Hydroxyzine Hydrochloride 25 MG Oral Tablet

Generic Name: HYDROXYZINE HYDROCHLORIDE
Brand Name: HYDROXYZINE HYDROCHLORIDE
  • Substance Name(s):
  • HYDROXYZINE HYDROCHLORIDE

OVERDOSAGE

SECTION 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. 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.

DESCRIPTION

SECTION HydrOXYzine hydrochloride has the chemical name of 2-[2-[4- (p-Chloro-α-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 or 50 mg hydrOXYzine HCl. Inactive ingredients include: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, polyethylene glycol, polysorbate 80, and titanium dioxide. image description

HOW SUPPLIED

SECTION HydrOXYzine Hydrochloride Tablets, USP, 10 mg – Round, white, film-coated tablet, debossed “H/105”, supplied in bottles of 100, 500, and 1000. Bottles of 100 NDC 23155-105-01 Bottles of 500 NDC 23155-105-05 Bottles of 1000 NDC 23155-105-10 25 mg – Round, white, film-coated tablet, debossed “H/106”, supplied in bottles of 100, 500, and 1000. Bottles of 100 NDC 23155-106-01 Bottles of 500 NDC 23155-106-05 Bottles of 1000 NDC 23155-106-10 50 mg- Round, white, film-coated tablet, debossed “H/107”, supplied in bottles of 100, 500, and 1000. Bottles of 100 NDC 23155-107-01 Bottles of 500 NDC 23155-107-05 Bottles of 1000 NDC 23155-107-10 Dispense in a tight container as defined in the USP. Store at controlled room temperature 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1-866-901-DRUG (3784) Iss.06/14

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION 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 & ADMINISTRATION SECTION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: Adults, 50-100 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: 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 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. Close