Orlistat

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Available since: 2019-09-19

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Clinical Pharmacology

Orlistat refers to specific inhibitors of long-acting gastrointestinal lipases. This substance manifests its effect in the lumen of the stomach and small intestine by forming a covalent bond with the active serine center of the gastric and pancreatic lipases. As a result of the influence of the hypolipidemic agent, the inactivated enzyme loses the ability to break down the triglyceride (TG) fats that come with food into monoglycerides and absorbable free fatty acids. Since unsplit TG is not absorbed from the gastrointestinal tract (GIT), fewer calories enter the body and, as a result, body weight decreases. Thus, the therapeutic effect of the drug is carried out without its absorption into the systemic circulation. Due to the activity of orlistat, 24–48 hours after oral administration of the agent, the concentration of fat in the stool mass increases. Leading to a decrease in fat depot, Orlistat-Akrikhin provides effective control of body weight. In clinical trials involving patients with obesity, in the group of patients receiving orlistat, there was a more pronounced loss of body weight compared with patients who were only on diet therapy. Weight loss was observed already during the first 2 weeks after the start of the administration of Orlistat-Akrikhin and thereafter within 6–12 months even in the presence of a negative response to diet therapy. A statistically significant significant improvement in the profile of obesity-related metabolic risk factors was recorded for two years. In addition, there was a significant decrease in fat deposits in the body when compared with the placebo group. Orlistat also demonstrated efficacy in its use in order to prevent re-gaining body weight. Approximately half of the patients showed a weight gain of no more than 25% of the loss, and the second half of the patients participating in the study did not regain weight, or even recorded a subsequent weight loss. In the course of clinical studies that lasted from 6 months to 1 year, patients with overweight or obesity and type 2 diabetes mellitus with orlistat showed a more significant loss of body weight compared with patients who were only on diet therapy. Weight loss occurred mainly as a result of a decrease in fat deposits in the body. It should be noted that in patients involved in the study, before the start of the study, despite the use of antidiabetic agents, there was often insufficient glycemia control. When treating orlistat, these patients showed a significant improvement in glycemic control. Also during the use of Orlistat-Akrikhin, a decrease in doses of antidiabetic agents, insulin concentrations, as well as a decrease in insulin resistance was observed. According to research data, which lasted 4 years, it was found that during the treatment with orlistat, the risk of the onset of type 2 diabetes mellitus was significantly reduced - by an average of 37% compared with placebo. This threat was reduced by approximately 45% in patients with an initial impaired glucose tolerance. In the group receiving orlistat, there was a more significant decrease in body weight compared with the placebo group, and besides this there was a significant improvement in the profile of metabolic risk factors. Achieved a new level of body weight was maintained throughout the 4 years of the study. In adolescents with obesity during the study with a duration of 1 year against the background of treatment with orlistat, a decrease in body mass index (BMI) was recorded, as well as a decrease in body fat and waist circumference and hips compared to the placebo group.Also in the period of taking Orlistat-Akrikhin, a significant decrease in diastolic blood pressure (BP) was observed in adolescents compared with those who received a placebo.

Suggested use

Orlistat-Akrikhin is used orally with each main meal (during meals, immediately before meals, or no later than 1 hour after meals). Capsules should be washed down with water. With prolonged therapy, patients with obesity (BMI ≥ 30 kg / m²) or overweight people (BMI ≥ 28 kg / m²) with obesity-related risk factors aged 12 years and older should follow a moderately restricted low-calorie diet. take Orlistat-Akrikhin in a dose of 120 mg of orlistat (1 capsule) 3 times a day. When prescribing the drug to adult patients with type 2 diabetes mellitus with obesity or overweight, it is recommended to take 120 mg of orlistat (1 capsule) 3 times a day with a combined intake of hypoglycemic agents and / or following a moderately limited hypocaloric diet. It is allowed to skip the next capsule intake in the event that the food does not contain fat or the meal was skipped. During the period of therapy, it is required to adhere to a balanced moderately restricted hypocaloric diet containing no more than 30% of calories in the form of fat, it is also recommended to include fruits and vegetables in the daily diet. The total amount of carbohydrates, fats and proteins consumed per day must be divided into three main methods. When using orlistat in doses exceeding 3 capsules per day, there was no increase in the therapeutic effect. The study of the safety and efficacy of taking Orlistat-Akrikhin in patients with functional disorders of the liver and / or kidneys has not been conducted.

Indications

Orlistat-Akrikhin is recommended for long-term treatment of patients with obesity with a BMI ≥ 30 kg / m² or patients with overweight with a BMI ≥ 28 kg / m², who have obesity-related risk factors, while conducting a moderately limited low-calorie diet. Orlistat-Akrikhin is also indicated for use in patients with type 2 diabetes with overweight or obesity in combination with a moderately limited hypocaloric diet and / or taking hypoglycemic drugs (insulin and / or sulfonylurea derivatives, metformin).

Composition

1 capsule contains: active ingredient: orlistat - 120 mg; additional components: sodium carboxymethyl starch, microcrystalline cellulose, sodium lauryl sulfate, anhydrous colloidal silicon dioxide; capsular shell: titanium dioxide (E171), gelatin, indigo carmine (E132).

Orlistat is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Orlistat Akrikhin			capsules
Listata®	Izvarino Pharma	Russia	pills
Orsoten slim	Krka dd Novo mesto AO	Slovenia	capsules
Orsoten	Krka dd Novo mesto AO	Slovenia	capsules
Xenical	Hoffmann la roch	Switzerland	capsules

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Dosage and Administration

Unwanted effects due to taking orlistat appeared in most cases on the part of the gastrointestinal tract and were associated with the pharmacological action of the agent that blocks the absorption of food fats. During the period of taking Orlistat-Akrikhin, the following violations may occur: metabolism and eating disorders: very often - hypoglycemia; infectious and parasitic lesions: very often - the flu; nervous system: very often - headache; mental disorders: often - anxiety; respiratory system, chest organs and mediastinum: very often - infections of the upper respiratory tract; often - lower respiratory tract infections; genitals and mammary gland: often - irregular menstruation; kidneys and urinary tract: often - urinary tract infections; Gastrointestinal tract: very often - oily discharge from the rectum, discomfort / abdominal pain, gas with some discharge, flatulence, loose stools, imperative urge to defecate, increased bowel movements, steatorrhea; often - discomfort / pain in the rectum, fecal incontinence, soft stools, abdominal distension, tooth damage, gum damage; common disorders: often - weakness. The nature and frequency of side effects in patients with type 2 diabetes were similar to those in patients without diabetes who are overweight and obese. During treatment, the frequency of adverse reactions from the gastrointestinal tract increased with increasing amount of fat in the consumed food. You can eliminate or reduce the severity of these disorders by following a low-fat diet. In most cases, the above effects were transient and mild, their appearance was noted mainly in the first 3 months of therapy and, as a rule, no more than one episode. Against the background of long-term use of Orlistat-Akrikhin, the frequency of occurrence of these phenomena decreased.

Contraindications

Absolute: cholestasis; chronic malabsorption syndrome; age up to 12 years; pregnancy and lactation period; hypersensitivity to any of the components of Orlistat-Akrihin. With extreme caution should be treated with the drug with concomitant use of cyclosporine, warfarin or other oral anticoagulants.

Drug interactions

amiodarone - there may be a decrease in the level of this substance in the blood plasma, clinical observation and monitoring of ECG parameters should be carried out; antiepileptic drugs - absorption of these drugs is reduced, which can cause the development of seizures; cyclosporine - the level of its content in the blood plasma decreases, which may entail a weakening of the immunosuppressive effectiveness of the drug; This combination is not recommended, if necessary, it is necessary to carry out frequent monitoring of the plasma concentration of cyclosporine, both with orlistat's concomitant use and after its completion; warfarin and other anticoagulants - may decrease the concentration of prothrombin and increase the international normalized ratio (INR), which can lead to changes in hemostatic parameters; with this combination, monitoring of indicators of INR is necessary; fat-soluble vitamins A, D, E, K and beta-carotene - the absorption of these substances is weakened; with combined use, they must be taken at bedtime or no earlier than 2 hours after taking orlistat; acarbose - it is recommended to avoid combined use due to the lack of pharmacokinetic interaction studies; levothyroxine sodium - hypothyroidism may develop and / or its control may be reduced due to a decrease in the absorption of levothyroxine sodium and / or inorganic iodine; oral contraceptives - the risk of contraceptive action is aggravated, which in some cases increases the likelihood of an unplanned pregnancy; additional contraceptive methods should be used, including when severe diarrhea occurs; antiretrovirals for the treatment of human immunodeficiency virus (HIV), neuroleptics (including lithium preparations), antidepressants, benzodiazepines - a decrease in the therapeutic effect of these drugs is possible; Starting therapy with orlistat in these patients should be after a thorough assessment of the expected benefit from this treatment and the possible risk; fibrates, atorvastatin, digoxin, amitriptyline, biguanides, losartan, pravastatin, fluoxetine, phentermine, sibutramine, nifedipine, phenytoin, ethanol — no interaction with these drugs was observed.

Special instructions

Orlistat-Akrikhin is recommended for long-term control of body weight (including reducing body weight, maintaining it at the desired level achieved and preventing re-gaining body weight). In patients with type 2 diabetes as a result of weight reduction, the use of the drug increases the likelihood of improved carbohydrate metabolism, against the background of which a reduction in the dose of hypoglycemic drugs may be required. Orlistat-Akrikhin therapy should not last more than 2 years. If 12 weeks after the start of the course it was not possible to achieve a weight loss of at least 5%, the use of the drug should be stopped. If such symptoms as fatigue, weakness, fever, darkening of urine and jaundice occur during the treatment, it is necessary to consult a doctor in order to rule out possible abnormalities in liver function. During the period of drug treatment, predominantly in patients with concomitant chronic kidney lesions and / or dehydration, hyperoxaluria and oxalate nephropathy may develop, which in some cases may lead to the appearance of renal failure.

Overdosage

Cases of drug overdose are not described. When taking single (800 mg) and multiple doses (for 15 days, up to 400 mg three times a day) orlistat did not occur in people with normal body weight / obesity. When receiving orlistat by obese patients for 6 months at a dose of 240 mg three times a day, an increase in the incidence of undesirable reactions was not observed. In the event of a significant overdose of Orlistat-Akrikhin, the patient should be monitored for 24 hours. According to clinical and preclinical studies, the systemic effects should be rapidly reversible with orlistat’s lipase-inhibiting properties.