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Cover structure: Opadry II Blue (85F205040) — 34 mg, including polyvinyl alcohol — 40% titanium dioxide — 22.48%, macrogol 3350 — 20.20%, talc — 14.8%, lacquer alyumininievy blue — 2.28%, iron oxide yellow dye — 0.24%; Opadry silver (63F97546) — 6 mg, including polyvinyl alcohol — 47.03% talcum 27% — Macrogol 3350 — 13.27% pearlescent pigment — 10% polysorbate-80 — 2.7%. pharmachologic effect Orlistat — a powerful, specific and reversible inhibitor of gastrointestinal lipases having prolonged action. Its therapeutic effect is carried in the lumen of the stomach and small intestine and is to form a covalent bond with the active serine site of gastric and pancreatic lipases. Inactivated enzyme thus loses the ability to cleave food fats coming in the form of triglycerides, for soaked free fatty acids and monoglycerides. Since unsplit triglycerides are not absorbed, arising as a result of the reduction of calories in the body leads to a decrease in body weight. Thus, the therapeutic effect is carried out without absorption into the systemic circulation Side effects Data from clinical studies
Side effects of the drug are systematized with respect to each of the organ systems, depending on the frequency of occurrence, using the following classification: very common (more than 1/10); frequently (more than 1/100, less than 1/10); rare (more than 1/1000, less than 1/100); rarely (over 1/10000, 1/1000 less); very rare, including isolated reports (less than 1/10000). Adverse reactions encountered when using orlistat mainly by the gastrointestinal tract (GIT) and pharmacological effects were due orlistat prevents absorption of fat food. It is often observed phenomena such as oily discharge from the rectum, gassing with a certain amount of discharge, urgency to defecate, steatorrhea, increased frequency of bowel movements, diarrhea, flatulence, pain or discomfort in the abdomen. Their frequency increases with the fat content in food. Patients should be informed of the possibility of adverse reactions from the gastrointestinal tract and to teach how to solve their diet, particularly in relation to the amount of fat it contains. The use of a diet low in fat reduces the likelihood of side effects from the gastrointestinal tract and thereby help patients to monitor and regulate the intake of fat.
Typically, these side effects are mild and transient. They occur early in treatment (during the first three months), and most patients did not have more than one episode sale Properties prescription Special conditions Listata drug effective in long term control of body weight (body weight loss and its maintenance, prevention of weight gain retransmission). Treatment with Listata leads to improved risk profile and diseases associated with obesity, including hypercholesterolemia, type 2 diabetes, impaired glucose tolerance, hyperinsulinemia, hypertension, and decreases the amount of visceral fat.
When used in combination with hypoglycemic drugs such as metformin, sulfonylureas and / or insulin in patients with type 2 diabetes are overweight (BMI 2 2 less than 28 kg / m) or obese (BMI at least 30 kg / m ) Listata drug in combination with a moderately hypocaloric diet contributes to further improving the compensation of carbohydrate metabolism.
In clinical studies, the majority of patients the concentration of vitamins A, D, E, K and beta-carotene in the course of four years treatment with orlistat remained within normal limits. To ensure an adequate supply of minerals can be used multivitamins.
The patient should receive a balanced, moderately hypocaloric diet containing no more than 30% of energy intake in the form of fat. It is recommended a diet rich in fruits and vegetables. The daily intake of fat, carbohydrate and protein should be distributed into three basic techniques. The likelihood of adverse reactions from the gastrointestinal tract may increase if Listata take medication on a background of a diet rich in fat (eg 2000 kcal / day, of which more than 30% in the form of fat, which equals about 67 grams of fat). If the drug is taken with food Listata, very rich in fat, the possibility of gastrointestinal reactions increases.
In patients with type 2 diabetes, weight loss in the treatment of drug Listata accompanied by an improvement of compensation of carbohydrate metabolism, which may allow or require a dose reduction of hypoglycemic agents (eg, sulfonylureas).
Effects on ability to drive and use machines
Listata The drug does not affect the ability to drive and use machines. Patients with type 2 diabetes who use Listata drug in combination with hypoglycemic agents, should be careful in the management of vehicles and mechanisms in relation to the possible development of hypoglycemia accompanied by dizziness, visual impairment. testimony Prolonged treatment of obese patients with a body mass index (BMI) of at least 30 kg / m or patients who are overweight with a BMI of at least 28 kg / m, including those associated with obesity risk factors in combination with moderately hypocaloric diet.
In combination with hypoglycemic agents (metformin, sulfonylureas and / or insulin) and / or mildly hypocaloric diet for patients with type 2 diabetes are overweight or obese. Contraindications Hypersensitivity sensitivity to orlistat or any other components of the formulation; chronic malabsorption syndrome; pregnancy, breast-feeding; Children up to age 12 years.
Application of pregnancy and in the period of breast-feeding
In reproductive toxicity studies in animals teratogenic and embryotoxic effects of the drug orlistat were observed. In the absence of teratogenic effects in animals similar effect in humans is not expected. Since no clinical data on the use of orlistat during pregnancy, use of Listata the drug in pregnant women is contraindicated.
Due to the fact that there are no data on the allocation of orlistat in breast milk, use Listata drug during breast feeding is contraindicated.
Dosing and Administration Inside, squeezed water. Drug interactions There was no interaction between orlistat with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, pravastatin, warfarin, nifedipine GITS (gastro-intestinal therapeutic system) and nifedipine slow release, sibutramine or ethanol (in based on studies of interactions between drugs). However, care must be taken when performance INR concurrent therapy with warfarin or other anticoagulants of indirect action.
When concomitantly with orlistat was a decrease in absorption of vitamins D, E and beta-carotene. If multivitamins are recommended, they should be taken at least 2 hours after taking orlistat or at bedtime.
Dosage The inside of 120 mg during each main meal or within hours after a meal, usually not more than 3 times / day. If the food is low in fat, you can skip reception listaty.