MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Meclizine Hydrochloride (UNII: HDP7W44CIO) (Meclizine - UNII:3L5TQ84570)

Available from:

Quality Care Products LLC

INN (International Name):

Meclizine Hydrochloride

Composition:

Meclizine Hydrochloride 12.5 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval-shaped, scored, debossed with TL122) NDC: 35356-901-30  Bottles of 30 NDC: 35356-901-60  Bottles of 60 NDC: 35356-901-90  Bottles of 90 25 mg (Yellow, oval-shaped, scored, debossed with TL121) NDC: 35356-914-20  Bottles of 20 NDC: 35356-914-30  Bottles of 30 NDC: 35356-914-60  Bottles of 60 NDC: 35356-914-90  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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE - MECLIZINE HYDROCHLORIDE TABLET
QUALITY CARE PRODUCTS LLC
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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 pregnant wome