MECLIZINE HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

STAT Rx USA LLC

INN (Nome Internazionale):

MECLIZINE HYDROCHLORIDE

Composizione:

MECLIZINE HYDROCHLORIDE 12.5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

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 30        NDC  16590-301-30     Bottles of 60        NDC  16590-301-60     Bottles of 90        NDC  16590-301-90 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 14         NDC  16590-146-14     Bottles of 15         NDC  16590-146-15     Bottles of 20         NDC  16590-146-20     Bottles of 30         NDC  16590-146-30     Bottles of 40         NDC  16590-146-40     Bottles of 60         NDC  16590-146-60     Bottles of 90         NDC  16590-146-90 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   Revised: 11/09 OS034-01-1-11 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

MECLIZINE HYDROCHLORIDE - MECLIZINE HYDROCHLORIDE TABLET
STAT RX USA LLC
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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
Since drowsiness may, on occasion, occur with use of this drug,
patients should be warned of this
25
27
2
2
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 years of age