MECLIZINE HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Life Line Home Care Services, Inc.

INN (Mezinárodní Name):

MECLIZINE HYDROCHLORIDE

Složení:

MECLIZINE 25 mg

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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.

Přehled produktů:

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

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

MECLIZINE HYDROCHLORIDE - MECLIZINE HYDROCHLORIDE TABLET
LIFE LINE HOME CARE SERVICES, INC.
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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.
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