MECLIZINE HYDROCHLORIDE- 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:

REMEDYREPACK INC.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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.

Přehled produktů:

Meclizine Hydrochloride Tablets, USP are available as follows: 12.5 mg, blue, modified oval-shaped tablets, de-bossed “ Є12 ” on one side and plain on the other side. They are supplied as follows: NDC 42806-012-01 in bottles of 100 NDC 42806-012-10 in bottles of 1000 25 mg, white, modified oval-shaped tablets, de-bossed “ Є14 ” on one side and plain on the other side. They are supplied as follows: NDC 42806-014-01 in bottles of 100 NDC 42806-014-10 in bottles of 1000 Store at 20º to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Rev.05-2018-00 MF012REV05/18 OE1035

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET
REMEDYREPACK INC.
----------
MECLIZINE HYDROCHLORIDE TABLETS USP, 12.5 MG AND 25 MG
RX ONLY
DESCRIPTION
Chemically, meclizine hydrochloride is 1-(
_p_-chloro-α-phenylbenzyl)-4-( _m_-methylbenzyl) piperazine
dihydrochloride monohydrate.
C
H
CIN
·2HCl·H
0 M.W. 481.89
Meclizine hydrochloride tablets, USP are available in two different
strengths, 12.5 mg and 25 mg.
Inactive ingredients: microcrystalline cellulose, lactose monohydrate,
croscarmellose sodium and
magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1
Aluminum Lake.
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.
ABS ORPTION
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.
DIS TRIBUTION
Drug distribution characteristics for meclizine in humans are unknown.
METABOLIS M
The metabolic fate of meclizine in humans is unknown. In an _in vitro_
metabolic study using human hepatic
25
27
2
2
max
microsome and recombinant CYP enzyme, CYP 2D6 was found to be the
dominant enzyme for
metabolism of meclizine.
The genetic polymorphism of CYP2D6 that results in extensive-, poor-,
intermediate- and ultrarapid
metabolizer phenotypes could contribute to large inter-individual
variability in meclizine exposure.
ELIMINATION
Meclizine has a plasma elimination half-life of about 5-6 hours in
humans.
INDICATIONS AND USAGE
Meclizine hydroc