Listata pills 120mg №60

Composition

Active ingredient: orlistat 120 mg;

Excipients: sodium lauryl sulfate - 12 mg; acacia gum - 210 mg; ludiflesh (mannitol - 84-92%, crospovidone - 4-6%, polyvinyl acetate - 3.5-6%, povidone - 0.25-0.6%) - 580 mg; copovidone - 20 mg; Crospovidone - 50 mg; Magnesium stearate - 8 mg;

Film casing: opadry II blue (85F205040) (polyvinyl alcohol - 40%, titanium dioxide - 22.48%, macrogol 3350 - 20.2%, talc - 14.8%, aluminum lacquer - 2.28%, iron dye yellow oxide (0.24%) - 34 mg; Silver opadry (63F97546) (polyvinyl alcohol - 47.03%, talc - 27%, macrogol 3350 - 13.27%, pearlescent pigment - 10%, polysorbate 80 - 2.7%) - 6 mg

Mechanism of action

Listata is a lipase inhibitor. When ingested, orlistat inhibits gastric and pancreatic lipases. As a result, the breakdown of dietary fat is impaired and their absorption from the gastrointestinal tract is reduced. With the systematic use of this effect leads to a decrease in body weight in patients with obesity. Orlistat is practically not absorbed from the gastrointestinal tract and therefore practically has no resorptive effect.

Indications

• long-term therapy of patients with obesity with a BMI of at least 30 kg / m2 or patients with overweight with a BMI of at least 28 kg / m2, including having obesity-associated risk factors in combination with a moderately low-calorie diet;
• in combination with hypoglycemic drugs (metformin,sulfonylurea derivatives and / or insulin) and / or a moderately low-calorie diet in patients with type 2 diabetes with overweight or obesity.

Contraindications

• hypersensitivity to orlistat or any other component of the drug;
• chronic malabsorption syndrome;
• pregnancy;
• breastfeeding period;
• children under 12 years old.

Side effects

On the part of the gastrointestinal tract: often - "soft" stools, pain or discomfort in the rectum, fecal incontinence, abdominal distension, tooth damage, gum damage.

Other adverse reactions: very often - headache, upper respiratory tract infections, flu; often - lower respiratory tract infections, urinary tract infections, dysmenorrhea, anxiety, weakness.

Interaction

There was no interaction between orlistat and Amitriptyline, Atorvastatin, biguanides, Digoxin, fibrates, fluxetine, Losartan, phenytoin, oral contraceptives, peeters, pravastatin, Warfarin, Nifedipine GITS (gastrointestinal therapy, n, and ny, and the ny, and the ny; based on research on drug interactions). However, it is necessary to monitor the indicators of MHO with simultaneous therapy with warfarin or other indirect anticoagulants.

While taking with orlistat, a decrease in the absorption of Vitamins D, E and beta-carotene was noted.If multivitamins are recommended, they should be taken no less than 2 hours after taking orlistat or before bedtime.

With the simultaneous use of orlistat and cyclosporine, a decrease in plasma concentration of cyclosporine was noted, therefore more frequent determination of the concentration of cyclosporine in plasma was recommended while the cyclosporine and orlistat were taken simultaneously.

When administered with Amiodarone during orlistat therapy, there was a decrease in systemic exposure of amiodarone and dezethylamidarone (by 25-30%), however, due to the complex pharmacokinetics of amiodarone, the clinical significance of this phenomenon is unclear. Adding orlistat to long-term treatment with amiodarone may lead to a decrease in the therapeutic effect of amiodarone (no studies have been conducted).

Simultaneous administration of orlistat and acarbose should be avoided due to the lack of data from pharmacokinetic studies.

While taking orlistat and antiepileptic drugs, there have been cases of seizures. The causal relationship between the development of seizures and therapy with orlistat has not been established. However, patients should be monitored for possible changes in the frequency and / or severity of the convulsive syndrome.

How to take, the course of administration and dosage

Inside, drinking water.

Treatment of patients with obesity with a BMI of at least 30 kg / m2 or patients with overweight with a BMI of at least 28 kg / m2, incl.having associated with obesity risk factors, in combination with a moderately low-calorie diet: adults and children over 12 years old - the recommended dose of the drug Listat - 1 table. (120 mg) with each main meal (with meals or no later than 1 hour after meals).

In combination with hypoglycemic drugs (metformin, sulfonylurea derivatives and / or insulin) and / or a moderately low-calorie diet in patients with type 2 diabetes with overweight or obesity: adults - the recommended dose of the drug Listat - 1 tab. (120 mg) with each main meal (with meals or no later than 1 hour after meals).

If a meal is skipped or food does not contain fat, then you may also skip taking the drug Listat

The drug Listat should be taken in combination with a balanced, moderately low-calorie diet, containing no more than 30% of calories in the form of fat. Daily intake of fats, carbohydrates and proteins must be distributed between the 3 main meals.

Increasing the dose of the drug Listat over the recommended (120 mg 3 times a day) does not lead to an increase in its therapeutic effect.

Special patient groups

The efficacy and safety of Listat in patients with impaired liver and / or kidney function, as well as in elderly patients and children under 12 years of age have not been studied.

Special notes

The drug Listata is effective in terms of long-term control of body weight (weight loss and its maintenance, preventing re-gaining body weight).Treatment with Listat leads to an improvement in the profile of risk factors and diseases associated with obesity, including hypercholesterolemia, type 2 diabetes mellitus, impaired glucose tolerance, hyperinsulinemia, hypertension, and a decrease in visceral fat.

When used in combination with hypoglycemic drugs such as Metformin, sulfonylurea derivatives and / or insulin, in patients with diabetes mellitus type 2 overweight (BMI not less than 28 kg / m2) or obese (BMI not less than 30 kg / m2), the drug Listat in combination with a moderately low-calorie diet helps to further improve the compensation of carbohydrate metabolism.

In clinical studies in most patients, the concentrations of vitamins A, D, E, K and beta-carotene during four years of therapy with orlistat remained within the normal range. To ensure adequate intake of all minerals, multivitamins can be used.

The patient should receive a balanced, moderately low-calorie diet containing no more than 30% of calories in the form of fat. Food rich in fruits and vegetables is recommended. Daily intake of fats, carbohydrates and proteins should be divided into three main steps.

The likelihood of adverse reactions from the gastrointestinal tract may increase if the preparation of Listat is taken on a diet rich in fats (for example, 2000 kcal / day, of which more than 30% is in the form of fat, which equals approximately 67 g of fat).If the drug Listat is taken with food that is very rich in fat, the likelihood of gastrointestinal reactions increases.

In patients with type 2 diabetes, a decrease in body weight during treatment with Listat is accompanied by an improvement in the compensation of carbohydrate metabolism, which may or may require a reduction in the dose of hypoglycemic drugs (for example, sulfonylurea derivatives).

Influence on ability to steer vehicles and work with mechanisms. The preparation of Listat does not affect the ability to drive vehicles and mechanisms. Patients with diabetes mellitus type 2, using the drug Listat in combination with hypoglycemic drugs, should be careful when driving vehicles and mechanisms in connection with the possible development of hypoglycemia, accompanied by dizziness, visual impairment.

Pills

In the dark place at a temperature of no higher than 25 ° C