Instructions for Orsoten (Orlistat) capsules
Release Form:
caps. 120 mg: 21, 42 or 84 pcs.
Description:
White to white capsules with yellowish color; Content of capsules - microgranules or a mixture of powder and microgranules of white or almost white color; Aglomerates that are monitored and easily dissipated by pressure are allowed.
1 caps.
orhundreds of semi-finished granules* 225.6 mg,
which corresponds to the content of an Orlistat of 120 mg
100 g of semi-finished granules contain: Orlistat - 53.1915 g, cellulose microcrystalline.
Auxiliary substances: cellulose is microcrystalline.
Chassis composition and cap capsule: Hypromellosis, water, titanium dioxide (E171).
7 pcs. - cell contour (3) packaging - cardboard packs.
7 pcs. - cell contour (6) packaging - cardboard packs.
7 pcs. - cell contour (12) packaging - cardboard packs.
21 pcs. - cell contour (1) packaging - cardboard packs.
21 pcs. - cell contour (2) packaging - cardboard packs.
21 pcs. - cell contour (4) packaging - cardboard packs.
ATX codes
A08AB01 Orlistat
Pharmacological groups / Group membership:
Obesity medication - gastrointestinal lipas inhibitor
Active substance:
Orlistat
Pharmacy Group
Lipaz inhibitor LCD
Pharmaceuticals:
Lipaz inhibitor. The Orlistat inhibates the gastric and pancreatic lipases. As a result, food fats are broken off and their absorption from LCD is reduced. If systematically applied, this effect reduces the body weight of obese patients. The Orlistat is practically non-intake from the LCT and therefore has practically no resorption effect.
indications for use:
- Obesity (combined with moderate calorie diet).
Method of application, course and dosage:
Inside. Recommended dose - 60 mg 3 times/day. Maximum daily dose - 180 mg. The duration of the treatment course is not more than 6 months.
Drug Interaction:
When simultaneously using Orlistat and cyclosporin, it is possible to reduce the concentration of cyclosporin in the blood plasma, which can lead to a decrease of immunosuppressive efficiency of cyclosporin. Simultaneous use of Orlistat and cyclosporine is contrademonstrated.
When simultaneously using Orlistat with amyodarone, there was a decrease in the concentration of amyodarone in the blood plasma after a single application. The application of this convention is possible only on the recommendation of the doctor.
When simultaneously taking Orlistat and varfarin or other anticoagulants, there may be a decrease in protrombin concentration and an increase in MNO, which results in a change in hemostatic indicators. Simultaneous use of Orlistat and varfarin or other oral anticoagulants is contraindicated.
Orlistat can potentially worsen the absorption of fat-soluble vitamins (A, D, E, K and beta carotene). If a polyvitamin intake is shown, it should be taken not earlier than 2 hours after the reception of the orlistat or before going to bed.
Orlistat can reduce the intake of anti-epileptic drugs Orsoten, which can lead to convulsions.
Orlistat can indirectly reduce the effectiveness of oral contraceptives, which in some cases can lead to unplanned pregnancy. In case of development of diarrhea on the background applied
Use in pregnancy and breastfeeding
Contradicted to use during pregnancy and lactation (breastfeeding).
Side Action:
From the immune system: The frequency is unknown - skin itching, rash, nettling, angionevrotic edema, bronchospasm, anaphylaxia.
From the digestive system:
Very often - oil-based extracts from rectal intestines, gas deviation with a certain amount of separable, mandatory calls for de-fection, stadium, meteorism;
Often - abdominal pain, stain, liquid chair, increased defecation;
The frequency is unknown - slight bleeding from the rectum, sabotage, pancreatitis.
On the side of the liver and bile-producing tract:
frequency unknown - increase of activity of "liver" transaminaz, SFF, hepatitis, bile disease.
n the side of the urinary system: The frequency is unknown - hyperoxalaturia, oxalate nephropathy, which can sometimes lead to kidney failure.
On the skin and subcutaneous tissue side: Frequency unknown - bull rash.
Others: frequency unknown - anxiety;
At the same time, the use of Orlistat and indirect anticoagulants decreased the concentration of protrombin blood in plasma and increased the indicator of international normalized attitude (MNE).
Contraindications to use:
Increased sensitivity to the Orsoten; Chronic malabsorption syndrome, cholestace; Simultaneous use with varfarin or other oral anticoagulants of indirect effect, co-therapy with cyclosporin, simultaneous application with Sitagliptin; Pregnancy, lactation period (breastfeeding); Children and teenagers under 18 years of age.
Special Instructions
Diet and exercise are an important component of the weight reduction program. It is recommended that you start a diet program and exercise before you start an Orlistat therapy. During the use of Orlistat, the patient must receive a moderately hypocaloric diet with a balanced nutrient content of approximately 30% fat. It is recommended that food be rich in fruits and vegetables. The diet and exercise program should continue after the use of the Orlistat has been discontinued.
It should be kept in mind that the frequency and intensity of side effects increase when the food content of fats increases. When the fat content of food is reduced, the likelihood of side effects is reduced. It is recommended that the amount of fats consumed per day should be fairly evenly distributed over all meals.
In the course of the treatment of the Orlistat, as the body mass decreases, it is possible to improve the flow of pathological processes often associated with obesity, including arterial hypertension, diabetes mellitus, lipid exchange disorders. Patients with type 2 diabetes should consult a doctor and, if necessary, correct doses of hypoglycemic drugs Orsoten before starting Orlistat therapy. Patients who take hypotensive and hypolypidemic drugs Orsoten together with an Orlistat should consult a doctor and, if necessary, correct the dosage of these drugs Orsoten.
If diarrhea occurs against the backdrop of the use of Orlistat, it is recommended to use an additional method of contraception to prevent possible inefficiency of oral contraceptives .
If symptoms such as weakness, fatigue, increased body temperature, yellowness and urine darkening occur, consult your doctor to prevent liver function damage.
In the application of Orlistat, there were rare cases of hypothyroxine development and/or its control, which may be due to a decrease in iodized salt and/or sodium levotiroxin intake.
Use in patients with impaired renal function
Patients with kidney diseases should consult a doctor before using Orsoten, because it is possible to develop oxalate nephropathy, which can sometimes lead to the development of renal failure. An increased risk is observed in patients with chronic renal failure and / or dehydration.
Use in cases of liver function disorders
It can be used in patients with impaired liver function according to the indications, in the recommended doses.
Use in elderly patients
It can be used in elderly patients (>65 years) according to the indications, in the recommended doses.
It is contraindicated in children and adolescents under the age of 18 years (efficacy and safety have not been established).
Nosology (ICD codes)
Obesity
