Orlistat (Listata Mini) 60 mg – [40 tablets]

Description

Listata Mini Pharmacodynamics
Orlistat is a potent, specific and reversible inhibitor of long-acting gastrointestinal lipases. Its therapeutic effect is carried out in the lumen of the stomach and small intestine and consists in the formation of covalent bonds with the active serine site of gastric and pancreatic lipases. The inactivated enzyme loses its ability to break down food fats that come in the form of triglycerides into absorbable free fatty acids and monoglycerides. Since unchecked triglycerides are not absorbed, the resulting decrease in the intake of calories into the body leads to a decrease in body weight. Thus, the therapeutic effect of the drug is carried out without absorption into the systemic bloodstream.
After oral administration, the content of fat in the feces increases after 24-48 hours. After discontinuation of the drug, the content of fat in feces usually returns to the initial level in 48-72 hours.
Reduction of body weight caused by using orlistat in dose of 60 mg 3 times a day is accompanied by other favorable effects: reduction of total cholesterol, low-density lipoprotein cholesterol and waist circumference.

Indications
Reduction of excessive body mass in adults with body mass index (BMI) > 28 kg/m2 when used only in combination with a moderately caloric diet containing not more than 30% of the daily caloric intake in the form of fat.

Contraindications
? Hypersensitivity to orlistat or any of the excipients of the drug;
? chronic malabsorption syndrome;
? cholestasis;
? concomitant use with warfarin or other indirect-acting oral anticoagulants;
? concomitant therapy with cyclosporine;
? concomitant use with sitagliptin;
? period of pregnancy and breast-feeding;
? age less than 18 years.
Use in pregnancy and during breastfeeding
Animal studies have shown no direct or indirect harmful effects of orlistat administration on pregnancy, embryo/fetal development, delivery, or postnatal development.
There are no clinical data on the use of orlistat during pregnancy, therefore the use of Listat Mini during pregnancy is contraindicated.
Due to the absence of data about orlistat penetration into breast milk, use of Listat Mini during breast feeding is contraindicated.

Directions for use and dosages.

• Orally. Recommended dose is 60 mg (1 tablet) 3 times a day with water, with each main meal, immediately before, during or not later than one hour after a meal. If a meal is skipped or the meal does not contain fat, the drug Listata Mini may be skipped.
• The maximum daily dose of the drug is 180 mg (not more than 3 tablets per day). Orlistat should be taken only in the recommended doses. The course of treatment should not exceed 6 months.
• Compliance with diet and physical activity regimen is recommended to start before taking Listat Mini. If after 12 weeks of the drug therapy by Listat Mini weight loss is not observed (ie, weight loss less than 5% of the initial weight), it is necessary to consult a physician to decide on the appropriateness of further therapy continuation.
• Use in special clinical groups of patients
• Elderly patients (>65 years)
  There are limited data on the use of orlistat in elderly patients. However, taking into account that absorption of orlistat is minimal, no dose adjustment is required in this group of patients.
• Patients with hepatic and renal insufficiency
  The effect of orlistat in patients with hepatic and/or renal insufficiency has not been studied. However, taking into account that absorption of orlistat is minimal, there is no need for dose adjustment in patients with hepatic and/or renal insufficiency.
• Children and adolescents
  The use of the drug in children and adolescents under the age of 18 years is contraindicated because of the lack of data on safety and efficacy in this age group.