Buy Orlistat Online
Other forms and dosages
capsules 60/120 mg
International nonproprietary name
Orlistat
Composition
Composition per capsule: Active ingredient: Orlistat, pellet substance 50% - 120.00 mg, in terms of orlistat - 60.00 mg. Excipients of the pellet substance: microcrystalline cellulose 49.32 mg, sodium carboxymethyl starch 5.04 mg, sodium lauryl sulfate 3.12 mg, povidone-KZ0 2.52 mg.
Group
Gastrointestinal lipase inhibitors
Indications for use
Reduction of excess body weight in adult patients (over 18 years of age) with a body mass index (BMI) over 28 kg/m2 when used only in combination with a moderately hypocaloric diet containing no more than 30% of daily calories in the form of fat.
Method of administration and dosage
Orally, 1 capsule (60 mg) three times a day with each main meal in combination with a moderately hypocaloric diet with a low fat content. The capsule should be taken immediately before a meal, during a meal, or no later than 1 hour after a meal, with water. If a meal is missed or the meal does not contain fat, taking Orlistat can also be skipped. No more than three capsules of 60 mg of Orlistat can be taken within 24 hours. Orlistat should be taken only in recommended doses. The course of treatment should not exceed 6 months. It is recommended to discuss the results of weight loss with your doctor. If after 12 weeks of taking Orlistat there is no weight loss (i.e. weight loss is less than 5% of the initial weight), you should consult your doctor to decide whether to continue taking the drug. Special patient groups. Elderly patients (> 65 years): there are limited data on the use of orlistat in the elderly. However, given that the absorption of orlistat is minimal, no dose adjustment is required in this group of patients. Patients with liver and kidney failure: the effect of orlistat in individuals with liver and/or kidney failure has not been studied. However, given that the absorption of orlistat is minimal, no dose adjustment is required in patients with liver and/or kidney failure. Children: the use of orlistat 60 mg is contraindicated in children under 18 years of age due to insufficient data on safety and efficacy.
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Contraindications
Hypersensitivity to orlistat or any of the components of the drug. Chronic malabsorption syndrome. Cholestasis. Concomitant use of cyclosporine. Concomitant use of indirect anticoagulants (warfarin). Concomitant use of sitagliptin. Pregnancy, breastfeeding. Children under 18 years of age. Use during pregnancy and breastfeeding: the use of the drug Orlistat is contraindicated in pregnancy due to the lack of reliable clinical data confirming the safety of its use. It has not been established whether orlistat penetrates into breast milk, therefore, the use of the drug Orlistat during breastfeeding is contraindicated.
Pharmacological action
Pharmacodynamics: The active substance of the drug Orlistat - orlistat is a potent specific inhibitor of gastrointestinal lipases of long action. It exhibits its therapeutic activity in the lumen of the stomach and small intestine, forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme loses the ability to hydrolyze dietary fats (triglycerides) into absorbable free fatty acids and monoglycerides. Unsplit triglycerides are not absorbed, which leads to a decrease in the number of calories absorbed by the body and to a decrease in body weight. The therapeutic effect of orlistat is thus achieved without absorption into the systemic circulation. According to the results of clinical studies, orlistat taken daily at a dose of 60 mg 3 times a day blocks the absorption of approximately 25% of fats included in the daily diet. Along with weight loss, with long-term use of orlistat 60 mg, a decrease in such parameters as waist circumference, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in the blood plasma is noted. After 6 months of therapy with orlistat 60 mg, the average concentration of TC in the blood plasma decreases by an average of 2.4%, LDL-C - by 3.5%. Waist circumference after 6 months of taking orlistat decreases by an average of 4.5 cm. Pharmacokinetics. Absorption: absorption of the drug is minimal. Excretion: about 97% of the orally administered dose of orlistat is excreted through the intestines, 83% of this amount is unchanged. Orlistat is completely excreted in 3-5 days. Excretion of orlistat, both in volunteers with normal body weight and in obese patients is similar.
Side effects
Adverse reactions when taking orlistat are observed from the gastrointestinal tract (GIT) and are due to its pharmacological action. Adverse gastrointestinal reactions identified in clinical studies (lasting 18 to 24 months) were generally mild and transient. They typically occurred early in therapy (within the first 2 months), and most patients experienced only one episode. Low-fat diet reduces the likelihood of such reactions. Adverse reactions reported during clinical studies. Gastrointestinal disorders: very common - oily rectal discharge, fatty oily stools, soft stools, flatulence with some discharge, flatulence, urgency to defecate, steatorrhea; common - increased frequency of defecation, loose stools, fecal incontinence, abdominal pain. Psychiatric disorders: common - anxiety. Post-marketing surveillance. The following adverse reactions have been reported during post-marketing use of orlistat, the frequency of which is unknown: Immune system disorders: pruritus, rash, urticaria, angioedema, bronchospasm, anaphylaxis. Psychiatric disorders: anxiety. Gastrointestinal disorders: mild rectal bleeding, diverticulitis, pancreatitis. Hepatobiliary disorders: cholelithiasis, hepatitis (including serious cases requiring transplantation or leading to death). Skin and subcutaneous tissue disorders: bullous rash. Renal and urinary disorders: oxalate nephropathy, which may lead to renal failure. Effect on laboratory and instrumental test results: decreased prothrombin concentration and increased international normalized ratio (INR) in patients taking orlistat together with indirect anticoagulants; increased activity of "liver" transaminases and alkaline phosphatase. It is likely that treatment with orlistat may lead to the development of anxiety in anticipation of primary or repeated adverse reactions from the gastrointestinal tract.
Overdose
No significant adverse reactions were observed when orlistat was administered at a single dose of 800 mg and at a dose of up to 400 mg three times daily for 15 days in both normal weight and obese patients. No increase in the incidence of dose-related adverse reactions was observed when orlistat was administered at a dose of 240 mg three times daily for 6 months. Most post-marketing reports of orlistat overdose either did not report adverse reactions or were similar to those that may occur after taking the recommended doses of the drug. In case of overdose, consult a physician. In case of significant overdose of orlistat, it is recommended to observe the patient for 24 hours. According to preclinical and clinical studies, systemic effects associated with lipase inhibition are usually rapidly reversible.
Interactions
Cyclosporin: Several drug interaction studies of cyclosporine have reported decreased plasma cyclosporine concentrations when co-administered with orlistat. This may potentially result in decreased immunosuppressant efficacy of the latter. Concomitant use of orlistat and cyclosporine is contraindicated. Indirect anticoagulants: co-administration of warfarin or other oral anticoagulants with orlistat may alter INR values. Fat-soluble vitamins: orlistat may potentially impair absorption of fat-soluble vitamins (A, D, E, K, and beta-carotene). Acarbose: given the lack of pharmacokinetic interaction studies, concomitant use of orlistat and acarbose is not recommended. Amiodarone: co-administration of orlistat with orlistat has been associated with a decrease in plasma amiodarone concentrations after a single dose. The clinical significance of this effect in patients taking amiodarone is unclear. Concomitant use of orlistat and amiodarone should only be done under medical advice. Sodium levothyroxine: Hypothyroidism and/or decreased control of hypothyroidism may occur when orlistat is co-administered with sodium levothyroxine. This may be due to decreased absorption of inorganic iodine and/or sodium levothyroxine. Antiepileptic medicinal products: Seizures have been reported in patients receiving orlistat and antiepileptic medicinal products, such as lamotrigine, for which a causal relationship cannot be excluded. Orlistat may decrease the absorption of antiepileptic medicinal products, leading to seizures. Antiretroviral medicinal products: According to literature reports and post-marketing data, orlistat may decrease the absorption of antiretroviral medicinal products used to treat HIV infection, which may negatively affect their efficacy. Antidepressants, neuroleptics (including lithium) and benzodiazepines: cases of decreased efficacy of antidepressants, neuroleptics (including lithium) and benzodiazepines have been reported, coinciding with the initiation of orlistat in previously compensated patients. No interaction: Orlistat does not interact with amitriptyline, phenytoin, fluoxetine, sibutramine, phentermine, atorvastatin, pravastatin, fibrates, biguanides, digoxin, nifedipine, losartan and ethanol.
Special instructions
Diet and exercise are an integral part of the weight loss program. It is recommended to start a diet and exercise program before starting therapy with Orlistat. While taking Orlistat, it is necessary to follow a fractional, balanced, moderately hypocaloric diet, with a fat content of no more than 30% of the daily caloric intake of the diet (e.g. with a diet of 2000 kcal / day, fat intake should be no more than 66 g / day). It is necessary to follow the received recommendations on the diet and physical activity, both during and after stopping the drug. The use of Orlistat leads to an increase in the fat content in the feces after 24-48 hours after the start of treatment. After stopping Orlistat, the fat content in the feces usually returns to the original level within 48-72 hours. Adherence to a low-fat diet reduces the likelihood of adverse reactions from the gastrointestinal tract. Taking orlistat can potentially impair the absorption of fat-soluble vitamins (A, D, E, K and beta-carotene). In the vast majority of patients receiving orlistat in four-year clinical trials, the concentration of vitamins A, D, E, K and beta-carotene were within the normal range. For prophylactic purposes, it is recommended to take multivitamins at night. Since weight loss is usually accompanied by an improvement in carbohydrate metabolism, patients with type 2 diabetes mellitus should consult a doctor before starting therapy with Orlistat and, if necessary, adjust the dose of hypoglycemic drugs. Weight loss during treatment may be accompanied by a decrease in blood pressure and plasma TC concentration. Patients taking antihypertensive or lipid-lowering drugs should consult a doctor and, if necessary, adjust the dose of these drugs. In clinical trials, interactions between oral contraceptives and orlistat were not observed. However, orlistat may indirectly reduce the bioavailability of oral contraceptives, which may lead to the development of unwanted pregnancy. It is recommended to use additional contraception in case of acute diarrhea. Patients with kidney disease should consult a doctor, as hyperoxaluria and nephropathy may develop. Patients taking amiodarone, warfarin or other oral anticoagulants should also consult a doctor before starting therapy with orlistat, as changes in the INR value are possible. Patients should stop taking Orlistat and consult a doctor if symptoms occur: yellowing of the sclera or skin, skin itching, darkening of urine and loss of appetite. Cases of rectal bleeding have been observed with orlistat. If this phenomenon occurs, the patient should consult a doctor. Hypothyroidism and/or decreased control of hypothyroidism may develop with the combined use of orlistat and levothyroxine sodium. Patients taking levothyroxine sodium should consult a doctor before starting treatment with orlistat, as it may be necessary to take orlistat and levothyroxine sodium at different times, and the dose of levothyroxine sodium may need to be adjusted. Patients taking antiepileptic drugs should consult a doctor before starting treatment with orlistat, as they should be monitored for possible changes in the frequency and severity of seizures. In these cases, it should be considered to take orlistat and antiepileptic drugs at different times. Patients should consult a doctor before starting treatment with: orlistat simultaneously with antiretroviral drugs used to treat HIV infection. Orlistat may reduce the absorption of antiretroviral drugs and negatively affect their effectiveness. Effect on ability to drive vehicles, operate machinery: Orlistat does not affect the ability to drive vehicles and operate machinery.
Do not buy or take Orlistat - without consulting your doctor!
Diseases / Symptoms
Obesity
Storage conditions
Keep out of reach of children, at a temperature not exceeding 25 °C.
