Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
H.J. Harkins Company, Inc.
MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE 12.5 mg
ORAL
PRESCRIPTION DRUG
For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Meclizine Hydrochloride Tablets, USP 12.5 mg - blue, oval tablets debossed with “034” on one side and “par” on the other side. Tablets may contain characteristic dye spots. They are supplied in bottles of 100 (NDC 49884-034-01) and 1000 (NDC 49884-034-10). Meclizine Hydrochloride Tablets, USP 25 mg - yellow, oval tablets debossed with “035” on one side and “par” on the other side. They are supplied in bottles of 100 (NDC 49884-035-01) and 1000 (NDC 49884-035-10). Dispense in tight, light-resistant containers as defined in the USP. Store at controlled room temperature 15°-30°C (59°-86°F). Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, NY 10977 Repacked by: H.J. Harkins Company, Inc. Nipomo, CA 93444 Revised: 11/11 OS034-01-1-11
Abbreviated New Drug Application
MECLIZINE HYDROCHLORIDE - MECLIZINE HYDROCHLORIDE TABLET H.J. HARKINS COMPANY, INC. ---------- DESCRIPTION Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula: C H CIN •2HCI•H O M.W. 481.89 The chemical name is 1-(_p_-chloro-alpha-phenylbenzyl)-4-(_m_-methyl-benzyl) - piperazine dihydrochloride monohydrate. Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration. *Contains FD&C Yellow #5 (see PRECAUTIONS). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, and stearic acid. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5. CLINICAL PHARMACOLOGY Meclizine hydrochloride is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum. INDICATIONS AND USAGE For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness. CONTRAINDICATIONS Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it. WARNINGS 25 27 2 2 Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking the drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland. Do not give to children under 12 y Lugege kogu dokumenti