Detailed information
Composition:
Each capsule contains: sibutramine hydrochloride monohydrate 10 mg or 15 mg
Properties:
Sibutramine is an orally agent for the treatment of obesity, it is a centrally acting appetite suppressant drugs, it produces its therapeutic effects by norepinephrine, serotonin and dopamine reuptake inhibition . sibutramine exerts its pharmacolo¬gical actions via its secondary (Mi) and primary (M2)amine metabolites.
pharmacokinetics :
Sibutramine is rapidly absorbed from the GI tract following oral administration and undergoes extensive first pass metabolism in the liver.
The half-life is 1.1 h ,peak plasma concentrations are reached within 3 to 4hours, sibutramine and its metabotites are extensively bound to human plasma proteins. it is metabolized in the liver principally by the cytochrome P450 isoenzyme.
Indications:
Tramactil is used for the management of obesity , including weight loss and maintenance of weight loss and should be used in conjunction with a reduced calorie diet.
Contraindications:
Patients receiving monoamine oxidase inhibitors.
Patients with hypersensitivity to sibutramine or any of the ingredient Patients who have anorexia nervosa
Patients taking other centrally acting appetite suppressant drugs
Side effects:
Most commonly constipation , dry mouth , insomnia , nausea, tachycardia , palpitations , hypertension , vasodilation , headache , anxiety , sweating , taste disturbance, and rarely blurred vision.
Precautions:
Sibutramine increases blood pressure in some patients .regular monitoring of blood pressure is required when prescribing tramactil Sibutramine should not be used in severe hepatic or renal impairment.
Patients should be advised to inform their physicians if they are taking,
decongestants , antidepressants , cough suppressants , tryptophan.
The use of sibutramine during pregnancy and lactation is not recommended. The safety and effectiveness of sibutramine in pediatric patients under 16 years of age have not been established.
Drug interactions:
Caution is advised if the concomitant administration of tramactil with other
centrally-acting drugs is indicated.
At least 2 weeks should elapse between discontinuation of a MAOI and •
initiation of treatment with tramactil.
Caution should be used when prescribing tramactil to patients who use the drugs which may raise blood pressure or heart rate.
Dosage and administration:
Initially 10 mg daily with or without food daily in the morning . increase if weight loss less 2 kg after 4 weeks to 15 mg daily , discontinue if weight loss less than 2 kg after 4 weeks at higher dose . Maximum period of treatment 1 year.
Presentation:
box of 20 Capsuls lOmg. box of 20 Capsuls 15mg.
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