Atarax 25mg Tablets

Manufacturer PFIZER U.S. Active Ingredient Hydroxyzine Capsules and Tablets(hye DROKS i zeen) Pronunciation hye DROKS i zeen
It is used to treat itching.It is used to treat anxiety.It is used to put you to sleep for surgery.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihistamine, Anxiolytic, Sedative
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Pharmacologic Class
First-generation H1-receptor antagonist
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Pregnancy Category
C
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FDA Approved
Mar 1956
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydroxyzine is an antihistamine that can help relieve itching from allergies, reduce anxiety, and cause drowsiness to help you relax before surgery. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction, and by affecting certain chemicals in the brain to produce a calming effect.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Ensure that all medications are kept in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a drug take-back program in your area.

Missing a Dose

If you take this medication on a regular schedule, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) as they can increase drowsiness and dizziness.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause significant drowsiness and impair your ability to perform tasks requiring alertness.
  • To relieve dry mouth, suck on sugarless candy or ice chips, chew sugarless gum, or use a saliva substitute.
  • Avoid overheating and dehydration, as this medication can reduce sweating and increase risk of heatstroke.

Dosing & Administration

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Adult Dosing

Standard Dose: 25 mg three to four times daily (for pruritus); 50-100 mg up to four times daily (for anxiety); 50-100 mg single dose (pre-operative sedation)
Dose Range: 25 - 400 mg

Condition-Specific Dosing:

pruritus: 25 mg three to four times daily
anxiety: 50-100 mg up to four times daily
pre_operative_sedation: 50-100 mg single dose
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with caution, generally not recommended)
Child: Pruritus: 0.5-1 mg/kg/dose every 6-8 hours; Pre-operative sedation: 0.6 mg/kg single dose
Adolescent: Pruritus: 25 mg three to four times daily; Anxiety: 50-100 mg up to four times daily; Pre-operative sedation: 50-100 mg single dose
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor for increased sedation
Moderate: Reduce dose by 50%
Severe: Reduce dose by 50-75%
Dialysis: Not significantly dialyzable; administer after dialysis, reduce dose

Hepatic Impairment:

Mild: No specific adjustment, monitor for increased sedation
Moderate: Reduce dose by 50%
Severe: Reduce dose by 50-75%

Pharmacology

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Mechanism of Action

Hydroxyzine is a first-generation piperazine derivative antihistamine that acts as a potent H1-receptor antagonist. Its anxiolytic, sedative, antiemetic, and anticholinergic effects are attributed to its central nervous system (CNS) depressant activity, including subcortical areas. It also has some bronchodilator and skeletal muscle relaxant properties.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (well absorbed)
Tmax: Approximately 2 hours
FoodEffect: Food may delay absorption but does not significantly affect bioavailability.

Distribution:

Vd: Approximately 16 L/kg
ProteinBinding: Approximately 93%
CnssPenetration: Yes

Elimination:

HalfLife: Adults: 14-25 hours (highly variable); Children: 7-11 hours; Elderly: Prolonged (up to 40 hours)
Clearance: Not available (primarily hepatic metabolism and renal excretion)
ExcretionRoute: Renal (primarily as metabolites, with a small amount of unchanged drug)
Unchanged: Less than 1% (as unchanged drug)
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: Approximately 2 hours
DurationOfAction: 4-6 hours (sedative effects), up to 24 hours (antihistaminic effects)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Fast or abnormal heartbeat
Severe dizziness or fainting
Difficulty controlling body movements
Confusion
A rare but serious skin reaction, characterized by:
+ Fever
+ Multiple small skin spots within large areas of redness and swelling

If you experience a rash or any of these symptoms, contact your doctor right away.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

Dry mouth
Drowsiness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or dizziness
  • Difficulty urinating
  • Blurred vision
  • Confusion or hallucinations
  • Fast, pounding, or irregular heartbeat (palpitations)
  • Fainting or severe dizziness (may indicate QT prolongation)
  • Unusual muscle movements or tremors
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of prolonged QT interval on an electrocardiogram (ECG).
If you are in the early stages of pregnancy. Note that this medication should not be taken during early pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. It is also crucial to discuss the use of alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter medications that may cause drowsiness, with your doctor beforehand.

This medication has been associated with an abnormal and potentially life-threatening heart rhythm known as long QT interval on an electrocardiogram (ECG), which may increase the risk of sudden death. Therefore, it is vital to consult with your doctor about this risk.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects.

If you are pregnant or planning to become pregnant, inform your doctor, as it is necessary to weigh the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Severe sedation
  • Stupor or coma
  • Seizures
  • Severe anticholinergic effects (e.g., severe dry mouth, dilated pupils, flushed skin, hyperthermia, urinary retention, absent bowel sounds)
  • Respiratory depression
  • Hypotension
  • Cardiac arrhythmias (including QT prolongation and Torsade de Pointes)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage may be considered if ingestion is recent. Activated charcoal may be administered. Monitor vital signs, cardiac rhythm (ECG), and respiratory function. Physostigmine may be used for severe anticholinergic symptoms, but with caution due to potential for cardiac effects. Do not induce vomiting.

Drug Interactions

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Contraindicated Interactions

  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, certain antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, tricyclic antidepressants, some antifungals)
  • Patients with known acquired or congenital QT prolongation
  • Patients with significant cardiovascular disease (e.g., recent myocardial infarction, uncompensated heart failure, clinically significant bradycardia, uncorrected hypokalemia or hypomagnesemia)
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Major Interactions

  • CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedatives/hypnotics): Increased CNS depression
  • Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine): Increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
  • Cholinesterase inhibitors (e.g., donepezil, rivastigmine): Reduced efficacy of cholinesterase inhibitors
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Moderate Interactions

  • CYP3A4/5 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase hydroxyzine levels (minor interaction)
  • CYP3A4/5 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease hydroxyzine levels (minor interaction)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Patient history (cardiac conditions, electrolyte imbalances, other medications)

Rationale: To identify risk factors for QT prolongation and drug interactions

Timing: Prior to initiation

ECG (Electrocardiogram)

Rationale: To assess baseline QTc interval, especially in patients with cardiac risk factors or on other QT-prolonging drugs

Timing: Prior to initiation (if risk factors present)

Electrolytes (Potassium, Magnesium)

Rationale: To ensure normal levels, as imbalances can increase risk of QT prolongation

Timing: Prior to initiation (if risk factors present)

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Routine Monitoring

Sedation level

Frequency: Daily, especially during dose titration

Target: Acceptable level of drowsiness without excessive impairment

Action Threshold: Excessive sedation, somnolence, impaired coordination; consider dose reduction or discontinuation

Anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)

Frequency: Daily

Target: Minimal to tolerable side effects

Action Threshold: Severe or intolerable anticholinergic symptoms; consider dose reduction or alternative

Cardiac rhythm (symptoms of arrhythmia, e.g., palpitations, dizziness, syncope)

Frequency: As needed, if symptoms arise

Target: Normal rhythm

Action Threshold: New onset of palpitations, dizziness, syncope; perform ECG, discontinue drug, investigate

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Confusion (especially in elderly)
  • Tremor
  • Palpitations
  • Syncope

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Avoid use, especially in early pregnancy, unless absolutely necessary.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal studies; avoid if possible.
Second Trimester: Limited data; use with caution.
Third Trimester: Potential for neonatal withdrawal symptoms (e.g., tremors, irritability) if used close to delivery; avoid if possible.
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Lactation

L4 (Potentially Hazardous). Not recommended during breastfeeding. Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. May cause sedation, irritability, or anticholinergic effects in the infant. May also decrease milk supply due to anticholinergic effects.

Infant Risk: Sedation, irritability, anticholinergic effects (e.g., dry mouth, constipation), potential for decreased milk supply.
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Pediatric Use

Use with caution, especially in infants and young children, due to increased susceptibility to CNS depression and anticholinergic effects. Dosing is weight-based. Not recommended for neonates. Paradoxical excitation may occur in some children.

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Geriatric Use

Use with extreme caution. Elderly patients are more susceptible to the sedative and anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth, falls). Start with the lowest effective dose and titrate slowly. Avoid if possible in patients with dementia or cognitive impairment due to increased risk of delirium and falls. Consider Beers Criteria recommendations.

Clinical Information

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Clinical Pearls

  • Hydroxyzine is a first-generation antihistamine with significant sedative and anticholinergic properties, making it useful for anxiety, pruritus, and pre-operative sedation.
  • Due to its sedative effects, it is often prescribed for bedtime use for pruritus or anxiety.
  • Caution is advised regarding its potential for QT prolongation, especially in patients with pre-existing cardiac conditions or those taking other QT-prolonging medications. An ECG may be warranted in high-risk patients.
  • The active metabolite, cetirizine, is a second-generation antihistamine with less sedation and anticholinergic effects.
  • Avoid concomitant use with alcohol or other CNS depressants.
  • Elderly patients are particularly vulnerable to adverse effects, including falls and cognitive impairment; use with extreme caution or consider alternatives.
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Alternative Therapies

  • For pruritus: Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine), topical corticosteroids.
  • For anxiety: Buspirone, benzodiazepines (short-term), SSRIs/SNRIs (long-term), gabapentin, pregabalin.
  • For sedation: Diphenhydramine, benzodiazepines.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (25mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.