Instructions for Listata (Orlistat) Pills
Release Form:
Film wrapped tablets
Description:
Pills coated with a blue film wrapper with pearl effect, oval, two-headed, with a risk on one side and a symbol "f" on the other; On the cross slice - a white or almost white kernel.
1 tab
orlistat 120 mg
Auxiliary substances: sodium lauryl sulfate - 12 mg, acacia kamed - 210 mg, mannitol - 580 mg, crossovidon - 50 mg, magnesium stearat - 8 mg.
Shell composition: Opadra II blue (85F205040) - 34 mg
including polyvinyl alcohol - 40%
titanium dioxide - 22.48%
macrogol 3350 20.20%
talc - 14.8%
aluminum blue lacquer - 2.28%
iron yellow oxide dye - 0.24%
silver (63F97546) - 6 mg
including polyvinyl alcohol - 47.03%
talc - 27%
macrogoal 3350 - 13 .27%
pearl pigment - 10%
polysorbat-80 - 2.7%.
10 pcs. - cell contour (1) packaging - cardboard packs.
10 pcs. - cell contour (2) packaging - cardboard packs.
10 pcs. - cell contour (3) packaging - cardboard packs.
10 pcs. - cell contour (6) packaging - cardboard packs.
10 pcs. - cell contour (9) packaging - 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 Listata should be stored in a light-protected place that is not accessible to children at a temperature not exceeding 25°C.
Shelf life:
Shelf life - 2 years.
Pharmacodynamics
The Orlistat is a powerful, specific and reversible gastrointestinal lipase inhibitor with long-lasting effects. Its therapeutic action is carried out in the glow of the stomach and the small intestine and consists in the formation of covalent connection with the active serine area of the gastric and pancreatic lipase.
Inactivated enzyme loses the ability to split food fats in the form of triglycerides, free fatty acids and monoglycerides. Because unsplit triglycerides are not absorbed, the resulting reduction in calorie intake results in reduced body weight. Thus, therapeutic action of the drug Listata is carried out without injection into the system blood flow.
Judging by the results of the fat content in the cala, the Orlistat action begins 24-48 hours after the reception. After the elimination of the Orlistat, the fat content in the cala after 48-72 hours is usually returned to the level that occurred before the start of the therapy.
Clinical Efficiency:
Patients who take Orlistat have a large loss of body weight compared to those who are on dietotherapy. The reduction in body weight begins within the first 2 weeks of treatment and continues from 6 to 12 months even in patients with a negative response to dietotherapy. For 2 years there has been a statistically significant improvement in the profile of metabolic risk factors associated with obesity. In addition, there is a significant decrease in fat in the body compared to placebo. Orlistat is effective in preventing re-addition of body weight. Recycling of body weight, no more than 25% of lost weight, occurs in about half of the patients, and half of these patients do not have re-mass re-injection, or even see a further decline.
Patients with overweight or obesity and diabetes mellitus of type 2 who take Orlistat for 6 months to
Testimonials:
- long-term treatment of obese patients with BMI of at least 30 kg/m2 or overweight patients with BMI of at least 28 kg/m2, including those with obesity-associated risk factors, combined with a moderately hypocaloric diet
- in combination with hypoglycemic preparations (metaphormine, derivatives of sulfonyl urea and/or insulin) and/or moderately hypocaloric diets in patients with diabetes-2 types of sugar with excess body weight or burn irenium.
- Method of application, course and dosage
- Inside, drinking water.
Treatment of obesity patients with BMI of at least 30 kg/m2 or overweight patients with BMI of at least 28 kg/m2, including those with obesity-associated risk factors, combined with a moderately low calorie diet
Adults and children over 12
The recommended dose of the drug Listata - 1 tab (120 mg) with each main meal (during the meal or not later than 1 hour after the meal).
In combination with hypoglycemic preparations (metaphormine, derivatives of sulfonyl urea and/or insulin) and/or moderately hypocaloric diets in patients with diabetes-2 types of sugar with excess body weight or burn irrigation
Adults
Recommended dose of drug Listata 1 tab. (120 mg) with each main meal (during meal or not later than 1 hour after meal).
If the meal is missed or if the food does not contain fat, the drug Listata can also be missed.
Listat should be taken in combination with a balanced, moderately hypocaloric diet containing no more than 30% of the fat calorage. Daily intake of fats, carbohydrates and proteins should be distributed among the 3 main meals.
The increase in the dose of Listatius above the recommended (120 mg 3 times/day) does not increase its therapeutic effect.
The effectiveness and safety of the Lystat drug Listata in patients with liver and/or kidney disorders, as well as in patients of old age and children under 12 years of age were not examined.
Overdose:
In people with normal body weight and patients with obesity, 800 mg of single doses or 400 mg multiple intake 3 times/day for 15 days was not accompanied by significant unwanted phenomena. In addition, patients with obesity have an experience of using an Orlistat of 240 mg 3 times/day for 6 months, which was not accompanied by a reliable increase in the frequency of unwanted phenomena.
In cases of overdose of the Orlistat, either there were no unwanted phenomena or unwanted phenomena were not different from those observed in the use of Orlistat in therapeutic doses.
In the case of a pronounced overdose of the Orlistat, it is recommended to observe the patient within 24 hours. According to human and animal studies, any system effects that could be associated with the lipasoingibative properties of the Orlistat should be quickly reversible.
Drug Interaction:
No interaction of Orlistat with amitriptyl, atorvastatin, biguanides, digoxin, fibrants, fluoroxetine, lozartan, phenyton, oral contraception detected lives, phenthermin, pastatin, varfarine, nifedypin GITS (gastrointestinal therapeutic system) and nifedypin with slow release, sibutramin or etha zero (based on research into drug Listata interactions). However, it is necessary to keep track of the MNO's indicators when simultaneously using varfarin or other indirect anticoagulants.
At the same time, with Orlistat, there was a decrease in the intake of vitamins D, E and beta-carotene. If polyvitamins are recommended, they should be taken at least 2 hours after taking an Orlistat or before going to bed.
When simultaneously taking Orlistat and cyclosporin, there was a decrease in the concentration of cyclosporin in the blood plasma, so it is recommended to more often determine the concentration of cyclosporin in the blood plasma, while simultaneously taking cyclosporin and Orlistat.
When taking an amiodaron inside during the Orlistat therapy
Side Action:
Clinical research data
Side actions of the drug Listata are systemized for each system of organs according to frequency of occurrence, using the following classification: very often (more than 1/10); Often (more than 1/100, less than 1/10); Infrequently (more than 1/1000, less than 1/100); rarely (more than 1/10,000, less than 1/1,000); Very rare, including single messages (less than 1/10,000). Side reactions in the application of Orlistat were mainly caused by LCT, and were caused by the pharmacological action of an Orlistat preventing the intake of food fats. Very often, oily rectal excretions, gas discharge with a certain amount of separable, mandatory defection calls, stéar, increased defecation, liquid chair, meteorism, pain or abdominal discomfort were noted. Their frequency increases when the fat content in the food increases. Patients should be informed of the possibility of incidental reactions by the LCD, and trained on how to eliminate their diet, especially with regard to the amount of fat contained therein. The use of low fat diet reduces the likelihood of side effects Listata from LCD and thus helps patients control and regulate fat consumption.
As a rule, these side reactions are weak and transient.
They occur in the early stages of treatment (in the first 3 months), with most patients having no more than one episode of such reactions.
