Orlistat-Acrihin capsules 120mg 42pcs

Composition

1 capsule contains: Active ingredient: orlistat – 120 mg. Additional components: sodium carboxymethyl starch, microcrystalline cellulose, sodium lauryl sulfate, colloidal anhydrous silicon dioxide. Capsule shell: titanium dioxide (E 171), gelatin, indigo carmine (E 132).

Pharmacological action

Orlistat is a specific long-acting gastrointestinal lipase inhibitor. This substance shows its effect in the lumen of the stomach and small intestine by forming a covalent bond with the active serine center of gastric and pancreatic lipases. As a result of the influence of the lipid-lowering agent, the inactivated enzyme loses its ability to break down fats coming from food in the form of triglycerides (TG) to monoglycerides and absorbed free fatty acids. Since undivided TG is not absorbed from the gastrointestinal tract (GI), the body receives fewer calories, 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, the concentration of fat in the feces increases 24-48 hours after oral use of the drug. By reducing fat storage, Orlistat-Akrikhin provides effective body weight control. In clinical trials involving obese patients, the orlistat-treated group showed a more pronounced loss of body weight compared to patients receiving diet therapy alone. Weight loss was observed within the first 2 weeks after starting Orlistat-Akrikhin and then for 6-12 months, even if there was a negative response to diet therapy. Statistically significant improvements in the profile of obesity-related metabolic risk factors were recorded over two years. In addition, there was a significant reduction in body fat deposits when compared with the placebo group. Orlistat has also been shown to be effective when used to prevent repeated body weight gain. Approximately half of the patients experienced a weight gain of no more than 25% of the weight lost, and the second half of the patients who participated in the study did not re-gain weight, or even recorded a subsequent weight loss. During clinical trials that lasted from 6 months to 1 year, patients with overweight or obesity and type 2 diabetes mellitus experienced a more significant loss of body weight when using orlistat compared to patients who were only on diet therapy. Weight loss occurred mainly as a result of a decrease in the deposition of fat masses in the body. It should be noted that patients involved in the study, before the start of the study, despite taking antidiabetic drugs, often had insufficient glycemic control. When treated with orlistat, such patients showed a significant improvement in glycemic control. Also, during the use of Orlistat-Akrikhin, a decrease in antidiabetic doses, insulin concentrations, and a decrease in insulin resistance were observed. According to studies that lasted 4 years, orlistat therapy significantly reduced the risk of developing type 2 diabetes mellitus – an average of 37% compared to placebo. This threat was reduced by approximately 45% in patients with an initial glucose tolerance disorder. The orlistat group showed a more significant reduction in body weight compared to the placebo group, as well as a significant improvement in the profile of metabolic risk factors. The achieved new body weight level was maintained during all 4 years of the study. In obese adolescents, a 1-year study with orlistat showed a decrease in body mass index (BMI), as well as a decrease in body fat and waist and hip circumference compared to the placebo group. Adolescents also experienced a significant reduction in diastolic blood pressure (BP) when taking Orlistat-Akrikhin compared to those who received placebo.

Indications

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

Recommendations for use

Orlistat-Akrikhin is used orally with each main meal (during a meal, immediately before a meal, or no later than 1 hour after a meal). Capsules should be washed down with water. During long-term therapy, patients with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 28 kg/m2), with obesity-related risk factors, aged 12 years and older, with a moderately limited low-calorie diet, should take Orlistat-Akrikhin at 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 with combined hypoglycemic agents and/or following a moderately limited hypocaloric diet, it is recommended to take 120 mg of orlistat (1 capsule) 3 times a day. It is allowed to skip the next capsule intake if the food does not contain fat or the meal was missed. During the period of therapy, it is required to adhere to a balanced, moderately limited hypocaloric diet containing no more than 30% of calories in the form of fat, and it is also recommended to include fruits and vegetables in the daily diet. The total amount of carbohydrates, fats, and protein consumed per day should be divided into three main meals. When using orlistat in doses exceeding 3 capsules per day, no increase in the therapeutic effect was noted. The safety and efficacy of Orlistat-Akrikhin in patients with functional disorders of the liver and/or kidneys have not been studied.

Contraindications

Absolute: cholestasis; chronic malabsorption syndrome; age up to 12 years; pregnancy and lactation; hypersensitivity to any of the components of Orlistat-Akrikhin. Special caution should be exercised when taking cyclosporine, warfarin, or other oral anticoagulants concomitantly.

Side effects

Undesirable effects due to orlistat use appeared in most cases from the gastrointestinal tract and were associated with the pharmacological action of the drug that blocks the absorption of food fats. During the admission period Orlistat-Akrikhin may cause the following disorders: : metabolic and nutritional disorders: very often – hypoglycemia;infectious and parasitic lesions: very often – flu; nervous system: very often – headache;mental disorders: often – anxiety;respiratory system, chest and mediastinal organs: very often – upper respiratory tract infections; 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, abdominal discomfort/pain, gas release with a certain amount of discharge, flatulence, loose stools, imperative urge to defecate, increased defecation, steatorrhea; often – discomfort/pain in the rectum, fecal incontinence, soft stools, bloating, tooth damage, gum damage;general disorders: often – weakness. The nature and frequency of side effects in patients with type 2 diabetes mellitus were similar to those in patients without diabetes mellitus, who are overweight and obese. During treatment, the frequency of adverse reactions from the gastrointestinal tract increased with an increase in the 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 poorly expressed, 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 incidence of these phenomena decreased.

Interaction

– amiodarone – may be a decrease in the level of the substance in the blood plasma should be clinical observation and monitoring of the ECG; – antiepileptic drugs – decreases absorption of these funds, which can cause the development of seizures; cyclospo