MECLIZINE HYDROCHLORIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

RedPharm Drug, Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval-shaped, scored, debossed with TL122) Bottles of 100 NDC 59746-122-06 Bottles of 1000 NDC 59746-122-10 25 mg (Yellow, oval-shaped, scored, debossed with TL121) Bottles of 100 NDC 59746-121-06 Bottles of 1000 NDC 59746-121-10 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

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
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DESCRIPTION
Chemically, Meclizine HCl is
1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine
dihydrochloride monohydrate.
[Structure of Meclizine HCl]
C25H27ClN2. 2HCl. H2O 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
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 pregnant women,
however, do not
indicate that medi