Orsoten Slim - instructions for use, dose, side effects, contraindications

Hard gelatin capsules No. 3, capsule body white, cap capsule light yellow. Contents of capsules: microgranules or a mixture of powder and microgranules white or almost white.

It is allowed to have caked agglomerates that easily break down when pressed.

Pharmacotherapeutic group:Inhibitor of gastrointestinal tract lipases

ATX: & nbsp

A.08.A.B.01 Orlistat

Pharmacodynamics:

Orlistat is a potent specific inhibitor of long-acting gastrointestinal lipases. It manifests its therapeutic activity in the lumen of the stomach and small intestine, forming a covalent bond with the active serine portion of the gastric and pancreatic lipases. The inactivated enzyme loses the ability to hydrolyze dietary fats (triglycerides) into absorbable free fatty acids and monoglycerides.Undivided triglycerides are not absorbed, which leads to a decrease in the number of calories digested by the body, and to a decrease in body weight. The therapeutic effect of the drug is thus carried out without being absorbed into the systemic bloodstream. According to the results of clinical studies orlistat, taken daily at a dose of 60 mg 3 times a day, blocks the absorption of approximately 25% of the fats included in the daily diet.

Along with a decrease in body weight, with a prolonged intake of orlistat at a dose of 60 mg, there are decreases in such parameters as waist circumference, total cholesterol concentration (OXc) and low density lipoprotein cholesterol (LDL cholesterol) in blood plasma. After 6 months of treatment with orlistat in a dose of 60 mg, the average concentration of OXC in blood plasma is reduced by an average of 2.4%, LDL cholesterol by 3.5%. The waist circumference after 6 months of taking the drug decreases, on average, by 4.5 cm.

Pharmacokinetics:

Suction

Absorption of the drug is minimal.

Excretion

About 97% of the dose taken internally is secreted through the intestine, 83% of this amount is unchanged.

The excretion of orlistat and its metabolites by the kidneys is less than 2% of the dose taken. The drug is completely eliminated after 3-5 days.The excretion of orlistat as in volunteers with normal body weight, and in patients with obesity is similar.

Indications:

Reduction in overweight in adults (over 18 years) with a body mass index (BMI) of more than 28 kg / m². It is used only in combination with a moderately hypocaloric diet containing not more than 30% of the daily caloric value in the form of fats.

Contraindications:

- Hypersensitivity to orlistat or to any of the components of the drug;

- syndrome of chronic malabsorption;

- cholestasis;

- simultaneous application of cyclosporine;

- simultaneous use of indirect anticoagulants (warfarin);

- simultaneous application of sitagliptin;

- pregnancy and the period of breastfeeding;

- age to 18 years.

Pregnancy and lactation:

The drug Orsoten® Slim should not be used in pregnancy due to the lack of reliable clinical data to confirm the safety of its use.

It is not established whether the orlistat in breast milk, and therefore, the use of the drug Orsoten® slim during breastfeeding is not recommended.

Dosing and Administration:

For adults, the recommended dose of Orsoten® Slimis 60 mg (1 capsule) 3 times a day with each main meal in combination with a moderately hypocaloric diet with a low fat content. The capsule should be taken immediately before meals, during meals or no later than 1 hour after meals, with water. If meals are missed or if the food does not contain fat, you can skip the intake of Orsoten® Slim.

Within a day, you can take no more than 3 capsules of the drug Orsoten® Slim.

The drug Orsoten ® Slim should be taken only at recommended doses.

Treatment is recommended to be conducted no more than 6 months. It is recommended to discuss the results of weight loss with a doctor. If after 12 weeks of Orsoten ® slym administration there is no decrease in body weight (that is, a decrease in body weight of less than 5% of the original), a doctor's consultation is needed to decide whether to continue taking the drug.

Side effects:

Undesirable reactions (HP) when taking Orsoten ® Slim, as a rule, are observed from the side of the gastrointestinal tract (GIT) and are caused by the pharmacological action of the drug.

Classification of the frequency of development HP, recommended by the World Health Organization (WHO):

Very often ≥ 1/10

Frequently from ≥ 1/100 to <1/10

Infrequently from ≥ 1/1000 to <1/100

Rarely from ≥ 1/10000

Very rarely to <1/1000 <1/10000

Can not be evaluated based on available data.

Below is the frequency HP from various organs and systems.

Clinical studies to study the use of orlistat in a dose of 60 mg lasting from 18 to 24 months are established HP On the part of the gastrointestinal tract, which as a whole were light and reversible. Usually they were manifested at the beginning of treatment. Compliance with a diet low in fat reduces the likelihood of such reactions.

From the digestive tract:

very often: oily discharges from the rectum, the passage of gases with a certain amount of detachable, imperative urges for defecation, steatorrhea; often: abdominal pain, fecal incontinence, loose stool, frequent bowel movements.

As a rule, these HP are weakly expressed and transient. They occur in the early stages of treatment (in the first 3 months of therapy), and in most patients there was not more than one episode of such reactions.

Post-marketing research

During the post-registration application of orlistat, the following HP, whose frequency is unknown:

From the hematopoiesis: reduction in the concentration of prothrombin and an increase in the international standardized ratio (INR) in plasma in patients taking orlistat simultaneously with indirect anticoagulants.

From the digestive tract: minor bleeding from the rectum, diverticulitis.

From the skin and subcutaneous tissue: bullous rash.

From the immune system: hypersensitivity reactions, including pruritus, skin rash, hives, angioedema, bronchospasm and anaphylaxis.

From the liver and bile ducts: cholelithiasis, hepatitis, an increase in the activity of "liver" transaminases and alkaline phosphatase in the blood plasma.

Overdose:

When using orlistat at a dose of 800 mg once and at a dose of up to 400 mg 3 times daily for 15 days, both in individuals with normal body weight and in patients with obesity, significant HP not found. When using orlistat in a dose of 240 mg 3 times a day for 6 months increasing the frequency of dose-dependent HP not noted.

In most reports on cases of overdose of orlistat in the post-marketing period, indications of HP or are absent, or they are similar to those that can be after taking the recommended doses of the drug.

In case of an overdose, consult a doctor.If there is a significant overdose of orlistat, it is recommended that the patient be monitored for 24 hours. According to preclinical and clinical studies, systemic effects associated with inhibition of lipase are usually rapidly reversible.

Interaction:

Cyclosporin

In several studies on the drug interaction of cyclosporine, when it is used simultaneously with orlistat, a decrease in the concentration of cyclosporine in the blood plasma is reported. Potentially, this can lead to a decrease in the immunosuppressive effectiveness of the latter. The simultaneous use of the drug Orsoten® Slim and cyclosporine is contraindicated.

Indirect anticoagulants

With the simultaneous use of warfarin or other anticoagulants for oral administration with the drug Orsoten® silt, the values of INR may vary.

Fat-soluble vitamins

Taking Orsoten® Slim can potentially impair the absorption of fat-soluble vitamins (A, D, E, K and beta-carotene).

Acarbose

Given the lack of studies studying pharmacokinetic interactions, it is not recommended to use Orsoten® Sulim at the same time as acarbose.

Amiodarone

With simultaneous use with orlistatom decreased concentration of amiodarone in the blood plasma after a single dose. The clinical significance of this effect for patients taking amiodarone, is unclear. Simultaneous use of the drug Orsoten® Slim and Amiodarone is possible only on the advice of a doctor.

Lack of interaction

Orlistat does not interact with amitriptyline, phenytoin, fluoxetine, sibutramine, phentermine, atorvastatin, pravastatin, fibrates, biguanides, digoxin, nifedipine, losartan, and ethanol.

Special instructions:

Diet and exercise are an integral part of the program to reduce body weight. It is recommended to begin the diet program and physical exercises before the beginning of therapy with the drug Orsoten® slime.

When taking Orsoten ® Slim, a fractional, balanced, moderately hypocaloric diet with a fat content of no more than 30% of the daily calorie intake should be adhered to (for example, with a diet of 2000 kcal / day, fat intake should not exceed 66 g / day). Follow the recommendations on diet and physical activity, both during and after discontinuation of the drug.

The use of the drug Orsoten® Slim leads to an increase in the fat content in the stool after 24-48 hours after the beginning of the admission. After discontinuation of Orsoten®, the fat content in the feces usually returns to the baseline within 48-72 hours.

Compliance with a low-fat diet reduces the likelihood of HP from the digestive tract.

The intake of orlistat can potentially impair the absorption of fat-soluble vitamins (A, D, E, K and beta-carotene). The overwhelming majority of patients who received orlistat in the course of four-year clinical trials, the concentration of vitamins A, D, E, K and beta-carotene were within the normal range. With the preventive purpose, it is recommended to take multivitamins at night.

Since weight loss is usually accompanied by an improvement in carbohydrate metabolism, patients with type 2 diabetes mellitus should consult with a doctor before starting therapy with Orsoten Slym and, if necessary, adjust the dose of hypoglycemic drugs.

Decrease in body weight during treatment can be accompanied by a decrease in blood pressure and the concentration of OXc in blood plasma.Patients taking antihypertensive or hypolipidemic drugs should consult a doctor and, if necessary, adjust the dose of these drugs.

In clinical studies, there was no interaction between contraceptives for oral administration and orlistat. but orlistat can indirectly reduce the bioavailability of oral contraceptives, which can lead to the development of unwanted pregnancies. It is recommended to use additional methods of contraception in case of development of acute diarrhea.

Patients suffering from kidney disease should consult with a doctor, as it is possible to develop hyperoxaluria and nephropathy.

Patients receiving amiodarone, warfarin or other anticoagulants for oral administration, should also consult a physician before orlistat therapy, since changes in the INR are possible.

Patients should stop taking Orsoten ® slym and consult a doctor if symptoms appear: icteric staining of the sclera or skin, skin itching, darkening of urine and loss of appetite.

Effect on the ability to drive transp. cf. and fur:

The drug Orsoten® Slim does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:

Capsules, 60 mg.

Packaging:

For 21 capsules in a contour mesh package made of a combined material PVC / PVDC and aluminum foil.

2 or 4 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000301

Date of registration:17.02.2011 / 18.02.2016

Expiration Date:Unlimited

The owner of the registration certificate:KRKA-RUS, LLC KRKA-RUS, LLC Russia

Manufacturer: & nbsp

KRKA-RUS, LLC Russia

Information update date: & nbsp12.06.2017

Illustrated instructions

Instructions

Orsotene® Slim (Orsoten® slim)