Hydroxyzine Hydrochloride

Class: Anxiolytics, Sedatives, and Hypnotics; Miscellaneous
Note: This monograph also contains information on Hydroxyzine Pamoate
VA Class: CN309
CAS Number: 2192-20-3
Brands: Anx, Atarax, Vistaril

Introduction

Antihistamine; piperazine-derivative.^b

Uses for Hydroxyzine Hydrochloride

Anxiety

Symptomatic management of anxiety and tension associated with psychoneuroses and as an adjunct in patients with organic disease states who have associated anxiety;^{a c} however, most clinicians consider other anxiolytic agents (e.g., benzodiazepines) more effective.^c

Has been used to allay anxiety in prepartum and postpartum states.^{b c}

Has been used for prompt control of acutely disturbed or hysterical patients.^{b c}

Pruritus

Management of pruritus caused by allergic conditions (e.g., chronic urticaria, atopic or contact dermatoses) and in histamine-mediated pruritus.^{a c}

Preoperative and Postoperative Adjunctive Therapy

Sedation before and after general anesthesia.^{a c}

Has been used to reduce opiate analgesic requirements.^{b c}

Alcohol Withdrawal

Has been used to manage agitation caused by acute alcohol withdrawal.^{b c}

Motion Sickness

Has been used to control motion sickness.^c

Nausea and Vomiting

Management of nausea and vomiting of various etiologies (e.g., postoperative).^{b c}

Safety for prevention and treatment of nausea and vomiting of pregnancy not established; contraindicated during early pregnancy.^{a b c}

Hydroxyzine Hydrochloride Dosage and Administration

Administration

Administer orally or by IM injection.^{a b}

Do not administer parenteral preparation by sub-Q, intra-arterial, or IV injection.^{b c}

Oral therapy should replace IM therapy as soon as possible.^b

IM Administration

Administer commercially available injection without further dilution.^b

Use caution to avoid extravasation or inadvertent sub-Q, IV, or intra-arterial injection (see Local Effects under Cautions).^{b c} Z-track injection technique may prevent sub-Q infiltration.^c

Adults: Administer preferably deep into the upper outer quadrant of the gluteus maximus or the midlateral thigh.^{b c} To avoid radial nerve injury, use the deltoid area with caution and only if well developed.^{b c} Do not administer into the lower and mid-third of the upper arm.^{b c}

Children: Administer into the midlateral muscles of the thigh.^{b c}

Infants and small children: If IM injection is required, administer in the periphery of the upper outer quadrant of the gluteus maximus.^{b c} (See Pediatric Use under Cautions.)

Dosage

Available as hydroxyzine pamoate and hydroxyzine hydrochloride; dosage expressed in terms of the hydrochloride.^b

Use the smallest possible effective dosage.^{b c}

Pediatric Patients

Anxiety

Oral

Children <6 years of age: 50 mg daily given in divided doses.^{a c}

Children ≥6 years of age: 50–100 mg daily given in divided doses.^{a c}

Pruritus

Oral

Children <6 years of age: 50 mg daily given in divided doses.^{a c}

Children ≥6 years of age: 50–100 mg daily given in divided doses.^{a c}

Preoperative and Postoperative Adjunctive Therapy

Sedation

Oral

0.6 mg/kg administered before and following general anesthesia.^{a c}

IM

1.1 mg/kg administered before and following general anesthesia.^{b c}

Nausea and Vomiting

IM

Initially, 1.1 mg/kg; adjust subsequent dosage according to individual requirements and response.^{b c}

Adults

Anxiety

Oral

50–100 mg 4 times daily.^{a c}

Prepartum and Postpartum Anxiety

IM

Initially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.^{b c}

Acutely Disturbed or Hysterical Patients

IM

50–100 mg repeated every 4–6 hours as needed to control symptoms.^{b c}

Pruritus

Oral

25 mg 3 or 4 times daily.^{a c}

Preoperative and Postoperative Adjunctive Therapy

Sedation

Oral

50–100 mg administered before and following general anesthesia.^{a c}

IM

25–100 mg administered before and following general anesthesia.^b

Reduction of Opiate Analgesic Requirements

IM

Initially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.^b

Alcohol Withdrawal

IM

50–100 mg repeated every 4–6 hours as needed to control symptoms.^{b c}

Nausea and Vomiting

IM

Initially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.^b

Special Populations

Geriatric Patients

Use initial dosage at low end of the recommended dosage range.^{a b} (See Geriatric Use under Cautions.)

Cautions for Hydroxyzine Hydrochloride

Contraindications

• 
  

  Early pregnancy.^{a b c}

  
  


• 
  

  Known hypersensitivity to hydroxyzine.^{a b c}

  
  

Warnings/Precautions

General Precautions

Nervous System Effects

Possible drowsiness; performance of activities requiring mental alertness or physical coordination may be impaired.^{a b c}

Concurrent use of other CNS depressants may potentiate CNS depression.^{a b c} (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.^c (See Administration under Dosage and Administration.)

Phlebitis and hemolysis reported following IV administration.^c

Specific Populations

Pregnancy

Category C.^a Contraindicated in early pregnancy.^{a b c}

Lactation

Not known whether hydroxyzine is distributed into milk.^{a b} Use is not recommended.^a

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.^{b c}

Geriatric Use

Response similar to that in younger adults, however, possible increased risk of sedative effects.^{a b} Close observation and cautious dosing recommended.^{a b}

Common Adverse Effects

Drowsiness, dry mouth.^{a b}

Interactions for Hydroxyzine Hydrochloride

Specific Drugs

Drug	Interaction	Comments
Anticholinergic agents	Additive anticholinergic effectsc
CNS depressants (e.g., alcohol, opiates and other analgesics, anesthetics, barbiturates, sedatives)	Additive CNS effectsa	Use caution to avoid excessive sedation; reduce CNS depressant dosage by up to 50%a b
Epinephrine	Inhibition and reversal of vasopressor effect of epinephrinec	If vasopressor is required, use alternative drug (e.g., norepinephrine)b

Hydroxyzine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration.^c

Onset

Onset of sedative action is 15–30 minutes following oral administration.^{c e}

Duration

Sedative effect persists for 4–6 hours following single dose.^c

Suppresses the inflammatory response (wheal and flare reaction) and pruritus for up to 4 days after intradermal skin tests with allergens and histamine.^c

Distribution

Extent

Widely distributed into most body tissues and fluids in animals.^c Not known whether hydroxyzine crosses the placenta or is distributed into milk.^e

Elimination

Metabolism

Exact metabolic fate not clearly established; appears to be completely metabolized, principally in the liver.^c Carboxylic acid metabolite is cetirizine, a long-acting antihistamine.^{c e}

Elimination Route

Excreted in feces via biliary elimination.^c

Half-life

20 hours.^e

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at ≤40°C (preferably 15–30°C).^c

Suspension or Solution

Tight, light-resistant containers at ≤40°C (preferably 15–30°C).^c Avoid freezing.^c

Parenteral

Injection

<30°C.^b Avoid freezing.^b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Drug Compatibility

Syringe CompatibilityHID

Compatible
Atropine sulfate
Atropine sulfate with meperidine HCl
Butorphanol tartrate
Chlorpromazine HCl
Cimetidine HCl
Codeine phosphate
Diphenhydramine HCl
Doxapram HCl
Droperidol
Fentanyl citrate
Fluphenazine HCl
Glycopyrrolate
Hydromorphone HCl
Lidocaine HCl
Meperidine HCl
Meperidine HCl with atropine sulfate
Metoclopramide HCl
Midazolam HCl
Morphine sulfate
Nalbuphine HCl
Oxymorphone HCl
Pentazocnie lactate
Perphenazine
Procaine HCl
Prochlorperazine edisylate
Promethazine HCl
Scopolamine HBr
Sufentanil citrate
Incompatible
Dimenhydrinate
Haloperidol lactate
Ketorolac tromethamine
Pentobarbital sodium
Ranitidine HCl

ActionsActions

• 
  

  Exhibits antihistaminic, CNS depressant, anticholinergic, antispasmodic, local anesthetic activity, analgesic, sedative and antiemetic activity.^{a b c} Also exhibits primary skeletal muscle relaxant activity.^{a b}

  
  


• 
  

  Sedative and tranquilizing effects result principally from suppression of activity at subcortical levels of the CNS.^a

  
  


• 
  

  Antispasmodic activity apparently mediated through interference with the mechanism that responds to spasmogenic agents such as acetylcholine, histamine, and serotonin.^b

  
  


• 
  

  Antiemetic and antimotion sickness actions may result at least in part from central anticholinergic and CNS depressant properties.^c

  
  

Advice to Patients

• 
  

  Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.^a

  
  


• 
  

  Importance of avoiding CNS depressants, including alcohol-containing beverages or products.^a

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^a

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a

  
  


• 
  

  Importance of informing patients of other important precautionary information.^a (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hydroxyzine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	10 mg/5 mL*	Atarax Syrup (with alcohol 0.5%)	Pfizer
	Tablets	10 mg*	Atarax	Pfizer
		25 mg*	Atarax	Pfizer
		50 mg*	Atarax	Pfizer
		100 mg	Atarax	Pfizer
	Tablets, film-coated	10 mg*
		25 mg*	Anx (scored)	EconoMed
		50 mg*
Parenteral	Injection, for IM use only	25 mg/mL*	Vistaril (with benzyl alcohol 0.9%)	Pfizer
		50 mg/mL*	Vistaril (with benzyl alcohol 0.9%)	Pfizer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hydroxyzine Pamoate

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 (with propylene glycol)	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 05/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

HydrOXYzine HCl 10MG/5ML Syrup (MORTON GROVE PHARMACEUTICALS): 473/$61.99 or 1419/$149.97

HydrOXYzine HCl 10MG Tablets (TEVA PHARMACEUTICALS USA): 30/$17.99 or 90/$35.97

HydrOXYzine HCl 50MG Tablets (HARRIS PHARMACEUTICAL): 30/$30.99 or 90/$72.98

HydrOXYzine HCl 50MG Tablets (TEVA PHARMACEUTICALS USA): 30/$30.99 or 90/$72.98

HydrOXYzine Pamoate 100MG Capsules (TEVA PHARMACEUTICALS USA): 30/$19.99 or 90/$55.99

HydrOXYzine Pamoate 25MG Capsules (SANDOZ): 60/$14.98 or 90/$22.47

Vistaril 25MG Capsules (PFIZER U.S.): 30/$58.43 or 90/$154.33

Vistaril 50MG Capsules (PFIZER U.S.): 30/$67.24 or 90/$180.56

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Pfizer Inc. Vistaril capsules and oral suspension prescribing information. New York, NY; 2001 Oct.

b. Vistaril (hydroxyzine hydrochloride) intramuscular solution prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2003. Updated 2003 Oct. 12.

c. AHFS Drug Information 2003. McEvoy GK, ed. Hydroxyzine Hydrochloride Hydroxyzine Pamoate. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1294-6.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:913-19.

e. Simons FE, Simons KJ, Frith EM. The pharmacokinetics and antihistaminic of the H1 receptor antagonist hydroxyzine. J Allergy Clin Immunol. 1984; 73:69-75. [PubMed 6141198]

More Hydroxyzine Hydrochloride resources

• Hydroxyzine Hydrochloride Side Effects (in more detail)
• Hydroxyzine Hydrochloride Use in Pregnancy & Breastfeeding
• Drug Images
• Hydroxyzine Hydrochloride Drug Interactions
• Hydroxyzine Hydrochloride Support Group
• 99 Reviews for Hydroxyzine Hydrochloride - Add your own review/rating

• Atarax Consumer Overview


• Atarax MedFacts Consumer Leaflet (Wolters Kluwer)


• Atarax Prescribing Information (FDA)


• Hydroxyzine Prescribing Information (FDA)


• Hydroxyzine MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydroxyzine Professional Patient Advice (Wolters Kluwer)


• Vistaril Prescribing Information (FDA)


• Vistaril Consumer Overview

Compare Hydroxyzine Hydrochloride with other medications

• Allergic Urticaria
• Allergies
• Anxiety
• Interstitial Cystitis
• Nausea/Vomiting
• Pain
• Pruritus
• Sedation