País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
AvKARE
MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE 12.5 mg
ORAL
PRESCRIPTION DRUG
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Meclizine Hydrochloride 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. Meclizine Hydrochloride 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: Bottles of 1000: NDC 42291-609-10 Meclizine Hydrochloride Tablets, USP 50 mg, are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured for: AvKARE Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of New York, LLC Brookhaven, NY 11719 Mfg. Rev. 10-2019-05 AV 03/23
Abbreviated New Drug Application
MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET AVKARE ---------- MECLIZINE HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Chemically, meclizine hydrochloride, 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 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 max 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 to 6 hours in humans. INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment Llegiu el document complet