What are the uses of duloxetine oral? What are the side effects of duloxetine oral? How does duloxetine oral interact with other medications? What warnings should be considered when taking duloxetine oral? Get answers to these questions and more.

Duloxetine Oral: Comprehensive Guide on Uses, Side Effects, Interactions, and More

Duloxetine is a medication primarily used to treat depression, anxiety, and certain types of nerve pain. It belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs), which work by helping to restore the balance of serotonin and norepinephrine in the brain. This comprehensive guide will explore the various uses, side effects, interactions, and important considerations when taking duloxetine oral.

Uses of Duloxetine Oral

Duloxetine is approved for the treatment of several conditions, including:

1. Depression: Duloxetine can be used to treat major depressive disorder, helping to improve mood, sleep, appetite, and energy levels.
2. Anxiety: Duloxetine is also approved for the treatment of generalized anxiety disorder, which can help reduce feelings of nervousness and worry.
3. Diabetic Peripheral Neuropathy: Duloxetine is effective in relieving the nerve pain associated with diabetic peripheral neuropathy, a common complication of diabetes.
4. Chronic Musculoskeletal Pain: Duloxetine can help alleviate ongoing pain due to conditions such as arthritis, chronic back pain, and fibromyalgia.

Side Effects of Duloxetine Oral

Like all medications, duloxetine can cause side effects. Some of the most common side effects include:

• Nausea
• Dry mouth
• Constipation
• Loss of appetite
• Fatigue
• Drowsiness
• Increased sweating

Most of these side effects tend to be mild and may improve over time as the body adjusts to the medication. However, it is important to report any persistent or worsening side effects to your healthcare provider.

Interactions with Duloxetine Oral

Duloxetine can interact with various other medications, supplements, and medical conditions. It is essential to inform your doctor about all the medications, both prescription and over-the-counter, that you are currently taking. Some common interactions include:

• Other antidepressants: Combining duloxetine with certain other antidepressants can increase the risk of serotonin syndrome, a potentially serious condition.
• Blood thinners: Duloxetine may increase the risk of bleeding when taken with blood-thinning medications.
• Alcohol: Consuming alcohol while taking duloxetine can increase the risk of side effects, such as drowsiness and impaired coordination.
• Certain medical conditions: Duloxetine may not be suitable for individuals with certain liver or kidney problems, high blood pressure, or a history of seizures.

Warnings and Precautions for Duloxetine Oral

Duloxetine, like other antidepressants, carries several important warnings and precautions:

1. Suicidal thoughts or behavior: A small number of people, especially those under the age of 25, may experience worsening depression, suicidal thoughts, or other mental health changes when starting or changing the dose of an antidepressant. It is crucial to monitor for these symptoms and report any changes to your healthcare provider immediately.
2. Serotonin syndrome: Combining duloxetine with certain other medications, such as other antidepressants, can increase the risk of serotonin syndrome, a potentially life-threatening condition. Symptoms to watch for include agitation, hallucinations, rapid heartbeat, and fever.
3. Discontinuation symptoms: Abruptly stopping duloxetine can lead to withdrawal-like symptoms, such as dizziness, confusion, and brief electric shock sensations. Your doctor may need to gradually decrease your dose to minimize these effects.
4. Increased blood pressure: Duloxetine may cause an increase in blood pressure, particularly in individuals with pre-existing hypertension. Regular monitoring of blood pressure is recommended.

Dosing and Administration of Duloxetine Oral

Duloxetine is typically taken once or twice daily, with or without food. The dosage is based on your age, medical condition, and response to treatment. Your healthcare provider may start you on a low dose and gradually increase it to minimize the risk of side effects. It is important to follow your doctor’s instructions carefully and not stop taking the medication without consulting them, as this can lead to withdrawal symptoms.

Conclusion

Duloxetine is a versatile medication used to treat a variety of conditions, including depression, anxiety, and certain types of nerve pain. While it can be an effective treatment, it is important to be aware of the potential side effects, interactions, and warnings associated with this medication. By working closely with your healthcare provider and following their instructions, you can safely and effectively use duloxetine to improve your overall health and well-being.

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

Warnings:

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

Warnings:

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

… Show More

Uses

Duloxetine is used to treat depression and anxiety. In addition, duloxetine is used to help relieve nerve pain (peripheral neuropathy) in people with diabetes or ongoing pain due to medical conditions such as arthritis, chronic back pain, or fibromyalgia (a condition that causes widespread pain).Duloxetine may improve your mood, sleep, appetite, and energy level, and decrease nervousness. It can also decrease pain due to certain medical conditions. Duloxetine is known as a serotonin-norepinephrine reuptake inhibitor (SNRI). This medication works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain.

How to use duloxetine oral

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using duloxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 1 or 2 times a day with or without food. If you have nausea, it may help to take this drug with food. Swallow the capsule whole. Do not crush or chew the capsule or mix the contents with food or liquid. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your age, medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as dizziness, confusion, mood swings, headache, tiredness, diarrhea, sleep changes, and brief feelings similar to electric shock. Your dose may need to be gradually decreased to reduce side effects. Report any new or worsening symptoms right away.

Tell your doctor if your condition lasts or gets worse.

Side Effects

See also Warning section.

Nausea, dry mouth, constipation, loss of appetite, tiredness, drowsiness, or increased sweating may occur. If any of these effects last or get worse, tell your doctor promptly.

Dizziness or lightheadedness may occur, especially when you first start or increase your dose of this drug. To reduce the risk of dizziness, lightheadedness, or falling, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: confusion, easy bleeding/bruising, decreased interest in sex, changes in sexual ability, muscle cramps/weakness, shaking (tremor), difficulty urinating, signs of liver problems (such as nausea that doesn’t stop, stomach/abdominal pain, vomiting, yellowing eyes/skin, dark urine).

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

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.

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, skin blisters, mouth sores.

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.

Precautions

Before taking duloxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), personal or family history of suicide attempts, bleeding problems, personal or family history of glaucoma (angle-closure type), high blood pressure, kidney disease, liver disease, seizure disorder, stomach problems (such as slow emptying of the stomach), use/abuse of alcohol.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

If you have diabetes, duloxetine may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially bleeding, dizziness, lightheadedness, or loss of coordination. Older adults may also be more likely to develop a type of salt imbalance (hyponatremia), especially if they are taking “water pills” (diuretics). Dizziness, lightheadedness, or loss of coordination can increase the risk of falling.

Children may be more sensitive to the side effects of this drug, especially loss of appetite and weight loss. Monitor weight and height in children who are taking this drug. See also Warning.

During pregnancy, this medication should be used only when clearly needed. When this medication is taken during the last 30 days of pregnancy, the mother may be at an increased risk of bleeding at birth. This medication may also harm an unborn baby. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

Since untreated mental/mood problems (such as depression, anxiety) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug are: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, “blood thinners” such as dabigatran/warfarin).

Other medications can affect the removal of duloxetine from your body, which may affect how duloxetine works. Examples include cimetidine, viloxazine, certain quinolone antibiotics (such as ciprofloxacin, enoxacin), among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include antiarrhythmic drugs (such as propafenone, flecainide, quinidine), antipsychotics (such as thioridazine), tricyclic antidepressants (such as desipramine, imipramine), among others.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and at least 5 days after treatment with this medication. Ask your doctor when to start or stop taking this medication.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, other SNRIs such as desvenlafaxine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, fainting.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, liver function) should be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Duloxetine Dosage Guide + Max Dose, Adjustments

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Medically reviewed by Drugs.com. Last updated on Nov 1, 2021.

Applies to the following strengths: 20 mg; 60 mg; 30 mg; 40 mg

Usual Adult Dose for:

• Depression
• Fibromyalgia
• Generalized Anxiety Disorder
• Pain
• Neuropathic Pain
• Chronic Pain

Usual Geriatric Dose for:

• Generalized Anxiety Disorder

Usual Pediatric Dose for:

• Generalized Anxiety Disorder
• Fibromyalgia

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose for Depression

Initial dose: 20 mg to 30 mg orally 2 times a day
Maintenance dose: 60 mg per day, given either once a day OR 30 mg orally 2 times a day
Maximum dose: 120 mg/day

Comments:

• Some patients may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day
• Data are lacking to show that doses greater than 60 mg per day confer any additional benefits.
• Acute episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended.

Use: Treatment of major depressive disorder (MDD)

Usual Adult Dose for Fibromyalgia

Initial dose: 30 mg orally once a day for at least 1 week
Maintenance dose: 30 to 60 mg orally once a day

Comments:

• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy has been demonstrated for up to 3 months in placebo-controlled studies; effectiveness beyond this has not been demonstrated in longer studies; therefore, continued treatment should be based on individual patient response.

Use: Treatment of fibromyalgia

Usual Adult Dose for Generalized Anxiety Disorder

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 120 mg orally once a day
Maximum dose: 120 mg/day

Comments:

• Some patients may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
• The dose may be increased in increments of 30 mg once a day if clinically appropriate.
• There is no evidence that doses greater than 60 mg per day confer additional benefit.
• Episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended.

Use: Treatment of generalized anxiety disorder (GAD)

Usual Adult Dose for Pain

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day

Comments:

• Some patients for whom tolerability may be a concern may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy beyond 12 weeks in the treatment of diabetic peripheral neuropathy has not been established; effectiveness should be based on individual patient response.
• Efficacy in the treatment of chronic musculoskeletal pain beyond 13 weeks has not been established.

Uses:

• Treatment of chronic musculoskeletal pain
• Treatment of diabetic peripheral neuropathic pain

Usual Adult Dose for Neuropathic Pain

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day

Comments:

• Some patients for whom tolerability may be a concern may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy beyond 12 weeks in the treatment of diabetic peripheral neuropathy has not been established; effectiveness should be based on individual patient response.
• Efficacy in the treatment of chronic musculoskeletal pain beyond 13 weeks has not been established.

Uses:

• Treatment of chronic musculoskeletal pain
• Treatment of diabetic peripheral neuropathic pain

Usual Adult Dose for Chronic Pain

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day

Comments:

• Some patients for whom tolerability may be a concern may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy beyond 12 weeks in the treatment of diabetic peripheral neuropathy has not been established; effectiveness should be based on individual patient response.
• Efficacy in the treatment of chronic musculoskeletal pain beyond 13 weeks has not been established.

Uses:

• Treatment of chronic musculoskeletal pain
• Treatment of diabetic peripheral neuropathic pain

Usual Geriatric Dose for Generalized Anxiety Disorder

Initial dose: 30 mg orally once a day for at least 2 weeks
Maintenance dose: 60 mg orally once a day
Maximum dose: 120 mg/day

Comments:

• An increase to 60 mg orally once a day may be considered after 2 weeks with an initial dose.
• If the dose is increased beyond 60 mg, it should be done in increments of 30 mg once a day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit.
• Episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended.

Use: Treatment of GAD

Usual Pediatric Dose for Generalized Anxiety Disorder

7 to 17 years:

• Initial dose: 30 mg orally once a day for at least 2 weeks
• Maintenance dose: 30 to 60 mg orally once a day
• Maximum dose: 120 mg/day

Comments:

• An increase to 60 mg orally once a day may be considered after 2 weeks with an initial dose.
• If the daily dose is increased beyond 60 mg, it should be done in increments of 30 mg once a day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit.
• Episodes generally require several months or more of sustained pharmacological therapy.
• A periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended.

Use: Treatment of GAD

Usual Pediatric Dose for Fibromyalgia

13 years and older:

• Initial dose: 30 mg orally once a day for at least 1 week
• Maintenance dose: 30 to 60 mg orally once a day

Comments:

• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy has been demonstrated for up to 3 months in placebo-controlled studies; effectiveness beyond this has not been demonstrated in longer studies; therefore, continued treatment should be based on individual patient response.

Use: Treatment of fibromyalgia

Renal Dose Adjustments

Mild to moderate renal dysfunction (glomerular filtration rate [GFR] 30 mL/min and greater OR CrCl 30 mL/min and greater): Data not available
Severe renal dysfunction (GFR less than 30 mL/min OR CrCl 15 to less than 30 mL/min): Not recommended.

Liver Dose Adjustments

Mild to severe liver dysfunction (Child-Pugh A to C): Not recommended.
Chronic liver dysfunction or cirrhosis: Not recommended.

Jaundice of clinically significant liver dysfunction during treatment: Treatment should be discontinued, and should not be resumed unless other causes can be established.

Dose Adjustments

Treatment withdrawal:

• Tapering of the dose is recommended for therapy lasting over 1 week.
• The dose should be gradually reduced over at least 2 weeks
• If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.

Switching from this drug to a MAO inhibitor (MAOI) MAOI intended to treat psychiatric disorders: At least 5 days should elapse after stopping this drug and starting a MAOI.

Switching from a MAOI intended to treat of psychiatric disorders to this drug: At least 14 days should elapse after stopping a MAOI and starting this drug.

Patients who require urgent treatment with linezolid/IV methylene blue during treatment:

• The potential benefits must outweigh the risks of serotonin syndrome.
• This drug should be stopped promptly before administering linezolid/IV methylene blue.
• Patients should be monitored for serotonin syndrome for 5 days OR 24 hours after the last dose of linezolid/IV methylene blue, whichever comes first.
• Treatment may resume 24 hours after the last dose of linezolid/IV methylene blue.

Patients with substantial alcohol use: Use is not recommended

Precautions

CONTRAINDICATIONS:

• Starting treatment with this drug in patients who are being treated with MAOIs (e.g., linezolid, IV methylene blue)
• Use of MAOIs intended to treat psychiatric disorders with this drug or within 5 days of stropping treatment with this drug
• Use of this drug within 14 days of stopping a MAOI intended to treat psychiatric disorders

US BOXED WARNINGS:
SUICIDAL THOUGHTS AND BEHAVIORS:

• Antidepressants increased the risk of suicidal thoughts and behaviors in children, adolescents, (e. g., pediatric patients) and young adults in short-term studies.
• These studies did not show an increased risk of suicidal thoughts and behaviors with antidepressant use in patients over 24 years of age; there was a reduction in risk with antidepressant use in patients 65 years and older.

Recommendations:

• The emergence of suicidal thoughts and behaviors and clinical worsening of symptoms should be monitored closely in patients of all ages who are started on antidepressant therapy.
• The need for close observation and communication with the patient’s healthcare provider should be discussed with families and caregivers.

Safety and efficacy in the treatment of GAD have not been established in patients younger than 7 years; this drug is not recommended for use in these patients.
Safety and efficacy in the treatment of fibromyalgia have not been established in patients younger than 13 years; this drug is not recommended for use in these patients.
Safety and efficacy in the treatment of chronic musculoskeletal pain, diabetic peripheral neuropathy, and/or MDD have not been established in children; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Severe renal dysfunction on hemodialysis: Not recommended.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Doses may be taken without regard to meals.
• Swallow doses whole; do not chew or crush the capsules.
• Alternative administration (e.g., sprinkled on applesauce, given via nasogastric tube): The manufacturer product information should be consulted.

General:

• There are no data regarding the effect of gastric motility alterations in the stability of the enteric coating of oral formulations.
• This drug may affect urethral resistance.
• Limitation of use: Animal models demonstrated efficacy in treating inflammatory, neuropathic, and/or persistent pain; however, analgesic activity was not demonstrated for acute and/or arthritic pain.

Monitoring:

• CARDIOVASCULAR: Regular blood pressure monitoring
• HEPATIC: Regular liver function tests
• NERVOUS SYSTEM: Signs/symptoms of serotonin syndrome
• PSYCHIATRIC: Discontinuation symptoms, worsening/emergence of suicidal thoughts, and/or unusual changes in mood/behavior
• RENAL: Regular renal function tests

Patient advice:

• Patients, families, and caregivers should report worsening of depression, suicidal ideation, or any unusual changes in behavior, especially during early antidepressant treatment and when doses are adjusted up or down.
• Patients should be instructed to avoid alcohol use while taking this medicine, as this combination may be associated with severe liver injury.
• Advise patients that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
• Patients should avoid overheating and dehydration.
• Patients should speak with their healthcare provider if they are taking, or plan to take any new prescription or over the counter medications because there is a potential for drug interactions; patients should be advised to avoid alcohol as it may make some side effects worse.
• Inform patients that this drug may cause dizziness and sedation, and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

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Active ingredient DULOXETINUM | Compendium – drug reference book

• Pharmacological properties
• Indications DULOXETINE
• Application of DULOXETINE
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Diagnosis
• Recommended alternatives
• Trade names

Medicinal preparations containing the active substance DULOXETINE

Depratal

enteric tablets 30 mg blister № 28

ADAMED PHARMA S.A

Pharmacy prices

Depratal

enteric tablets 60 mg ster, No. 28

ADAMED PHARMA S.A

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Duloxin ^®

capsules hard, enteric 30 mg blister, № 28

Acino

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Duloxin ^{® 900 46}

capsules, hard, enteric 60 mg blister, no. 28 9Nobel yuxet

enteric capsules 60 mg blister № 28

Nobel

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Duloc ^®

capsules, hard, enteric soluble 30 mg blister, № 30

Farmak

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Duloc ^®

capsules, hard, enteric 60 mg blister, No. 30 9Nobel 28 Neksetin

capsules, hard, enteric-soluble 40 mg blister, № 28

Nobel

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Revival

hard capsules with gastro-resistant granules 30 mg blister, № 30

Medochemie Ltd

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Revival

hard capsules with gastro-resistant granules 60 mg blister no. 30

Medochemie Ltd

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Symbia®

enteric capsules 30 mg blister no. 28

Darnitsa

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Symbia®

enteric capsules 60 mg blister, № 28

Darnitsa

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Shimoda

gastroresistant capsules 30 mg blister, № 28 -Dupnitza AD

Prices in pharmacies

Shimoda

gastroresistant capsules 60 mg blister, № 28

Balkanpharma-Dupnitza AD

Prices in pharmacies

serotonin reuptake inhibitor and norepinephrine. It slightly inhibits dopamine uptake, has no significant affinity for histamine and dopamine, cholinergic and adrenergic receptors. The mechanism of the therapeutic action of duloxetine in depression is due to inhibition of the reuptake of serotonin and norepinephrine and, as a result, an increase in serotonergic and noradrenergic neurotransmission in the CNS. Duloxetine also normalizes the pain threshold in some experimental models of neuropathic and inflammatory pain and reduces pain in the chronic pain model. The analgesic effect of duloxetine is probably due to a slowdown in the transmission of nociceptive impulses in the CNS.

Duloxetine is well absorbed after oral administration. Cmax _max in blood plasma is reached 6 hours after ingestion. Simultaneous food intake slows down absorption, the period of reaching C _max in the blood increases from 6 to 10 hours, and absorption decreases (by approximately 11%).

Duloxetine is highly bound to plasma proteins (>90%).

Duloxetine is extensively metabolized in the body, metabolites are excreted primarily in the urine. Isoenzymes CYP 2D6 and CYP 1A2 catalyze the formation of two main metabolites of duloxetine (glucuronide combined with 4-hydroxy duloxetine, sulfate combined with 5-hydroxy-, methoxy-duloxetine). The resulting metabolites do not have pharmacological activity.

T _½ duloxetine is 12 hours. The mean plasma clearance of duloxetine is 101 l/h.

Patients with end-stage renal disease who are constantly on dialysis have a doubling of duloxetine plasma concentrations and an increase in AUC compared to healthy individuals. Therefore, in patients with CKD, duloxetine is prescribed at a lower initial dose.

depression; diabetic neuropathy.

for depression and diabetic neuropathy is prescribed orally at a dose of 60 mg 1 time per day daily, regardless of food intake. Some patients may be recommended to prescribe a higher dose (up to a maximum of 120 mg / day in 2 divided doses). The possibility of prescribing at doses exceeding 120 mg / day has not been studied.

Initial dosage for patients with end-stage renal disease (creatinine clearance <30 ml/min) is 30 mg once daily.

Patients with cirrhosis of the liver are prescribed at a lower initial dose or with longer intervals between doses.

No dose adjustment of duloxetine is required in elderly or senile patients. In patients under the age of 18, the effect of duloxetine has not been studied.

hypersensitivity to duloxetine, concomitant therapy with MAO inhibitors.

during clinical trials, side effects such as constipation, nausea, dry mouth, dizziness, fatigue, insomnia and headache (≥10%) were noted. Less commonly (with a frequency of <10%, but ≥1%) - tachycardia, dyspepsia, vomiting, loss of appetite, drowsiness, tremor, lethargy, increased sweating, feeling hot, yawning. On the part of the reproductive system, ejaculation and erection disorders were recorded (with a frequency of <10%, but ≥1%), a decrease in libido and anorgasmia. Rarely (<1%, but ≥0.1%) - gastroenteritis, stomatitis, increased blood pressure, weight gain, muscle tension, taste and vision disturbances, agitation, urinary retention.

Treatment with duloxetine in placebo-controlled clinical trials was associated with non-significant increases in ALT, ASAT, and CPK compared to placebo.

In clinical studies with duloxetine for the treatment of diabetic neuropathy, the median duration of diabetes mellitus was approximately 11 years, median baseline fasting serum glucose was up to 163 mg/dl, and median baseline glycated hemoglobin was 7.8%. These studies noted a slight increase in the initial concentration of fasting blood glucose after 12 weeks in patients taking duloxetine compared with placebo in the usual mode for 52 weeks. There were no changes in the rate of glycated hemoglobin, body weight of patients, lipid concentrations (Cholesterol, LDL, HDL, TG) or any side effects associated with diabetes mellitus.

Post-marketing reports of the following side effects:

on the part of the organ of vision: very rarely (<0. 01%) – glaucoma;

from the side of the hepatobiliary system: very rarely (<0.01%) - hepatitis, jaundice;

from the side of the immune system: very rarely (<0.01%) - anaphylactic reactions;

on the part of laboratory parameters: very rarely (<0.01%) - increased activity of ALT, AST, alkaline phosphatase, bilirubin level in the blood;

from the side of metabolism: very rarely (<0.01%) - hyponatremia;

on the skin side: rarely (0.01-0.1%) – rash; very rarely (<0.01%) - angioedema, Stevens-Johnson syndrome, urticaria;

from the side of the cardiovascular system: very rarely (<0.01%) - orthostatic hypotension and syncope (especially at the beginning of treatment).

patients with a high risk of suicide during the treatment period should be under strict supervision, since the possibility of suicidal attempts is not excluded before the onset of a pronounced remission.

Duloxetine has not been studied in patients under the age of 18 and should not be used in this age group.

As with other drugs that act on the central nervous system, duloxetine should be used with caution in patients with a manic syndrome, a history of seizures.

There have been reports of mydriasis in association with duloxetine, so duloxetine should be used with caution in patients with elevated intraocular pressure or at risk of developing acute narrow-angle glaucoma.

An increase in the concentration of duloxetine in blood plasma has been reported in patients with severe renal insufficiency (creatinine clearance <30 ml / min) or severe hepatic insufficiency. In such patients, it is recommended to prescribe duloxetine at a lower initial dose.

In some patients, taking duloxetine leads to an increase in blood pressure. In patients with hypertension and / or other diseases of the cardiovascular system, it is recommended to monitor blood pressure.

In clinical studies, an increase in the activity of liver enzymes in the blood was noted. In most patients treated with duloxetine, this increase was transient and disappeared after discontinuation of duloxetine treatment. A significant increase in liver enzyme activity (more than 10 times higher than normal) or liver damage with cholestasis or a significant increase in enzyme activity in combination with liver damage occurred rarely, in some cases it was associated with alcohol abuse.

Duloxetine was not mutagenic in experiments in vitro and in vivo .

Adequate and well-controlled studies of the effects of duloxetine in pregnant women have not been conducted, therefore its use during pregnancy is not recommended.

Duloxetine is excreted in breast milk. The approximate daily dose in an infant is 0.14% of the dose for a nursing woman (mg/kg). The safety of duloxetine use in an infant has not been established, so breast-feeding while taking duloxetine is not recommended.

During the period of treatment with duloxetine, patients should refrain from potentially hazardous activities that require increased attention and speed of psychomotor reactions.

duloxetine should not be given concomitantly with MAO inhibitors or within at least 14 days after stopping treatment with MAO inhibitors. Taking into account T _½ duloxetine, MAO inhibitors should also not be prescribed for at least 5 days after discontinuation of duloxetine treatment.

In clinical studies with the simultaneous administration of theophylline, a CYP 1A2 substrate, with duloxetine at a dose of 60 mg 2 times a day, no significant changes in their pharmacokinetics were noted. These results indicate that duloxetine is unlikely to have a clinically significant effect on the metabolism of CYP 1A2 substrates.

Since CYP 1A2 is involved in the metabolism of duloxetine, concomitant use of duloxetine with active inhibitors of CYP 1A2 may lead to an increase in duloxetine plasma concentrations. Fluvoxamine (at a dose of 100 mg 1 time per day), being an active inhibitor of CYP 1A2, reduces the clearance of duloxetine from blood plasma by approximately 77%. In this regard, when prescribing duloxetine with CYP 1A2 inhibitors (some quinolone antibacterial agents), it is advisable to prescribe duloxetine at a lower dose.

Duloxetine is a moderate inhibitor of CYP 2D6. When prescribing duloxetine at a dose of 60 mg 2 times a day with a single dose of desipramine, which is a substrate of CYP 2D6, the AUC of desipramine increases by 3 times. Co-administration of duloxetine (at a dose of 40 mg 2 times a day) increases the stationary AUC of tolterodine (2 mg 2 times a day) by 71%, but does not affect the pharmacokinetics of the 5-hydroxyl metabolite. In this regard, when prescribing duloxetine with CYP 2D6 inhibitors, which have a narrow therapeutic index, care must be taken.

Since CYP 2D6 is involved in the metabolism of duloxetine, concomitant use of duloxetine with active inhibitors of CYP 2D6 can lead to an increase in the concentration of duloxetine in the blood. Paroxetine (20 mg once daily) reduces the plasma clearance of duloxetine by approximately 37%. In this regard, when prescribing duloxetine with CYP 2D6 inhibitors, care must be taken.

When prescribing duloxetine in combination with other drugs that affect the central nervous system, especially with a similar mechanism of action, care should be taken.

Duloxetine binds to plasma proteins (>90%), so the administration of duloxetine to a patient taking other drugs that are highly bound to plasma proteins may lead to an increase in the free concentration of any of these drugs.

Clinical data on duloxetine overdose are limited. There have been cases of drug overdose (up to 1400 mg), including in combination with other drugs, but they did not lead to death.

In experiments on animals, the main manifestations of toxicity in case of overdose were noted from the side of the central nervous system and gastrointestinal tract. These included symptoms such as tremor, clonic convulsions, ataxia, vomiting, and anorexia.

No specific antidote known. Immediately after an overdose, gastric lavage and activated charcoal are indicated. The airway should be secured. It is recommended to monitor the main vital signs, primarily cardiac activity, if necessary, symptomatic and supportive therapy. Duloxetine has a large volume of distribution, which is why forced diuresis, hemoperfusion and exchange perfusion are ineffective in case of overdose.

Duloxetine Canon, 60 mg, enteric capsules, 28 pcs.

The most commonly reported side effects in patients taking duloxetine were nausea, headache, dry mouth, drowsiness and dizziness. However, most of these side effects were mild to moderate, occurred at the beginning of therapy, and subsequently decreased in severity.

WHO classification of side effects:

very common – 1/10 prescriptions (> 10%)

often – 1/100 appointments (> 1% and <10%)

infrequently – 1/1000 appointments (>0.1% and <1%)

rare – 1/10000 appointments (>0.01% and <0.1) % )

very rare – less than 1/10000 prescriptions (<0.01%)

Infectious and parasitic diseases

Uncommon: laryngitis.

Immune system disorders

Rare: anaphylactic reaction, hypersensitivity.

Endocrine disorders

Rare: hypothyroidism.

Metabolic and nutritional disorders

Very common: loss of appetite ¹⁵ .

Uncommon: hyperglycemia (especially common in patients with diabetes mellitus).

Rare: dehydration, hyponatremia, syndrome of inappropriate secretion of antidiuretic hormone ⁶ .

Mental disorders

Very common: insomnia ¹¹ .

Often: agitation ¹⁰ , anxiety, unusual dreams ²⁰ , decreased libido (including loss of libido), orgasm disturbance (including anorgasmia).

Uncommon: suicidal thoughts ^5.22 , sleep disorders, bruxism, disorientation ¹⁹ , apathy.

Rare: suicidal behavior ^5.22 , mania, hallucinations, aggression and hostility ⁴ .

Nervous system disorders

Very common: dizziness, headache, drowsiness ¹² .

Often: tremor, paresthesia ¹⁸ .

Uncommon: myoclonus, akathisia ²² , irritability, impaired concentration, lethargy, dysgeusia, dyskinesia, restless legs syndrome, decreased quality of sleep.

Rare: serotonin syndrome ⁶ , convulsions ¹ , psychomotor agitation ⁶ Extrapyramidal disorders.

Visual disturbances

Often: blurred vision.

Uncommon: mydriasis, blurred vision.

Rare: glaucoma, dry eyes.

Hearing and labyrinth disorders

Common: tinnitus ¹ .

Uncommon: vertigo, earache.

Cardiac disorders

Often: palpitations.

Uncommon: tachycardia, supraventricular arrhythmias, predominantly atrial fibrillation.

Vascular disorders

Common: flushing (including flushing).

Uncommon: hypertension ^3.22 , increased blood pressure ^3.14 , cold extremities, orthostatic hypotension, syncope.

Rare: hypertensive crisis ^3.6 .

Respiratory, thoracic and mediastinal disorders

Common: yawning, pain in the oropharynx.

Uncommon: tightness in the throat, epistaxis.

Gastrointestinal disorders

Very common: dry mouth (12.8%), nausea (24.3%), constipation.

Common: diarrhea, vomiting, dyspepsia (including abdominal discomfort), flatulence, abdominal pain ⁹ .

Uncommon: gastrointestinal bleeding ⁷ , gastroenteritis, gastritis, belching, dysphagia.

Rare: stomatitis, bad breath, hematochezia.

Liver and biliary disorders

Uncommon: hepatitis ³ , acute liver injury.

Rare: liver failure ⁶ , jaundice ⁶ .

Skin and subcutaneous tissue disorders

Common: increased sweating, rash, itching.

Uncommon: night sweats, urticaria, contact dermatitis, cold sweat, photosensitivity, increased tendency to bruise.

Rare: Stevens-Johnson syndrome ⁶ , angioedema ⁶ .

Very rare: tissue contusion.

Musculoskeletal and connective tissue disorders

Common: musculoskeletal pain ¹⁷ , muscle stiffness ¹⁶ , muscle spasms.

Uncommon: muscle cramps.

Rare: lockjaw.

Renal and urinary tract disorders

Often: frequent urination.

Uncommon: urinary retention, dysuria, difficulty initiating urination, nocturia, polyuria, decreased urine flow.

Rare: unusual smell of urine.

Genital and breast disorders

Common: erectile dysfunction.

Uncommon: Ejaculation disorders ²¹ , delayed ejaculation, sexual dysfunction, gynecological bleeding, menstrual disorders, testicular pain.

Rare: menopausal symptoms, galactorrhea, hyperprolactinemia.

General disorders and injection site disorders

Very common: fatigue ¹³ .

Often: falls ⁸ , change in taste sensations.

Uncommon: chest pain ²² , atypical sensations, hunger, thirst, chills, malaise, feeling hot, gait disturbance.

Laboratory and instrumental data

Often: weight loss.

Infrequently: weight gain, increased concentrations of alanine aminotransferase (ALT), aspartate aminotransferase (ACT), alkaline phosphatase, gamma-glutamyl transpeptidase, bilirubin, creatine phosphokinase, abnormal liver enzymes, increased blood potassium concentration.

Rare: increased blood cholesterol levels.

¹ Cases of seizures and tinnitus have also been reported after completion of duloxetine treatment.

² Orthostatic hypotension and syncope were noted especially at the beginning of treatment.

³ See Special Instructions section.

⁴ Cases of aggression and hostility have been noted especially at the beginning of treatment with duloxetine or after its completion.

⁵ Cases of suicidal thoughts or suicidal behavior have been reported during duloxetine therapy or in the early period after completion of treatment.

⁶ Estimated frequency of adverse reactions. Not observed in clinical studies.

⁷ Also includes hemorrhagic diarrhoea, lower gastrointestinal bleeding, hematemesis, hemorrhoidal bleeding, melena, rectal bleeding, ulcerative bleeding.

⁸ Falls were more common in the elderly (≥ 65 years).

⁹ Includes upper and lower abdominal pain, anterior abdominal wall tension, abdominal discomfort, gastrointestinal pain.

¹⁰ Includes internal trembling, restlessness, tension, psychomotor agitation.

¹¹ Includes awakenings in the middle of the night, early morning awakenings, difficulty falling asleep.

¹² Includes hypersomnia, sedation.

¹³ Including asthenia.

¹⁴ Including increased systolic blood pressure, diastolic pressure, systolic hypertension, diastolic hypertension, essential hypertension, hypertension.

¹⁵ Including anorexia.

¹⁶ Including muscle stiffness.

¹⁷ Includes myalgia and neck pain.

¹⁸ Including hypesthesia, hypesthesia of the face, hypesthesia of the genital area, paresthesia of the oral cavity, very rarely (<0.01%) sensation of electric shock (when therapy is stopped).

¹⁹ Including confusion.

²⁰ Nightmares included.

²¹ Including no ejaculation.

²² No statistically significant difference from placebo.

Withdrawal of duloxetine (particularly at the same time) most commonly results in a “withdrawal” syndrome that includes the following symptoms: dizziness, sensory disturbances (including paresthesia), sleep disturbance (including insomnia and vivid dreams), weakness, drowsiness, agitation, or anxiety , nausea and/or vomiting, tremor, headache, irritability, diarrhea, hyperhidrosis and vertigo.

In general, with SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs), these effects are mild to moderate and limited. However, in some patients, these events may be more severe and/or prolonged.

Short-term use of duloxetine (up to 12 weeks) in patients with painful peripheral diabetic neuropathy showed a slight increase in fasting blood glucose while maintaining a stable concentration of glycosylated hemoglobin, both in duloxetine and in the placebo group.