Listata mini, tablets 60 mg 60 pcs.

Listat mini is a lipase inhibitor.

Ingestion orlistat inhibits gastric and pancreatic lipases. As a result, the breakdown of dietary fats is impaired and their absorption from the gastrointestinal tract is reduced.

When systematically used this effect leads to weight loss in patients with obesity.

The Orlistat is practically not absorbed from the gastrointestinal tract and because of this it has almost no resorptive effect.

Indications

Obesity, Overeating, Dietary Error

• long-term therapy in obese patients with a BMI of at least 30 kg/m² or in overweight patients with a BMI of at least 28 kg/m², including
• in combination with hypoglycemic drugs (metformin, sulfonylurea derivatives and/or insulin) and/or a moderately hypocaloric diet in overweight or obese patients with type 2 diabetes.

Active ingredient

Orlistat

Composition

Active ingredient:

orlistat 60 mg;

Associates:

sodium lauryl sulfate, 12 mg;

acacia gum, 210 mg;

ludiflash (mannitol – 84-92%, crosspovidone – 4-6%, polyvinyl acetate – 3.5-6%, povidone – 0.25-0.6%) – 640 mg;

Copovidone – 20 mg;

Crospovidone – 50 mg;

Magnesium stearate – 8 mg;

Film coating:

Opadray II blue (85F30720) (polyvinyl alcohol – 40%, titanium dioxide – 21.4%, macrogol 3350 – 20.2%, talc – 14.8%, quinoline yellow aluminum varnish – 0.1%, indigo carmine – 3.5%) – 34.8 mg; Silver Opadray (63F97546) (polyvinyl alcohol 47.03%, talc 27%, macrogol 3350 13.27%, pearlescent pigment 10%, polysorbate 80 2.7%) – 6 mg

How to take, the dosage

Inhaled with water, immediately before a meal, with a meal, or no later than 1 hour after a meal.

The recommended dose is 60 mg 3 times daily with each main meal, combined with a moderately hypocaloric, low-fat diet. If a meal is skipped or the food is fat-free, the Lystata Mini should be skipped.

The maximum daily dose is 3 tablets of 60 mg.

The treatment is recommended for no more than 6 months. If after 12 weeks of therapy there is no decrease in body weight (ie, weight loss is less than 5% of baseline), it is necessary to consult a physician to decide whether to continue the use of the drug.

Patient special groups

Elderly patients, patients with hepatic and renal dysfunction. No dose adjustment is necessary.

Children. Listata Mini is not recommended for use in children and adolescents less than 18 years of age because of insufficient safety and efficacy data.

Interaction

Concomitant administration of orlistat and cyclosporine may decrease the plasma concentration of cyclosporine, therefore it is necessary to monitor the plasma concentration of cyclosporine. Simultaneous use of Listat Mini and cyclosporine is contraindicated.

Concomitant use of Orlistat with amiodarone may decrease the plasma concentration of amiodarone. The clinical significance of this effect is unclear. Concomitant use of orlistat and warfarin or other oral anticoagulants may lead to decreased prothrombin concentration and increased INR. Simultaneous use of Listat Mini and warfarin or other oral anticoagulants is contraindicated.

Orlistat may decrease absorption of fat-soluble vitamins A, D, E, K and beta-carotene. If multivitamins are indicated, they should not be taken before 2 hours after taking Orlistat or before bedtime.

Orlistat can decrease absorption of antiepileptic drugs, which can lead to seizures.

Because of the lack of pharmacokinetic interaction studies, co-administration of orlistat and acarbose is not recommended.

In some cases orlistat may indirectly decrease the bioavailability of oral contraceptives. An additional contraceptive method is recommended in cases of severe diarrhea.

In concomitant administration with levothyroxine sodium, due to decreased absorption of inorganic iodine and/or levothyroxine sodium, hypothyroidism and/or decreased control of hypothyroidism may develop.

Drug interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine, sibutramine and ethanol have not been identified.

Special Instructions

Diet and exercise are important components of a weight loss program. It is recommended to start a dietary program and exercise before starting therapy with Listat Mini. A patient should receive a moderately hypocaloric diet containing no more than 30% of calories in the form of fat (e.g. at a caloric value of 2000 kcal/day, a meal should contain no more than 67 g of fat). The daily fat intake should be distributed among the three main meals.

Low-fat diets decrease the likelihood of GI adverse events.

Patients taking antiepileptic drugs should consult their physician before starting Lystata Mini, as the frequency and severity of seizures may change. In these cases, you may consider taking Orlistat and antiepileptic drugs at different times.

Patients with renal disease should consult a physician, as hyperoxaluria and nephropathy may develop.

In patients with type 2 diabetes, due to weight loss while taking Orlistat Mini, carbohydrate metabolism may improve, so the physician should be consulted before starting Orlistat and the dose of hypoglycemic drugs decreased, if necessary.

Decrease in body weight may be accompanied by a decrease in BP and cholesterol concentrations. Patients taking hypotensive and hypolipidemic medications should consult a physician before starting orlistat and adjust the dose of these medications, if necessary.

If symptoms such as weakness, fatigue, fever, jaundice, and darkened urine occur, a physician should be consulted to rule out liver function.

Impact on the ability to drive and operate machinery.Orlistat does not affect the ability to operate vehicles and machinery.

Contraindications

• high sensitivity to orlistat or any other component of the drug
• pregnancy;
• breastfeeding period;
• children under 12 years of age.

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Side effects

Gastrointestinal disorders: very common – oily discharge from the rectum, discharge of gas with some excreta, imperative defecation urges, steatorrhea; common – abdominal pain, fecal incontinence, liquid stool, increased frequency of defecation.

Some side effects reported in the post-marketing period (frequency unknown)

Gastrointestinal disorders: minor bleeding from the rectum, diverticulitis.

Hepatic and biliary tract disorders: increased hepatic transaminases and TSH activity, hepatitis, cholelithiasis.

Skin and subcutaneous tissue disorders: bullous rash.

Immune system disorders: hypersensitivity reactions (itching, rash, urticaria, angioedema, bronchospasm and anaphylaxis).

Others: decreased prothrombin concentration, increased INR in patients who have taken orlistat together with indirect anticoagulants.

Similarities

Xenical, Orsotene, Orsotene Slim, Listata, Orlistat