MECLIZINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct_Rx

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:

Meclizine hydrochloride tablets, USP are available in the following strengths and package sizes: 12.5 mg (Blue, oval shaped tablets, debossed with “TL 122” with score on one side and plain on the other side.) Bottles of 100 Bottles of 1000 25 mg (Yellow, oval shaped tablets, debossed with “TL 121” with score on one side and plain on the other side.) Bottles of 100 Bottles of 1000 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 HYDROCHLORIDE TABLET
DIRECT_RX
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MECLIZINE HYDROCHLORIDE
Meclizine HCl, USP an oral antiemetic, is a white or slightly
yellowish, crystalline powder. It has the
following structural formula:
[Structure of Meclizine HCl]
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.
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 Tmax 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 meclizine in humans is unknown. In an in vitro
met