Description
Orsotene Slim Pharmacodynamics
Orlistat is a potent specific inhibitor of long-acting gastrointestinal lipases. It exhibits its therapeutic activity in the lumen of the stomach and small intestine, forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme loses its ability to hydrolyze dietary fats (triglycerides) into absorbable free fatty acids and monoglycerides. Unchecked triglycerides are not absorbed, which leads to a decrease in the number of calories absorbed by the body and to a decrease in body weight. Thus, the therapeutic effect of the drug is carried out without absorption into the systemic bloodstream. According to the results of clinical studies, orlistat taken daily in a dose of 60 mg 3 times a day blocks the absorption of about 25% of fats in the daily diet.
In addition to weight loss, long-term use of orlistat at a dose of 60 mg showed a decrease in such parameters as waist circumference, the concentration of total cholesterol (GCs) and the concentration of low-density lipoprotein cholesterol (LDL-C) in blood plasma. After 6 months of therapy with orlistat at a dose of 60 mg, the average plasma concentration of GCs decreased by an average of 2.4%, LDL cholesterol – by 3.5%. Waist circumference after 6 months of taking the drug decreases, on average, by 4.5 cm.
Indications
Reduction of excessive body weight in adult patients (over 18 years) with body mass index (BMI) more than 28 kg/m2. Used only in combination with a moderately hypocaloric diet containing no more than 30% of daily calories in the form of fat.
Contraindications .
– Hypersensitivity to orlistat or to any of the components of the drug;
– Chronic malabsorption syndrome;
– cholestasis;
– Concomitant use of cyclosporine;
– concomitant use of indirect anticoagulants (warfarin);
– concomitant use of sitagliptin;
– Pregnancy and breast-feeding;
– Under 18 years of age.
Pregnancy and lactation:
Orsotene® Slim should not be used during pregnancy due to the lack of reliable clinical data confirming the safety of its use.
It is not known whether orlistat penetrates into the breast milk, and therefore the use of Orsothen® Slim is not recommended during breast-feeding.
Dosage and administration
- For adult patients, the recommended dose of Orsothen® Slim is 60 mg (1 capsule) 3 times a day with each main meal, in combination with a moderately hypocaloric low-fat diet. The capsule should be taken immediately before a meal, with a meal or no later than 1 hour after a meal, with water. If a meal is skipped or if the food does not contain fat, it is possible to skip taking Orsothen® Slim.
- No more than 3 capsules of Orsoten® Slim may be taken during a day.
- Orsotene® Slim should be taken only in the recommended doses.
- Treatment is recommended for no more than 6 months. It is recommended to discuss the results of weight loss with your doctor. If after 12 weeks of using Orsotene® Slim there is no decrease in body weight (i.e., weight loss is less than 5% of the initial weight loss), a physician should be consulted to decide whether to continue taking the drug.