Orsoten - a drug that reduces the absorption of fats in the intestines. It has an active substance called orlistat.
This component inhibits gastric and pancreatic lipase. Due to the occurrence of covalent bonds, the main ingredient prevents the breakdown of lipids that are found in food.
The therapeutic effect of Orsoten is carried out without absorption into the systemic circulation. The action of orlistat leads to an increase in the fat content in the feces after 24-48 hours after taking the drug Orsotena. After discontinuation of the drug, the fat content in the fecal masses usually returns to the initial level after 48-72 hours.
Clinical and pharmacological group
The drug for the treatment of obesity is an inhibitor of gastrointestinal lipases.
Pharmacy sales terms
It is released on prescription.
How much does Orsoten in pharmacies? The average price in 2017-2018 is at the level of 800 rubles.
Release form and composition
Two-section hypromellose capsules of white or yellowish color, containing microgranules (or a mixture of microgranules with powder) of white or almost white color. Contour cellular packing, cardboard pack.
- The composition of one capsule of Orsoten is the following: it contains 120 mg of orlistat, as well as auxiliary ingredient - microcrystalline cellulose.
The capsules are contained in a blister of 7 pieces each, in a cardboard bundle there are 3, 6, or 12 such blisters. Also, capsules can be packaged in a blister of 21 pieces each, in a carton containing 1, 2 or 4 blisters with capsules.
The energy value of fats is 9.3 kcal / g, which is almost twice as high as the caloric content of carbohydrates and proteins. Getting into the gastrointestinal tract in the form of triglycerides, fats of plant or animal origin are broken down by the enzyme lipase to free fatty acids. They are used by the body as a source of energy, excess ones are stored in reserve, as fat accumulations.
The specific lipase blocker, orlistat, is able to form strong bonds with these enzymes, thereby depriving them of the ability to break down triglycerides. In this case, the fats pass through the digestive system, not digested, and are excreted in feces and partially with urine. The principle of action of orlistat is the same as that of any fat-free diet - the body's consumption of fat reserves accumulated earlier for energy needs.
The results of clinical studies of Orsoten showed that its use for 3 months in combination with a low-calorie diet reduces body weight by 10–15%, while using only dietary methods only by 5–7%.
Orlistat has a therapeutic effect without absorption into the systemic circulation. After 8 hours after internal use, the concentration of the drug in the blood plasma is less than 5 ng / ml. However, its minimum absorption is confirmed by the absence of signs of cumulation.
The drug is 99% bound to albumin and lipoproteins, in minimal quantities found in red blood cells. Metabolized mainly in the intestine. Forms pharmacologically inactive metabolites M1 and M3. About 97% of orlistat is excreted with feces, 83% - unchanged. Within 24-48 hours after the start of the drug in the feces, the fat content increases. The time of complete elimination of the drug is 3-5 days.
Indications for use
Prolonged treatment of obese patients with a body mass index (BMI) ≥30 kg / m2, or patients with overweight (BMI ≥28 kg / m2), incl. associated with obesity-associated risk factors, in combination with a moderately low-calorie diet.
Orsoten can be prescribed in combination with hypoglycemic drugs and / or a moderately low-calorie diet for patients with type 2 diabetes with overweight or obesity.
Contraindications for medication following:
- chronic malabsorption syndrome;
- the period of pregnancy and lactation (breastfeeding);
- age up to 18 years (the safety and efficacy of Orsoten for this age group of patients have not been studied);
- hypersensitivity to the drug.
Orsoten is prescribed with caution in the following diseases:
- type 2 diabetes;
- renal dysfunction;
- change in the volume of interstitial fluid.
Use during pregnancy and lactation
It is not recommended to prescribe Orsoten during pregnancy, since there are no clinical data regarding the use of the drug in this category of patients.
The same applies to the use of Orsoten tablets during breastfeeding (not available).
Dosage and method of use
The instructions for use indicate that the recommended single dose Orsoten for weight loss is 1 caps. (120 mg). The capsule is washed down with water, ingested immediately before each main meal, during meals, or no later than 1 hour after meals. If the meal is missed or if the food does not contain fat, then the intake of orlistat can be skipped.
- Doses of orlistat more than 120 mg 3 times / day do not enhance its therapeutic effect. The duration of therapy is no more than 2 years.
Dose adjustment is not required for elderly patients or patients with impaired liver or kidney function.
The safety and efficacy of orlistat for the treatment of children and adolescents under the age of 18 years has not been established.
Most often during the reception Orsotena develop disorders of the digestive tract associated with an increased amount of fat in the feces. In most cases, these disorders are mild and transient in nature and develop during the first 3 months of therapy. With prolonged therapy, the number of cases of side effects decreases.
The following disorders may develop during the use of Orsoten:
- Metabolism: hypoglycemia (with type 2 diabetes);
- Central nervous system: anxiety, headache;
- Skin: very rarely - bullous rash;
- Allergic reactions: rarely - angioedema, pruritus, urticaria, rash, anaphylaxis, bronchospasm;
- Digestive system: urging to stool, flatulence with rectal discharge, oily / fatty stools, oily rectal discharge, liquid and / or soft stools, steatorrhea (including fat in the feces), discomfort and / or pain in the abdomen and in the rectum, fecal incontinence, increased bowel movement, imperative urge to have a bowel movement, damage to the gums and teeth; very rarely - cholelithiasis, diverticulitis, hepatitis (possibly severe), increased alkaline phosphatase and activity of hepatic transaminases;
- Other: fatigue, dysmenorrhea, flu-like syndrome, infections of the upper respiratory tract and urinary organs.
At the moment, cases of overdose Orsoten not described. Significant side effects from the intake of the active substance in a dose of 800 mg, several doses up to 400 mg daily, have not been detected for 15 days.
There was no increase in the side effects of the drug when patients who had been diagnosed with obesity received triple use of the dose of 240 mg of orlistat per day for six months.
In case of overdose of the drug, it is necessary to monitor the patient throughout the day.
To ensure adequate nutrition of patients, it is recommended to take multivitamin preparations.
If after 12 weeks of therapy there is no decrease in body weight by at least 5%, the use of orlistat should be discontinued.
A decrease in body weight during treatment with orlistat may be accompanied by an improvement in the compensation of carbohydrate metabolism in patients with type 2 diabetes, which may reduce the dose of hypoglycemic drugs.
Patients should follow dietary guidelines. They should receive a balanced, moderately low-calorie diet that contains no more than 30% of calories in the form of fat. Daily fat intake should be divided into three main meals.
Orlistat is effective for long-term control of body weight (weight loss, maintaining it at an appropriate level and preventing re-gaining body weight). 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, and diabetes mellitus type 2), and a decrease in visceral fat.
The likelihood of adverse reactions from the gastrointestinal tract may increase if orlistat is taken on a diet rich in fats (for example, 2000 kcal / day,> 30% of daily calorie intake comes in the form of fat, which is approximately 67 g of fat). Patients should be aware that the more accurately they follow a diet (especially with respect to the permitted amount of fat), the less likely they are to develop adverse reactions. A low-fat diet reduces the likelihood of adverse gastrointestinal reactions and helps patients monitor and regulate fat intake.
When using the drug, you must consider the interaction with other drugs:
- Increases the bioavailability and hypolipidemic effect of pravastatin, increasing its plasma concentration by 30%.
- Interaction with amitriptyline, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, nifedipine (including delayed release), sibutramine, furosemide, captopril, chromomas, nyfedipine, nibedramine, nyfedipine, sibutramine, furosemide, captopril, nyfedipine.
- Patients receiving warfarin or other anticoagulants and orlistat may experience a decrease in the level of prothrombin, an increase in INR, which leads to changes in hemostatic parameters.
- Treatment with orlistat potentially disrupts the absorption of fat-soluble vitamins (A, D, E, K). If taking multivitamins is recommended, they should be taken no earlier than 2 hours after taking orlistat or at bedtime.
- A decrease in body weight can improve the metabolism in diabetic patients, as a result of which it is necessary to reduce the dose of oral hypoglycemic agents.
- In patients receiving amiodarone, clinical observation and monitoring of ECG should be carried out more thoroughly, because Cases of a decrease in the concentration level of amiodarone in the blood plasma are described.
- With the simultaneous use of orlistat and cyclosporine, a decrease in the plasma concentration level of cyclosporine was noted, therefore it is recommended to determine the concentration level of cyclosporine in the blood plasma more often.
We picked up some reviews of people losing weight using the drug Orsoten:
- Novel. Because of my health I had to start taking Orsoten. For the first month I got rid of 4 kg, then the weight loss stopped. Added fitness, and over the next 3 months, threw another 6 kg.
- Yana I opted for this drug, sitting on the Internet for three days and read about this type of diet pills. There are a lot of reviews, of course more negative ones, but I want to try, because I feel I cannot do without the help of pills. It seems I want to eat less, but I quickly break down, I don’t have an incentive, and I’ll buy expensive capsules, I’ll have to eat less and have a better diet. My weight is not critical, but over the past two years I have gained a lot of extra kilos, I have to do something. I'll start with the reception of Orsotena, tomorrow morning in the pharmacy)
- Alexandra. I tried to take the drug Orsoten and more expensive analogue - Xenical. According to my observations, Orsoten is more effective, despite the reviews of doctors. With the rejection of all harmful, sweet, for the year on a diet with this medicine dropped 12 kg without exercise.
- Masha. After the reception, I noticed tangible changes in the volume and in clothes, and outwardly it became noticeable, while I had drunk half, I took 42 tablets. I think the results will please me. In parallel, I try to do cardio every day, whenever possible, and limit myself to sweets. At this stage, I want to say that the drug really works. All good double digits on the scales!
Doctors reviews about Orsotene for weight loss
In general, the opinions of the attending specialists are positive with respect to the means described. Endocrinologists and nutritionists confirm the safety of orlistat and its main advantage - low absorption in the blood. In addition, many doctors prefer to use Orsoten in the treatment of type 2 diabetes, emphasizing its unique ability to reduce cholesterol concentration, improve metabolism and speed up metabolism.
However, there is an important nuance: the treatment with this drug must be combined with a low-calorie diet and minimal physical exertion (at least 20 minutes a day in the form of a charge).
Otherwise, the intake of fats in the body will quickly recover after the abolition of Orsotena and the lost excess weight will return. Moreover, it is desirable to exclude from the diet simple carbohydrates and foods rich in lipid compounds during the treatment with orlistat, so that the digestive system is easier to cope with the load in the future.
To combat the extra kilos, Orsoten’s cheap counterparts are the following:
- Xenical. The drug from the same pharmacological group with Orsoten also contains orlistat.
- Xenalten. A copy of Orsoten, contains orlistat. A means of inhibiting gastrointestinal lipases.
- Orsoten Slim. Dosage Orsoten (Orsoten) with a lower content of the active substance in a single capsule (60 mg).
- Allie. Lipase inhibitor. The mechanism of action is due to a violation of the splitting of fats from food and a decrease in their absorption from the gastrointestinal tract.
Before using analogues consult your doctor.
Storage conditions and shelf life
Store in a dry, protected from light, out of reach of children, at a temperature not exceeding 25 C. The shelf life of the drug for 3 years.
After this period, the use of the drug is prohibited.