Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
ZYDUS-FLUOXETINE 20 mg (capsules) SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): ZYDUS-FLUOXETINE 20 mg (capsules) COMPOSITION: Each capsule contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine . PHARMACOLOGICAL CLASSIFICATION: A.1.2 Psychoanaleptics (antidepressants) PHARMACOLOGICAL ACTION: Fluoxetine is a selective serotonin (5-HT) uptake inhibitor in the central nervous system. The antidepressant and anti- obsessive-compulsive effects of fluoxetine are thought to be related to its effect on serotonergic neurotransmission. Pharmacokinetics: Fluoxetine is well absorbed after oral administration and metabolised by demethylation in the liver to the active metabolite, norfluoxetine, and other unidentified metabolites. The involvement of cytochrome P450 2D6(CYP2D6) has been identified in fluoxetine metabolism. The elimination half-life of fluoxetine is 4 to 6 days, whereas that of the active metabolite, norfluoxetine, is 4 to 16 days. Excretion is about 80% renal and approximately 15% in the faeces. INDICATIONS: ZYDUS-FLUOXETINE is indicated for the treatment of: • Major depressive disorders • Obsessive-compulsive disorder • Bulimia nervosa CONTRA-INDICATIONS: • Hypersensitivity to fluoxetine or to any of the ingredients. • Concomitant use of a monoamine oxidase inhibitor (MAOI). At least 14 days should elapse between discontinuing a MAOI and initiating therapy with ZYDUS-FLUOXETINE. In view of the long half-life of ZYDUS-FLUOXETINE at least 5 weeks should elapse after stopping therapy with ZYDUS-FLUOXETINE before starting a MAOI. If ZYDUS-FLUOXETINE has been prescribed chronically and/or at a high dose, a longer interval should be considered. There have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonu Read the complete document