Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
NuCare Pharmaceuticals, Inc.
MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE 25 mg
ORAL
PRESCRIPTION DRUG
Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows: Effective: Management of nausea and vomiting, and dizziness associated with motion sickness. Final classification of the less than effective indications requires further investigation. Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Meclizine Hydrochloride Tablets USP are available as: 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 66267-801-04 in bottles of 4 NDC 66267-801-06 in bottles of 6 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 Manufactured in USA Revised January 2016 MF012REV01/16 OE1035
Abbreviated New Drug Application
MECLIZINE HYDROCHLORIDE- MECLIZINE HYDROCHLORIDE TABLET NUCARE PHARMACEUTICALS, 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. _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 25 27 2 2 max hepatic 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 Based on a Прочитајте комплетан документ