MECLIZINE HYDROCHLORIDE tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NuCare Pharmaceuticals,Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

For the management of nausea and vomiting, and dizziness associated with motion sickness. Meclizine Hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

Vörulýsing:

12.5 mg (Blue, oval-shaped, scored, debossed with TL122) NDC 68071-3308-2 Bottles of 20 NDC 68071-3308-3 Bottles of 30 NDC 68071-3308-6 Bottles of 60 NDC 68071-3308-9 Bottles of 90 Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 03/11

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
MECLIZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Chemically, Meclizine HCl is 1-( _p_-chloro-α-phenylbenzyl)-4-(
_m_-methylbenzyl) piperazine
dihydrochloride monohydrate.
C
H
ClN
. 2HCl . H
O M .W . 481 .88
Meclizine HCI Tablets, USP are available in two different strengths:
12.5 mg and 25 mg.
In addition each tablet contains the following inactive ingredients:
Colloidal Silicon Dioxide,
Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate,
Microcrystalline
Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg contains FD&C Blue
#1 Aluminum
Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow
#10
Aluminum Lake (15-20%).
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 management of nausea and vomiting, and dizziness associated
with motion
sickness.
CONTRAINDICATIONS
25
27
2
2
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 possibility and cautioned against driving a car or
operating dangerous
machinery.
Patients should avoid alcoholic beverages while taking this 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.
PRECAUTIONS
_PREGNANCY, Teratogenic Effects _
Pregnancy Category B. Reproduction studies in rats have shown cleft
palates at 25-50
times the human dose. Epidemiological studies in pregn