RVP

Drug Catalog - Product Detail

HYDROXYZINE HCL TAB 25MG 500CT

NDC Mfr Size Str Form
68462-0353-05 GLENMARK PHARMACEUTICALS 500 25MG TABLET
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Description
DESCRIPTION HydrOXYzine hydrochloride has the chemical name of 2-[2-[4-( p -Chloro--phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. HydrOXYzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg and 50 mg hydrOXYzine HCl. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and Opadry Beige (Hypromellose, Titanium dioxide, Iron oxide yellow, PEG 400, Iron oxide red, and Polysorbate 80). chemical_structure
How Supplied
HOW SUPPLIED HydrOXYzine Hydrochloride Tablets, USP 10 mg, 25 mg and 50 mg are supplied as follows: 10 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘ IG ’on one side and ‘ 275 ’on other. Bottles of 100 NDC # 68462-352-01 Bottles of 500 NDC # 68462-352-05 25 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘ IG ’on one side and ‘ 276 ’on other. Bottles of 100 NDC # 68462-353-01 Bottles of 500 NDC # 68462-353-05 50 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘ IG ’on one side and ‘ 277 ’on other. Bottles of 100 NDC # 68462-354-01 Bottles of 500 NDC # 68462-354-05 Dispense in a tight container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma.com/usa Rev: 10/16 logo
Indications & Usage
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. 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: in adults, 50-100 mg q.i.d.; 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: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50-100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50-100 mg in 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.