Hydroxyzine
FDA Drug Information • Also known as: Hydroxyzine, Hydroxyzine Hydrochloride
- Brand Names
- Hydroxyzine, Hydroxyzine Hydrochloride
- Route
- ORAL
- Dosage Form
- TABLET, FILM COATED
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 0 2
What Is Hydroxyzine Used For?
INDICATIONS AND USAGE 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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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 and Administration
DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: Adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 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: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic: Dry mouth. Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose. Involuntary motor activity including rare instances of tremor and convulsions has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System: QT prolongation, Torsade de Pointes. In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole: Allergic reaction. Nervous System: Headache. Psychiatric: Hallucination. Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports. Pruritus, rash, urticaria. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings and Precautions
WARNINGS 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.
Contraindications
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 is contraindicated in patients with a prolonged QT interval. 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.
Overdosage
OVERDOSAGE The most common manifestation of hydroxyzine 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 levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts its pressor action. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose. 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.
How Supplied
HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are white, round, film-coated, biconvex tablets containing 10 mg, 25 mg, or 50 mg of Hydroxyzine Hydrochloride, and supplied as: 10 mg Tablets: Debossed ‘75’ on one side and ‘A’ on the other NDC 65162-575-10 Bottles of 100 NDC 65162-575-50 Bottles of 500 NDC 65162-575-11 Bottles of 1000 25 mg Tablets: Debossed ‘71’ on one side and ‘AN’ on the other NDC 65162-671-10 Bottles of 100 NDC 65162-671-50 Bottles of 500 NDC 65162-671-11 Bottles of 1000 50 mg Tablets: Debossed ‘77’ on one side and ‘AN’ on the other NDC 65162-577-10 Bottles of 100 NDC 65162-577-50 Bottles of 500 NDC 65162-577-11 Bottles of 1000 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (if required) and in a tight container as defined in the USP. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev: 10-2016-00
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.