Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ECTIVA® 10 Capsules RECALLED October 2010 ECTIVA® 15 Capsules RECALLED October 2010 SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): ECTIVA® 10 Capsules RECALLED October 2010 ECTIVA® 15 Capsules RECALLED October 2010 COMPOSITION Ectiva® 10 Each capsule contains Sibutramine hydrochloride monohydrate 10 mg equivalent to 8,37 mg of sibutramine free base. Ectiva® 15 Each capsule contains Sibutramine hydrochloride monohydrate 15 mg equivalent to 12,55 mg of sibutramine free base. PHARMACOLOGICAL CLASSIFICATION A 11.3 Anorexigenics PHARMACOLOGICAL ACTION Ectiva® is a serotonin (5-HT) and noradrenaline reuptake inhibitor (SNRI), which exerts its effects in vivo through its secondary and primary amine metabolites. In animal models, sibutramine reduces body weight gain by a dual action to decrease calorie intake through enhancement of post-ingestive satiety responses and to increase energy expenditure by enhancing resting metabolic rate. Pharmacokinetic properties Sibutramine is well absorbed and undergoes extensive first-pass metabolism. Peak plasma levels were achieved 1.2 hours after a single oral dose of 20 mg and half-life of the parent compound is 1.1 hours. The pharmacologically-active metabolites 1 and 2 reach Tmax in three hours with elimination half-lives of 14 and 16 hours, respectively. Linear kinetics have been demonstrated over the dose range 10 to 30 mg, with no dose-related change in elimination half-lives and a dose-proportionate increase in plasma concentrations. On repeated dosing, steady- state concentrations of metabolites 1 and 2 are achieved within four days, with an approximately two-fold accumulation. Pharmacokinetics of sibutramine and its metabolites are similar in obese subjects to those in normal weight subjects and there is no evi Прочитать полный документ