Listata 60 mg, 80 pcs.

Izvarino Pharma, Russia

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$58
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Product Overview

Composition

Active substance: 

orlistat 60 mg; 

Excipients:

sodium lauryl sulfate - 12 mg; 

acacia gum - 210 mg;

ludiflash (mannitol - 84–92%, crospovidone - 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 casing:

Opadrai 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; Opadry silver (63F97546) (polyvinyl alcohol - 47.03%, talc - 27%, macrogol 3350 - 13.27%, pearlescent pigment - 10%, polysorbate 80 - 2.7%) - 6 mg.

pharmachologic effect

Listata mini - lipase inhibitor.

When taken orally, orlistat inhibits gastric and pancreatic lipases. As a result, the breakdown of food fats is disrupted and their absorption from the gastrointestinal tract decreases.

With systematic use, this effect leads to a decrease in body weight in obese patients.

Orlistat is practically not absorbed from the gastrointestinal tract and, therefore, practically does not have a resorptive effect.

Indications

 

  • Long-term therapy of obese patients with a BMI of at least 30 kg / m2 or overweight patients with a BMI of at least 28 kg / m2, incl. having risk factors associated with obesity, in combination with a moderately hypocaloric diet;

  • in combination with hypoglycemic drugs (metformin, sulfonylurea derivatives and / or insulin) and / or a moderately hypocaloric diet in patients with type 2 diabetes mellitus who are overweight or obese.

Contraindications

  • Hypersensitivity to orlistat or any other components of the drug;

  • chronic malabsorption syndrome;

  • pregnancy;

  • period of breastfeeding;

  • children under 12 years old.

Side effects

On the part of the gastrointestinal tract: very often - oily discharge from the rectum, discharge of gases with a certain amount of discharge, imperative urge to defecate, steatorrhea; often - abdominal pain, fecal incontinence, loose stools, increased frequency of bowel movements.

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

From the gastrointestinal tract: minor bleeding from the rectum, diverticulitis.

From the liver and biliary tract: increased activity of hepatic transaminases and AP, hepatitis, cholelithiasis.

Skin and subcutaneous tissue disorders: bullous rash.

From the immune system: hypersensitivity reactions (itching, rash, urticaria, angioedema, bronchospasm and anaphylaxis).

Others: a decrease in the concentration of prothrombin, an increase in the INR indicator in patients taking orlistat in conjunction with indirect anticoagulants.

Interaction

With the simultaneous administration of orlistat and cyclosporine, it is possible to reduce the concentration of cyclosporine in the blood plasma, in connection with which it is necessary to monitor the content of cyclosporine in the blood plasma. The simultaneous use of the drug Listata Mini and cyclosporine is contraindicated.

With the simultaneous use of orlistat with amiodarone, a decrease in the concentration of amiodarone in blood plasma is possible. The clinical significance of this effect is unclear. With the simultaneous administration of orlistat and warfarin or other oral anticoagulants, a decrease in the concentration of prothrombin and an increase in the INR value may be observed. 

The simultaneous use of the drug Listata Mini and warfarin or other oral anticoagulants is contraindicated.

Orlistat may reduce the absorption of fat-soluble vitamins A, D, E, K and beta-carotene. If multivitamins are indicated, they should be taken no earlier than 2 hours after taking orlistat or before bedtime.

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

Due to the lack of pharmacokinetic interaction studies, the combined use of orlistat and acarbose is not recommended.

In some cases, orlistat can indirectly reduce the bioavailability of oral contraceptives. In the event of severe diarrhea, an additional method of contraception is recommended.

When taken simultaneously with levothyroxine sodium, due to a decrease in the absorption of inorganic iodine and / or levothyroxine sodium, hypothyroidism and / or a decrease in the control of hypothyroidism may develop.

No drug interactions were found with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine, sibutramine and ethanol.

How to take, course of administration and dosage

Inside, with water, immediately before meals, during meals or not later than 1 hour after meals.

The recommended dose is 60 mg 3 times daily with each main meal, in combination with a moderately low-fat, low-fat, hypocaloric diet. If a meal is skipped or the meal does not contain fat, Listata Mini should be skipped. 

The maximum daily dose is 3 tablets of 60 mg.

Treatment is recommended for no more than 6 months. If after 12 weeks of therapy there is no decrease in body weight (i.e., the decrease in body weight is less than 5% of the initial), a doctor's consultation is necessary to decide whether to continue using the drug.

Special patient groups

Elderly patients, patients with impaired liver and kidney function. No dose adjustment is required.

Children. Listata Mini is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy.

Special instructions

Diet and exercise are important parts of a weight loss program. It is recommended to start the dietary program and exercise before starting therapy with Listata Mini. The patient should receive a moderately hypocaloric diet containing no more than 30% of calories in the form of fat (for example, with a calorie content of 2000 kcal / day, food should contain no more than 67 g of fat). 

The daily fat intake should be spread over the three main meals.

A low-fat diet reduces the likelihood of developing gastrointestinal adverse events. 

Patients taking antiepileptic drugs should consult a doctor before using Listata Mini, because the frequency and severity of seizures may change. In these cases, you can consider taking orlistat and antiepileptic drugs at different times. 

Patients with kidney disease need to consult a doctor as development of hyperoxaluria and nephropathy is possible.

Due to a decrease in body weight while taking Listat Mini, it is possible to improve carbohydrate metabolism in patients with type 2 diabetes mellitus, in connection with which it is necessary to consult with the attending physician before taking orlistat and, if necessary, reduce the dose of hypoglycemic drugs 

A decrease in body weight may be accompanied by a decrease in blood pressure and cholesterol concentration. Patients taking antihypertensive and lipid-lowering drugs should consult a doctor before starting taking orlistat and, if necessary, adjust the dose of these drugs.

If symptoms such as weakness, fatigue, fever, jaundice and dark urine appear, you should consult your doctor to rule out liver dysfunction.

Influence on the ability to drive vehicles and work with mechanisms.

Orlistat does not affect the ability to drive vehicles and mechanisms.

Storage conditions

In a dark place at a temperature not exceeding 25 ° C.

Shelf life

2 years.

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