Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SERTRALINE HYDROCHLORIDE
Neshdwara Services
SERTRALINE HYDROCHLORIDE
28tablet Tablets
IPCA LABORATORIES LIMITED
MALAYSIA In-house P:\Art Work Data\Open Artworks\Inosert\Malaysia SIZE: 4 0 X 120 MM 0 Ph Code: 5050 STD _For the use only of a Registered Medical Practitioner or a Hospital or_ _a Laboratory_ Inosert Sertraline Tablets DESCRIPTION Sertraline is a selective serotonin reuptake inhibitor (SSRI) for oral administration. Sertraline hydrochloride has the following chemical name: (1S-cis) – 4 - (3,4 - dichlorophenyl) - 1,2,3,4 – tetrahydro –N- methyl-1-naphthalenamine hydrochloride. The empirical formula is C H NCl HCl with molecular weight of 342.7 (free base 306.2). 17 17 2 COMPOSITION INOSERT-50 Each film-coated tablet contains: Sertraline Hydrochloride equivalent to Sertraline 50 mg INOSERT-100 Each film-coated tablet contains: Sertraline Hydrochloride equivalent to Sertraline 100mg PRODUCT DESCRIPTION INOSERT-50: White to off white, caplet shaped, biconvex, film coated tablets. INOSERT-100: White to off white, caplet shaped, biconvex, film coated tablets. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Sertraline inhibits the CNS neuronal uptake of serotonin (5HT). Sertraline also blocks the uptake of serotonin into human platelets. Sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. Sertraline's inhibition of serotonin reuptake enhances serotonergic transmission, which results in subsequent inhibition of adrenergic activity in the locus ceruleus. Sertraline has no affinity for muscarinic, serotonergic, dopaminergic adrenergic, histaminergic, GABA or benzodiazepine receptors. It is devoid of stimulant, sedative or anticholinergic activity or cardiotoxicity in animals. PHARMACOKINETICS Sertraline appears to be slowly but well absorbed from the GI tract following oral administration with peak plasma concentrations occurring about 4.5 to 8.4 hours after ingestion. Area under the plasma concentration time curve (AUC) was slightly increased when drug was administered with food but the C was 25% greater, max while the Prečítajte si celý dokument