Listata
Listata: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Listata
ATX code: A08AB01
Active ingredient: orlistat (Orlistat)
Producer: LLC "Izvarino Pharma" (Russia)
Description and photo update: 2020-10-08
Prices in pharmacies: from 399 rubles.
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Listata - a drug for the treatment of obesity, has an inhibitory effect on gastrointestinal lipases.
Release form and composition
The drug is produced in the form of film-coated tablets: blue, pearlescent, oval, biconvex, the symbol "f" is applied on one side, the dividing risk is on the other; the core is almost white or white (10 pcs. in blisters, in a cardboard box 1, 2, 3, 6 or 9 packages and instructions for use Listata).
1 tablet contains:
- active substance: orlistat - 120 mg;
- auxiliary components: sodium lauryl sulfate, acacia gum, mannitol, copovidone, crospovidone, magnesium stearate;
- film casing: Opadry II blue (85F205040) (polyvinyl alcohol, macrogol 3350, titanium dioxide, aluminum blue varnish, iron oxide yellow dye, talc), Opadry silver (63F97546) (polyvinyl alcohol, polysorbate-80, macrogol 3350, pearlescent pigment, talc).
Pharmacological properties
Pharmacodynamics
Listata is a drug for the treatment of obesity. Its active ingredient, orlistat, is a strong, specific and reversible inhibitor of gastrointestinal lipases with a long-lasting effect. Orlistat does not enter the systemic circulation, its action is realized in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. This leads to inactivation of the enzyme and the loss of its ability to break down dietary fats in the form of triglycerides, absorbed free fatty acids and monoglycerides. The decrease in the patient's body weight is due to a decrease in the intake of calories into the body, since the undigested triglycerides are not absorbed from the digestive tract, but are immediately excreted through the intestines. This is confirmed by the results of a study of feces,where the fat content rises sharply after taking the drug for two days.
After canceling Listata, the level of fat in the stool usually returns to the previous level within two to three days.
Compared to diet therapy, the clinical efficacy of orlistat results in higher weight loss. After starting treatment, a decrease in body weight is observed already within the first 14 days. Even in patients with a negative response to diet therapy, it can last from 180 to 365 days. A statistically significant improvement in the profile of metabolic risk factors associated with obesity was confirmed over two years. In addition, there was a significant decrease in the amount of body fat compared to taking a placebo. Orlistat prevents re-gain in body weight. A repeated increase in body weight was observed in about half of the patients; it was no more than 1/4 of the lost weight. In 50% of patients, there was no re-gain in body weight, or even its further decrease was noted.
In patients with type 2 diabetes mellitus with obesity or overweight, taking Listata for 180–365 days contributes to a higher weight loss compared to patients who are only on diet therapy. Weight loss occurs primarily by reducing the amount of body fat. At the same time, there is a statistically and clinically significant improvement in glycemic control, a decrease in the dose of hypoglycemic agents, insulin concentration and a decrease in insulin resistance.
The use of orlistat for 4 years significantly (by about 37%) reduces the risk of developing type 2 diabetes. It should be noted that with an initial impairment of glucose tolerance, the degree of reduction of this risk is more significant (by about 45%).
During the entire period of taking Listata, a new level of body weight is maintained.
In obese adolescents, the use of orlistat for 365 days helps to reduce body weight index, fat mass, waist and hip circumference.
During orlistat therapy, a significant decrease in diastolic blood pressure (blood pressure) was noted.
Pharmacokinetics
Orlistat has a minimal systemic effect, this is confirmed by research results. In obese volunteers with normal body weight, after oral administration of the drug at a dose of 360 mg, orlistat in unchanged form was not detected in blood plasma. This means that the absorption of orlistat is minimal, the level of its concentration is less than 5 ng / ml, that is, it is below the limit of quantitative determination.
There are no signs of cumulation.
Binding to blood plasma proteins (mainly lipoproteins and albumin) in vitro is more than 99%. It can penetrate in the smallest quantities into erythrocytes.
It is metabolized mainly in the intestinal wall. In obese patients, about 42% of the orlistat fraction, which has penetrated the systemic circulation, undergoes biotransformation with the formation of two main pharmacologically inactive metabolites: M1 (four-membered hydrolyzed lactone ring), M3 (M1 with a cleaved N-formylleucine residue). Plasma concentration of M1 and M3 molecules is extremely low; it averages 26 ng / ml and 108 ng / ml, respectively. Their inhibitory activity is 1000 and 2500 times weaker than that of orlistat.
It is excreted through the intestines about 97% of the dose taken, including 83% unchanged.
Less than 2% of the dose taken is excreted through the kidneys in the form of various substances structurally related to orlistat.
It is completely excreted from the body within 3-5 days.
The active substance and its metabolites can be excreted in the bile.
While taking the same doses of Listata, the concentration level of orlistat and its main metabolites in blood plasma in adults and children is comparable.
During the treatment period, the daily excretion of fat with feces is 27% of the food intake.
Indications for use
The use of Listata is indicated for the following conditions and diseases:
- obesity with a BMI (body mass index) of at least 30 kg / m 2, overweight with a BMI of at least 28 kg / m 2 (including patients who have risk factors associated with obesity) - as a long-term therapy in combination with moderately hypocaloric diet;
- type 2 diabetes mellitus in patients with overweight or obesity - in combination with a moderately hypocaloric diet and / or hypoglycemic agents (sulfonylurea derivatives, metformin and / or insulin).
Contraindications
- cholestasis;
- chronic malabsorption syndrome;
- period of pregnancy;
- breast-feeding;
- age up to 12 years;
- hypersensitivity to the components of the drug Listat.
Listata, instructions for use: method and dosage
Listat tablets are taken orally, during each main meal (but no later than 1 hour after a meal), washed down with water.
In cases where a meal is skipped or does not contain fat, the tablet can be skipped.
A balanced, moderately hypocaloric diet should be followed that contains no more than 30% calories as fat. The daily intake of fats, carbohydrates and proteins must be divided between three main meals. When prescribing Listata, the doctor must inform the patient about the possible occurrence of side effects from the gastrointestinal tract (GIT) and how to eliminate them by following a diet. A low-fat diet may help reduce the risk of gastrointestinal adverse reactions.
Recommended dosage: 1 pc. 3 times a day.
It should be borne in mind that an increase in a single dose does not lead to an increase in the therapeutic effect of Listata.
Side effects
- on the part of the digestive system: very often (more than 1/10) - discomfort or pain in the abdomen, flatulence, gas with some discharge, oily discharge from the rectum, steatorrhea, urge to defecate, loose stools, increased frequency of bowel movements (indicated side reactions occur in the first 3 months of therapy, are mild and transient in nature, their frequency increases with an increase in the fat content in food); often (more than 1/100, but less than 1/10) - damage to the teeth and / or gums, bloating, pain or discomfort in the rectum, soft stools, fecal incontinence; very rarely (less than 1/10 000) - increased activity of liver transaminases and alkaline phosphatase, hepatitis; the frequency has not been established (the available data do not allow us to establish the incidence of adverse events) - rectal bleeding, diverticulitis, cholelithiasis,pancreatitis;
- allergic reactions: rarely (more than 1/10 000, but less than 1/1000) - itching, skin rash, urticaria, bronchospasm, angioedema, anaphylaxis; very rarely, a bullous rash;
- others: very often - upper respiratory tract infections, headache, flu; often - anxiety, weakness, urinary tract infections, lower respiratory tract infections, dysmenorrhea; frequency not established - oxalate nephropathy.
In addition, hypoglycemic conditions and abdominal distention were often recorded in patients with type 2 diabetes mellitus during post-marketing surveillance.
Overdose
The onset of symptoms of an overdose of Listata with a significant excess of single doses or their repeated administration is unlikely.
In case of an overdose, it is recommended to monitor the patient's condition for 24 hours. It is possible to develop undesirable phenomena that are characteristic of therapeutic doses of orlistat and are quickly reversible.
special instructions
The effectiveness of Listata has been confirmed in terms of reducing body weight and preventing its re-gain, reducing the amount of visceral fat, improving the profile of risk factors for the development of diseases associated with obesity, such as impaired glucose tolerance, type 2 diabetes mellitus, hyperinsulinemia, hypercholesterolemia, arterial hypertension.
Patients with type 2 diabetes with obesity (BMI at least 30 kg / m 2) or overweight (BMI of at least 28 kg / m 2) combination therapy hypoglycemic drugs and orlistat in combination with moderately hypocaloric diet contributes to further improvement in compensation of carbohydrate metabolism … A dose reduction of hypoglycemic agents may be required.
To ensure adequate intake of vitamins A, D, E, K, beta-carotene and other minerals, the use of multivitamins is indicated.
It should be borne in mind that foods that are very rich in fat increase the likelihood of developing gastrointestinal reactions.
Influence on the ability to drive vehicles and complex mechanisms
The use of Listata does not adversely affect the ability of patients to drive vehicles and complex mechanisms. It is recommended to observe caution in patients with type 2 diabetes mellitus who take pills in combination with hypoglycemic agents. This is due to the fact that against the background of this combination, hypoglycemia may develop, which often causes visual impairment, dizziness.
Application during pregnancy and lactation
The use of Listata for weight loss during pregnancy and breastfeeding is contraindicated.
Pediatric use
The use of Listata in children under the age of 12 is contraindicated.
The study of the effectiveness and safety of the drug in children under 12 years of age has not been conducted.
With impaired renal function
The study of the efficacy and safety of Listata in patients with impaired renal function has not been conducted.
For violations of liver function
The study of the efficacy and safety of Listata in patients with impaired liver function has not been conducted.
Use in the elderly
There has not been a study of the efficacy and safety when using Listata for weight loss in elderly patients.
Drug interactions
- amitriptyline, atorvastatin, digoxin, fibrates, biguanides, fluoxetine, losartan, phenytoin, phentermine, pravastatin, slow-release nifedipine, nifedipine GITS (gastrointestinal therapeutic system), sibutramine, oral drugs with non-oral drugs, oral protivoids drug interactions;
- indirect anticoagulants (including warfarin): against the background of concomitant therapy with indirect anticoagulants, a decrease in prothrombin, an increase in INR values (international normalized ratio), a change in hemostatic parameters are possible;
- antiepileptic drugs: there is a risk of seizures in patients taking anticonvulsants;
- acarbose: it is recommended to avoid the combination with Listat;
- beta-carotene, vitamins D and E: the absorption of these vitamins decreases against the background of orlistat, so they should be taken before bedtime or 2 hours after taking the drug;
- cyclosporine: a decrease in its level of concentration in blood plasma is possible;
- amiodarone (oral dosage form): there is a 25-30% decrease in the systemic exposure of amiodarone and desethylamiodarone, possibly a decrease in its clinical effect.
Analogs
The analogs of Listat are Orlistat, Orlistat Canon, Orlistat Mini, Alli, Xsenalten, Xsenalten Slim, Xsenalten Light, Xenical, Orliksen 120, Orliksen 60, Orlimax, Orsoten, Orsoten slim, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C in a dark place.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Listat
Reviews about Listat are controversial. Patients who give a positive assessment of the effectiveness of the drug report a fairly good tolerance, a noticeable decrease in weight and the need to adhere to a low-calorie diet during treatment. In some of them, in the first days of taking orlistat, adverse events from the digestive system (including frequent and / or loose stools, flatulence) were observed.
At the same time, there are often reviews in which patients indicate the absence of any therapeutic effect of Listata, the appearance of side effects in the form of headache, diarrhea, nausea, vomiting.
Listata price in pharmacies
The price of Listata for a package containing 90 tablets can be from 2,429 rubles, 80 tablets - from 2,385 rubles, 60 tablets - from 1,835 rubles, 40 tablets - from 1,648 rubles, 20 tablets - from 799 rubles.
Listata: prices in online pharmacies
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Drug name Price Pharmacy |
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Listata Mini 60 mg film-coated tablets 30 pcs. 399 RUB Buy |
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Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
