Orsoten - instructions for use, analogs, reviews and release forms (capsules or tablets 120 mg and 60 mg Slim) drugs for weight loss and reduce excess weight in adults, children and pregnancy. Composition and side effect
In this article, you can read the instructions for using the drug Orsotene. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of experts on the use of Orsotene in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Orsotene in the presence of existing structural analogues. Use to lose weight and reduce excess weight in adults, children, as well as during pregnancy and lactation.Composition of the preparation.
Orsotene - a specific inhibitor of gastrointestinal lipases, which has a prolonged action. Has a therapeutic effect in the lumen of the stomach and small intestine, forming a covalent bond with the active serine portion of the gastric and intestinal lipases. Inactivated in this way, the enzyme loses the ability to break down food fats that come in the form of triglycerides, to sucking free fatty acids and monoglycerides. Since uncleaved triglycerides are not absorbed, the intake of calories into the body decreases, which leads to a decrease in body weight.
The therapeutic effect of the drug is carried out without absorption into the systemic bloodstream. The action of Orlistat (the active ingredient of the drug Orsoten) leads to an increase in the fat content in the feces after 24-48 hours after taking the drug. After the drug is withdrawn, the fat content in the stools usually returns to the initial level after 48-72 hours.
Composition
Orlistat + auxiliary substances.
Pharmacokinetics
Absorption of orlistat is low. Signs of cumulation are absent, which confirms the minimal absorption of the drug.Orlistat is metabolized mainly in the intestinal wall with the formation of pharmacologically inactive metabolites: M1 (hydrolyzed four-membered lactone ring) and M3 (M1 with the cleaved N-formylleucine residue). The main way of elimination is through the intestine - about 97% of the dose of the drug, of which 83% - unchanged. The cumulative excretion through the kidneys of all substances structurally associated with orlistat is less than 2% of the accepted dose of the drug. The time for complete elimination is 3-5 days. Orlistat and metabolites can be excreted with bile.
Indications
- prolonged treatment of obese patients with a body mass index (BMI) ≥ 30 kg / m2, or patients with an overweight (BMI ≥ 28 kg / m2), incl. who are associated with obesity risk factors, in combination with a moderately low-calorie diet (a means to lose weight).
Forms of release
Capsules 60 mg (Orsotene Slim).
Capsules 120 mg.
Other dosage forms, such as tablets, do not exist.
Instructions for use and reception scheme
The recommended single dose is 120 mg.
The capsule is taken with water, taking in immediately before each main meal, during meals or not later than 1 hour after a meal.If food is missed or if the food does not contain fat, you can skip the intake of orlistat.
Doses of orlistat more than 120 mg 3 times a day do not enhance its therapeutic effect. Duration of therapy - no more than 2 years.
Correction of the dose is not required for elderly patients or patients with impaired liver or kidney function.
Side effect
- flatulence, accompanied by secretions from the rectum;
- desires for defecation;
- oily / oily stool;
- oily discharge from the rectum;
- loose stools;
- a soft chair;
- inclusion of fat in stool (steatorrhea);
- pain / discomfort in the abdomen;
- more bowel movements;
- pain / discomfort in the rectum;
- imperative urges for defecation;
- fecal incontinence;
- defeat of teeth and gums;
- hypoglycemia in patients with type 2 diabetes mellitus;
- diverticulitis;
- cholelithiasis;
- headache;
- sense of anxiety;
- itching;
- rash;
- hives;
- angioedema;
- bronchospasm;
- anaphylaxis;
- bullous rash;
- influenza-like syndrome;
- feeling tired;
- upper respiratory infections;
- urinary tract infections;
- dysmenorrhea.
Contraindications
- syndrome of chronic malabsorption;
- cholestasis;
- pregnancy;
- lactation period (breastfeeding);
- children under 18 years of age (efficacy and safety not studied);
- hypersensitivity to orlistat or any other components of the drug.
Application in pregnancy and lactation
According to the results of preclinical studies, teratogenicity and embryotoxicity with Orsotene were not observed. Clinical data on the use of orlistat in pregnancy are absent, so you should not prescribe the drug in this period.
Data on application during lactation are absent, therefore orlistat should not be prescribed during lactation.
special instructions
Orsotene is effective for prolonged monitoring of body weight (weight loss, maintaining it at an appropriate level and preventing repeated body weight gain). Treatment with orlistat leads to an improvement in the profile of risk factors and diseases associated with obesity (including hypercholesterolemia, impaired glucose tolerance, hyperinsulinemia, arterial hypertension, type 2 diabetes mellitus), and a reduction in visceral fat.
Decreased body weight during treatment with orlistat may be accompanied by an improvement in the compensation of carbohydrate metabolism in patients with type 2 diabetes mellitus, which can reduce the dose of hypoglycemic drugs.
To ensure adequate nutrition of patients it is recommended to take multivitamin preparations.
Patients should adhere to dietary guidelines. They should receive a balanced, moderately low-calorie diet, containing no more than 30% of calories in the form of fats. Daily intake of fat should be divided into three main meals.
The likelihood of adverse reactions from the GI tract may increase if orlistat is taken amid a diet rich in fats (for example, 2000 kcal per day,> 30% of the daily caloric intake comes in the form of fats, which is approximately 67 g of fat). Patients should be aware that the more precisely they observe a diet (especially regarding the allowed amount of fat), the less likely the development of adverse reactions. A low-fat diet reduces the likelihood of adverse reactions from the gastrointestinal tract and helps patients control and regulate fat intake.
If after 12 weeks of therapy there was no decrease in body weight, at least 5%, Orsoten should be stopped.
Drug Interactions
Patients receiving Warfarin or other anticoagulants and orlistat may experience a decrease in the level of prothrombin, an increase in INR, leading to changes in haemostatic parameters.
Interactions with amitriptyline, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, Nifedipine (including delayed release), sibutramine, furosemide, captopril, atenolol, glibenclamide or ethanol have not been observed.
Increases the bioavailability and hypolipidemic effect of pravastatin, increasing its concentration in plasma by 30%.
A decrease in body weight can improve metabolism in diabetic patients, and as a result, it is necessary to reduce the dose of oral hypoglycemic agents.
Treatment with Orsotenum can potentially interfere with the absorption of fat-soluble Vitamins (A, D, E, K). If multivitamins are recommended, they should be taken no earlier than 2 hours after taking orlistat or before bedtime.
With the simultaneous administration of orlistat and cyclosporine, a decrease in the level of cyclosporine concentration in the blood plasma was noted, therefore it is recommended to conduct a more frequent determination of the level of cyclosporin concentration in the blood plasma.
Patients receiving Amiodarone should be more carefully monitored and monitored by the ECG; cases of a decrease in the level of amiodarone concentration in the blood plasma are described.
Analogues of the drug Orsoten
Structural analogs for the active substance:
- Allie;
- Xenalten;
- Xenical;
- Orlimax;
- Orlistat;
- Orsoten Slim.
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