Krajina: Južná Afrika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Schering
LUVOX 100 tablets SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): LUVOX 100 tablets COMPOSITION Each Luvox 100 tablet contains fluvoxamine maleate (5-methoxy-4'-(trifluoromethyl)valerophenone(E)-O-(2- aminoethyl)oxime maleate (1:1)) 100 mg. PHARMACOLOGICAL CLASSIFICATION A. 1.2 Psychoanaleptics (antidepressants). PHARMACOLOGICAL ACTION Luvox is a psychotropic substance. Its mechanism of action is thought to be related to its specific serotonin re-uptake inhibition in brain neurones, whilst there is minimum interference with noradrenergic processes. Fluvoxamine maleate is variably absorbed after oral administration. The plasma half-life is approximately 15 hours after a single dose and 22 hours after multiple doses of 100 mg given orally. Fluvoxamine maleate is transformed in the liver into pharmacologically inactive metabolites which are excreted by the kidney. Steady state levels are attained within two weeks of treatment with a constant dose. The pharmacokinetic profile in elderly volunteers (over 60 years of age) did not differ substantially from that in a population with ages ranging from 20 to 35 years. INDICATIONS Luvox is indicated for the treatment of major depressive episodes and for the short-term treatment of severe, disabling obsessive-compulsive disorder, where the obsessions or compulsions cause marked distress, are time-consuming or significantly interfere with social or occupational functioning. CONTRA-INDICATIONS Sensitivity to fluvoxamine maleate. Pregnancy and lactation. Safety and efficacy have not been established in children. Safety in patients with liver dysfunction and moderate to pronounced renal function impairment has not been established. Safety has not been established in epileptics. Patients should not receive Luvox together with or within 2 weeks of termin Prečítajte si celý dokument