Hydroxyzine (oral)

Hydroxyzine (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Shanshan Cen, M.D. [2]

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Overview

Hydroxyzine (oral) is an antianxiety, antiemetic, central nervous system agent that is FDA approved for the treatment of anxiety and tension associated with psychoneurosis and pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses. It can be also used as a sedative when used as premedication and following general anesthesia. Common adverse reactions include xerostomia, headache, and somnolence..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

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.

The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Dosage

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.

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.

As a sedative when used as a premedication and following general anesthesia: 50-100 mg in adults.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxyzine (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

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.

The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Dosage

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: children over 6 years: 50-100 mg daily in divided doses.

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 children over 6 years, 50-100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 0.6 mg/kg in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.

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

Keep out of reach of children.

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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Hydroxyzine (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

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 (oral) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Hydroxyzine (oral) with respect to nursing mothers.

Pediatric Use

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

Geriatic Use

There is no FDA guidance on the use of Hydroxyzine (oral) with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Hydroxyzine (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Hydroxyzine (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Hydroxyzine (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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