Vistaril 50mg Capsules

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
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, which also causes drowsiness.
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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. You may also have access to drug take-back programs in your area.

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 while taking hydroxyzine, as this can increase drowsiness and dizziness.
  • Do not drive or operate heavy machinery until you know how this medication affects you.
  • To relieve dry mouth, suck on sugar-free candy or ice chips, or use artificial saliva.
  • Stay hydrated to help with dry mouth and constipation.
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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 to four times daily. For sedation (pre-operative/post-operative): 50-100 mg single dose.
Dose Range: 25 - 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
Child: For pruritus/anxiety: 0.6 mg/kg/day in divided doses (e.g., 0.6 mg/kg/day to 2 mg/kg/day). Max 50 mg/day for children under 6 years, max 100 mg/day for children 6 years and older. For sedation: 0.6 mg/kg single dose.
Adolescent: For pruritus/anxiety: 25-100 mg/day in divided doses. For sedation: 50-100 mg single dose.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for increased sedation.
Moderate: Consider 50% dose reduction.
Severe: Consider 50% dose reduction and extend dosing interval.
Dialysis: Hydroxyzine is not significantly dialyzable. Administer after dialysis; consider dose reduction.

Hepatic Impairment:

Mild: Consider 50% dose reduction.
Moderate: Consider 50% dose reduction.
Severe: Consider 50% dose reduction and extend dosing interval.

Pharmacology

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Mechanism of Action

Hydroxyzine is a first-generation antihistamine that acts as a potent antagonist of histamine H1 receptors in the periphery and central nervous system. Its anxiolytic and sedative effects are primarily due to its central nervous system depression, likely related to its H1 antagonism and possibly its anticholinergic and anti-serotonergic activities. It also possesses antiemetic and mild bronchodilator properties.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but well-absorbed orally.
Tmax: 2-4 hours
FoodEffect: Food may delay Tmax but does not significantly affect AUC.

Distribution:

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

Elimination:

HalfLife: Adults: 14-25 hours (highly variable); Elderly: ~20 hours; Children: ~7 hours; Hepatic impairment: Prolonged.
Clearance: Not readily available, but primarily hepatic metabolism and renal excretion of metabolites.
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1% (urine)
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Pharmacodynamics

OnsetOfAction: 15-30 minutes (sedation/anxiolysis)
PeakEffect: 2-4 hours
DurationOfAction: 4-6 hours (sedation), 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
Abnormal or rapid 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 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 symptoms that bother you or persist, 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, 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:

  • Severe drowsiness or dizziness
  • Difficulty breathing
  • Severe dry mouth or difficulty urinating
  • Confusion or hallucinations
  • Tremors or uncontrolled muscle movements
  • Fast, pounding, or irregular heartbeat (palpitations) – seek immediate medical attention
  • Seizures (rare)
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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 symptoms you experienced.
If you have 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 issues with your doctor and pharmacist. They will help determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dosage 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 forms of cannabis, as well as prescription or over-the-counter (OTC) 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, notify your doctor. It is necessary to have a discussion with your doctor about 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
  • Confusion
  • Hallucinations
  • Slurred speech
  • Ataxia (loss of coordination)
  • Seizures
  • Hypotension
  • Tachycardia
  • QT prolongation
  • Respiratory depression
  • Coma

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately. Treatment is supportive, including gastric lavage, activated charcoal, and maintaining airway, breathing, and circulation. ECG monitoring is crucial due to QT prolongation risk. Physostigmine may be considered for severe anticholinergic symptoms but is rarely used due to potential for adverse cardiac effects.

Drug Interactions

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Contraindicated Interactions

  • Drugs known to prolong the QT interval (e.g., Class IA and III antiarrhythmics, certain antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, certain antifungals, methadone, citalopram, escitalopram)
  • Patients with known acquired or congenital QT prolongation
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Major Interactions

  • CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedating antihistamines): Increased sedation and respiratory depression.
  • Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine): Increased anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation).
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Moderate Interactions

  • Beta-blockers (e.g., metoprolol, propranolol): May increase hydroxyzine levels due to shared metabolic pathways (minor).
  • CYP3A4/5 inhibitors (e.g., ketoconazole, ritonavir): May slightly increase hydroxyzine levels, but not clinically significant for most patients.
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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

Baseline ECG (if risk factors for QT prolongation are present)

Rationale: To assess baseline QTc interval.

Timing: Prior to initiation

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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, impaired daily activities, or respiratory depression warrants dose reduction or discontinuation.

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

Frequency: Daily

Target: Minimal to tolerable

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

QTc interval (if risk factors or concomitant QT-prolonging drugs)

Frequency: As clinically indicated

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

Action Threshold: QTc >500 ms or increase of >60 ms from baseline warrants discontinuation and cardiology consultation.

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Confusion (especially in elderly)
  • Tremor
  • Seizures (rare)
  • Palpitations or irregular heartbeat (seek immediate medical attention)

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy, especially in the first trimester, due to limited human data and some animal studies showing fetal abnormalities at high doses. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal abnormalities (limited human data, some animal data). Avoid if possible.
Second Trimester: Less data, but still generally avoided due to lack of safety data.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., tremors, irritability) if used close to term. Risk of anticholinergic effects in neonate.
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Lactation

Not recommended during breastfeeding. Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. Potential for sedation, anticholinergic effects (e.g., dry mouth, urinary retention), and irritability in the infant.

Infant Risk: L3 (Moderately Safe) to L4 (Potentially Hazardous) - Risk of infant sedation, irritability, and anticholinergic effects. Monitor infant closely if used; consider alternative.
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Pediatric Use

Used in children for pruritus, anxiety, and sedation. Dosing is weight-based. Children may be more susceptible to paradoxical excitation or excessive sedation. Use with caution and monitor closely.

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Geriatric Use

Use with extreme caution due to increased sensitivity to anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth) and sedative effects. Elderly patients are at higher risk for falls and cognitive impairment. Included in the Beers Criteria as a medication to avoid in older adults due to its strong anticholinergic properties and risk of sedation. Start with the lowest effective dose and titrate slowly.

Clinical Information

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Clinical Pearls

  • Hydroxyzine is a first-generation antihistamine with significant sedative and anticholinergic properties, making it useful for short-term anxiety, pruritus, and pre-operative sedation.
  • It is NOT recommended for long-term management of generalized anxiety disorder due to its side effect profile and the availability of safer, more effective long-term treatments.
  • Due to the risk of QT prolongation, especially with higher doses or in patients with pre-existing cardiac conditions or on other QT-prolonging drugs, an ECG may be warranted before initiation.
  • The active metabolite, cetirizine (Zyrtec), is a second-generation antihistamine with less CNS penetration and fewer sedative/anticholinergic effects.
  • Patients should be warned about additive CNS depression with alcohol and other sedatives.
  • Often used as a non-benzodiazepine alternative for acute anxiety or insomnia, but its anticholinergic burden limits its utility, especially in the elderly.
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Alternative Therapies

  • For anxiety: Benzodiazepines (e.g., lorazepam, alprazolam - short-term), SSRIs/SNRIs (e.g., escitalopram, sertraline, duloxetine - long-term), Buspirone, Gabapentin, Propranolol.
  • For pruritus: Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine), topical corticosteroids, doxepin (topical or oral at low doses).
  • For sedation: Diphenhydramine, melatonin, zolpidem (for insomnia).
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (50mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (most insurance plans cover generic hydroxyzine well)
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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 this 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 overdose, including the medication taken, the amount, and the time it occurred.