البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
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 اقرأ الوثيقة كاملة