rare: liver disorders (such as hepatitis, sometimes with jaundice and / or liver failure).

There are reports of increased levels of liver enzymes. Liver side reactions (such as hepatitis, sometimes associated with jaundice and / or liver failure) have also been reported very rarely. Consideration should be given to discontinuing paroxetine if elevated liver function tests persist.

Skin and subcutaneous tissue.

Often: increased sweating.

Rarely: skin rash, itching.

Very rare: severe skin adverse reactions (including polymorphic erythema, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, photosensitivity.

Urinary system.

Rare: urinary retention, urinary incontinence.

Reproductive system.

Very common: sexual dysfunction.

Rare: hyperprolactinemia / galactorrhea, menstrual irregularities (including menorrhagia, metrorrhagia, amenorrhea, delayed and irregular menstruation).

Very rare: priapism.

Musculoskeletal system

Rarely: arthralgia, myalgia.

Epidemiological studies, conducted mainly among patients aged 50 years and older, indicate an increased risk of bone fractures in patients receiving SSRIs (selective serotonin reuptake inhibitors) and TCA (tricyclic antidepressants).The mechanism leading to this risk is unknown.

General disorders.

Often: asthenia, weight gain.

Very rare: peripheral edema.

Symptoms due to drug withdrawal.

Often: dizziness, sensitivity disorders, sleep disorders, anxiety, headache.

Rarely: agitation, nausea, tremors, confusion, sweating, diarrhea, emotional instability, visual disturbances, increased heart rate, agitation.

As with other drugs for the treatment of mental disorders, withdrawal of Paxil (especially sudden) can lead to symptoms such as dizziness, sensory disturbances (including paresthesias, electric shock and ringing in the ears), sleep disturbances (including intense dreams) , agitation or anxiety, nausea, headache, tremors, confusion, diarrhea, sweating, increased heart rate, agitation, emotional lability, visual disturbances.In most patients, these symptoms are mild to moderate and go away without treatment. There is no special risk group for the occurrence of these symptoms, therefore, if it is necessary to discontinue Paxil treatment, the dose should be reduced gradually (see Sections “Dosage and Administration” and “Application Features”).

Adverse reactions obtained during clinical trials on the use of the drug in children.

During clinical studies on the use of the drug in children, the following side effects were obtained (with a frequency of at least 2% of patients, with a frequency of occurrence twice as high as compared with the placebo group): emotional lability (including self-harm, suicidal thoughts, crying with threats of suicide and mood changes), hostility, decreased appetite, tremors, increased sweating, hyperkinesia and agitation.Suicidal thoughts and attempted suicide have been observed primarily in clinical trials in adolescents with depressive disorders. Hostility was observed predominantly in children with obsessive-compulsive disorder, especially in children under 12 years of age.

When conducting studies using a gradual dose reduction regimen (reducing the daily dose by 10 mg / day with an interval of 1 week to a dose of 10 mg / day for a week) or after discontinuation of the drug, such symptoms were observed (with a frequency of at least 2% of patients , and with a frequency of occurrence twice as high as compared with the placebo group): emotional lability, nervousness, dizziness, nausea and abdominal pain (see.section “Features of application”).

Expiry date

3 years.

Storage conditions

Store at a temperature not exceeding 30 ° C. Keep out of reach of children.

Package

There are 14 tablets in a blister, 2 blisters in a cardboard box.

Vacation category

By prescription.

Manufacturer

GlaxoSmіtKline Pharmaceuticals S.A., Poland.

GlaxoSmithKline Pharmaceuticals SA, Poland.

The location of the manufacturer and his address for the implementation of activities.

GlaxoSmithKline Pharmaceuticals S.A., 189, st. Grunwald, 60-322 Poznan, Poland.

GlaxoSmithKline Pharmaceuticals SA, Grunwaldzka 189, 60-322 Poznan, Poland.

instructions, use, drug analogues, composition, indications, contraindications, side effects in the UNIAN drug reference book

Paxil is a powerful selective inhibitor of 5-hydroxytryptamine reuptake (5-HT, serotonin). Its antidepressant effect and efficacy in the treatment of obsessive-compulsive and panic disorders is due to the specific inhibition of the uptake of 5-hydroxytryptamine by brain neurons.In its chemical structure, Paxil differs from tricyclic, tetracyclic and other known antidepressants.

Application of Paxil

Major depressive disorder. Treatment of major depressive disorder.

Obsessive-compulsive disorder. Treatment of symptoms and prevention of relapse of obsessive-compulsive disorder.

Panic disorder . Treating symptoms and preventing recurrence of panic disorder, with or without concomitant agoraphobia.

Social phobias / social anxiety disorders. Treatment of social phobias / social anxiety conditions.

Generalized anxiety disorder. Treatment of symptoms and prevention of recurrence of generalized anxiety disorder.

Post-traumatic stress disorder. Treatment of PTSD.

Paxil – composition and release form of the drug

Active ingredient: paroxetine, 1 tablet contains paroxetine (in the form of hemihydrate hydrochloride) 20 mg;

Excipients: dibasic calcium phosphate (dihydrate), sodium starch glycolate (type A), magnesium stearate, Opadry White YS-1R-7003 (hydroxypropyl methylcellulose, titanium dioxide (E 171), polyethylene glycol 400, polysorbate 80).

Dosage form – film-coated tablets.

Paxil: how to take the drug

Major depressive disorder. The recommended dose is 20 mg per day. For some patients, an increase in dose may be required. This should be done gradually, increasing the dose by 10 mg (up to a maximum of 50 mg per day), depending on the clinical effectiveness of the treatment.

Obsessive-compulsive disorder . The recommended dose is 40 mg per day.Treatment should be started with a dose of 20 mg per day, and then weekly increased by 10 mg per day. In some patients, improvement is observed only with a maximum dose of 60 mg per day.

Panic disorder . The recommended dose is 40 mg per day. Treatment should be started with a dose of 10 mg per day, and then weekly increased by 10 mg, depending on the clinical effect. In some patients, improvement is observed only with a maximum dose of 60 mg per day.

Paxil – contraindications, side effects

Contraindications.

Hypersensitivity to paroxetine or any other component of the drug.

Paxil should not be administered concurrently with monoamine oxidase (MAO) inhibitors, including linezolid, an antibiotic that is an inverse non-selective inhibitor of monoamine oxidase and methylthionine chloride (methylene blue), and earlier than 2 weeks after stopping treatment with MAO inhibitors.Similarly, MAO inhibitors can be used no earlier than 2 weeks after stopping treatment with Paxil.

The drug should not be used in combination with thioridazine, because, like other drugs that suppress the hepatic enzyme CYP450 2D6, Paxil can increase thioridazine levels. The use of thioridazine can cause prolongation of the QT interval with associated severe ventricular arrhythmias (eg, torsades de pointes) and sudden death. Paxil should not be used in combination with pimozide.

Adverse reactions.

  • Increased bleeding, mainly of the skin and mucous membranes (including ecchymosis and gynecological bleeding).
  • thrombocytopenia.
  • severe and potentially fatal allergic reactions (including anaphylactoid reactions and angioedema).
  • Syndrome due to insufficient secretion of antidiuretic hormone.
  • Increased cholesterol levels, decreased appetite.
  • hyponatremia. Hyponatremia is mainly observed in elderly patients, sometimes associated with a syndrome caused by insufficient secretion of antidiuretic hormone.
  • drowsiness, insomnia, agitation, abnormal dreams (including nightmares).
  • confusion, hallucinations.
  • manic reactions, anxiety, depersonalization, panic attacks, akathisia.
  • suicidal ideation, suicidal behavior and aggression.

Analogs of Paxil

Source: State Register of Medicines of Ukraine.The instructions are published with abbreviations for information only. Before use, consult your doctor and read the instructions carefully. Self-medication can be harmful to your health.

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