Riik: Lõuna-Aafrika Vabariik
keel: inglise
Allikas: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
ZYLIN (Tablets) SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): ZYLIN (Tablets) COMPOSITION: Each film-coated ZYLIN tablet contains sertraline hydrochloride equivalent to 50 mg sertraline . PHARMACOLOGICAL CLASSIFICATION: A 1.2 Psychoanaleptics (Antidepressants) PHARMACOLOGICAL ACTION: The mechanism of action of sertraline is presumed to be linked to the inhibition of central nervous system neuronal uptake of serotonin (5HT). Sertraline blocks the uptake of serotonin into human platelets. Sertraline is a specific inhibitor of neuronal serotonin re-uptake and has only very weak effects on the norepinephrine and dopamine neuronal re-uptake. It is devoid of stimulant, sedative or anticholinergic activity or cardiotoxicity in animals. Sertraline does not enhance catecholaminergic activity and it has no affinity for cholinergic, serotonergic (5HT1A, 5HT1B, 5HT2), dopaminergic, adrenergic (alpha1, alpha2, beta) histaminergic, GABA or benzodiazepine receptors. Pharmacokinetics: The chronic administration of sertraline in animals was associated with downregulation of brain norepinephrine receptors as observed with other clinically effective antidepressants. Sertraline exhibits dose proportional pharmacokinetics over the range 50 mg –200 mg. After oral administration over the range of 50 –200 mg once daily for 14 days, mean peak blood levels are reached at 4,5 –8,4 hours post dose. The average terminal plasma half-life is about 26 hours. Steady-state plasma levels are reached after approximately one week of once daily dosing. Approximately 98% of the circulating drug is bound to plasma proteins. Consistent with the terminal elimination half-life, there is approximately two-fold accumulation with repeated dosing as compared to a single dose. Sertraline undergoes extensive Lugege kogu dokumenti