MECLIZINE HYDROCHLORIDE- meclizine tablet MECLIZINE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Major Pharmaceuticals

INN (International Name):

MECLIZINE HYDROCHLORIDE

Sammensætning:

MECLIZINE HYDROCHLORIDE 12.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Management of nausea and vomiting, and dizziness associated with motion sickness. Meclizine HCl, USP is contraindicated in individuals who have shown a previous hypersensitivity to it.

Produkt oversigt:

Meclizine HCl Tablets, USP 12.5 mg, are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. They are available as follows: 100 Tablets in unit dose blisters per box, NDC 0904-6516-61 Meclizine HCl Tablets, USP 25 mg, are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: 100 Tablets in unit dose blisters per box, NDC 0904-6517-61 (10 cards of 10 tablets each) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Rx only Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Rev. 10-2015-00

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MECLIZINE HYDROCHLORIDE- MECLIZINE TABLET
MAJOR PHARMACEUTICALS
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MECLIZINE HCL TABLETS, USP
DESCRIPTION
Chemically, meclizine HCl, USP is
1-(_p_-chloro-α-phenylbenzyl)-4-(_m_-methylbenzyl)
piperazine dihydrochloride monohydrate.
Inactive ingredients for the tablets are: colloidal silicon dioxide,
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, sodium starch
glycolate and talc. The
12.5 mg tablets also contain FD&C Blue #1 Aluminum Lake. The 25 mg
tablets also
contain D&C Yellow #10 Aluminum Lake.
CLINICAL PHARMACOLOGY
Meclizine HCl 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
max
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 to 6 hours in
humans.
INDICATIONS AND USAGE
Management of nausea and vomiting, and dizziness associated with
motion sickness.
CONTRAINDICA