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HydrOXYzine Drug Information Provided by Lexi-Comp

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Medication Safety Issues

Sound-alike/look-alike issues:

HydrOXYzine may be confused with hydrALAZINE, hydroxyurea

Atarax® may be confused with amoxicillin, Ativan®

Vistaril® may be confused with Restoril®, Versed, Zestril®

International issues:

Vistaril® may be confused with Vastarel® which is a brand name for trimetazidine in multiple international markets

Pronunciation

(hye DROKS i zeen)

U.S. Brand Names

  • Vistaril®

Index Terms

  • Hydroxyzine Hydrochloride
  • Hydroxyzine Pamoate

Generic Available

Yes

Canadian Brand Names

  • Apo-Hydroxyzine®
  • Atarax®
  • Hydroxyzine Hydrochloride Injection, USP
  • Novo-Hydroxyzin
  • PMS-Hydroxyzine
  • Vistaril®

Pharmacologic Category

  • Antiemetic
  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, First Generation

Pharmacologic Category Synonyms

  • Antihistamine
  • Antihistamine, H1 Selective
  • H1 Antagonist
  • H1 Blocker
  • First Generation H1 Antagonist

Use: Labeled Indications

Treatment of anxiety; preoperative sedative; antipruritic

Use: Dental

Treatment of anxiety, as a preoperative sedative in pediatric dentistry

Use: Unlabeled/Investigational

Antiemetic; ethanol withdrawal symptoms

Pregnancy Risk Factor

C

Pregnancy Considerations

Hydroxyzine-induced fetal abnormalities at high dosages in animal studies. Neonatal withdrawal symptoms have been reported following long-term maternal use or the use of large doses near term. Use in early pregnancy is contraindicated by the manufacturer.

Lactation

Excretion in breast milk unknown/not recommended

Contraindications

Hypersensitivity to hydroxyzine or any component of the formulation; early pregnancy; SubQ, intra-arterial, or I.V. administration of injection

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

Disease-related concerns:

• Glaucoma: Use with caution in patients with narrow-angle glaucoma; condition may be exacerbated by cholinergic blockade. Screening is recommended.

• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.

• Respiratory disease: Use with caution in patients with asthma or COPD.

Concurrent drug therapy issues:

• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.

Special populations:

• Elderly: Anticholinergic effects are not well tolerated in the elderly; may be useful as a short-term antipruritic, but it is not recommended for use as a sedative or anxiolytic in the this population.

Other warnings/precautions:

• Appropriate administration: I.V., SubQ, and intra-arterial administration are contraindicated since tissue damage, intravascular hemolysis, thrombosis, and digital gangrene can occur.

Adverse Reactions

Frequency not defined.

Central nervous system: Dizziness, drowsiness, fatigue, hallucination, headache, nervousness, seizure

Dermatologic: Pruritus, rash, urticaria

Gastrointestinal: Xerostomia

Neuromuscular & skeletal: Involuntary movements, paresthesia, tremor

Ocular: Blurred vision

Respiratory: Thickening of bronchial secretions

Miscellaneous: Allergic reaction

Metabolism/Transport Effects

Inhibits CYP2D6 (weak)

Drug Interactions

Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Paliperidone. Risk C: Monitor therapy

Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase CNS depression).

Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).

Storage

Injection: Store at 15°C to 30°C. Protect from light.

Compatibility

Compatibility in syringe: Compatible: Atropine, atropine with meperidine, butorphanol, chlorpromazine, cimetidine, codeine, diphenhydramine, doxapram, droperidol, fentanyl, fluphenazine, glycopyrrolate, hydromorphone, lidocaine, meperidine, methotrimeprazine, metoclopramide, midazolam, morphine, nalbuphine, oxymorphone, pentazocine, perphenazine, procaine, prochlorperazine edisylate, promazine, promethazine, scopolamine, sufentanil. Incompatible: Dimenhydrinate, haloperidol, ketorolac, pentobarbital, ranitidine.

Mechanism of Action

Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. Possesses skeletal muscle relaxing, bronchodilator, antihistamine, antiemetic, and analgesic properties.

Pharmacodynamics/Kinetics

Onset of action: Oral: 15-30 minutes

Duration: 4-6 hours

Absorption: Oral: Rapid

Metabolism: Forms metabolites

Half-life elimination: 3-7 hours

Time to peak: ?2 hours

Excretion: Urine

Dosage

Children:

Preoperative sedation:

Oral: 0.6 mg/kg/dose

I.M.: 0.5-1 mg/kg/dose

Pruritus, anxiety: Oral:

<6 years: 50 mg daily in divided doses

?6 years: 50-100 mg daily in divided doses

Adults:

Antiemetic (unlabeled use): I.M.: 25-100 mg/dose every 4-6 hours as needed

Anxiety: Oral, I.M.: 50-100 mg 4 times/day

Preoperative sedation:

Oral: 50-100 mg

I.M.: 25-100 mg

Pruritus: Oral, I.M.: 25 mg 3-4 times/day

Dosing interval in hepatic impairment: Change dosing interval to every 24 hours in patients with primary biliary cirrhosis

Dental Usual Dosing

Anxiety: Adults: Oral: 50-100 mg 4 times/day

Preoperative sedation:

Children:

Oral: 0.6 mg/kg/dose

I.M.: 0.5-1 mg/kg/dose

Adults:

Oral: 50-100 mg

I.M.: 25-100 mg

Administration: I.M.

Do not administer SubQ or intra-arterially. Administer I.M. deep in large muscle.

Administration: I.V.

Extravasation can result in sterile abscess and marked tissue induration.

Administration: I.V. Detail

pH: 3.5-6.0

Monitoring Parameters

Relief of symptoms, mental status, blood pressure

Patient Education

Will cause drowsiness. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Use caution when driving or engaging in activities requiring alertness until response to drug is known. Report hallucinations, seizure activity, tremors or involuntary movements, or loss of sensation. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is contraindicated.

Geriatric Considerations

Anticholinergic effects are not well tolerated in the elderly and frequently result in bowel, bladder, and mental status changes (ie, constipation, confusion, and urinary retention). Hydroxyzine may be useful as a short-term antipruritic, but it is not recommended for use as a sedative or anxiolytic in the elderly.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Comment

Commonly used as an anxiolytic, especially in individuals with a history of or active substance use. Postmarketing experience revealed cases of headache and hallucinations.

Nursing: Physical Assessment/Monitoring

Assess other medications patient may be taking for effectiveness and possible interactions. Systemic: Monitor therapeutic effectiveness and adverse reactions; ensure patient safety (institute safety precautions), have patient void prior to administration; and ensure adequate hydration and environmental temperature control. Oral: Monitor therapeutic effectiveness according to purpose for use and adverse reactions. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.

Oncology: Emetic Potential

Very low (<10%)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, as pamoate: 25 mg, 50 mg, 100 mg

Vistaril®: 25 mg, 50 mg

Injection, solution, as hydrochloride: 25 mg/mL (1 mL); 50 mg/mL (1 mL, 2 mL, 10 mL)

Suspension, oral, as pamoate:

Vistaril®: 25 mg/5 mL (120 mL, 480 mL) [lemon flavor] [DSC]

Syrup, as hydrochloride: 10 mg/5 mL (120 mL, 480 mL)

Tablet, as hydrochloride: 10 mg, 25 mg, 50 mg

Pricing: U.S. (www.drugstore.com)

Capsules (HydrOXYzine Pamoate)

25 mg (60): $14.98

50 mg (90): $19.00

100 mg (30): $19.99

Capsules (Vistaril)

25 mg (30): $45.99

50 mg (30): $53.39

Solution (HydrOXYzine HCl)

50 mg/mL (25): $44.38

Suspension (Vistaril)

25 mg/5 mL (240): $102.98

Tablets (HydrOXYzine HCl)

10 mg (30): $17.99

50 mg (30): $30.99

References

Baumgartner T, “Administration of Hydroxyzine Injection,” Am J Hosp Pharm, 1979, 36(12):1660.

Serreau R, Komiha M, Blanc F, et al, “Neonatal Seizures Associated With Maternal Hydroxyzine Hydrochloride in Late Pregnancy,” Reprod Toxicol, 2005, 20(4):573-4.

Simons FE, Simons KJ, and Frith EM, “The Pharmacokinetics and Antihistaminic of the H1 Receptor Antagonist Hydroxyzine,” J Allergy Clin Immunol, 1984, 73(1 Pt 1):69-75.

Simons FE, Watson WT, Chen XY, et al, “The Pharmacokinetics and Pharmacodynamics of Hydroxyzine in Patients With Primary Biliary Cirrhosis,” J Clin Pharmacol, 1989, 29(9):809-15.

Simons KJ, Watson WT, Chen XY, et al, “Pharmacokinetic and Pharmacodynamic Studies of the H1-Receptor Antagonist Hydroxyzine in the Elderly,” Clin Pharmacol Ther, 1989, 45(1):9-14.

International Brand Names

  • Abacus (TH)
  • Antizine (TH)
  • Atarax (AT, AU, BB, BE, BG, BM, BS, BZ, CH, CZ, DE, DK, ES, FI, FR, GB, GR, GY, HK, HN, HU, IE, IN, IT, JM, LU, MX, MY, NL, NO, PE, PL, PT, RU, SE, SR, TH, TR, TT)
  • Atarax Uce (PK)
  • Ataraxone (AR)
  • Aterax (ZA)
  • Bestalin (ID)
  • Cedar (CO)
  • Centilax (KP)
  • Cerax (TH)
  • Disron-P (JP)
  • Drazine (TH)
  • Hiderax (CO)
  • Histan (TH)
  • Hizin (SG, TH)
  • Hydroksyzyna (PL)
  • Hydroxyzinum (PL)
  • Iremofar (GR)
  • Iterax (ID, PH)
  • Otarex (IL)
  • Paxistil (BE)
  • Postarax (TH)
  • Prurid (PY)
  • Qualidrozine (HK)
  • R-Rax (TH)
  • Serecid (NZ)
  • Trandozine (TH)
  • Ucerax (IE, KP)
  • Unamine (TH)
  • Vistaril (KE, SE, TR, TW)
  • Warazix (JP)

Lexi-Comp.com

Last full review/revision August 2008

Content last modified August 2008

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