Universal reference book for medicines
Product name: ORSOTEN ® SLIM (ORSOTEN ® SLIM)

Active substance: orlistat

Type: An agent for the treatment of obesity - an inhibitor of gastrointestinal lipases

Manufacturer: КРКА-РУС (Russia)
Composition, form of production and packaging
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Capsules hard gelatinous, size 3, body white, lid of light yellow color; the contents of the capsules are microgranules or a mixture of powder and microgranules of white or almost white color; it is allowed to have caked agglomerates that easily break down when pressed.
1 caps.

Orsotene semi-finished pellets 112.8 mg,

which corresponds to the content of orlistat 60 mg

Auxiliary substance of semi-finished granules: microcrystalline cellulose.

Excipients: microcrystalline cellulose - 22.2 mg.

The composition of hard gelatin capsules №3: capsule body - titanium dioxide (E171) - 0.58 mg, gelatin - 28.22 mg;
cap of the capsule - titanium dioxide (E171) - 0.19 mg, iron oxide yellow (E172) - 0.04 mg, gelatin - 18.97 mg.
21 pcs.
- packings cellular planimetric (2) - packs cardboard.
21 pcs.
- packings cellular planimetric (4) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Long-acting lipase inhibitor.
The therapeutic activity of orlistat is realized in the lumen of the stomach and small intestine and consists in the formation of a covalent bond with the active serine portion of the gastric and pancreatic lipases. The enzyme thus inactivated loses the ability to hydrolyze edible fat in the form of triglycerides to sucked free fatty acids and monoglycerides. Undigested triglycerides are not absorbed, and the resulting calorie deficit can have a positive effect on body weight control. Orlistat in a dose of 60 mg 3 times / day blocks the absorption of approximately 25% of edible fat. The therapeutic effect of orlistat is realized without its systemic absorption. The effect of orlistat leads to the fact that the concentration of fat in the contents of the intestine increases already after 24-48 hours after its application inside. After cancellation of orlistat, the concentration of fat in the intestinal contents usually returns to the initial parameters after 48-72 hours.
In adult patients with a BMI of 28 kg / m 2 orlistat at a dose of 60 mg 3 times / day is effective in combination with a low-fat hypocaloric diet.
Thus the basic loss of weight of a body occurs during the first 6 months of treatment.
The decrease in body weight, caused by the use of orlistat at a dose of 60 mg 3 times / day, is accompanied by another beneficial effect: a decrease in the concentration of total cholesterol, LDL cholesterol, and a decrease in the circumference of the waist.

PHARMACOKINETICS

Suction

Studies in volunteers with normal and increased body weight showed that the degree of absorption of orlistat is minimal.
The concentration of unchanged orlistat in the blood plasma is below the limit of quantitative determination (below 5 ng / ml) 8 hours after oral intake of orlistat at a dose of 360 mg. In general, when used in therapeutic doses, the determination of unchanged orlistat in blood plasma is sporadic, and its concentration is extremely low (less than 10 ng / ml or 0.02 μmol / L), with no cumulation signs indicating a minimal degree of absorption.
Distribution

V d can not be determined, since orlistat is absorbed to a minimum and does not have established systemic pharmacokinetics.
The binding of orlistat with plasma proteins is more than 99% (mainly with lipoproteins and albumins). Orlistat can penetrate into the erythrocytes to a minimum.
Metabolism

Metabolism of orlistat occurs mainly in the walls of the stomach and small intestine.

Excretion

Approximately 97% of the dose is excreted through the intestine, 83% of this amount is in the form of unchanged orlistat.
Cumulative excretion by the kidneys of all orlistat-containing substances is less than 2% of the dose taken. The time to achieve complete excretion (through the intestine and kidneys) is from 3 to 5 days.
INDICATIONS

- to reduce body weight in patients over the age of 18 with an overweight (BMI = 28 kg / m 2 ) in combination with a moderate hypocaloric diet with a low fat diet.

DOSING MODE

Take inside 60 mg (1 caps.) 3 times / day, immediately before, during or for 1 hour after each meal.
Capsules are washed down with water.
If food intake is missed or the food does not contain fat, use orlistat should be skipped.

Within 24 hours you can take no more than 3 capsules of 60 mg of the drug Orsoten ® Slim.

The course of treatment should not exceed 6 months.

If, after 12 weeks of Orsoten ®, weight loss does not occur (no more than 5% of the original weight), the patient should consult a physician to determine whether further use is advisable.

Diet and exercise are an important component 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 Orsotene ® slime.
During the use of Orsoten ® , the patient should receive a moderately hypocaloric diet with a balanced nutrient content, in which approximately 30% is fats (for example, at a caloric value of 2000 kcal / day, the food should not contain more than 67 g of fat).
The daily intake of fats, carbohydrates and protein should be distributed among the three main meals. The program of diet and exercise should continue after the use of the drug Orsotene ® slim will be discontinued.
Data on the use of orlistat in elderly patients are limited.

Effects of orlistat in patients with impaired liver and / or kidney function have not been studied, but given that orlistat absorption is minimal, dose adjustment inelderly patients and patients with impaired liver and / or kidney function is not required.

SIDE EFFECT

Classification of the incidence of adverse events (WHO): very often (? 1/10);
often (from? 1/100 to <1/10); infrequently (from? 1/1000 to <1/100); rarely (from? 1/10 000 to <1/1000); very rarely (from <1/10 000), including individual messages.
When using orlistat usually there are reactions from the gastrointestinal tract and are associated with the pharmacological action of the drug.

On the part of the digestive system: very often - oily discharge from the rectum, the release of gases with a certain amount of detachable, imperative urges for defecation, steatorrhea;
often - abdominal pain, fecal incontinence, loose stool, frequent bowel movements.
During the postmarketing application of orlistat, the following adverse reactions were noted (frequency unknown).

On the part of the hematopoiesis system: a decrease in the concentration of prothrombin;
an increase in INR in patients taking orlistat simultaneously with anticoagulants.
On the part of the digestive system: a small rectal bleeding, diverticulitis, hepatitis, cholelithiasis, an increase in the activity of hepatic transaminases and alkaline phosphatase.

From the skin: bullous rash.

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

CONTRAINDICATIONS

- a syndrome of glucose-galactose malabsorption;

- cholestasis;

- concomitant therapy with cyclosporine;

- Pregnancy;

- the period of lactation (breastfeeding);

- children and adolescence under 18;

- hypersensitivity to orlistat or to any of the components of the drug.

PREGNANCY AND LACTATION

Clinical data on the use of orlistat in pregnancy are absent, so the drug Orsoten ® Slim should not be used during pregnancy.

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

APPLICATION FOR FUNCTIONS OF THE LIVER

Effects of orlistat in patients with impaired renal function have not been studied, but given that orlistat absorption is minimal, dose adjustment in patients with impaired renal function is not required.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Effects of orlistat in patients with impaired liver function have not been studied, but given that orlistat absorption is minimal, dose adjustment in patients with impaired liver function is not required.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

Data on the use of orlistat in elderly people are limited.

SPECIAL INSTRUCTIONS

Patients should point out the need to adhere to their dietary recommendations.
The likelihood of side effects from the GI tract is higher if a single meal or diet is generally characterized by a high fat content.
Treatment with Orsoten ® Slim can lead to impaired absorption of fat-soluble vitamins (A, D, E and K).
For this reason, multivitamins should be taken before bedtime.
Since weight loss may be accompanied by improved metabolic control in patients with diabetes mellitus, those who receive hypoglycemic drugs should consult with a doctor before starting the use of Orsoten ® Slim and, if necessary, adjust the dose of hypoglycemic agents.

Decreased body weight may be accompanied by an improvement in blood pressure and a decrease in cholesterol concentration.
Patients taking medications for hypertension or hypercholesterolemia should be consulted with a doctor when applying Orsoten ® Slym and, if necessary, dose adjustment of these medications.
Patients taking amiodarone should consult a physician before starting therapy with Orthoten ® Slim.

In patients using orlistat, cases of rectal bleeding are described.
If this phenomenon occurs, the patient should consult a physician.
It is recommended to use an additional method of contraception to prevent possible ineffectiveness of oral contraceptives in the event of severe diarrhea.

Impact on the ability to drive vehicles and manage mechanisms

Orsoten ® Slim does not affect the management of vehicles and work with technical devices that require an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

In the application of orlistat 800 mg once and at a dose of up to 400 mg 3 times / day, no significant adverse reactions were detected daily, for 15 days, both in patients with normal body weight and in obese patients.
When using orlistat 240 mg 3 times / day for 6 months, an increase in the frequency of undesired reactions was not noted.
Symptoms: Most reports of orlistat overdose in the postmarketing period either lack specific information about adverse reactions, or describe undesirable reactions that do not differ from those observed with the recommended doses of orlistat.

Treatment: In case of an overdose, consult a doctor.
In case of a significant overdose of orlistat, observation of the patient is recommended within 24 hours. Based on the data of studies in humans and animals, all systemic effects of orlistat due to inhibition of lipase are usually rapidly reversible.
DRUG INTERACTION

With the simultaneous use of cyclosporine and orlistat, there is a decrease in the concentration of cyclosporine in the blood plasma, which may be accompanied by a decrease in its immunosuppressive activity.
The simultaneous use of the drug Orsotene ® slim and cyclosporine is contraindicated.
With the simultaneous use of warfarin or other oral anticoagulants and orlistat may change the value of MHO.

The use of orlistat may lead to impaired absorption of fat-soluble vitamins (A, D, E and K).

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

With simultaneous use with orlistatom a decrease in the concentration of amiodarone in the blood plasma after a single application was noted.
The clinical significance of this effect for patients taking amiodarone is unclear. Simultaneous use of orlistat and amiodarone is possible only on the advice of a doctor.
Orlistat does not interact with amitriptyline, phenytoin, fluoxetine, sibutramine, phentermine;
atorvastatin, pravastatin, fibrates; biguanides; digoxin, nifedipine, losartan; oral contraceptives and ethanol.
TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children, in the original package, at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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