MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NuCare Pharmaceuticals,Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

25 mg (Yellow, oval shaped tablets, debossed with TL 121 with score on one side and plain on the other side.) NDC 68071-4694-4 BOTTLES OF 4 NDC 68071-4694-6 BOTTLES OF 6 Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised 05/2018

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCLORIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
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 Molecular Weight 481 .88
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%).
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
25
27
2
2
max
Drug distribution characteristics for meclizine in humans are unknown.
METABOLISM
The metabolic fate of meclizine in humans is unknown. In an _in vitro_
metabolic study
using human hepatic microsome and recombinant CYP enzyme, CYP2D6 was
found to
be the dominant enzyme for metabolism of meclizine.
The genetic polymorphism of CYP2D6 that results in extensive-, poor-,
intermediate- and
ultra-rapid metabolizer phenotypes could c