Listata Mini

Release form and composition

The drug is produced in the form of film-coated tablets: light blue in color with a pearlescent tint, oval, biconvex, on one side there is a dividing line, on the other the letter “f” is engraved (10 pcs. in blister packs, in cardboard pack of 1, 2, 3, 6 or 9 packs and instructions for use of Leaflets Mini).

1 tablet contains:

active ingredient: orlistat – 60 mg;
auxiliary components: copovidone, crospovidone, acacia gum, sodium lauryl sulfate, magnesium stearate, ludiflash (povidone, crospovidone, polyvinyl acetate, mannitol);
film shell composition: opadry II blue (85F30720) (macrogol 3350, polyvinyl alcohol, indigo carmine, titanium dioxide, aluminum quinoline yellow varnish, talc), opadry silver (63F97546) (macrogol 3350, polysorbate-80, polyvinyl alcohol, pearlescent pigment, talc ).

Listata mini 60 mg, 20 film-coated tablets

Registration Certificate Holder

IZVARINO PHARMA (Russia)

Dosage form

Medicine - Listata Mini

Description

Film-coated tablets

light blue with a pearlescent effect, oval, biconvex, with a mark on one side and an engraving
“f”
on the other.

1 tab.

orlistat 60 mg

Excipients

: sodium lauryl sulfate, acacia gum, ludiflash (mannitol, crospovidone, polyvinyl acetate, povidone), copovidone, crospovidone, magnesium stearate.

Shell composition:

opadry II blue (85F30720) (polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, indigo carmine, quinoline yellow aluminum varnish), opadry silver (63F97546) (polyvinyl alcohol, talc, macrogol 3350, pearlescent pigment, polysorbate 80).

10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cellular contour packages (3) — cardboard packs. 10 pieces. — contour cell packaging (6) — cardboard packs. 10 pieces. — contour cell packaging (9) — cardboard packs.

Indications

Obesity (in combination with a moderate calorie diet).

Contraindications for use

Chronic malabsorption syndrome, hypersensitivity to orlistat.

pharmachologic effect

Lipase inhibitor. When taken orally, orlistat inhibits gastric and pancreatic lipases. As a result, the breakdown of dietary fats is disrupted and their absorption from the gastrointestinal tract is reduced. When used systematically, this effect leads to a decrease in body weight in obese patients. Orlistat is practically not absorbed from the gastrointestinal tract and therefore has virtually no resorptive effect.

Drug interactions

It has been shown that orlistat leads to a decrease in the absorption of beta-carotene and α-tocopherol from the gastrointestinal tract.

Dosage regimen

Take 120 mg orally with each main meal or within an hour after meals, usually no more than 3 times a day. If your meal is low in fat, you can skip orlistat.

Side effect

Maybe:

oily discharge from the rectum, flatulence, “greasy” stools, frequent bowel movements, urgency to defecate, fecal incontinence.

special instructions

It must be borne in mind that the frequency and severity of side effects increase with increasing fat content in food. By reducing the fat content in food, the likelihood of side effects decreases. It is recommended that the amount of fat consumed per day be distributed fairly evenly across all meals.

During treatment, as body weight decreases, it is possible to improve the course of pathological processes that often accompany obesity, incl. arterial hypertension, diabetes mellitus, lipid metabolism disorders.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution.

Orlistat is used with extreme caution during pregnancy and lactation.

Pharmacological properties

Pharmacodynamics

Listata Mini is a drug for weight loss. Its active ingredient, orlistat, is a strong, specific and reversible long-acting inhibitor of gastrointestinal lipases. A special feature of the drug is that its therapeutic effect is achieved exclusively in the lumen of the stomach and small intestine, without absorption of orlistat into the systemic circulation. The substance begins to act as a result of the formation of a covalent bond with the active serine site of gastric and pancreatic lipases, which leads to inactivation of the enzyme. Gastrointestinal lipases lose their ability to break down dietary fats, which come in the form of triglycerides, absorbable free fatty acids and monoglycerides. Since unsplit triglycerides cannot be absorbed, fewer calories enter the body, which helps reduce body weight. 24–48 hours after oral administration of orlistat at a dose of 60 mg 3 times a day, a significant increase in the fat content in the stool is observed.

In addition to reducing body weight and reducing waist circumference, the beneficial effects of Listata Mini include a decrease in the concentration of total cholesterol, as well as low-density lipoprotein cholesterol.

After discontinuation of orlistat, the initial level of fecal fat is usually restored within 48–72 hours.

Pharmacokinetics

After taking Listata Mini orally, the absorption of orlistat into the systemic circulation is minimal.

Orlistat is metabolized primarily in the intestinal wall. As a result of biotransformation, the following pharmacologically inactive metabolites are formed: M1 (tetravalent hydrolyzed lactone ring) and M3 (M1 with a cleaved N-formylleucine residue). They have an open beta-lactone ring, so the ability of M1 to inhibit lipase is 1000 times, and M3 2500 times weaker than orlistat.

Approximately 97% is excreted through the intestines (including unchanged - 83%), through the kidneys - less than 2% of the dose taken. Orlistat is completely eliminated from the body within 3–5 days. Elimination is similar in both obese and normal weight patients.

Listata Mini, instructions for use: method and dosage

Listat Mini tablets are taken orally immediately before breakfast, lunch and dinner or during each main meal (but no later than 1 hour after meals).

If the meal does not contain fat or a meal is missed, then it is not necessary to take the tablet.

Recommended dosage: 1 pc. (60 mg) 3 times a day. The duration of the course of treatment is no more than 180 days.

The maximum daily dose of orlistat is 180 mg.

Before starting treatment, the patient should switch to a moderately high-calorie diet, the daily fat content of which does not exceed 30%, and follow a physical activity regimen. If after using the drug for 84 days there is no desired clinical effect, that is, body weight has decreased by less than 5% of the original, you must stop taking Listata Mini and consult a doctor to decide whether to continue therapy.

In case of hepatic and/or renal failure and for patients aged 65 years and older, no dose adjustment is required.

Side effects

from the immune system: frequency has not been established (available data do not allow us to establish the frequency of adverse reactions) - bronchospasm, itching, rash, urticaria, angioedema, anaphylaxis;
mental disorders: often (≥ 1/100, < 1/10) – anxiety;
from the gastrointestinal tract: very often (≥ 1/10) - flatulence, imperative urge to defecate, passage of gas with some discharge, oily discharge from the rectum, steatorrhea; often - loose stools, fecal incontinence, abdominal pain, increased frequency of bowel movements; frequency not established - pancreatitis, diverticulitis, mild bleeding from the rectum;
from the liver and biliary tract: frequency not established - hepatitis, increased activity of alkaline phosphatase and/or liver transaminases, cholelithiasis;
from the urinary system: frequency has not been established - hyperoxalaturia, oxalate nephropathy (including with the development of renal failure);
from the skin and subcutaneous tissues: frequency not established – bullous rash;
from the blood and lymphatic system: the frequency has not been established - a decrease in prothrombin and an increase in INR (international normalized ratio) when orlistat is combined with indirect anticoagulants.

special instructions

The body weight loss program includes the following three mandatory main components: taking the drug, diet and exercise. Patients should be informed of the need to strictly adhere to the recommendations of the diet prescribed by the doctor. Nutrition during the treatment period should be moderately low-calorie with a high content of fruits and vegetables. Daily fat intake should not exceed 30% of the total diet; it should be distributed between three main meals. It is recommended to start a dietary program and exercise before starting therapy with Listata Mini and continue after its discontinuation.

It should be borne in mind that a low fat content in food reduces the likelihood of side effects from the gastrointestinal tract.

The appearance of mental disorders in the form of anxiety may be associated with the constant expectation of adverse events from the gastrointestinal tract or against their background.

It should be taken into account that the risk of developing oxalate nephropathy increases with chronic renal failure and/or dehydration.

Patients with type 2 diabetes are advised to pay attention to possible improvements in carbohydrate metabolism. They should be careful and, if necessary, adjust the dose of hypoglycemic agents.

The effect of orlistat, along with a decrease in body weight, may help improve blood pressure and lower cholesterol concentrations. Therefore, when taking Listata Mini simultaneously with antihypertensive or lipid-lowering drugs, their dose should be adjusted if necessary.

When combining the drug with oral contraceptives, in case of diarrhea, it is recommended to use additional barrier methods of contraception.

If you experience rectal bleeding or symptoms of liver dysfunction (including fever, weakness, fatigue, jaundice, dark urine), you should consult your doctor.

Impact on the ability to drive vehicles and complex mechanisms

The use of Listata Mini for weight loss does not have a negative effect on patients’ ability to drive vehicles or operate complex machinery.

Patients should be instructed to adhere to the dietary recommendations they receive.

Diet and exercise are an important component of a weight loss program. It is recommended to begin a dietary program and exercise before starting drug therapy. While using the drug, the patient should receive a moderately hypocaloric diet with a balanced content of nutrients, in which approximately 30% is fat. Daily fat intake should be distributed between three main meals. It is recommended that the food be rich in fruits and vegetables. The diet and exercise program should be continued after the drug is discontinued.

Orlistat should be discontinued if, after 12 weeks of therapy, body weight has decreased by less than 5% compared to initial body weight.

The likelihood of HP from the gastrointestinal tract is higher if a particular meal or diet as a whole is characterized by a high fat content. A low-fat diet reduces the likelihood of developing gastrointestinal adverse events.

Drug interactions

cyclosporine: the concentration of cyclosporine in the blood plasma may decrease, which can lead to a decrease in its immunosuppressive effectiveness;
amiodarone: there is a decrease in its level in the blood plasma. Patients taking amiodarone are not recommended to initiate orlistat therapy without consulting a physician;
oral forms of anticoagulants (including warfarin): there is a risk of changes in hemostatic parameters against the background of a decrease in prothrombin concentration and an increase in INR;
lamotrigine and other antiepileptic drugs: seizures may occur in patients on antiepileptic therapy;
beta-carotene, vitamins A, D, E, K: the absorption of these fat-soluble vitamins may be impaired, so they should be taken only 2 hours after taking Listata Mini or before bedtime;
Oral contraceptives: There is a risk of reduced effectiveness of oral contraceptives, especially in cases where the treatment of obesity is accompanied by the development of severe diarrhea. To avoid unplanned conception, during diarrhea it is recommended to be careful and use additional barrier methods of contraception;
levothyroxine sodium: the absorption of levothyroxine sodium and/or inorganic iodine decreases, the risk of developing hypothyroidism and/or reducing its control increases;
phenytoin, phentermine, amitriptyline, atorvastatin, fibrates, fluoxetine, biguanides, digoxin, losartan, pravastatin, sibutramine, nifedipine GITS (gastrointestinal system), nifedipine slow release, ethanol: drug interactions of orlistat with any of the listed drugs have not been identified;
antiretroviral drugs for the treatment of HIV (human immunodeficiency virus), antidepressants, lithium drugs and antipsychotics: in previously compensated patients, the possible decrease in absorption and effectiveness of each of these drugs should be taken into account when starting orlistat therapy. Before prescribing Listata Mini to patients on antiretroviral therapy, a careful assessment of the ratio of expected benefits and potential risks is required.

Listata mini 60mg 80 pcs. film-coated tablets

Patients should be instructed to adhere to the dietary recommendations they receive.

Orlistat should be discontinued if, after 12 weeks of therapy, body weight has decreased by less than 5% compared to initial body weight.

Patients with kidney disease should consult a doctor because... the development of hyperoxaluria and nephropathy is possible.

Cases of rectal bleeding have been observed with the use of orlistat. If bleeding occurs, the patient should consult a doctor.

The use of an additional method of contraception is recommended to prevent possible failure of oral contraceptives if diarrhea occurs.

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

Patients taking amiodarone should consult their physician before starting orlistat therapy.

Impact on the ability to drive vehicles and operate machinery

There were no negative effects of orlistat on the ability to drive vehicles and machines.