What can be cooked from squid: quick and tasty

pharmachologic effect

Mode of application

Interaction

Side effect

Contraindications

Overdose

special instructions

Composition and release form of the drug

Capsules from white to white with a yellowish tinge; the contents of the capsules are microgranules or a mixture of powder and microgranules of white or almost white; the presence of caked agglomerates, easily crumbling under pressure, is allowed.

* 100 g of semi-finished granules contain: orlistat - 53.1915 g, microcrystalline cellulose.

Excipients: microcrystalline cellulose.

Composition of the capsule body and cap: hypromellose, water, titanium dioxide (E171).

7 pcs. - contour cell packaging (3) - cardboard packs.
7 pcs. - contour cell packaging (6) - cardboard packs.
7 pcs. - contour cell packaging (12) - cardboard packs.
21 pcs. - contour cell packaging (1) - cardboard packs.
21 pcs. - contour cell packaging (2) - cardboard packs.
21 pcs. - contour cell packaging (4) - cardboard packs.

pharmachologic effect

Lipase inhibitor. When taken orally, orlistat inhibits gastric and pancreatic lipases. As a result, the breakdown of dietary fats is disrupted and their absorption from the gastrointestinal tract decreases. With systematic use, this effect leads to a decrease in body weight in obese patients. Orlistat is practically not absorbed from the gastrointestinal tract and, therefore, practically does not have a resorptive effect.

Indications

Obesity (in combination with a moderate calorie diet).

Contraindications

Chronic malabsorption syndrome, hypersensitivity to orlistat.

Dosage

It is taken orally at 120 mg during each main meal or within an hour after meals, usually no more than 3 times / day. If the food is low in fat, you can skip taking orlistat.

Side effects

Perhaps: oily discharge from the rectum, "fat" stools, frequent bowel movements, urge to defecate, fecal incontinence.

Drug interactions

It has been shown that orlistat leads to a decrease in the absorption of beta-carotene and α-tocopherol from the gastrointestinal tract.

special instructions

It must be borne in mind that the frequency and severity side effects increase with increasing fat content in food. By reducing the fat content of food, the likelihood of side effects decreases. It is recommended that the amount of fat consumed per day is distributed fairly evenly across all meals.

In the course of treatment, as the body weight decreases, it is possible to improve the course of pathological processes that are often associated with obesity, incl. , diabetes mellitus, lipid metabolism disorders.

Pregnancy and lactation

Orlistat is used with extreme caution during pregnancy and lactation.

Suction. The absorption of orlistat is low. 8 hours after ingestion of a therapeutic dose, unchanged orlistat in blood plasma is practically undetectable (concentration -

Indications

Arterial hypertension; - IHD: stable exertional angina, angiospastic angina (Prinzmetal's angina).

Contraindications

Hypersensitivity to orlistat or any other components of Orsoten; chronic malabsorption syndrome; cholestasis; pregnancy; breastfeeding; children under 18 years of age (efficacy and safety have not been studied).

Application during pregnancy and lactation

Orlistat is effective for long-term control of body weight (reducing body weight, maintaining it at an appropriate level and preventing re-weight gain). Orlistat treatment 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 decrease in the amount of visceral fat. A decrease in body weight during treatment with orlistat may be accompanied by an improvement in carbohydrate compensation. exchange in patients with type 2 diabetes, which may reduce the dose of hypoglycemic drugs. To ensure adequate nutrition, patients are advised to take multivitamins. Patients should adhere to dietary recommendations. They should eat a balanced, moderately low-calorie diet with no more than 30% of their calories as fat. The daily fat intake should be divided into three main meals. The likelihood of developing adverse reactions from the gastrointestinal tract may increase if orlistat is taken on a diet rich in fats (for example, 2000 kcal / day, more than 30% of the daily calorie intake comes in the form of fat, which equals approximately 67 g fat). Patients should be aware that the more closely they follow the diet (especially with respect to the allowed amount of fat), the less likely it is to develop adverse reactions. A low-fat diet reduces the likelihood of gastrointestinal adverse reactions and helps patients control and regulate fat intake. If after 12 weeks of therapy, there has been no decrease in body weight by at least 5%, orlistat should be discontinued.

Method of administration and dosage

Orsoten is taken orally with water, immediately before each main meal, during meals or no later than an hour after meals. The recommended single dose of orlistat is 1 caps. 120 mg each. If a meal is skipped or the food does not contain fat, then orlistat can be skipped. Doses of orlistat over 120 mg 3 times a day do not enhance its therapeutic effect. The duration of therapy is no more than 2 years. No dose adjustment is required for elderly patients or patients with impaired liver or kidney function. The safety and efficacy of using orlistat in the treatment of children under the age of 18 has not been established.

Side effects

In patients receiving warfarin or other anticoagulants and orlistat, there may be a decrease in prothrombin levels, an increase in the international normalization ratio (INR), which leads to changes in hemostatic parameters. , phentermine, nifedipine GITS, sustained release nifedipine, sibutramine, furosemide, captopril, atenolol, glibenclamide, or ethanol was not observed. Increases the bioavailability and hypolipidemic effect of pravastatin, increasing its plasma concentration by 30%. Decrease in body weight can improve metabolism in patients with diabetes mellitus, as a result of which it is necessary to reduce the dose of oral hypoglycemic agents. Orlistat treatment 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 cyclosporin, a decrease in the concentration of cyclosporine in the blood plasma was noted, therefore it is recommended to more often determine the concentration of cyclosporine in the blood plasma. patients receiving amiodarone should conduct more careful clinical observation and monitoring of the ECG, because Cases of a decrease in the level of concentration of amiodarone in blood plasma have been described.

Overdose

Adverse reactions to orlistat were mainly noted from the gastrointestinal tract and were due to an increased amount of fat in the feces. Usually, the observed side reactions are mild and transient. The appearance of these phenomena was observed at the initial stage of treatment during the first 3 months (but not more than one case). With prolonged use of orlistat, the number of cases of side effects decreases: flatulence accompanied by rectal discharge, urge to defecate, oily / oily stools, oily rectal discharge, loose stools, soft stools, fat inclusions in the stool (steatorrhea), pain / feeling of discomfort in the abdomen, increased frequency of bowel movements, pain / discomfort in the rectum, urge to defecate, fecal incontinence, damage to the teeth and gums; hypoglycemia in patients with type 2 diabetes mellitus, headache, anxiety, flu, fatigue, upper respiratory tract infections, urinary tract infections, dysmenorrhea, rarely - allergic reactions (for example, itching, rash, urticaria, angioedema, bronchospasm, anaphylaxis) ; very rarely - diverticulitis, gallstone disease, hepatitis (possibly severe), bullous rash, increased levels of hepatic transaminases and alkaline phosphatase.

Instructions for use

Active ingredients

Release form

Composition

1 capsule contains: Active substance: orsoten semi-finished granules 112.8 mg Excipients: MCC 22.2 mg Capsule shell: titanium dioxide (E171) 0.58 mg; gelatin 28.22 mg, iron oxide yellow (E172) 0.04 mg.

Pharmacological effect

A specific inhibitor of gastrointestinal lipases with a long-lasting effect. It has a therapeutic effect in the lumen of the stomach and small intestine, forming a covalent bond with the active serine site of gastric and intestinal lipases. The enzyme inactivated in this way loses its ability to break down dietary fats in the form of triglycerides into free fatty acids and monoglycerides that are absorbed. Since the undigested triglycerides are not absorbed, the intake of calories in the body is reduced, which leads to a decrease in body weight. The therapeutic effect of the drug is carried out without absorption into the systemic circulation. The action of orlistat leads to an increase in the fat content in the feces within 24-48 hours after taking the drug. After discontinuation of the drug, the fat content in the feces usually returns to the initial level after 48-72 hours.

Pharmacokinetics

Absorption The absorption of orlistat is low. 8 hours after oral administration of a therapeutic dose, unchanged orlistat in the blood plasma is practically undetectable (concentration less than 5 ng / ml). There are no signs of cumulation, which confirms the minimal absorption of the drug. Distribution In vitro, orlistat binds more than 99% to plasma proteins (mainly lipoproteins and albumin). In minimal amounts, orlistat can penetrate into erythrocytes. Metabolism 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 a cleaved N-formylleucine residue). Excretion The main route of elimination is through the intestines - about 97% of the dose taken, of which 83% is unchanged. The cumulative excretion through the kidneys of all substances structurally related to orlistat is less than 2% of the dose taken. The time for complete elimination is 3-5 days. Orlistat and metabolites can be excreted in the bile

Indications

Orsoten is indicated for the long-term treatment of obese patients with a body mass index (BMI)> 30 kg / m, or overweight patients (BMI> 28 kg / m), including those with obesity-associated risk factors, in combination with moderate low-calorie diet. Orsotene can be given in combination with hypoglycemic drugs and / or a moderately low-calorie diet in overweight or obese patients with type 2 diabetes mellitus.

Contraindications

Chronic malabsorption syndrome; cholestasis; hypersensitivity to orlistat or any other components of the drug; pregnancy and breastfeeding: children under 18 years of age (efficacy and safety have not been studied)

Precautionary measures

Before prescribing orlistat, an organic cause of obesity, such as hypothyroidism, should be ruled out. During treatment, a balanced low-calorie diet in which fat provides no more than 30% of calories is recommended. The likelihood of developing side effects from the gastrointestinal tract increases with a high content of fat in food (more than 30% of the daily calorie content). The daily intake of fats, carbohydrates and proteins should be divided between the three main meals. Since orlistat reduces the absorption of some fat-soluble vitamins, patients should take a multivitamin formulation containing fat-soluble vitamins to ensure adequate intake of these vitamins. In addition, the content of vitamin D and beta-carotene in obese patients may be lower than in non-obese people. Multivitamins should be taken 2 hours before or 2 hours after taking orlistat, for example at bedtime. Taking orlistat in doses exceeding 120 mg 3 times a day does not provide an additional effect. In patients taking orlistat and cyclosporine at the same time, more frequent monitoring of the plasma cyclosporine level is required. in the following percentage of cases (data in the placebo group are indicated in brackets): vitamin A 2.2% (1%), vitamin D 12.0% (6.6%), vitamin E 5.8% (1%), beta -carotene 6.1% (1.7%). In some patients, against the background of orlistat, the content of oxalates in the urine may increase. As with other weight loss drugs, some groups of patients (for example, with anorexia nervosa or bulimia nervosa) are likely to abuse orlistat. Induction of orlistat weight loss may be combined with improved metabolic control of diabetes mellitus, which will require a decrease in doses of oral hypoglycemic drugs (derivatives sulfonylurea, metformin, etc.) or insulin.

Application during pregnancy and lactation

According to the results of preclinical studies, teratogenicity and embryotoxicity were not observed when taking orlistat. There are no clinical data regarding the use of orlistat during pregnancy, therefore, the drug should not be prescribed during this period. Because there are no data on the use during lactation, orlistat should not be prescribed during lactation.

Method of administration and dosage

The recommended single dose of orlistat is one 120 mg capsule, which is taken orally with water, immediately before each main meal, during meals or no later than an hour after meals. If a meal is skipped, or if the meal does not contain fat, then orlistat can be skipped. Doses of orlistat over 120 mg 3 times a day do not enhance its therapeutic effect. Duration of therapy is not more than 2 years No dose adjustment is required for elderly patients or patients with impaired liver or kidney function

Side effects

Adverse reactions were mainly noted from the gastrointestinal tract and were due to an increased amount of fat in the feces. Usually, the observed side reactions are mild and transient. The appearance of these reactions was observed at the initial stage of treatment during the first 3 months. (but not more than one case). With prolonged use of orlistat, the number of side effects decreases. On the part of the digestive system: flatulence accompanied by rectal discharge, urge to defecate, oily / oily stools, oily rectal discharge, loose stools, soft stools, inclusions of fat in the stool (steatorrhea), pain / discomfort in the abdomen, increased frequency of bowel movements, pain / discomfort in the rectum, urge to defecate, fecal incontinence, damage to the teeth and gums, hypoglycemia in patients with type 2 diabetes mellitus; very rarely - diverticulitis, cholelithiasis, hepatitis, possibly severe, increased levels of hepatic transaminases and alkaline phosphatase. From the side of the central nervous system: headache, anxiety. Allergic reactions: itching, rash, urticaria, angioedema, bronchospasm, anaphylaxis; very rarely, a bullous rash. Others: flu-like syndrome, feeling tired, upper respiratory tract infections, urinary tract infections, dysmenorrhea.

Overdose

Overdose cases are not described. Reception of a single dose of 800 mg orlistat or multiple doses up to 400 mg 3 times / day for 15 days was not accompanied by significant adverse reactions. In addition, a dose of 240 mg 3 times / day, prescribed to obese patients for 6 months, did not cause a significant increase in adverse reactions. In case of overdose of orlistat, it is recommended to observe the patient for 24 hours.

Interaction with other drugs

In patients receiving warfarin or other anticoagulants and orlistat. there may be a decrease in the level of prothrombin, an increase in the international normalization rate (INR), which leads to changes in hemostatic parameters. Interaction with amitriptyline, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, nifedipine GITS, sustained-release nifedipine, sibutramine, furosemide, neoblastolamidomopril, atenolamopril. Increases the bioavailability and hypolipidemic effect of pravastatin, increasing its plasma concentration by 30%. Decrease in body weight can improve metabolism in patients with diabetes mellitus, as a result of which it is necessary to reduce the dose of oral hypoglycemic agents. Orlistat treatment 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 concentration of cyclosporine in the blood plasma was noted, therefore it is recommended to more often determine the level of concentration of cyclosporine in the blood plasma. In patients receiving amiodarone, clinical observation and ECG monitoring should be carried out more closely, because Cases of a decrease in the level of concentration of amiodarone in blood plasma have been described.

special instructions

Orlistat is effective for long-term control of body weight (reducing body weight, maintaining it at an appropriate level and preventing re-weight gain). Orlistat treatment 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 to a decrease in the amount of visceral fat. 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 mellitus, which may allow a decrease in the dose of hypoglycemic drugs. To ensure adequate nutrition of patients, it is recommended to take multivitamin preparations. Patients should adhere to dietary recommendations. They should eat a balanced, moderately low-calorie diet with no more than 30% of their calories as fat. Divide your daily fat intake into three main meals. The likelihood of gastrointestinal adverse reactions may increase if orlistat is taken with a diet rich in fats (eg, 2000 kcal / day,> 30% of daily caloric intake comes in the form of fat, which is approximately 67 g of fat). Patients should be aware that the more closely they follow the diet (especially with respect to the allowed amount of fat), the less likely it is to develop adverse reactions. A low-fat diet reduces the likelihood of gastrointestinal side reactions and helps patients control and regulate their fat intake. If after 12 weeks of therapy there has been no decrease in body weight by at least 5%, orlistat should be discontinued.

Orsoten (Latin Orsoten) is a medicine for weight loss. Belongs to the class of lipid-lowering drugs. The active ingredient is orlistat, which blocks the action of lipolytic enzymes in the digestive tract and thus reduces fat absorption. The drug is recommended for complex treatment obesity combined with a low-calorie diet.

Orlistat was first synthesized in 1985 by biochemists of the Swiss pharmaceutical company F. Hoffman-La Roche Ltd. " (F. Hoffmann-La Roche Ltd).

Lipstatin, a product of the vital activity of Streptomyces toxytricini bacteria, became the initial component for obtaining a medicinal substance. After studying the properties of the new compound, scientists discovered that it has the ability to inhibit human lipases. However, lipstatin itself turned out to be chemically unstable, so its formula was modified.

The resulting synthetic derivative - tetrahydrolipstatin - was given the international non-proprietary name "orlistat". It took the company another 13 years to develop a dosage form for a new drug and conduct clinical trials. In 1998, the product was registered in Switzerland under the trade name Xenical and became available to patients.

In 1999, Xenical was approved for use in 17 countries, including the USA, Canada, Australia and several EU countries.

The term of patent protection for the original orlistat expired in 2007. At the same time, the first medicinal copies of the drug appeared in the USA, Great Britain and India: Alli, Orleans, Orlik, etc.

In Russia, the first generic Xenical was Orsoten, registered in 2009 by the Slovenian company KRKA.

Properties of the active substance

International non-proprietary name: orlistat (lat.orlistat).

Trivial name: tetrahydrolipstatin.

IUPAC name:] -1 - [(3-hexyl-4-oxo-2-oxetanyl) -methyl] N-formyl-L-leucine dodecyl ester.

Structural formula:

Gross formula: C29H53NO5

Molecular weight: 495.74.

Orlistat is a white crystalline powder, readily soluble in organic solvents (methanol, ethanol) and practically insoluble in water. The substance is highly lipophilic.

Clinical data

The World Organization of Gastroenterologists classifies orlistat as a moderately effective anti-obesity agent.

In clinical studies, the drug caused a significant decrease in body weight in 75% of volunteer patients. For 12 weeks of treatment, patients managed to lose up to 5% of their initial weight. Higher results (up to 10%) were observed in those who combined taking the drug with a hypocaloric diet and physical activity.

In the course of the trials, other positive effects of the therapy were noted.

In particular, in patients with essential hypertension, a persistent decrease in blood pressure was observed:

• systolic ("upper") - an average of 12.9 mm Hg. Art.,
• diastolic ("lower") - by 7.6 mm Hg. Art.

All volunteers showed an improvement in lipid metabolism. After 24 weeks from the beginning of the treatment course, the level of total cholesterol and the content of low density lipoproteins (LDL) in the blood decreased.

Several studies have proven that orlistat helps prevent the onset or slow the progression of type II diabetes. In patients with impaired glucose tolerance, on the background of its administration, tissue sensitivity to insulin improved. In patients with already developed diabetes, treatment made it possible to reduce the doses of hypoglycemic agents taken.

Legal status of the active substance

Orlistat is currently the only medication officially approved for the long-term treatment of obesity. However, due to the little experience of using the drug in different countries there is a lot of controversy regarding the rules of his vacation.

Orlistat was originally only available with a prescription. This situation continues to this day in Canada.

In Australia and New Zealand in 2003, the drug was transferred to the over-the-counter category. In 2006, the Consumer Association of Australia contacted the Government Office of Trade medicines with a request to return orlistat to its previous prescription status, justifying this by the fact that free sales may lead to uncontrolled use of the drug. The petition was rejected, but the Office ruled to ban advertising for orlistat.

In the USA and in the countries of the European Union in 2006-2009. it was allowed to dispense over-the-counter drugs with a dosage of 60 mg orlistat. Preparations with an active substance content of 120 mg can still only be purchased upon presentation of a special form.

Instructions

Composition, release form, packaging

Orsoten is obtained biologically using a culture of Streptomyces toxytricini bacteria. The final product of the production is a semi-finished product consisting of orlistat and an auxiliary component - microcellulose.

The drug is available in capsule form. One capsule contains 225.6 mg of a granular semi-finished product, which corresponds to 120 mg of orlistat. The capsule cap and body are made of hypromellose and are white or slightly yellowish in color.

The product is packed in plastic cell blisters and then in cardboard packages of 21, 42 or 84 pcs.

Mechanism of action

In the lumen of the alimentary canal, Orsoten interacts with gastric and pancreatic lipases, blocking their active centers. Enzymes inactivated in this way cease to participate in the breakdown of fats. Since whole lipid molecules are not able to be absorbed into the blood, they are excreted from the intestine unchanged. The number of calories from food is reduced by an average of 30%, which leads to a decrease in body weight. The use is especially effective in patients who are accustomed to eating a diet high in fat.

In addition to the main task, the drug:

• reduces the level of "bad" cholesterol in the blood,
• prevents the development of type II diabetes mellitus,
• lowers high blood pressure.

With prolonged use of Orsoten, a conditioned reflex is formed in patients, which consists in the fact that a violation of the diet towards fatty foods is firmly associated with unpleasant side reactions of the drug (diarrhea and fatty stools). As a result, even with a rather weak motivation to lose weight, the patient begins to involuntarily adhere to a low-calorie diet.

With long-term therapy, body weight is gradually reduced in accordance with dietary standards. On average, over 3 months of treatment, patients lose 5 to 8 extra pounds.

Metabolism and excretion

The drug acts in the digestive tract, practically not being absorbed into the bloodstream. 8 hours after taking Orsoten, its concentration in the blood is about 6 ng / ml, which confirms the low absorption of the drug.

The main part of the drug is excreted from feces, and 83% of the dose taken - unchanged. A small amount breaks down in the intestinal walls to inactive products. Metabolites are excreted in the kidneys and bile.

The period of complete elimination of the drug from the body is from 3 to 5 days.

Indications

• for long-term treatment of obesity (with a body mass index of more than 30 kg / m²),
• to combat overweight (with a BMI of at least 27 kg / m²).

The drug can be used by patients who are at high risk of developing cardiovascular disease and diabetes mellitus. If necessary, it is permissible to carry out therapy in combination with hypoglycemic agents.

Taking capsules should be combined with a moderate, low-calorie diet. Fat content in daily diet should not exceed 30%.

Contraindications

Orsoten is contraindicated in the following conditions:

• Hypersensitivity to orlistat or other components of the drug.
• Malabsorption nutrients in the intestine (malabsorption syndrome).
• Cholestasis.

Due to insufficient knowledge, the drug should not be used under the age of 18 years.

Pregnancy and lactation

There are no clinical data on the effect of orlistat on the fetus, therefore it is not recommended to take Orsoten during pregnancy.

Breastfeeding therapy is also considered highly undesirable. The drug inhibits the absorption of fat-soluble vitamins, the deficiency of which can negatively affect the development of the child.

Influence on the ability to control mechanisms

Orsoten does not reduce concentration of attention and does not affect the ability to control transport and complex mechanisms.

How to take and dose

For the manifestation of the effects of orlistat, the presence of lipases in the digestive tract is required. Since the production of enzymes occurs only during meals, it is necessary to use it with meals or no later than an hour after it.

Recommended therapy regimen: 1 capsule 3 times a day. The drug should be taken with a little water. If the food does not contain fat or the patient skips the meal, then it is possible not to take it. The maximum allowable duration of a treatment course is 2 years.

Taking the drug in doses exceeding therapeutic doses does not lead to an increase in its effect.

Side effects

Commonly reported adverse reactions include:

• oily stools
• fatty discharge from the rectum,
• bloating
• frequent urge to defecate,
• pain in the abdomen,
• feeling of discomfort in the intestines,
• increased stool
• fecal incontinence
• damage to the teeth and gums,
• the appearance of anxiety,
• weakness,
• upper respiratory and urinary tract infections.

Very rarely, patients have:

• allergic reactions (in the form of skin rash, itching, bronchospasm or anaphylaxis),
• cholelithiasis,
• hepatitis,
• increased levels of hepatic transaminases and alkaline phosphatase,
• diverticulitis
• bullous rash.

The severity of side effects from the gastrointestinal tract directly depends on the fat content in food, therefore it is important to combine the drug intake with a low-calorie diet.

Most often, negative effects appear in the first 3 months of therapy. As treatment continues, the unpleasant symptoms subside.

special instructions

Reduces intestinal absorption of fat-soluble vitamins by 30%:

• beta-carotene (vit. A),
• tocopherol (vit. E),
• phylloquinone (vit. K),
• calciferol (vit. D).

To compensate for the loss of nutrients, patients should take multivitamins during the entire duration of therapy. The optimal dosage regimen is once a day, 2 hours after the use of Orsoten, or at night.

In patients with diabetes mellitus, the use of the drug may be accompanied by an improvement in carbohydrate metabolism, which requires a decrease in the doses of hypoglycemic agents.

Orsoten is recommended for long-term treatment of obesity. However, if after 3 months from the start of treatment, body weight has not decreased by at least 5%, then further use of the drug must be abandoned.

Interaction with other medicinal products

May interfere with the absorption of cyclosporine. Simultaneous therapy with these agents should be carried out under the supervision of a physician, constantly monitoring the level of cyclosporine in the blood plasma.

The combination of orlistat with warfarin and other anticoagulants leads to a decrease in prothrombin levels and an increase in the international normalization rate.

It has been reliably established that Orsoten does not interact with the following drugs:

• antidepressants (fluoxetine, amitriptyline),
• oral contraceptives,
• ACE inhibitors and angiotensin-converting enzyme blockers (captopril, losartan),
• beta blockers (atenolol),
• calcium channel blockers (nifedipine),
• biguanides,
• fibrates,
• furosemide,
• sibutramine (Meridia),
• glibenclamide,

The intake of alcoholic beverages does not affect the effects of the drug.

Overdose

During the application, no cases of its overdose were recorded. Taking increased doses of the drug does not lead to an increase in its side effects.

Storage

At a temperature of 25 ° C, in a place well protected from children. It must be stored in pharmacies and medical institutions according to the terms of list B.

Shelf life

2 years from the date of manufacture.

Vacation conditions

On prescription.

Manufacturer

The Orsoten brand belongs to the Slovenian pharmaceutical concern KRKA. The company is one of the largest manufacturers of generics in the world, and its products are represented in more than 70 countries.

The capsules are produced by the KRKA-RUS plant located in the city of Istra. Today the enterprise is one of the most modern in Russia. The production capacity of the plant is more than 1 million tablets and capsules per year. The production conditions meet the requirements of the international GMP standard.

Countries where sales are allowed

As of 2015, Russia is the only country in which Orsoten is registered. The drug was approved for use by the Ministry of Health and the Ministry of Health of the Russian Federation in 2009.

Similarity to the original

Orsoten is a medicinal copy developed according to the formula of the original Swiss orlistat - Xenical. When comparing the two drugs according to clinical and pharmacological articles, a difference is found in production technologies, the composition of auxiliary compounds and some points of the instruction.

Comparative characteristics:

Equal efficacy and safety were confirmed in the course of a comparative clinical study, which was conducted on the basis of 5 Russian medical centers:

• FGU Endocrinological Research Center (Moscow),
• FGU GKB No. 68 (Moscow),
• GU GKB No. 63 (Moscow),
• GU GKB No. 67 (Moscow),
• Federal Center for Heart, Blood and Endocrinology named after V.A. Almazov (St. Petersburg).

160 volunteer patients underwent a 12-week treatment program. In the group receiving Xenical, weight loss of more than 5% was recorded in 51.2% of patients, and in the group receiving Orsoten - in 47.6%. At the same time, the average weight loss in the first population was 5.2%, in the second - 5.4%.

When conducting a safety analysis, there were no statistically significant differences in the frequency and severity of side effects between the groups.

The data obtained proved that Orsoten and Xenical are clinically equivalent. However, according to a number of experts, the high content of impurities in Orsoten may be the reason for the more frequent development of allergic reactions to it.

Drugs with a similar therapeutic effect

Analogs include products that include orlistat in the same or lower dosage. All of these drugs are also copies of Xenical. Medicines are produced by different companies and differ in production methods, dispensing rules, chemical stability and shelf life. The cost of drugs is comparable.