Šalis: Pietų Afrika
kalba: anglų
Šaltinis: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN SERTRALINE 50 MG (TABLET) ASPEN SERTRALINE 100 MG (TABLET) SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): ASPEN SERTRALINE 50 MG (TABLET) ASPEN SERTRALINE 100 MG (TABLET) COMPOSITION: Each tablet contains: ASPEN SERTRALINE 50 MG TABLET: Sertraline Hydrochloride 56 mg equivalent to Sertraline 50 mg base ASPEN SERTRALINE 100 MG TABLET: Sertraline Hydrochloride 112 mg equivalent to Sertraline 100 mg base 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 to 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 circula Perskaitykite visą dokumentą