MECLIZINE HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)

제공처:

H.J. Harkins Company, Inc.

INN (International Name):

MECLIZINE HYDROCHLORIDE

구성:

MECLIZINE HYDROCHLORIDE 12.5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

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

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

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