MECLIZINE HYDROCHLORIDE- meclizine tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

PD-Rx Pharmaceuticals, Inc.

Designació comuna internacional (DCI):

MECLIZINE HYDROCHLORIDE

Composición:

MECLIZINE HYDROCHLORIDE 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Meclizine Hydrochloride Tablets, USP are available containing 25 mg of meclizine hydrochloride, USP. The 25 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 25 on the other side. They are available as follows: NDC 43063-662-10 bottles of 10 tablets NDC 43063-662-15 bottles of 15 tablets NDC 43063-662-30 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

MECLIZINE HYDROCHLORIDE- MECLIZINE TABLET
PD-RX PHARMACEUTICALS, INC.
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DESCRIPTION
Chemically, meclizine hydrochloride, USP is 1-(
_p_-Chloro-α-phenylbenzyl)-4-( _m_-methylbenzyl)
piperazine dihydrochloride monohydrate. The molecular weight is 481.88
g/mole.
Meclizine hydrochloride tablets, USP are available in two different
strengths, 12.5 mg and 25 mg.
Inert ingredients for the tablets are: anhydrous lactose, colloidal
silicon dioxide, crospovidone,
magnesium stearate and microcrystalline cellulose.
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 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 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.
max
INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of
vertigo associated with diseases
affec