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:

St. Mary's Medical Park Pharmacy

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system. Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

Product summary:

25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) NDC 60760-087-90 BOTTLES OF 90 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP). Keep this and all medication out of the reach of children. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised 01/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCLORIDE TABLET
ST. MARY'S MEDICAL PARK PHARMACY
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MECLIZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Meclizine HCl, USP an oral antiemetic, is a white or slightly
yellowish, crystalline powder. It
has the following structural formula:
Chemically, Meclizine HCl is 1-( _p_-chloro-α-phenylbenzyl)-4-(
_m_-methylbenzyl) piperazine
dihydrochloride monohydrate.
Meclizine hydrochloride 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 hydrochloride tablets USP,
12.5 mg contains
FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine hydrochloride
tablets USP, 25 mg
contains D&C Yellow #10 Aluminum Lake (15-20%).
Each meclizine HCl 12.5 mg tablet contains 12.5 mg of meclizine
dihydrochloride
equivalent to 10.53 mg of meclizine free base.
Each meclizine HCl 25 mg tablet contains 25 mg of meclizine
dihydrochloride equivalent
to 21.07 mg of meclizine free base.
CLINICAL PHARMACOLOGY
Meclizine hydrochloride is an antihistamine that 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.
PHARMACOKINETICS
The available pharmacokinetic information for meclizine following oral
administration has
been summarized from published literature.
ABSORPTION
Meclizine is absorbed after oral administration with maximum plasma
concentrations
reaching at a median T
value of 3 hours post-dose (range: 1.5 to 6 hours) for the
tablet dosage form.
DISTRIBUTION
Drug distribution characteristics for meclizine in humans are unknown.
METABOLISM
The metabolic fate of