Orsoten, 120 mg capsules 84 pcs

Orsotene is a drug whose action prevents the absorption of fats by the body.

The active ingredient of the drug Orsothen is Orlistat, which, when it enters the stomach and also directly into the duodenum, binds lipases (natural enzymes that break down fats).

As a result, the dietary fat is not broken down or absorbed, but excreted with the feces. You will feel the effects of Orsoten in 24 – 48 hours maximum after taking it.

The drug itself is almost not absorbed and is broken down into substances neutral for the human body, which are also excreted with the help of the intestine.

The area of application of this drug is the fight against excess weight, including people whose excess weight is caused by diabetes.

Indications

Weight loss in adults (over 18 years of age) with excess body weight (BMI ≥ 28 kg/m2).

It is only used in combination with a moderate low-fat, hypocaloric diet.

Active ingredient

Composition

1 capsule contains:

The active ingredient:

Orsothen semiprocessed pellets;

Associated Substance:

Microcrystalline cellulose.

How to take, the dosage

Orally with water immediately before each main meal, with a meal, or no later than one hour after a meal.

The recommended single dose of orlistat is 1 120 mg capsule. If a meal is skipped or the food does not contain fat, Orlistat can be skipped.

Doses of orlistat over 120 mg 3 times a day do not increase its therapeutic effect. The duration of therapy is not more than 2 years. Dose adjustment is not required for elderly patients or patients with hepatic or renal dysfunction.

The safety and effectiveness of Orlistat in treatment of children under 18 years of age has not been established.

Interaction

In patients receiving warfarin or other anticoagulants and Orlistat, there may be decreased prothrombin levels, increased international normalization ratio (INR), resulting in changes in hemostatic parameters.

. Interaction with amitriptyline, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, nifedipine GITS, delayed-release nifedipine, sibutramine, furosemide, captopril, atenolol, glibenclamide or ethanol was not observed.

Limits the bioavailability and hypolipidemic effect of pravastatin by increasing its plasma concentration by 30%. Reducing body weight may improve metabolism in patients with diabetes mellitus, due to which it is necessary to reduce the dose of oral hypoglycemic agents. Treatment with orlistat can potentially impair absorption of fat-soluble vitamins (A, D, E. K). If taking multivitamins is recommended, they should not be taken earlier than 2 hours after taking orlistat or before going to bed.

With simultaneous use of orlistat and cyclosporine, a decrease in plasma levels of cyclosporine has been noted, and therefore more frequent determination of plasma levels of cyclosporine is recommended.

In patients receiving amiodarone, clinical monitoring and ECG monitoring should be performed more carefully, since there have been described cases of decreased plasma amiodarone concentrations.

Special Instructions

Orlistat is effective for long-term weight control (weight loss, maintaining weight at an appropriate level and preventing weight gain again). Treatment with orlistat leads to improvement of the profile of risk factors and diseases accompanying obesity (including hypercholesterolemia, impaired glucose tolerance, hyperinsulinemia, arterial hypertension, type 2 diabetes) and reduction of visceral fat.

The reduction in body weight during treatment with orlistat may be accompanied by improved compensation of carbohydrate metabolism in patients with type 2 diabetes, which may allow a reduction in the dose of hypoglycemic drugs.

Patients are advised to take multivitamins to ensure adequate nutrition.

Patients should follow dietary recommendations. They should receive a balanced, moderately low-calorie diet containing no more than 30% of calories in the form of fat. The daily fat intake should be divided into three main meals.

The chance of gastrointestinal adverse reactions may increase if Orlistat is taken with a fat-rich diet (e.g., 2000 kcal/d, more than 30% of daily caloric intake comes in the form of fat, which equals approximately 67 g fat). Patients should be aware that the more closely they follow the diet (especially regarding the amount of fat allowed), the less likely they are to develop adverse reactions. A low-fat diet reduces the likelihood of GI adverse reactions and helps patients control and manage their fat intake.

If after 12 weeks of therapy there has not been at least a 5% decrease in body weight, Orlistat should be stopped.

Contraindications

Side effects

Adverse reactions to orlistat have mainly been reported in the gastrointestinal tract and have been caused by increased amounts of fat in the feces. Usually the observed adverse reactions are mild and transient. The occurrence of these phenomena was observed at the initial stage of treatment during the first 3 months (but not more than one case). With prolonged use of orlistat the number of adverse events decreases.

There are cases of: flatulence accompanied by rectal discharge, urge to defecate, greasy/oily stools, oily rectal discharge, liquid stools, soft stools, inclusions of fat in the stool (steatorrhea), pain/feeling of discomfort in the abdominal area, frequent defecation, pain/discomfort in the rectum, imperative defecation urges, stool incontinence, dental and gum damage; hypoglycemia in patients with type 2 diabetes, headache, anxiety, flu, fatigue, upper respiratory tract infections, urinary tract infections, dysmenorrhea, rare: Allergic reactions (e.g. itching, rash, urticaria, angioneurotic edema, bronchospasm, anaphylaxis); very rare: diverticulitis, cholelithiasis, hepatitis (possibly severe), bullous rash, increased liver transaminases and ALP levels.

Pregnancy use

According to the results of preclinical studies: teratogenicity and embryotoxicity when taking orlistat were not observed.

There are no clinical data regarding the use of orlistat during pregnancy; therefore, orlistat should not be prescribed during pregnancy.

Because there are no data on use during lactation, orlistat should not be taken during lactation.

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