hydrOXYzine Hydrochloride, hydrOXYzine Pamoate (Monograph)
Brand names: Anx, Atarax, Vistaril
Drug class: Anxiolytics, Sedatives, and Hypnotics; Miscellaneous
Introduction
Antihistamine; piperazine-derivative.
Uses for hydrOXYzine Hydrochloride, hydrOXYzine Pamoate
Anxiety
Symptomatic management of anxiety and tension associated with psychoneuroses and as an adjunct in patients with organic disease states who have associated anxiety; however, most clinicians consider other anxiolytic agents (e.g., benzodiazepines) more effective.
Has been used to allay anxiety in prepartum and postpartum states.
Has been used for prompt control of acutely disturbed or hysterical patients.
Pruritus
Management of pruritus caused by allergic conditions (e.g., chronic urticaria, atopic or contact dermatoses) and in histamine-mediated pruritus.
Preoperative and Postoperative Adjunctive Therapy
Sedation before and after general anesthesia.
Has been used to reduce opiate analgesic requirements.
Alcohol Withdrawal
Has been used to manage agitation caused by acute alcohol withdrawal.
Motion Sickness
Has been used to control motion sickness.
Nausea and Vomiting
Management of nausea and vomiting of various etiologies (e.g., postoperative).
Safety for prevention and treatment of nausea and vomiting of pregnancy not established; contraindicated during early pregnancy.
hydrOXYzine Hydrochloride, hydrOXYzine Pamoate Dosage and Administration
Administration
Administer orally or by IM injection.
Do not administer parenteral preparation by sub-Q, intra-arterial, or IV injection.
Oral therapy should replace IM therapy as soon as possible.
IM Administration
For solution and drug compatibility information, see Compatibility under Stability.
Administer commercially available injection without further dilution.
Use caution to avoid extravasation or inadvertent sub-Q, IV, or intra-arterial injection (see Local Effects under Cautions). Z-track injection technique may prevent sub-Q infiltration.
Adults: Administer preferably deep into the upper outer quadrant of the gluteus maximus or the midlateral thigh. To avoid radial nerve injury, use the deltoid area with caution and only if well developed. Do not administer into the lower and mid-third of the upper arm.
Children: Administer into the midlateral muscles of the thigh.
Infants and small children: If IM injection is required, administer in the periphery of the upper outer quadrant of the gluteus maximus. (See Pediatric Use under Cautions.)
Dosage
Available as hydroxyzine pamoate and hydroxyzine hydrochloride; dosage expressed in terms of the hydrochloride.
Use the smallest possible effective dosage.
Pediatric Patients
Anxiety
Oral
Children <6 years of age: 50 mg daily given in divided doses.
Children ≥6 years of age: 50–100 mg daily given in divided doses.
Pruritus
Oral
Children <6 years of age: 50 mg daily given in divided doses.
Children ≥6 years of age: 50–100 mg daily given in divided doses.
Preoperative and Postoperative Adjunctive Therapy
Sedation
Oral0.6 mg/kg administered before and following general anesthesia.
IM1.1 mg/kg administered before and following general anesthesia.
Nausea and Vomiting
IM
Initially, 1.1 mg/kg; adjust subsequent dosage according to individual requirements and response.
Adults
Anxiety
Oral
50–100 mg 4 times daily.
Prepartum and Postpartum Anxiety
IMInitially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.
Acutely Disturbed or Hysterical Patients
IM50–100 mg repeated every 4–6 hours as needed to control symptoms.
Pruritus
Oral
25 mg 3 or 4 times daily.
Preoperative and Postoperative Adjunctive Therapy
Sedation
Oral50–100 mg administered before and following general anesthesia.
IM25–100 mg administered before and following general anesthesia.
Reduction of Opiate Analgesic Requirements
IMInitially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.
Alcohol Withdrawal
IM
50–100 mg repeated every 4–6 hours as needed to control symptoms.
Nausea and Vomiting
IM
Initially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.
Special Populations
Geriatric Patients
Use initial dosage at low end of the recommended dosage range. (See Geriatric Use under Cautions.)
Cautions for hydrOXYzine Hydrochloride, hydrOXYzine Pamoate
Contraindications
-
Early pregnancy.
-
Known hypersensitivity to hydroxyzine.
Warnings/Precautions
General Precautions
Nervous System Effects
Possible drowsiness; performance of activities requiring mental alertness or physical coordination may be impaired.
Concurrent use of other CNS depressants may potentiate CNS depression. (See Specific Drugs under Interactions.)
Local Effects
Possible marked local discomfort, sterile abcesses, erythema, local irritation, and tissue necrosis at injection site; extravasation may cause marked localized sub-Q tissue induration. (See Administration under Dosage and Administration.)
Phlebitis and hemolysis reported following IV administration.
Specific Populations
Pregnancy
Category C. Contraindicated in early pregnancy.
Lactation
Not known whether hydroxyzine is distributed into milk. Use is not recommended.
Pediatric Use
Possible damage to sciatic nerve associated with IM administration in infants and small children; administer IM only when necessary in the periphery of the upper outer quadrant of the gluteus maximus.
Geriatric Use
Response similar to that in younger adults, however, possible increased risk of sedative effects. Close observation and cautious dosing recommended.
Common Adverse Effects
Drowsiness, dry mouth.
Drug Interactions
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Anticholinergic agents |
Additive anticholinergic effects |
|
CNS depressants (e.g., alcohol, opiates and other analgesics, anesthetics, barbiturates, sedatives) |
Additive CNS effects |
Use caution to avoid excessive sedation; reduce CNS depressant dosage by up to 50% |
Epinephrine |
Inhibition and reversal of vasopressor effect of epinephrine |
If vasopressor is required, use alternative drug (e.g., norepinephrine) |
hydrOXYzine Hydrochloride, hydrOXYzine Pamoate Pharmacokinetics
Absorption
Bioavailability
Rapidly absorbed following oral administration.
Onset
Onset of sedative action is 15–30 minutes following oral administration.
Duration
Sedative effect persists for 4–6 hours following single dose.
Suppresses the inflammatory response (wheal and flare reaction) and pruritus for up to 4 days after intradermal skin tests with allergens and histamine.
Distribution
Extent
Widely distributed into most body tissues and fluids in animals. Not known whether hydroxyzine crosses the placenta or is distributed into milk.
Elimination
Metabolism
Exact metabolic fate not clearly established; appears to be completely metabolized, principally in the liver. Carboxylic acid metabolite is cetirizine, a long-acting antihistamine.
Elimination Route
Excreted in feces via biliary elimination.
Half-life
20 hours.
Stability
Storage
Oral
Capsules
Tight, light-resistant containers at ≤40°C (preferably 15–30°C).
Suspension or Solution
Tight, light-resistant containers at ≤40°C (preferably 15–30°C). Avoid freezing.
Parenteral
Injection
<30°C. Avoid freezing.
Compatibility
Parenteral
Drug Compatibility
Compatible |
---|
Atropine sulfate |
Buprenorphine HCl |
Butorphanol tartrate |
Chlorpromazine HCl |
Diphenhydramine HCl |
Doxapram HCl |
Droperidol |
Fentanyl citrate |
Fluphenazine HCl |
Glycopyrrolate |
Hydromorphone HCl |
Lidocaine HCl |
Meperidine HCl |
Metoclopramide HCl |
Midazolam HCl |
Morphine sulfate |
Nalbuphine HCl |
Pentazocine lactate |
Prochlorperazine edisylate |
Promethazine HCl |
Scopolamine HBr |
Incompatible |
Dimenhydrinate |
Haloperidol lactate |
Ketorolac tromethamine |
Pentobarbital sodium |
Ranitidine HCl |
Actions
-
Exhibits antihistaminic, CNS depressant, anticholinergic, antispasmodic, local anesthetic activity, analgesic, sedative and antiemetic activity. Also exhibits primary skeletal muscle relaxant activity.
-
Sedative and tranquilizing effects result principally from suppression of activity at subcortical levels of the CNS.
-
Antispasmodic activity apparently mediated through interference with the mechanism that responds to spasmogenic agents such as acetylcholine, histamine, and serotonin.
-
Antiemetic and antimotion sickness actions may result at least in part from central anticholinergic and CNS depressant properties.
Advice to Patients
-
Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.
-
Importance of avoiding CNS depressants, including alcohol-containing beverages or products.
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
-
Importance of informing patients of other important precautionary information. (See Cautions.)
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Solution |
10 mg/5 mL* |
Atarax Syrup |
Pfizer |
Tablets |
10 mg* |
Atarax |
Pfizer |
|
25 mg* |
Atarax |
Pfizer |
||
50 mg* |
Atarax |
Pfizer |
||
100 mg |
Atarax |
Pfizer |
||
Tablets, film-coated |
25 mg* |
Anx (scored) |
EconoMed |
|
Parenteral |
Injection, for IM use only |
25 mg/mL* |
Vistaril |
Pfizer |
50 mg/mL* |
Vistaril |
Pfizer |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Capsules |
equivalent to hydroxyzine hydrochloride 25 mg* |
Vistaril |
Pfizer |
equivalent to hydroxyzine hydrochloride 50 mg* |
Vistaril |
Pfizer |
||
equivalent to hydroxyzine hydrochloride 100 mg* |
Vistaril |
Pfizer |
||
Suspension |
equivalent to hydroxyzine hydrochloride 25 mg/5 mL |
Vistaril |
Pfizer |
AHFS DI Essentials™. © Copyright 2024, Selected Revisions September 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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