Hydroxyzine Hydrochloride Oral
Generic Name: hydroxyzine hydrochloride oral
Brand Names:
Hydroxyzine Hydrochloride
DESCRIPTION Hydroxyzine hydrochloride, USP is designated chemically as (±)-2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows: C 21 H 27 ClN 2 O 2 •2HCl M.W. 447.83 g/mol Inactive ingredients for hydroxyzine hydrochloride oral solution, USP are: flavadew coolmint flavour; sodium benzoate; sucrose; and purified water. Anhydrous citric acid is used for pH adjustment. The pH range is between 2.0 and 4.3. Molecular Structure
Overview
DESCRIPTION Hydroxyzine hydrochloride, USP is designated chemically as (±)-2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows: C 21 H 27 ClN 2 O 2 •2HCl M.W. 447.83 g/mol Inactive ingredients for hydroxyzine hydrochloride oral solution, USP are: flavadew coolmint flavour; sodium benzoate; sucrose; and purified water. Anhydrous citric acid is used for pH adjustment. The pH range is between 2.0 and 4.3. Molecular Structure
Uses
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 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.
Dosage
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: in adults, 50 mg to 100 mg four times daily; children under 6 years, 50 mg daily in divided doses and children over 6 years, 50 mg 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: in adults, 25 mg three times to four times daily; children under 6 years, 50 mg daily in divided doses and children over 6 years, 50 mg to 100 mg daily in divided doses.
Side Effects
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Skin and appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP), fixed drug eruptions, pruritis, rash and urticaria in post marketing reports. Anticholinergic: Dry mouth. 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.
Warnings
WARNINGS Keep out of the 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. 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.
Storage
HOW SUPPLIED Hydroxyzine hydrochloride oral solution, USP 10 mg per 5 mL (teaspoonful) is a clear colourless, flavadew coolmint flavoured liquid, supplied in Pint (473 mL) bottles (NDC 69452-395-88). RECOMMENDED STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Hydroxyzine Hydrochloride Oral 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 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.
What are the side effects of Hydroxyzine Hydrochloride Oral?▼
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Skin and appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP), fixed drug eruptions, pruritis, rash and urticaria in post marketing reports. Anticholinergic: Dry mouth. 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.
What are the important warnings for Hydroxyzine Hydrochloride Oral?▼
WARNINGS Keep out of the 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. 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.