Hydroxyzine

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Hydroxyzine®
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration and Monitoring
IV Compatibility
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Drug Names
Drug Shortage Status
Price

For patient information regarding Hydroxyzine, click here.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-In-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Hydroxyzine is an antihistamine that is FDA approved for the treatment of for symptomatic relief of anxiety and tension associated with psychoneurosis, pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus, sedative when used as premedication and following general anesthesia. Common adverse reactions include xerostomia, headache, somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Symptomatic relief of anxiety
  • Dosing Information
  • For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50–100 mg q.i.d.
Chronic Urticaria
  • Dosing Information
  • For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.
Sedative when used as premedication and following general anesthesia
  • Dosing Information
  • As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
  • As a sedative when used as a premedication and following general anesthesia: 50–100 mg in adults.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydroxyzine in adult patients.

Non–Guideline-Supported Use

Seasonal allergic rhinitis
  • Dosing Information

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Symptomatic relief of anxiety
  • Dosing Information
  • For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: children under 6 years, 50 mg daily in divided doses and over 6 years, 50–100 mg daily in divided doses.
Chronic Urticaria
  • Dosing Information
  • For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: children under 6 years, 50 mg daily in divided doses and over 6 years, 50–100 mg daily in divided doses.
Sedative when used as premedication and following general anesthesia
  • Dosing Information
  • As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
  • As a sedative when used as a premedication and following general anesthesia: 0.6 mg/kg in children.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydroxyzine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non-Guideline-Supported Use of Hydroxyzine in pediatric patients.

Contraindications

  • Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.
  • Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to it.

Warnings

Precautions

  • THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore when central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced.
  • Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Atarax. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

Adverse Reactions

Clinical Trials Experience

  • Side effects reported with the administration of Atarax (hydroxyzine hydrochloride) are usually mild and transitory in nature.
  • Anticholinergic
  • Central Nervous System
  • Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Hydroxyzine in the drug label.


Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category

Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydroxyzine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hydroxyzine during labor and delivery.

Nursing Mothers

  • It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Hydroxyzine with respect to pediatric patients.

Geriatic Use

  • A determination has not been made whether controlled clinical studies of ATARAX included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
  • The extent of renal excretion of ATARAX has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.
  • Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of ATARAX and observed closely.

Gender

There is no FDA guidance on the use of Hydroxyzine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hydroxyzine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hydroxyzine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hydroxyzine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hydroxyzine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hydroxyzine in patients who are immunocompromised.


Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Hydroxyzine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Hydroxyzine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • The most common manifestation of Atarax overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
  • If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and Levophed® (levarterenol), or Aramine® (metaraminol). Do not use epinephrine as Atarax counteracts its pressor action.

Management

  • There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

Chronic Overdose

There is limited information regarding Chronic Overdose of Hydroxyzine in the drug label.

Pharmacology

Hydroxyzine.png
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Hydroxyzine
Systematic (IUPAC) name
(±)-2-(2-{4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl}ethoxy)ethanol
Identifiers
CAS number 68-88-2
ATC code N05BB01
PubChem 3658
DrugBank DB00557
Chemical data
Formula C21H27ClN2O2 
Mol. mass 374.904 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability High in-vivo
Protein binding 93%
Metabolism Hepatic
Half life 20–24 hours[1]
Excretion Urine, Feces
Therapeutic considerations
Pregnancy cat.

A(AU) C(US)

Legal status

Prescription Only (S4)(AU) Prescription only

Routes Oral, IM

Mechanism of Action

  • Atarax is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity, and anti- histaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and Atarax's clinical effects are usually noted within 15 to 30 minutes after oral administration.

Structure

  • Hydroxyzine hydrochloride is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy)-ethyl] piperazine dihydrochloride.
  • Inert ingredients for the tablets are: acacia; carnauba wax; dibasic calcium phosphate; gelatin; lactose; magnesium stearate; precipitated calcium carbonate; shellac; sucrose; talc; white wax. The 10 mg tablets also contain: sodium hydroxide; starch; titanium dioxide; Yellow 6 Lake. The 25 mg tablets also contain: starch; velo dark green. The 50 mg tablets also contain: starch; velo yellow. The 100 mg tablets also contain: alginic acid; Blue 1; polyethylene glycol; Red 3.
  • The inert ingredients for the syrup are: alcohol; menthol; peppermint oil; sodium benzoate; spearmint oil; sucrose; water.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Hydroxyzine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Hydroxyzine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Hydroxyzine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Hydroxyzine in the drug label.

How Supplied

  • Atarax Tablets
  • 10 mg–orange tablets
    • 100's (NDC 0049-5600-66)
  • 25 mg–green tablets
    • 100's (NDC 0049-5610-66),
    • 500's (NDC 0049-5610-73)
  • 50 mg–yellow tablets
    • 100's (NDC 0049-5620-66)
  • Atarax 100 Tablets
  • 100 mg–red tablets
    • 100's (NDC 0049-5630-66)
  • Atarax Syrup
  • 10 mg per teaspoon (5 ml)
    • 1 pint bottles (NDC 0049-5590-93)
    • Alcohol Content–Ethyl Alcohol–0.5% v/v


Images

Drug Images

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This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

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This image of the FDA label is provided by the National Library of Medicine.
Hydroxyzine02.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Hydroxyzine in the drug label.

Precautions with Alcohol

  • Alcohol-Hydroxyzine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. Simons FE, Simons KJ, Frith EM (January 1984). "The pharmacokinetics and antihistaminic of the H1 receptor antagonist hydroxyzine". The Journal of Allergy and Clinical Immunology 73 (1 Pt 1): 69–75. doi:10.1016/0091-6749(84)90486-x. PMID 6141198.
  2. ATARAX- hydroxyzine hydrochloride tablet ATARAX- hydroxyzine hydrochloride syrup.

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