Instructions for Orlistat capsules
Release form:
Caps. 120 mg: 21, 42 or 84
description:
Blue capsules, solid gelatin; The size of the capsule number one; the contents of the capsules are white powder or slightly compacted conglomerates.
1 caps.
orlistat 120 mg
Auxiliary substances: microcrystal cellulose 57.1 mg, carboxythylthical sodium 41.5 mg, silicon colloidal dioxide 9.1 mg, sodium laurylsulfate 2.3 mg.
Capsule shell composition: solid gelatin capsule No. 1: gelatin 75.14 mg, titanium dioxide (E171) 0.76 mg, indigocarmine (E132) 0.1 mg
7 pieces - blisters from PVC/PVD/aluminum foil (3) - packs of cardboard.
14 pieces - blisters from PVC/PVD/aluminum foil (3) - packs of cardboard.
14 pieces - blisters from PVC/PVD/aluminum foil (6) - packs of cardboard.
ATH codes
A08AB01 Orlistat
Clinical-pharmacological groups / Group affiliation
Drug for the treatment of obesity - inhibitor of gastrointestinal lipase
Active substance:
orlistat
Pharmaco Therapeutic Group:
Lipase inhibitor
Drugs:
Lipase inhibitor. When ingested, the orlistat inhibits gastric and pancreatic lipase. As a result, the breakdown of food fats is disrupted and their absorption from the gastrointestinal tract is reduced. 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 has almost no resorpative effect.
Testimony:
Obesity (combined with a moderate calorie diet).
How to use, course and dosage:
inwards. The recommended dose is 60 mg 3 times/day. The maximum daily dose - 180 mg. Duration of treatment - no more than 6 months.
Drug interaction:
With the simultaneous use of orlistat and cyclosporine, it is possible to reduce the concentration of cyclosporine in the blood plasma, which may lead to a decrease in the immunosuppressive effectiveness of cyclosporine. Simultaneous use of orlistat and cyclosporine is contraindicated.
With the simultaneous use of orlistat with amiodarone, there was a decrease in the concentration of amiodarone in the blood plasma after a single application. The use of this combination is possible only on the recommendation of a doctor.
With simultaneous administration of orlistat and warfarin or other anticoagulants, a decrease in the concentration of prothrombin and an increase in INR may be observed, which leads to a change in hemostatic parameters. Concomitant use of orlistat and warfarin or other oral anticoagulants is contraindicated.
Taking orlistat can potentially impair the absorption of fat-soluble vitamins (A, D, E, K, and beta-carotene). If multivitamins are indicated, they should be taken no earlier than 2 hours after taking orlistat or before bedtime.
Orlistat may reduce the absorption of antiepileptic drugs, which can lead to seizures.
Orlistat can indirectly reduce the effectiveness of oral contraceptives, which in some cases can lead to unplanned pregnancy. In the case of diarrhea on the background of the use of orlistat, it is recommended to use an additional method of contraception.
When taken concomitantly with levothyroxine sodium, due to a decrease in the absorption of inorganic iodine and/or levothyroxine sodium, hypothyroidism and/or decreased control of hypothyroidism may develop.
There have been cases of decreased effectiveness of antiretroviral drugs for the treatment of HIV, antidepressants and neuroleptics (including lithium preparations), coinciding with the beginning of the use of orlistat in previously compensated patients.
Use in pregnancy and breast-feeding
It is not suitable for use in pregnancy and lactation (breast-feeding).
Side action:
From the immune system: the frequency is unknown - cutaneous itching, rash, urticaria, angioedema, bronchospasm, anaphylaxis.
From the digestive system: very often - oily secretions from the rectum, the departure of gases with a certain amount of separable, imperative calls for defecation, steatorrhea, meteorism; often - abdominal pain, fecal incontinence, liquid stool, increased defecation; frequency unknown - minor bleeding from the rectum, diverticulitis, pancreatitis.
From the side of the liver and bile tract: the frequency is unknown - an increase in the activity of "hepatic" transaminases, BF, hepatitis, bile disease.
From the urinary system: the frequency is unknown - hyperoxalaturia, oxalate nephropathy, which can sometimes lead to the development of renal failure.
On the side of the skin and subcutaneous tissues: the frequency is unknown - a bullous rash.
Others: frequency unknown - feeling anxious; with simultaneous use of orlistat and indirect anticoagulants, there was a decrease in the plasma concentration of prothrombin and an increase in the international normalized ratio (MNO).
Contraindications to use:
Increased sensitivity to orlistat; chronic malabsorption syndrome, cholestasis; simultaneous use with warfarin or other indirect oral anticoagulants, concomitant cyclosporin therapy, simultaneous use with sitagliptin; pregnancy, lactation period (breastfeeding); children and adolescents under 18 years of age.
Special instructions:
Diet and exercise are an important component of the body weight reduction program. It is recommended to start a dietary program and exercise before starting orlistat therapy. During the use of orlistat, the patient should receive a moderately hypocaloric diet with a balanced nutrient content, in which approximately 30% are fats. It is recommended that food be rich in fruits and vegetables. The diet and exercise program should continue after orlistat is discontinued.
It should be borne in mind that the frequency and severity of side effects increase with increasing food fat content. With a decrease in fat content in food, the likelihood of side effects decreases. It is recommended that the amount of fat consumed per day is fairly evenly distributed across all meals.
In the process of treatment with orlistat, as body weight decreases, it is possible to improve the course of pathological processes often accompanying obesity, including arterial hypertension, diabetes mellitus, lipid metabolism disorders. Patients with type 2 diabetes before starting orlistat therapy should consult a doctor and, if necessary, correct the dose of hypoglycemic drugs. Patients taking hypotensive and hypolipidemic drugs together with orlistat should consult a doctor and, if necessary, correct the dose of these drugs.
If diarrhea occurs against the background of orlistat, it is recommended to use an additional method of contraception to prevent the possible inefficiency of oral contraceptives.
If symptoms such as weakness, fatigue, increased body temperature, jaundice and darkening of urine appear, you should consult your doctor to prevent impaired liver function.
When using orlistat, rare cases of hypothyroidism and/or impaired control thereof were noted, which may be due to a decrease in the absorption of the iodized salt and/or levothyroxine sodium.
Use in disorders of kidney function:
Patients with kidney diseases need to consult a doctor before using orlistat, since it is possible to develop oxalate nephropathy, which can sometimes lead to the development of renal failure. Increased risk is noted in patients with chronic renal failure and/or dehydration.
Use in impaired liver function:
It is possible to use in patients with impaired liver function according to the indications in the recommended doses.
Use in older patients:
It is possible to use in elderly patients (> 65 years) according to the indications in the recommended doses.
Use in children
Contraindicated use in children and adolescents under the age of 18 years (efficacy and safety not established).
Nosology (ICD codes)
Obesity
