Instructions for XENICAL (Orlistat) 120 mg 21 capsules
Release Form:
caps. 120 mg: 7, 14, 21, 42, 63, 84, 126, 252 pcs.
Description:
No. 1 capsules with a casing and a blue cap of white or almost white color. The contents of the capsule are granules.
1 caps.
Orlistat 120 mg
Auxiliary substances: cellulose microcrystalline 59.6 mg, sodium carboxymethyl starchmal (sodium starch glycol) 38.0 mg, sodium lauryl sulfate 10. 0 mg, podidon 10.0 mg, talc 2.4 mg.
Capsules solid gelatin (titanium dioxide
gelatin, blue patented dye). The average mass of the capsule content is 240 mg.
7 pcs. - contour cell packaging (1) - cardboard packs.
7 pcs. - contour cell packaging (2) - cardboard packs.
7 pcs. - contour cell packaging (3) - cardboard packs.
7 pcs. - contour cell packaging (6) - cardboard packs.
7 pcs. - contour cell packaging (12) - cardboard packs.
21 pcs. - contour cell packaging (1) - cardboard packs.
21 pcs. - contour cell packaging (2) - cardboard packs.
21 pcs. - contour cell packaging (3) - cardboard packs.
21 pcs. - contour cell packaging (6) - cardboard packs.
21 pcs. - contour cell packaging (12) - cardboard packs.
ATX codes
A08AB01 Orlistat
Pharmacological groups / Group membership:
Obesity medication - gastrointestinal lipas inhibitor
Active substance:
Orlistat
Pharmacy Group
Lipaz inhibitor LCD
Retention Terms
The drug XENICAL should be stored in a dry, light-protected place not accessible to children at a temperature not exceeding 25°C.
Shelf life
Shelf life - 2 years. Do not apply after the expiration date specified on the package.
Pharmaceuticals:
A specific inhibitor of the gastrointestinal lipase. It forms a covalent connection with the active serine area of the gastric and pancreatic lipaz in the glow of the stomach and the small intestine. Inactivated enzyme loses the ability to split fats of food in the form of triglycerides (TG). Unsplit TGs are not absorbed and the resulting reduction in calorie intake results in reduced body weight. Increases the fat concentration in the calum masses after 24-48 hours after taking. Provides effective control of body weight, reduction of the depot of fat.
No system absorption of the Orlistat is required for the activity, in the recommended therapeutic dose (120 mg 3 times/day) it ingibates the intake of food-derived fats by about 30%.
Indications:
- Treatment of obesity, including reduction and maintenance of body weight, combined with a hypocaloric diet.
- The Orlistat is also shown to reduce the risk of re-addition of body weight after its initial reduction.
- Orlistat is shown to patients with obesity in body mass index (BMI)>30 kg/m2 or >28 kg/m2, with other risk factors (diabetes mellitus, arterial hypertension, dyspydia).
- (BMI calculation: BMI = M/P2, where M is the body mass, kg; R - growth, m.)
Method of application, course and dosage
Intra, 120 mg (1 capsule) 3 times/day during each meal or not later than 1 hour after the meal (if the food does not contain fat, the reception can be missed).
Overdose:
No overdoses were reported.
A single intake of 800 mg of Orlistat or its repeated intake at a dose of up to 400 mg 3 times/day for 15 days by people with normal body weight and obesity was not accompanied by significant side effects.
If a significant Orlistat overdose is detected, the patient should be monitored for 24 hours. According to animal and human studies, the system effects associated with the lipasingibative properties of the Orlistat should be quickly reversible.
Drug Interaction XENICAL:
The Orlistat does not affect the pharmacokinetics of ethanol, digoxin (single dose) and phenytoin (single dose of 300 mg), on the bioavailability of nifedypin (prolongy pills) released). Ethanol does not affect the pharmacodynamics (fat excretion with calum) and the system exposure of the orlistat.
If both Orlistat and cyclosporine are used simultaneously, the level of the latter in plasma shall be lowered (orlistat and cyclosporin shall not be accepted at the same time; To reduce the likelihood of drug XENICAL interaction, cyclosporine should be taken 2 hours before or after 2 hours after the Orlistat).
When using warfarin or other indirect anticoagulants with an orlist simultaneously, the level of protrombin can decrease and the value of the indicator of the international normalized relationship (MHO) changes, therefore MHO control is necessary.
The Orlistat reduces the intake of the betacarotene contained in food additives by 30% and inhibates the intake of vitamin E (in the form of acetate tokopherol) by about 60%.
Increases the bioavailability and hypolypdidism effect of the right-astin, increasing its concentration in plasma by 30%.
When simultaneously taking with Orlistat, the intake of vitamins A, D, E and K is reduced. If polyvitamins are recommended, they should be taken
Use in pregnancy and breastfeeding
Orlistat is contraindicated to be used during pregnancy due to lack of reliable clinical data confirming the safety of its use.
It is not established whether Orlistat enters breast milk, and therefore the use of Xenalten during breastfeeding is not recommended.
Side Action:
The frequency of side reactions below was determined accordingly as follows: very often >1/10; often > 1/100, < 1/10; Sometimes > 1/1000, <1/100; rarely> 1/10,000, <1/1000; very rarely < 1/10,000, including individual messages.
On the LCT side: very often - oil-based extracts from the rectum, gas emissions with a certain amount of separable, mandatory calls for defecation, stadium, increased defecation, liquid chair, meteorism, pain or discomfort in the stomach. As a rule, these side reactions are low-expression and transistor, occur in the early stages of treatment (in the first 3 months). The frequency of these unwanted reactions increases when the fat content in the diet increases. Patients should be informed of the possibility of these side reactions and taught how to eliminate them by better maintaining the diet, especially with regard to the amount of fat contained therein. Often - soft chair, pain or discomfort in the rectum, stale incontinence, bloated stomach, tooth loss, gum damage.
On the side of the respiratory system, chest organs and medium: Very often - upper respiratory infections; Often - infections of lower respiratory tract.
From the immune system: Rarely - itching, nettle, rash, angionevrotic edema, bronchospasm, anaphylaxia.
On the side of the nervous system: Very often - headaches.
On the side of the liver and bile-producing tract: Very rarely - increase of activity of transaminaz and alkal phosphatase, hepatitis.
From kidneys and urinary tract: Often - urinary tract infections.
Others: very often - flu; Often - dismenorea, anxiety, weakness
Special Instructions:
During treatment, a balanced, low-calorie diet, containing no more than 30% of fat and enriched with fruits and vegetables, should be observed (possibly additional use of polyvitamins to compensate for the reduction of intake of fat-soluble vitamins).
Before you assign an Orlistat, you should exclude the organic cause of obesity, such as hypothyroiosis.
The probability of incidental events on the part of LCD increases with high fat content (more than 30% of daily caloric content). Daily intake of fats, carbohydrates and proteins should be distributed among the three main meals. Since the Orlistat reduces the intake of some fat-soluble vitamins, patients must take multivitamin preparations containing fat-soluble vitamins to ensure that they are properly absorbed. In addition, vitamin D and betakaroten content in obese patients may be lower than in non-obese patients. The olivitamins should be taken 2 hours before or 2 hours after the reception of the Orlistat, for example before going to bed. The use of orlistat in doses exceeding 120 mg 3 times/day does not provide additional effect.
In the case that it is impossible to avoid simultaneously taking an Orlistat with cyclosporin, it is necessary to constantly monitor the content of cyclosporin in plasma.
In patients who did not receive prophylactic vitamin supplements, during two or more consecutive visits to the doctor during the first and second years of treatment by the Orlistat, the level of vitamins in plasma was reduced.
In some patients with Orlistat background, oxalates in the urine may increase.
As with other body weight reduction drugs XENICAL , some groups of patients (e.g., neural anorexia or bulimia) are likely to abuse the Orlistat.
Since the absorption of vitamin K during Orlistat may decrease, patients receiving Orlistat against the backdrop of long-term continuous varfarin intake should be monitored
