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Hydroxyzine pamoate side effects: hydroxyzine pamoate 25 mg capsule

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Mental Health Medications | NAMI: National Alliance on Mental Illness

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Generic name: hydroxyzine (hye DROKS i zeen)

  • Capsules: 25 mg, 50 mg, 100 mg

Brand name: Vistaril®

  • Capsules: 25 mg, 50 mg


All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.

What Is Hydroxyzine And What Does It Treat?

Hydroxyzine is an antihistamine. It is approved for the treatment of anxiety. However, hydroxyzine is also used to treat difficulty sleeping, nausea, vomiting, itching, skin rash, and allergies.

Symptoms of anxiety include:

  • Feeling nervous
  • Feeling fearful
  • Excessive worrying
  • Difficulty sleeping
  • Difficulty concentrating
  • Irritability

What Is The Most Important Information I Should Know About Hydroxyzine?

Do not drive a car or operate machinery until you know how this medication affects you because you may notice that you feel tired or dizzy.

Hydroxyzine is not a controlled substance. It does not have the risk of addiction like some other medications used to treat anxiety e.g., lorazepam (Ativan®), alprazolam (Xanax®), clonazepam (Klonopin®), and other benzodiazepines.

Are There Specific Concerns About Hydroxyzine And Pregnancy?

If you are pregnant or planning to become pregnant, notify your health care provider to best manage your medications. People living with anxiety disorders who wish to become pregnant face important decisions. It is important to discuss this with your doctor and caregivers.

Hydroxyzine should not be used in the first trimester of pregnancy. Studies that were done with mice, rabbits, and rats found an increased risk of birth defects. The risk to humans in the first trimester is unclear due to lack of well-controlled studies in humans. Hydroxyzine may be used in the second and third trimesters of pregnancy, but it should not be used during or just prior to labor. Use of hydroxyzine during labor may increase seizure risk in infants, decrease fetal heart rate, and increase side effects when combined with narcotics.

Regarding breastfeeding, use is not recommended since hydroxyzine does pass into breast milk. Infants who have received other antihistamines have experienced drowsiness, irritability, or unusual excitement. In addition, it may lower milk production in the mother.

What Should I Discuss With My Health Care Provider Before Taking Hydroxyzine?

  • Symptoms of your condition that bother you the most
  • If you have thoughts of suicide or harming yourself
  • Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
  • If you experience side effects from your medications, discuss them with your health care provider. Some side effects may pass with time, but others may require changes in the medication.
  • Any other psychiatric or medical problems you have, including obstructive sleep apnea or abnormal heartbeat
  • All other medications you are currently taking (including over the counter products and herbal and nutritional supplements) and any medication allergies you have, including allergies to cetirizine (Zyrtec®) or levocetirizine (Xyzal®)
  • Other non-medication treatment you are receiving, such as talk therapy or substance abuse treatment. Your provider can explain how these different treatments work with the medication.
  • If you are elderly or are prone to falls
  • If you are pregnant, plan to become pregnant, or are breastfeeding
  • If you drink alcohol or use drugs
  • If you have a heart condition known as a prolonged QT interval

How Should I Take Hydroxyzine?

Hydroxyzine may be taken with or without food. Take with food if you experience an upset stomach.

Hydroxyzine may be taken every day at regular times or on an as needed (“PRN”) basis. Typically, your health care provider will limit the number of doses you should take in one day.

Your health care provider will determine the dose and method of taking the medication that is right for you based upon your response.

If you take the medication every day (instead of ‘as needed’), use a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take it. You may also ask a family member or friend to remind you or check in with you to be sure you are taking your medication.

What Happens If I Miss A Dose Of Hydroxyzine?

If you miss a dose of hydroxyzine, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your health care provider. Do not double your next dose or take more than what is prescribed.

What Should I Avoid While Taking Hydroxyzine?

Avoid drinking alcohol and using illegal drugs while you are taking hydroxyzine. They may decrease the benefits (e.g., worsen your condition) and increase the adverse effects (e.g., sedation) of the medication.

What Happens If I Overdose With Hydroxyzine?

If an overdose occurs call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

Symptoms of overdose include severe drowsiness, dry mouth, difficulty urinating, headache, rapid heartbeat, confusion, impaired coordination, slow reflexes, seizures, or coma.

A specific treatment to reverse the effects of hydroxyzine does not exist.

What Are Possible Side Effects Of Hydroxyzine?

Common side effects

  • Dizziness, drowsiness, fatigue, dry mouth
  • Urinary retention, blurred vision, confusion, irritability
  • Headache

Rare/serious side effects

  • Allergic reaction (difficulty breathing; hives; swelling of your lips, tongue or face)
  • Increased heart rate, unsafe heart beat (long QT on ECG), confusion, hallucinations
  • Priapism (an erection in males that does not go away after 4 hours)
  • Skin rash known as acute generalized exanthematous pustulosis (AGEP)

Are There Any Risks For Taking Hydroxyzine For Long Periods Of Time?

To date, there are no known problems associated with the long-term use of hydroxyzine. It is a safe and effective medication when used as directed.

A physician should reassess periodically the usefulness of the drug for the individual patient.

What Other Medications May Interact With Hydroxyzine?

The following medications may increase the levels and effects of hydroxyzine:

  • Other antihistamines, such as diphenhydramine (Benadryl®) and cetirizine (Zyrtec®)
  • Other medications with anticholinergic effects, such as benztropine (Cogentin®)
  • Other medications that can cause drowsiness, such as zolpidem (Ambien®)
  • Other medications that increase the heart’s QT interval such as amitriptyline (Elavil®), citalopram (Celexa®), and methadone.

How Long Does It Take For Hydroxyzine To Work?

Symptoms of anxiety or insomnia may improve within hours of the first dose of medication.

Summary of FDA Black Box Warnings

Hydroxizine does not have any black box warnings. 

 

Provided by

(January 2023)

©2022 The American Association of Psychiatric Pharmacists (AAPP) and the National Alliance on Mental Illness (NAMI). AAPP and NAMI make this document available under the Creative Commons Attribution-No Derivatives 4.0 International License. Last Updated: January 2016.

This information is being provided as a community outreach effort of the American Association of Psychiatric Pharmacists. This information is for educational and informational purposes only and is not medical advice. This information contains a summary of important points and is not an exhaustive review of information about the medication. Always seek the advice of a physician or other qualified medical professional with any questions you may have regarding medications or medical conditions. Never delay seeking professional medical advice or disregard medical professional advice as a result of any information provided herein. The American Association of Psychiatric Pharmacists disclaims any and all liability alleged as a result of the information provided herein.

Hydroxyzine for Anxiety — How It Works

When asked to think of medications commonly used to treat anxiety, chances are high that selective serotonin reuptake inhibitors (SSRIs)—such as Lexapro and Zoloft—or benzodiazepines—like Ativan, Xanax, and Klonopin —frequently come to mind. But these are not the only kinds of medications that can effectively treat anxiety. Another option to consider is hydroxyzine, a prescription antihistamine that is approved to treat anxiety. (Hydroxyzine for sleep is also a common treatment.)

This Minded Medication Guide will take a closer look at hydroxyzine for anxiety to help you when talking with your doctor, prescribing nurse, or Minded provider to choose the right medication for your treatment plan.

Read on to learn more about this medication, including:

  • What is hydroxyzine?
  • How does hydroxyzine work for anxiety?
  • What is the best dose of hydroxyzine for anxiety?
  • What are some of the possible side effects of hydroxyzine?
  • What cautions should you be aware of before, during, and after using hydroxyzine for anxiety?
  • How long does it take for hydroxyzine to work for anxiety?
  • How does hydroxyzine compare to other types of anxiety medications?

Minded Medication Guides, including Zoloft vs Prozac and Wellbutrin vs Lexapro, are intended as educational aids only. They are not intended as medical advice for individual conditions or treatment. They are not a substitute for a medical exam, nor do they replace the need for services provided by medical professionals. Talk to your doctor, nurse, or pharmacist before taking any prescription medication or following any treatment or regimen.

Hydroxyzine is an antihistamine used to treat anxiety. It is also sometimes used to treat:

  • Allergies
  • Difficulty sleeping
  • Itching
  • Nausea
  • Skin rash
  • Vomiting

As with all antihistamines, hydroxyzine works by reducing the effects of histamine (a chemical in your body that produces an allergic reaction).

However, while many antihistamines are available over-the-counter (without a prescription), hydroxyzine is a prescription medication. You may see it listed as hydroxyzine hydrochloride (hydroxyzine HCL) or hydroxyzine pamoate (hydroxyzine pam). It may also be listed under the brand name Vistaril.

How does hydroxyzine for anxiety work?

While hydroxyzine is an antihistamine, it is also a serotonin antagonist. In other words, taking hydroxyzine or Vistaril for anxiety works similarly to taking SSRIs—another type of medication used to treat anxiety—by making more serotonin available in your brain. As a serotonin antagonist, hydroxyzine boosts the levels of serotonin in your brain by blocking it from being reabsorbed into the nerves in your brain (called neurons). Serotonin is a neurotransmitter that plays a role in keeping your mood balanced. It also affects feelings of contentment, optimism, and satisfaction, and your overall sense of well-being.

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When taking hydroxyzine for anxiety, it can be prescribed in capsule, tablet, and liquid forms. As mentioned above, this medication is available as hydroxyzine hydrochloride (hydroxyzine HCL) or hydroxyzine pamoate (hydroxyzine pam). While hydroxyzine pamoate is available in both generic and branded forms (branded as Vistaril), hydroxyzine hydrochloride is only available as a generic. (The branded version of hydroxyzine HCL, called Atarax, was discontinued.)

Hydroxyzine pamoate for anxiety

Hydroxyzine pamoate (Vistaril):

Capsules

  • 25 mg
  • 50 mg

Liquid

  • 25 mg/5 ml

Hydroxyzine HCL for anxiety

Hydroxyzine hydrochloride (HCL)

Tablets

  • 10 mg
  • 25 mg
  • 50 mg

Liquid

  • 10 mg/5 ml

Best dose of hydroxyzine for anxiety

When prescribing hydroxyzine for anxiety, doctors and nurse practitioners typically recommend taking it in multiple doses throughout the day. For adults, 50 to 100 mg (taken 4 times a day) is typical, though some people may need higher doses to achieve symptom relief. For children under the age of 6 years old, no more than 50 mg per day (divided into small doses) is recommended.

Hydroxyzine can be taken daily (with or without food) at regularly scheduled times or on an as-needed basis. If you have an upset stomach after taking hydroxyzine, you may want to take it with food. Your doctor or prescribing nurse will provide you with instructions on how often and when to take this medication, as well as the maximum amount to take in a day.

If you miss a dose of hydroxyzine, either take the missed dose as soon as you remember—or, if it is closer to the time when you would take your next dose, just take the next dose.

Which is better for anxiety: hydroxyzine HCL vs hydroxyzine pam?

Both hydroxyzine hydrochloride (HCL) and hydroxyzine pamoate (pam) can be prescribed to treat anxiety. The main difference between the two is the form that each is available in—hydroxyzine HCL is available in tablets and liquid, while hydroxyzine pam is available in capsules and liquid.

You may prefer one form of medication over the other (tablets vs capsules), or you may find that one or the other works better for you personally. Your doctor, prescribing nurse, or Minded professional can work with you to determine which form of this medication is best for your anxiety treatment plan.

Hydroxyzine side effects

Common side effects of hydroxyzine include:

  • Blurred vision
  • Confusion
  • Dizziness
  • Drowsiness
  • Dry mouth
  • Fatigue
  • Headache
  • Irritability
  • Urinary retention (when your bladder does not empty all the way)

Talk to your doctor or the experts at Minded if you experience any of these or other side effects.

Rare or serious side effects of hydroxyzine include:

  • Allergic reaction to the medication, even though the medication generally is taken to reduce allergic reactions (symptoms of this could include: difficulty breathing; hives; and swelling in your lips, tongue, or face)
  • Confusion
  • Hallucinations
  • Increased heart rate and/or abnormal heartbeat
  • Priapism (an erection lasting longer than 4 hours)
  • Skin rash (called acute generalized exanthematous pustulosis, or AGEP)

Seek medical attention right away if you experience any of these (or other) serious side effects.

Hydroxyzine warnings

Drinking alcohol is not recommended while taking hydroxyzine. Alcohol can decrease the benefits of medications like hydroxyzine and increase their side effects (such as sedation). Alcohol also can impair memory and judgment, accidentally resulting in taking a higher dose of hydroxyzine than prescribed, which could induce an accidental overdose.

Symptoms of a hydroxyzine overdose include:

  • Coma
  • Confusion
  • Decreased coordination
  • Difficulty urinating
  • Drowsiness
  • Dry mouth
  • Headache
  • Rapid heartbeat
  • Slowed reflexes
  • Seizures

Always discuss your anxiety treatment plan with your doctor if you are pregnant or planning on becoming pregnant. Hydroxyzine should typically not be taken during the first trimester of pregnancy. While you may take it during the second and third trimesters, it should not be taken right before or during labor.

Because hydroxyzine can be passed to your baby through breast milk, taking it while breastfeeding is not recommended.

Tell your doctor or a Minded professional about any other medications or supplements you may be taking to determine if hydroxyzine might have any negative interactions with them.

When taking hydroxyzine or Vistaril for anxiety, how long does it take to work?

If you’re taking hydroxyzine for anxiety, you will find that it is relatively fast-acting compared to some other medications, like SSRIs. While you may have to take SSRIs for a few weeks before you start to see improvement in your anxiety symptoms, with hydroxyzine, you may notice your symptoms begin to improve quickly, often within hours of first taking it.

How long does hydroxyzine last for anxiety?

The effects of hydroxyzine typically last 3 to 4 hours.

SSRIs vs hydroxyzine for anxiety

While you can take selective serotonin reuptake inhibitors (SSRIs) or hydroxyzine for anxiety, there are some key differences to keep in mind.

  • How quickly your anxiety symptoms begin to decrease: While you may notice that your anxiety symptoms begin to decrease hours after first taking hydroxyzine, the benefits of SSRIs may not begin to become apparent until a few weeks after you start taking them.
  • How often you take the medications: Hydroxyzine is typically taken in multiple doses throughout the day. SSRIs usually are taken once daily.
  • Common side effects: Both hydroxyzine and SSRIs come with a risk of side effects, but the side effects for each are different.
  • Common side effects of hydroxyzine include: blurred vision, confusion, dizziness, dry mouth, fatigue, headache, irritability, urinary retention
  • Common side effects of SSRIs include: dizziness, drowsiness, dry mouth, headache, insomnia, nervousness, sexual problems, stomach upset, weight gain, and/or weight loss
  • Whether they can be taken during pregnancy and/or while breastfeeding: Hydroxyzine can be taken during the second and third trimesters, but not during the first trimester or right before or during labor. SSRIs may be taken during pregnancy, with the approval of an OB-GYN doctor. Neither hydroxyzine nor SSRIs should be taken while breastfeeding without first talking to your OB-GYN doctor or pediatrician.

Benzodiazepines vs hydroxyzine for anxiety

Benzodiazepines—such as Xanax and Ativan and Klonopin—are another type of medication that can be used to treat anxiety. Like hydroxyzine, these medications are relatively fast-acting—your symptoms may begin to decrease within hours of taking your first dose. Also, like taking hydroxyzine for anxiety, benzodiazepines are typically taken in multiple doses throughout the day. There are, however, several important differences between hydroxyzine and benzodiazepines to consider.

  • Common side effects: Both hydroxyzine and benzodiazepines come with a risk of side effects, but the side effects for each are different.
  • Common side effects of hydroxyzine include: blurred vision, confusion, dizziness, dry mouth, fatigue, headache, irritability, urinary retention
  • Common side effects of benzodiazepines include: decreased coordination, difficulty concentrating, dizziness, drowsiness, fatigue, lightheadedness 
  • Whether they can be taken during pregnancy and/or while breastfeeding: Hydroxyzine can be taken during the second and third trimesters, but not during the first trimester or right before or during labor. Benzodiazepines typically should not be taken during pregnancy. Neither hydroxyzine nor benzodiazepines should be taken while breastfeeding without talking to your OB-GYN doctor or pediatrician.
  • How long they are usually used for: While hydroxyzine may be taken long-term, benzodiazepines are typically prescribed for short-term use (weeks or months).

Another thing to keep in mind is that even though the Drug Enforcement Administration has classified benzodiazepines as controlled substances, they are considered safe for most people who take them for anxiety. The risk of dependence or abuse is higher in people with a history of a substance use disorder as well as those who take more than the prescribed dose of the medication.

On the other hand, hydroxyzine is not a controlled substance and does not carry the same risk of dependency or abuse.

Hydroxyzine vs Benadryl for anxiety

While hydroxyzine and Benadryl (the brand name for diphenhydramine) are both antihistamines, this does not mean they can both be used to treat anxiety. Benadryl, which is available over-the-counter (meaning it does not require a prescription) is not approved to treat anxiety—it is approved to treat hay fever, allergies, and cold symptoms. In fact, increased anxiety, agitation, and nervousness are potential side effects of Benadryl.

Additionally, while hydroxyzine is considered safe for long-term use, Benadryl may increase your risk of developing dementia if used long-term, according to a 2015 study published in CMAJ. A 2017 study published in Neurology Clinical Practice also found that there is a risk of becoming dependent on or misusing Benadryl. However, as with benzodiazepines, this risk may be higher in people who have a history of addiction.

If you are looking for a fast-acting medication that can be taken long-term for anxiety treatment, it may be worth discussing hydroxyzine with your doctor, prescribing nurse, or a Minded professional. 

When comparing hydroxyzine to other common types of anxiety medications, it is important to remember that each type of medication has its own pros and cons. And while there are some similarities between the different kinds of medications, there are also some key differences. For example:

  • Whether it is safe for long-term use: Like SSRIs (and generally unlike benzodiazepines), hydroxyzine can be taken long-term. 
  • The number of doses taken per day: Like benzodiazepines (and unlike SSRIs), hydroxyzine is taken in multiple doses throughout the day rather than once daily.
  • How quickly symptom relief may begin: Hydroxyzine is fast-acting (like benzodiazepines), with symptoms typically starting to improve within a few hours of the first dose (compared to a few weeks for SSRIs).
  • Whether it is safe to drink alcohol while taking this medication: Drinking alcohol is not recommended while on hydroxyzine (the same is true of SSRIs and benzodiazepines).
  • Whether this medication can be taken during pregnancy or while breastfeeding: Hydroxyzine can be taken during the second and third trimesters of pregnancy (except right before and during labor). SSRIs and benzodiazepines typically should not be taken during pregnancy. None of these medications should be taken while breastfeeding.

To find out if hydroxyzine could work for your anxiety treatment, visit Minded and get a free assessment. Minded offers online appointments with board-certified psychiatrists and nurse practitioners. If you already have a hydroxyzine prescription, Minded can help you refill or renew it online. Our team of professionals can also assist with adjusting your dosage or advising you about other medications that might be a good fit for your needs.

Canon Hydroxyzine instructions for use: indications, contraindications, side effects – description of Hydroxyzine Canon Film-coated tablets (43070)

📜 Instructions for use Hydroxysin Canon

💊 Composition of the drug Hydroxysin Canon

✅ Use of the drug Hydroxyzine Canon

📅 Storage conditions Hydroxyzine Canon

⏳ Expiration date Hydroxyzine Canon

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Product description

Hydroxyzine Canon
(Hydroxyzine Canon)

Based on the approved prescribing information and prepared for the 2014 Vidal E-Manual, updated on 2021. 10.25

Marketing authorization holder:

CANONPHARMA PRODUCTION CJSC
(Russia)

ATX code:

N05BB01

(Hydroxyzine)

Active substance:
hydroxyzine
(hydroxyzine)

Rec.INN

WHO registered

Dosage form

Hydroxyzine Canon

Tab., coated film coated, 25 mg: 20, 25, 30 or 50 pcs.

reg. No.: LP-002566
dated 06.08.14
– Active

Release form, packaging and composition
drug Hydroxysin Canon

Film-coated tablets white, round, biconvex, scored; almost white in cross section.

Excipients : pregelatinized corn starch – 30 mg, colloidal silicon dioxide – 0.7 mg, magnesium stearate – 1 mg, mannitol – 40 mg, microcrystalline cellulose – 33.3 mg.

10 pcs. – cellular contour packings (2) – packs of cardboard.
10 pcs. – cellular contour packings (3) – packs of cardboard.
10 pcs. – cellular contour packings (5) – packs of cardboard.
25 pcs. – cellular contour packings (1) – packs of cardboard.
25 pcs. – cellular contour packings (2) – packs of cardboard.

Clinical and pharmacological group:

Anxiolytic (tranquilizer)

Pharmaco-therapeutic group:

Anxiolytic agent (tranquilizer)

Pharmacological action

Hydroxyzine is a blocker of H 1 -histamine receptors of the first generation, a derivative of phenothiazine with antimuscarinic and sedative properties and diphenylmethane, promotes inhibition of the activity of certain subcortical zones.

H 1 has a histamine blocking, bronchodilating and antiemetic effect, has a moderate inhibitory effect on gastric secretion. Hydroxyzine significantly reduces itching in patients with urticaria, eczema, and dermatitis.

Hydroxyzine has a positive effect on cognitive abilities, improves attention and memory. Hydroxyzine does not cause addiction and psychological dependence, with prolonged use of the withdrawal syndrome was not observed.
Hydroxyzine is able to depress the central nervous system, also has anticholinergic, antihistamine, antispasmodic, local anesthetic, sympatholytic effects, and has muscle relaxant activity.

For liver failure H 1 – histamine blocking effect can be prolonged up to 96 hours after a single dose. It has moderate anxiolytic activity.

Polysomnography in patients with insomnia and anxiety demonstrates an increase in sleep duration, a decrease in the frequency of nocturnal awakenings after taking a single or repeated dose of hydroxyzine at a dose of 50 mg. A decrease in muscle tension in patients with anxiety was noted when taking the drug at a dose of 50 mg 3 times a day.

H 1 – histamine-blocking effect occurs approximately 1 hour after oral administration of the tablets. The sedative effect appears after 30-45 minutes.

Pharmacokinetics

Absorption

Absorption is high. TC max after oral administration – 2 hours. After taking an average dose of 50 mg, TC max in adults is 70 mg / ml.

Distribution

The distribution coefficient is 7-16 l/kg in adults. Hydroxyzine crosses the blood-brain barrier and the placenta, concentrating more in fetal than maternal tissues. After oral administration, hydroxyzine penetrates the skin well, while the concentration of hydroxyzine in the skin is much higher than the concentration in the blood serum, both after single and after multiple doses. The plasma concentration of hydroxyzine does not necessarily reflect its binding to tissues or distribution to skin receptors. It has an effect on skin inflammation depending on the serum concentration.

Metabolism

Hydroxyzine is metabolized in the liver. Cetirizine – the main metabolite (45%) is a blocker of H 1 -histamine receptors. Metabolites are found in breast milk.

Elimination

T 1/2 in adults – 14 hours (range: 7-20 hours). The total clearance of hydroxyzine is 13 ml / min / kg. About 0.8% of hydroxyzine is excreted unchanged through the kidneys. The main metabolite cetirizine is excreted mainly in the urine, also unchanged (25% of the dose of hydroxyzine taken).

Pharmacokinetics in special groups of patients

In elderly patients

In elderly patients T 1/2 was 29 hours. The volume of distribution is 22.5 l/kg. It is recommended to reduce the daily dose of hydroxyzine when administered to elderly patients.

Children under 1 year

In children, the total clearance is 2. 5 times higher than in adults. The dose must be adjusted. T 1/2 4 hours.

Children aged 1 to 14

T 1/2 11 o’clock.

In patients with hepatic insufficiency

In patients with secondary liver dysfunction due to primary biliary cirrhosis, the total clearance was approximately 66% of the value recorded in healthy volunteers. In patients with liver disease, T 1/2 increased up to 37 hours, the concentration of metabolites in the blood serum is higher than in young patients with normal liver function. Patients with hepatic insufficiency are advised to reduce the daily dose or frequency of administration.

In patients with renal insufficiency

The pharmacokinetics of hydroxyzine was studied in 8 patients with severe renal insufficiency (creatinine clearance 24+7 ml/min). The duration of exposure to hydroxyzine did not change significantly, while the duration of exposure to cetirizine was increased. To avoid any significant accumulation of the cetirizine metabolite after repeated use of hydroxyzine in patients with impaired renal function, the daily dose of hydroxyzine should be reduced.

Indications of the drug

Hydroxyzine Canon

  • symptomatic treatment of anxiety in adults;
  • as a sedative during premedication;
  • symptomatic treatment of itching of allergic origin.

Open list of ICD-10 codes

F41.9 Anxiety disorder, unspecified
L29 Itching
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified

Dosage regimen

The drug is used orally.

Children:

For the symptomatic treatment of itching of allergic origin:

From 3 to 6 years of age: 1.0 mg/kg/day to 2.5 mg/kg/day in divided doses.

Ages 6 years and older: 1.0 mg/kg/day to 2.0 mg/kg/day in divided doses.

For sedation: 1 mg/kg at night before anesthesia.

The dosage is calculated by the doctor individually depending on the body weight of the child in accordance with the recommended doses, it should be noted that the minimum dosage received, after dividing the tablet, is 12.5 mg.

Adults:

For symptomatic treatment of anxiety: standard dose of 50 mg per day divided into 3 doses (1/2 tablet (12.5 mg) in the morning, 1/2 tablet (12.5 mg) in the afternoon and 1 tablet (25 mg at night) For anxiety in severe cases, the drug is used at a dose of 50-100 mg 4 times a day. if necessary, the dose may be increased to 1 tablet (25 mg) 3-4 times daily.0006

For premedication in surgical practice: 2-8 tablets (50-200 mg) at night before anesthesia.

A single maximum adult dose should not exceed 8 tablets (200 mg), the maximum daily dose is not more than 12 tablets (300 mg).

Use in special groups of patients:

When used in the elderly, the dose is selected individually, taking into account concomitant diseases in the recommended dose range (see section Pharmacokinetics).

Use in patients with renal insufficiency and impaired liver function:

Patients with severe and moderate renal insufficiency, as well as with hepatic insufficiency, a dose reduction is necessary. In patients with hepatic insufficiency, it is recommended to reduce the daily dose by 33%. In patients with severe and moderate renal insufficiency, the drug is used in half the dose due to a decrease in the excretion of the main metabolite of hydroxyzine, cetirizine.

Side effects

Possible side effects are listed below by body system and frequency of occurrence.

WHO classification of side effects:

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

common – ≥1/100 to <1/10 prescriptions (>1% and <10%)

infrequently – from ≥ 1/1000 to <1/100 appointments (>0. 1% and <1%)

rarely – from ≥ 1/10000 to <1/1000 appointments (>0.01% and <0.1%)

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

The most common adverse reactions were drowsiness, headache, lethargy, dry mouth and fatigue.

Immune system disorders:

rare: hypersensitivity;

very rare: anaphylactic shock.

Nervous system disorders:

infrequently: dizziness, insomnia, tremor;

rare: convulsions, dyskinesia.

infrequently: agitation, confusion;

rare: hallucinations, disorientation.

Violations of the organ of vision:

rare: disturbance of accommodation, visual impairment.

Cardiac disorders:

rare: tachycardia;

frequency unknown: prolongation of the QT interval on the electrocardiogram, ventricular tachycardia of the “pirouette” type.

Vascular disorder:

rare: decrease in blood pressure.

Respiratory, thoracic and mediastinal disorders:

very rare: bronchospasm.

Gastrointestinal disorders:

infrequently: nausea; rarely: vomiting, constipation.

Liver and biliary disorders:

rare: abnormal liver function tests;

frequency unknown: hepatitis.

Renal and urinary disorders:

rare: urinary retention.

Rut and subcutaneous tissue disorders:

rare: pruritus, rash (erythematous, maculo-papular), urticaria, dermatitis;

very rare: angioedema, increased sweating, acute generalized exanthematous-pustular rash, erythema multiforme, Stevens-Johnson syndrome.

General disorders:

rare: hyperthermia, malaise.

The following side effects have been observed with cetirizine, the main metabolite of hydroxyzine: thrombocytopenia, aggression, depression, tic, dystonia, paresthesia, oculogeric crisis, diarrhea, dysuria, enuresis, asthenia, edema, weight gain and may occur with hydroxyzine.

Contraindications for use

  • hypersensitivity to any of the components of the drug, cetirizine and other piperazine derivatives, aminophylline or ethylenediamine;
  • porphyria;
  • children under 3 years of age;
  • pregnancy, childbirth and breastfeeding.

With caution: in myasthenia gravis, prostatic hyperplasia with clinical manifestations, difficulty urinating, constipation, glaucoma, dementia, convulsive disorders, including epilepsy, with a tendency to arrhythmia, including electrolyte imbalance (hypokalemia, hypomagnesemia), in patients with a history of heart disease (with heart failure and arterial hypertension) or with the use of drugs that can cause arrhythmia, with hyperthyroidism. Hydroxyzine contributes to a decrease in gastrointestinal motility, the development of a stenosing peptic ulcer, and respiratory failure.

Use during pregnancy and lactation

Hydroxysin Canon is contraindicated during pregnancy, childbirth and breastfeeding.

Use in hepatic impairment

Patients with hepatic impairment require dose reduction. In patients with hepatic insufficiency, it is recommended to reduce the daily dose by 33%.

Use for impaired renal function

Patients with severe and moderate renal insufficiency require a dose reduction. In patients with severe and moderate renal insufficiency, the drug is used in half the dose due to a decrease in the excretion of the main metabolite of hydroxyzine, cetirizine.

Use in children

Contraindicated in children under 3 years of age.

Use in the elderly

When used in the elderly, the dose is selected individually, taking into account concomitant diseases in the recommended dose range (see section Pharmacokinetics).

Special instructions

When used simultaneously with drugs with m-anticholinergic properties and drugs that depress the central nervous system, the dose of hydroxyzine must be reduced.

Hydroxyzine can lead to prolongation of the QT interval on the electrocardiogram, so concomitant use with other drugs that can interfere with cardiac activity may increase the risk of arrhythmias. It is suggested that other drugs that cause changes in the electrocardiogram (atropine, antiparkinsonian drugs, lithium carbonate, quinidine, phenothiazines, procainamide, tricyclic antidepressants, thioridazine) may exacerbate and exacerbate the changes that can be caused by hydroxyzine and increase the risk of sudden death. The simultaneous use of two or more drugs that prolong the QT interval should be avoided because of the risk of additive effects that can lead to the development of potentially life-threatening and severe cardiac arrhythmias.

In renal and/or hepatic insufficiency, doses should be reduced.

In the elderly, the dosage should be adjusted individually, starting with half the minimum dose, and adjusting in the range of recommended doses. If it is necessary to set up allergic tests or conduct a methacholine test, taking the drug Hydroxysin Canon should be discontinued 5 days before the study to prevent obtaining distorted data.

Alcohol should be avoided during treatment with Hydroxysin Canon.

Influence on the ability to drive vehicles and mechanisms

Hydroxyzine Canon may impair the ability to concentrate and the speed of psychomotor reactions. Taking other sedative medicines may increase this effect. Therefore, one should refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms of CNS toxicity are associated with excessive m-anticholinergic action, suppression or paradoxical stimulation of the CNS. These symptoms include nausea, vomiting, tachycardia, pyrexia, drowsiness, impaired pupillary reflex, tremors, confusion, or hallucinations. Subsequently, depression of consciousness, respiration, convulsions, lowering blood pressure, and arrhythmia may develop. Possible aggravation of coma and cardiopulmonary collapse.

Treatment: It is necessary to control the state of the respiratory tract, the state of respiration and circulation using Electrocardiographic (ECG) monitoring, to ensure adequate oxygenation. Heart activity and blood pressure should be monitored within 24 hours after the symptoms disappear.

At high doses, hydroxyzine can lead to QT interval prolongation and marked electrocardiogram changes.

In case of mental status disorder, other drugs or alcohol should be avoided, if necessary, the patient should be given oxygen inhalation, naloxone, dextrose (glucose) and thiamine. The use of analeptics is not allowed.

If a vasopressor effect is needed, norepinephrine or metaraminol is given. Epinephrine should not be used. In case of ingestion of a significant amount of the drug, it is possible to perform gastric lavage with previous endotracheal intubation. Activated charcoal may be used, but there is insufficient evidence to support its effectiveness. There is no specific antidote. Hemodialysis is not effective.

Literature data indicate that in the case of the development of severe, life-threatening, intractable m-anticholinergic effects that are not stopped by other drugs, it is possible to use a therapeutic dose of physostigmine. Physostigmine should not be used solely to bring the patient to consciousness. If the patient was taking tricyclic antidepressants, the use of physostigmine can provoke seizures and irreversible cardiac arrest. The use of physostigmine should also be avoided in patients with cardiac conduction disorders.

Drug interactions

The potentiating effect of hydroxyzine should be taken into account when used together with drugs that depress the central nervous system (CNS), such as narcotic analgesics, barbiturates, tranquilizers, hypnotics, alcohol. In this case, their doses should be selected individually. Simultaneous use with MAO inhibitors (MAO) and anticholinergics should be avoided. The drug interferes with the pressor action of epinephrine and the anticonvulsant activity of phenytoin, and also interferes with the action of betahistine and drugs – cholinesterase inhibitors.

Cimetidine 600 mg twice daily has been found to increase serum hydroxyzine concentration by 36% and decrease the maximum concentration of cetirizine metabolite by 20%.

The effect of atropine, belladonna alkaloids, cardiac glycosides, antihypertensive drugs, blockers of H 2 -histamine receptors do not change under the action of hydroxyzine. Hydroxyzine is an inhibitor of the CYP2D6 isoenzyme and in high doses can cause drug interactions with CYP2D6 substrates. Since hydroxyzine is metabolized in the liver, an increase in its plasma concentration can be expected when used simultaneously with inhibitors of microsomal liver enzymes. Since hydroxyzine is metabolized by alcohol dehydrogenase and the CYP3A4 / 5 isoenzyme, it is possible to increase the concentration of hydroxyzine in plasma when used simultaneously with drugs that potentially inhibit the CYP3A4 / 5 isoenzyme (telithromycin, clarithromycin, delavirdine, styripentol, ketoconazole, voriconazole, itraconazole, posaconazole and some inhibitors HIV proteases including atazanavir, indinavir, nelfinavir, ritonavir, saquinarine, lopinavir/ritonavir, saquinarine/ritonavir, and tipranavir/ritonavir). However, the inhibition of one metabolic pathway can be partially compensated by the work of another. The concomitant use of hydroxyzine with medicinal products that have the potential to cause arrhythmia may increase the risk of QT interval prolongation and torsades de pointes.

Co-administration with ototoxic agents such as gentamicin may mask symptoms of ototoxicity such as dizziness. The drug should be canceled 3 days before the planned skin tests with allergens.

Storage conditions of the drug Hydroxysin Canon

In a dry, dark place at a temperature not exceeding 25°C. Keep out of the reach of children.

Shelf life of the drug Hydroxysin Canon

Shelf life – 2 years.

Terms of sale

By prescription.

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Hydroxyzine Canon . Description of the drug in the reference book Vidal.

Hydroxyzine Pamoate in English – Product

Hydroxyzine Pamoate in English – Product – Medication.net

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Review

Hydroxyzine Pamoate Salt is indicated for the treatment of Anxiety, Tension, Psychoneurosis Related, Chronic Urticaria, Atopic Dermatitis, Contact Dermatitis , Histamine-mediated pruritus and other conditions.

Detailed Uses, Side Effects, Interactions, Contraindications and Reviews for Pamoate Hydroxyzine / Hydroxyzine Pamoate is provided below:

Uses

Hydroxyzine Pamoate is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms: 177

  • Atopic dermatitis
  • Contact dermatitis
  • Histamine-mediated pruritus
  • Learn more: Benefits

    Side effects

    The following is a list of possible side effects that may occur with medicines containing Hydroxyzine Pamoate. This list is not final. These side effects have been recorded previously, but are not always recorded when using the drug. Some of these side effects may be extremely rare, but have incredibly severe consequences. If you notice any side effects, contact your doctor immediately. Especially in the case of observing side effects for a long time.

    • Dry mouth
    • Tremor
    • Seizures

    If you experience side effects not listed above, contact your healthcare provider for advice. In addition, you can report side effects to your local Food and Drug Administration.

    Precautions

    Before starting this drug, tell your doctor about any medications you are taking, nutritional supplements (such as vitamins, natural supplements, etc.), allergies, existing medical conditions, and current health conditions (such as pregnancy, upcoming surgery, and etc.). The side effects of the drug may be more pronounced depending on the state of your body. Take this medicine as directed by your doctor, or follow the directions for use that come with your medicine. The dosage of the drug depends on your condition. Tell your doctor if there is no change or if your condition worsens. Important points to discuss with your healthcare provider are listed below.

    • Elderly patients
    • use caution when driving a car or operating heavy machinery

    For this information, please consult your physician, pharmacist or read the information on the product packaging.

    FAQ

    • Is it safe to drive or operate heavy machinery while using this product?

      If you experience drowsiness, dizziness, hypotension or a headache as side-effects when using Pamoate Pamoate medicine then it may not be safe to drive a vehicle or operate heavy machinery. You should stop driving if taking this medicine makes you drowsy, dizzy, or hypotensive. Doctors recommend that you stop drinking alcohol with such drugs, because. alcohol greatly increases the side effects and drowsiness. Please check for these effects on your body when using Hydroxyzine Pamoate. Be sure to consult your doctor for advice based on the characteristics of your body and general health.

    • Is this drug (product) addictive or addictive?

      Most drugs are not habit-forming or addictive. In most cases, the state classifies drugs that can be addictive as controlled dispensing drugs. For example, schedule H or X in India and schedule II-V in the USA. Please check the information on the drug packaging to make sure that this drug is not in the controlled category. Also, do not self-medicate or accustom your body to medications without consulting your doctor.

    • Can I stop using this product immediately or do I need to slowly stop using it?

      Some medications need to be stopped gradually due to a rebound effect. Be sure to consult your healthcare provider for advice based on your body, general health, and other medications you may be taking.

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