the product in the database has an inactive status
indications:
Body weight loss medication in overweight adults (BMI ≥28 kg / m2), it should be taken at the same time as a moderately low calorie diet with a reduced fat content.
Composition:
One capsule contains 60 mg of orlistat.
Action:
Orlistat is a potent, specific and long-acting inhibitor of lipases produced in the gastrointestinal tract. It works in the light of the stomach and small intestine after formation of binding to the active serine site of gastric and pancreatic lipase. The enzyme-depleted enzyme does not hydrolyse the fat used in food in the form of triglycerides, absorbing free fatty acids and monoglycerides. Orlistat 60 mg taken 3 times a day blocks the absorption of about 25% of fat in food. The effect of orlistat on increasing fats in stool occurs already 24-48 h after drug application. After discontinuation of the drug, the fat content in the stool returns to the value from before the treatment period after 48-72 hours. The orlistat absorption level is minimal. It is very rarely detected in plasma, and the concentrations achieved are very low, with no evidence of accumulation.In vitro Orlistat binds to plasma proteins in over 99% (mainly with lipoproteins and albumin); minimally penetrates into erythrocytes. It is probably mainly metabolised within the walls of the digestive tract. There were 2 major metabolites with minimal lipase inhibitory activity: M1 (hydrolyzed 4-membered lactone ring) and M3 (M1 with attached N-formyloleucine molecule), representing approximately 42% of total plasma concentration. In people with normal body weight and in obese, elimination of the unabsorbed medication is the main route of elimination. Approx. 97% of the administered dose was excreted in the faeces, 83% as unchanged orlistat. The total elimination time of orlistat (with faeces and urine) is 3-5 days. Orlistat and its metabolites M1 and M3 are excreted in bile.
Contraindications:
Hypersensitivity to orlistat or other ingredients of the preparation. Simultaneous use of cyclosporin. Chronic malabsorption syndrome. Cholestasis. Pregnancy and breastfeeding. Concurrent use of Warfarin or other oral anticoagulants.
Precautions:
If orlistat is taken with a single meal or a diet rich in fat, the likelihood of gastrointestinal symptoms may increase. In diabetic patients losing weight may be accompanied by improvement in metabolic parameters - the dose of an antidiabetic drug may need to be adjusted. Losing weight may be accompanied by an improvement in blood pressure and cholesterol levels - patients taking antihypertensive or cholesterol-lowering medication may need to adjust their dosage. Patients taking Amiodarone may need to adjust the amiodarone dose during orlistat therapy before starting treatment. It is recommended that an additional method of contraception be used to prevent the contraception from weakening in the event of severe diarrhea. The preparation should be used with caution in patients with renal insufficiency, as the use of orlistat may rarely be associated with excessive excretion of oxalates in the urine and oxalate nephropathy. If both orlistat and levothyroxine are used concomitantly, hypothyroidism and / or hypothyroidism may be reduced - it may be necessary to take orlistat and levothyroxine at different times of the day and you may need to adjust the dose of levothyroxine. Patients taking anti-epileptic drugs should be monitored for possible changes in the frequency and severity of seizures. In the event of such changes, consideration should be given to administration of orlistat and anti-epileptic medicines at different times of the day. The safety and efficacy of the preparation in children under 18 years has not been established.
Pregnancy and lactation:
There is no clinical data on the use of orlistat during pregnancy - the preparation is contraindicated during pregnancy.It has not been established whether orlistat is excreted in the milk of lactating women - the preparation is contraindicated during breastfeeding.
Side effects:
Very often: fatty spotting, gases with secretion, stool pressure, fatty, oily stools, oily bowel movements, flatulence with passing of gases, loose stools. Common: abdominal pain, stool incontinence, liquid stools, increased fecal discharge, anxiety (due to gastrointestinal side effects). Not known: decreased prothrombin activity and INR increase, hypersensitivity reactions (anaphylaxis, bronchospasm, angioedema, pruritus, rash, urticaria), diverticulitis, pancreatitis, mild rectal haemorrhage, oxalate nephropathy, hepatitis, cholelithiasis, increased transaminase levels and alkaline phosphatase, bullous eruptions.
Dosage:
Orally. Adults: the recommended dose is 60 mg 3 times a day. Treatment should not last longer than 6 months. Patients who have not lost weight after 12 weeks of treatment should be consulted, as it may be necessary to discontinue treatment. The capsules should be taken immediately before a meal, during meals or within 1 hour after each main meal, with water. If the patient does not eat a meal or if the meal does not contain fat, the dose of orlistat should be omitted.
(C)
