Orsoten capsules 60mg №84

Interaction

Cyclosporine

With the simultaneous use of cyclosporine and orlistat, a decrease in plasma concentration of cyclosporine is observed, which may be accompanied by a decrease in its immunosuppressive activity.

The simultaneous use of Orsoten and cyclosporine is contraindicated.

Oral anticoagulants

With the simultaneous use of Warfarin or other oral anticoagulants and orlistat, a change in the value of the International Normalized Relationship (INR) may occur.

Fat soluble Vitamins

The use of orlistat may impair the absorption of fat-soluble vitamins (A, D, E and K).

Acarbose

Due to the lack of data on pharmacokinetic interactions, it is not recommended to use orlistat simultaneously with acarbose.

Amiodarone

With simultaneous use with orlistat, a decrease in plasma concentration of Amiodarone was noted after a single use. The clinical significance of this effect for patients taking amiodarone is unclear. The simultaneous use of orlistat and amiodarone is possible only on the recommendation of a physician.

Orlistat does not interact with Amitriptyline, phenytoin, Fluoxetine, sibutramine, phentermine; Atorvastatin, pravastatin, fibrates; biguanides; Digoxin, Nifedipine, Losartan; oral contraceptives and ethanol.

Active substance

Orlistat

How to take, the course of administration and dosage

Inside, on 1 capsule (60 mg) three times a day, washing down with water, immediately before, during or within 1 h after each meal.

If the meal is skipped or food does not contain fat, the use of orlistat should be skipped.

Within 24 hours you can take no more than three capsules of 60 mg of the drug Orsoten® Slim.

Duration of treatment

The course of treatment should not exceed 6 months. If after 12 weeks of use of the drug Orsoten® Slim, there is no reduction in body weight (no more than 5% of the initial weight), the patient should consult with a physician to decide whether to continue using it.

Diet and exercise are an important component of a weight loss program. It is recommended to start a diet program and exercise before starting therapy with Orsoten® Slim.

During the use of the drug Orsoten®, the patient should receive a moderately low-calorie diet with a balanced nutrient content, in which approximately 30% are fat (for example, when the caloric content is 2000 kcal per day, the food should contain no more than 67 grams of fat). Daily intake of fat, carbohydrates and protein should be distributed between the three main meals. The program of diet and exercise should be continued after the use of the drug Orsoten® Slim will be discontinued.

Data on the use of orlistat in the elderly is limited.

Patients with impaired liver and kidney function

The effects of orlistat in individuals with impaired liver and / or kidney function have not been studied, but given that absorption of orlistat is minimal, dose adjustment in the elderly and in people with impaired liver and / or kidney function is not required.

Overdosage

Symptoms: when using orlistat at a dose of 800 mg once and at a dose of up to 400 mg three times a day, daily, for 15 days, both in patients with normal body weight and in patients with obesity, no significant adverse reactions were found. When using orlistat 240 mg three times a day for 6 months, an increase in the incidence of adverse reactions was not observed.

Most reports of an overdose of orlistat during the post-marketing period either lack specific information about undesirable reactions or describe undesirable reactions that do not differ from those observed when using the recommended doses of orlistat.

Treatment: in case of overdose, consult a doctor. With a significant overdose of orlistat, it is recommended to monitor the patient for 24 hours. Based on data from studies on humans and animals, all systemic effects of orlistat due to lipase inhibition are usually quickly reversible.

Side effects

Classification of the incidence of side effects (WHO):

• very often> 1/10;
• often from> 1/100 to <1/10;
• infrequently from> 1/1000 to <1/100;
• rarely from> 1/10000 to <1/1000, very rarely from <1/10000, including individual messages.

Adverse reactions when using orlistat are usually gastrointestinal in nature and are associated with its pharmacological action.

On the part of the digestive system: very often - oily discharge from the rectum, the release of gases with a certain amount of discharge, imperative desires to defecate, steatorrhea; often - pain in the abdomen, fecal incontinence, loose stools, increased bowel movement.

The following adverse reactions were noted during the post-marketing use of orlistat (frequency unknown):

From the hemopoietic system: a decrease in the concentration of prothrombin; an increase in the rate of the International Normalized Ratio (INR) in patients taking orlistat concurrently with anticoagulants.

On the part of the digestive system: slight rectal bleeding, diverticulitis, hepatitis, cholelithiasis, increased activity of “liver” transaminases and alkaline phosphatase.

On the part of the skin: bullous rash.

Allergic reactions: itching, rash, urticaria, angioedema, bronchospasm, anaphylaxis.

Indications

Reduced body weight in adults (over 18) with overweight (BMI ≥ 28 kg / m2). It is used only in combination with a moderate, low-fat, low-fat diet.

Use during pregnancy and lactation

There are no clinical data on the use of orlistat during pregnancy, so the drug Orsoten® Slim should not be used during pregnancy.

Since it is not known whether orlistat is excreted into breast milk, Orsoten® Slim should not be used during breastfeeding.