국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SERTRALINE HYDROCHLORIDE
PHARMAFORTE (MALAYSIA) SDN. BHD.
SERTRALINE HYDROCHLORIDE
100Capsule Capsules
APOTEX INC
NOT FOUND The requested URL /front-end/attachment/681/pharma/240256/Please refer to E12(6).pdf was not found on this server. 전체 문서 읽기
APO-SERTRALINE SERTRALINE HYDROCHLORIDE CAPSULES EQUIVALENT TO 50MG SERTRALINE ANTIDEPRESSANT PHARMACOLOGY The mechanism of action of sertraline is presumed to be linked to its ability to inhibit the neuronal reuptake of serotonin. It has only very weak effects on norepinephrine and dopamine neuronal reuptake. At clinical dose, sertraline blocks the uptake of serotonin into human platelets. Like most clinically effective antidepressants, sertraline down- regulates brain norepinephrine and serotonin receptors in animals. In receptor binding studies, sertraline has no significant affinity for adrenergic ( _alpha_ _1_ _, _ _alpha_ _2_ _ _ _& _ _beta_ ), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5-HT1A, 5- HT1B, 5-HT2) or benzodiazepine binding sites. Pharmacokinetics Following multiple oral once-daily doses of 200 mg, the mean peak plasma concentration (C max ) of sertraline is 0.19 µg/ml occurring between 6 to 8 hours post-dose. Following single or multiple oral once-daily doses of 50 to 400 mg/day the average terminal elimination half-life is approximately 26 hours. Linear dose proportionally has been demonstrated over the clinical dose range of 50 to 200 mg/day. Food appears to increase the bioavailability by about 40%; it is recommended that APO-SERTRALINE (sertraline hydrochloride) be administered with meals. Sertraline is extensively metabolized to N-desmethylsertraline, which shows negligible pharmacological activity. Both sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation and glucuronide conjugation. Biliary excretion of metabolites is significant. Approximately 98% of sertraline is plasma protein bound. The interactions between sertraline and other highly protein bound drugs have not been fully evaluated (see PRECAUTIONS). The pharmacokinetics of sertraline itself appears to be similar in young and elderly subjects. Plasma levels of N- desmethylsertraline show a 3-fold elevation in the elderly following multiple dosing, however, th 전체 문서 읽기