Orlistat-Acrihin, 120 mg capsules 42 pcs

Orlistat refers to specific inhibitors of long-acting gastrointestinal lipases. This substance shows its effect in the lumen of the stomach and small intestine by forming a covalent bond with the active serine center of gastric and pancreatic lipases. As a result of the effect of hypolipidemic agent inactivated enzyme loses the ability to break down fats coming with food in the form of triglycerides (TG) to monoglycerides and absorbable free fatty acids.

Since unreplenished TGs are not absorbed from the gastrointestinal tract (GIT), fewer calories are fed into the body and, as a result, body weight is reduced. Thus, the therapeutic effect of the drug is carried out without its absorption into the systemic bloodstream. Due to the activity of orlistat 24-48 hours after oral administration, the concentration of fat in feces increases. By reducing the fat depot, Orlistat provides effective body weight control.

In clinical studies involving obese patients, the group of patients receiving Orlistat showed more pronounced weight loss compared to patients on diet therapy alone. This weight loss was observed within the first 2 weeks of starting Orlistat-Acrychin and continued for 6-12 months even in the presence of a negative response to diet therapy.

Statistically significant significant improvement in the profile of metabolic risk factors associated with obesity was recorded for two years. In addition, there was a significant reduction in body fat deposits when compared to the placebo group. Orlistat-Acrihin a decrease in doses of antidiabetic agents, insulin concentrations, as well as a decrease in insulin resistance was observed.

According to 4-year studies, orlistat therapy was found to significantly reduce the threat of type 2 diabetes, by an average of 37% compared to placebo use. This threat was reduced by about 45% in patients with an initial impairment of glucose tolerance. The group receiving orlistat showed a greater reduction in body weight compared to the placebo group, as well as a significant improvement in the profile of metabolic risk factors. The achieved new body weight level was maintained during all 4 years of the study.

In adolescents with obesity during the 1-year study against the background of orlistat treatment a decrease in body mass index (BMI) as well as a decrease in fat deposits and waist and hip circumference were registered as compared to the placebo group. Also during the period of taking Orlistat-Acrihin a significant decrease in diastolic blood pressure (BP) was observed in adolescents compared to those who received placebo.

Indications

Orlistat-Acrichine is recommended for long-term therapy in obese patients with BMI ≥ 30 kg/m² or in overweight patients with BMI ≥ 28 kg/m² who have obesity-related risk factors on a moderately restricted low-calorie diet.

Also Orlistat-Acrihin is indicated for administration in patients with diabetes mellitus type 2 with excessive body weight or obesity in combination with moderately restricted hypocaloric diet and/or hypoglycemic drugs (insulin and/or sulfonylurea derivatives, metformin).

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Active ingredient

Orlistat

Composition

The 1 capsule contains:

Dthe active ingredient:

orlistat – 120 mg.

Additional Components:

sodium carboxymethyl starch,

microcrystalline cellulose,

sodium lauryl sulfate,

colloidal anhydrous silica.

Capsule shell:

titanium dioxide (E171),

gelatin,

indigo carmine (E132).

Interaction

– amiodarone – a decrease in plasma levels of this substance may be noted, clinical observation and ECG monitoring should be performed;

– anti-epileptic drugs – absorption of these drugs decreases, which may cause seizures;

– cyclosporin – cyclosporine decreases its plasma levels, which may lead to weakening of the immunosuppressive efficacy of the drug, this combination is not recommended, if necessary it requires frequent monitoring of the plasma concentration of cyclosporine both during concomitant administration of orlistat and after its completion; warfarin and other anticoagulants – possible decrease in prothrombin concentration and increase in the international normalized ratio (INR), which may lead to a change in hemostatic parameters, with

– fat-soluble vitamins A, D, E, K and beta-carotene -absorption of these substances is impaired, when combined they should be taken before bedtime or not earlier than 2 hours after taking orlistat;

– acarbose – it is recommended to avoid combined use due to lack of pharmacokinetic interaction studies;

– Oral contraceptives – the risk of decreased contraceptive action is exacerbated, which in some cases increases the likelihood of unplanned pregnancy, additional contraceptive methods should be resorted to, including. In the case of severe diarrhea;

– antiretroviral agents for the treatment of human immunodeficiency virus (HIV), neuroleptics (including antidepressants, benzodiazepines – the therapeutic effect of these drugs may weaken, therapy with orlistat in such patients should be started after careful evaluation of the expected benefit of this treatment and possible risk;

– fibrates, atorvastatin, digoxin, amitriptyline, biguanides, losartan, pravastatin, fluoxetine, phentermine, sibutramine, nifedipine, phenytoin, ethanol – no interaction with these drugs was observed.