Atarax 10mg 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-Hypnotic
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Pharmacologic Class
H1-receptor antagonist
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Pregnancy Category
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 a medication that can help reduce anxiety, calm you down before a procedure, or relieve itching from allergies. It works by blocking a natural substance in your body called histamine, and it also has a calming effect on the brain.
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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, taking it with food may help.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep all medications in a safe place, 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. Instead, check with your pharmacist for guidance on the best disposal method. Your area may also have drug take-back programs available.

Missing a Dose

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

  • Avoid alcohol and other sedating medications (e.g., pain relievers, sleep aids) 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.
  • To relieve dry mouth, suck on sugar-free candy or ice chips, or use artificial saliva products.
  • Stay hydrated to help with dry mouth and constipation.
  • Avoid grapefruit juice, as it may interact with this medication.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: For anxiety: 50-100 mg four times daily. For pruritus: 25 mg three or four times daily. For sedation (pre-operative/post-operative): 50-100 mg single dose.
Dose Range: 10 - 400 mg

Condition-Specific Dosing:

anxiety: 50-100 mg QID
pruritus: 25 mg TID or QID
sedation: 50-100 mg single dose
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally avoided due to sedation and anticholinergic effects)
Child: For pruritus: 0.5-1 mg/kg/dose every 6 hours. For pre-operative sedation: 0.6 mg/kg single dose.
Adolescent: For pruritus: 0.5-1 mg/kg/dose every 6 hours (max 100 mg/day). For pre-operative sedation: 0.6 mg/kg single dose (max 100 mg).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for increased sedation.
Moderate: Consider 50% dose reduction or extend dosing interval.
Severe: Consider 50% dose reduction or extend dosing interval. Avoid if possible due to accumulation of active metabolite (cetirizine).
Dialysis: Hydroxyzine is not significantly removed by dialysis. Dose adjustment needed based on residual renal function.

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor for increased sedation.
Moderate: Consider 50% dose reduction or extend dosing interval.
Severe: Consider 50% dose reduction or extend dosing interval. Avoid if possible.

Pharmacology

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Mechanism of Action

Hydroxyzine is a first-generation piperazine antihistamine that acts as a potent H1-receptor antagonist. It also possesses anticholinergic, antiemetic, and mild bronchodilator properties. Its anxiolytic and sedative effects are attributed to its action on subcortical areas of the central nervous system.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: Adults: 14-25 hours (mean 20 hours); Elderly: ~29 hours; Children: 7-11 hours
Clearance: Not available
ExcretionRoute: Mainly renal, primarily as cetirizine and other metabolites.
Unchanged: <1% (as hydroxyzine)
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: Approximately 2 hours
DurationOfAction: 4-6 hours (sedative effects may persist longer)
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

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 develop a rash or any of these symptoms, contact your doctor immediately.

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 unusual symptoms that bother you or do not go away, contact your doctor:

Dry mouth
Drowsiness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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:

  • Excessive drowsiness or sedation that interferes with daily activities
  • Severe dizziness or lightheadedness
  • Difficulty urinating or inability to urinate
  • Blurred vision or eye pain
  • Confusion or hallucinations (especially in older adults)
  • Fast, pounding, or irregular heartbeat (palpitations)
  • Muscle tremors or uncontrolled movements
  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
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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. Do not initiate, stop, or adjust 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.

Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Before consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

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. Discuss this risk with your doctor.

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, notify your doctor. It is crucial to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe sedation or stupor
  • Coma
  • Seizures
  • Hypotension (low blood pressure)
  • Tachycardia (fast heart rate)
  • QT prolongation
  • Respiratory depression
  • Nausea and vomiting

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including gastric lavage, activated charcoal, and maintaining vital signs. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, certain antifungals, tricyclic antidepressants)
  • Drugs that cause electrolyte imbalance (e.g., hypokalemia, hypomagnesemia)
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Major Interactions

  • CNS depressants (e.g., alcohol, benzodiazepines, opioids, barbiturates, other sedatives, hypnotics) - increased sedation and respiratory depression
  • Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine, oxybutynin) - increased anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation)
  • Cholinesterase inhibitors (e.g., donepezil, rivastigmine) - hydroxyzine may antagonize their effects
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Moderate Interactions

  • CYP3A4/5 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - potential for increased hydroxyzine levels
  • CYP3A4/5 inducers (e.g., rifampin, carbamazepine, phenytoin) - potential for decreased hydroxyzine levels
  • Betahistine - hydroxyzine may antagonize its effects

Monitoring

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Baseline Monitoring

ECG

Rationale: To assess baseline QTc interval, especially in patients with pre-existing cardiac conditions or risk factors for QT prolongation.

Timing: Prior to initiation in at-risk patients.

Renal and Hepatic Function Tests

Rationale: To guide initial dosing and identify patients who may require dose adjustments due to impaired drug clearance.

Timing: Prior to initiation, especially in elderly or those with suspected impairment.

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Routine Monitoring

Sedation Level/Mental Status

Frequency: Daily or as needed, especially during dose titration.

Target: Desired level of sedation without excessive drowsiness or impairment.

Action Threshold: Excessive sedation, confusion, or paradoxical excitation warrants dose reduction or discontinuation.

Pruritus/Anxiety Symptom Relief

Frequency: Daily or as needed.

Target: Reduction in target symptoms.

Action Threshold: Lack of efficacy after appropriate trial warrants re-evaluation or alternative therapy.

Anticholinergic Side Effects (e.g., dry mouth, blurred vision, urinary retention, constipation)

Frequency: Daily or as needed.

Target: Absence or mild, tolerable symptoms.

Action Threshold: Severe or intolerable symptoms warrant dose reduction or discontinuation.

QTc Interval (if risk factors present)

Frequency: Periodically, especially with dose increases or initiation of interacting drugs.

Target: <450 ms (men), <470 ms (women)

Action Threshold: Significant QTc prolongation (>500 ms or >60 ms increase from baseline) warrants discontinuation and cardiology consultation.

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Symptom Monitoring

  • Drowsiness
  • Sedation
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Confusion (especially in elderly)
  • Tremor
  • Involuntary muscle movements (rare, e.g., dyskinesia)
  • Palpitations or irregular heartbeat (rare, indicative of QT prolongation)

Special Patient Groups

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Pregnancy

Hydroxyzine is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid use, especially in the first trimester, due to potential for fetal abnormalities observed in animal studies at high doses.

Trimester-Specific Risks:

First Trimester: Potential for fetal abnormalities; generally avoided.
Second Trimester: Use with caution; risks of sedation and anticholinergic effects in mother.
Third Trimester: Use with caution; risks of sedation and anticholinergic effects in mother and potential for withdrawal symptoms or respiratory depression in neonate if used close to delivery.
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Lactation

Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. Due to the potential for sedation, anticholinergic effects, and respiratory depression in the infant, hydroxyzine is generally not recommended during breastfeeding. If use is necessary, monitor the infant closely for adverse effects.

Infant Risk: L4 (Potentially Hazardous) - Risk of sedation, irritability, poor feeding, and respiratory depression in the infant. Consider alternative agents or temporary cessation of breastfeeding.
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Pediatric Use

Use with caution, especially in very young children, due to increased susceptibility to anticholinergic effects and paradoxical excitation. Dosing is weight-based. Not recommended for infants under 6 months.

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Geriatric Use

Elderly patients are more susceptible to the sedative and anticholinergic side effects (e.g., confusion, urinary retention, constipation, dry mouth, falls). Hydroxyzine is on the Beers Criteria list for potentially inappropriate medication use in older adults. Start with lower doses and titrate slowly. Avoid if possible, especially for chronic use.

Clinical Information

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Clinical Pearls

  • Hydroxyzine is a versatile first-generation antihistamine used for anxiety, pruritus, and sedation.
  • It has significant sedative and anticholinergic properties, which can be beneficial for some indications but problematic for others, especially in the elderly.
  • The active metabolite, cetirizine, is also an antihistamine (second-generation) and contributes to the overall effect.
  • Caution is advised with concomitant use of other CNS depressants or anticholinergic medications.
  • Monitor for QT prolongation, especially in patients with cardiac risk factors or those on other QT-prolonging drugs.
  • Often preferred over benzodiazepines for short-term anxiety or sleep in patients with a history of substance abuse due to lower abuse potential.
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Alternative Therapies

  • For anxiety: Buspirone, SSRIs/SNRIs, benzodiazepines (short-term), gabapentin, pregabalin.
  • For pruritus: Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine), topical corticosteroids, doxepin (topical or oral at low doses).
  • For sedation: Zolpidem, zaleplon, eszopiclone, trazodone, low-dose mirtazapine.
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (10mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.