Xenical capsules 120mg №84

Capsules

Composition

One capsule contains:
active substance: orlistat 120 mg (in the form of pellets * 240 mg);
* composition of pellets: orlistat - 120 mg, microcrystalline cellulose - 93.60 mg, sodium carboxymethyl starch (primogel) - 7.20 mg, povidone K-30 - 12.00 mg, sodium lauryl sulfate - 7.20 mg;
Excipients: talc - 0.24 mg;
capsule shell composition: gelatin, indigo carmine, titanium dioxide.

Packing

84 pcs.

Mechanism of action

Xenical is a powerful, specific and reversible inhibitor of gastrointestinal lipases, which has a long lasting effect. Its therapeutic action is carried out in the lumen of the stomach and small intestine and consists in the formation of a covalent bond with the active serine portion of the gastric and pancreatic lipases.

An inactivated enzyme at the same time loses the ability to break down food fats, coming in the form of triglycerides, into absorbable free fatty acids and monoglycerides. Since unsplit triglycerides are not absorbed, the resulting reduction in calorie intake leads to a decrease in body weight. Thus, the therapeutic effect of the drug is carried out without absorption into the systemic circulation.

Judging by the results of fat content in feces, the action of orlistat begins 24-48 hours after ingestion. After discontinuation of the drug, the fat content in the feces after 48-72 hours usually returns to the level that occurred before the start of therapy.

Indications and usage

Long-term therapy for patients with obesity or overweight patients, including those with associated risk factors for obesity, in combination with a moderately low-calorie diet.
In combination with hypoglycemic drugs (metformin, sulfonylurea derivatives and / or insulin) or a moderately low-calorie diet in patients with type 2 diabetes who are overweight or obese.

Contraindications

Chronic malabsorption syndrome, cholestasis, hypersensitivity to the drug components.

Pregnancy and Breastfeeding

Due to the lack of clinical data, Xenical should not be given to pregnant women.
Excretion of orlistat with breast milk has not been studied, so it should not be taken during breastfeeding.

Dosage and administration

Long-term therapy for patients with obesity or overweight patients, including those with associated risk factors for obesity, in combination with a moderately low-calorie diet:
in adults and children over 12 years The recommended dose of orlistat is one 120 mg capsule with each main meal (with meals or no later than one hour after meals).

In combination with hypoglycemic drugs (metformin, sulfonylurea derivatives and / or insulin) or a moderately low-calorie diet in patients with type 2 diabetes with overweight or obesity:
in adults The recommended dose of orlistat is one 120 mg capsule with each main meal (with meals or no later than one hour after meals).

If a meal is missed or if the food does not contain fat, then the intake of Xenical can also be skipped.
The drug should be taken in combination with a balanced, moderately low-calorie diet containing no more than 30% of calories in the form of fat. Daily intake of fats, carbohydrates and proteins should be divided into three main steps.

Adverse reactions

Gastrointestinal: oily discharge from the rectum, gas, imperative urge to stool, steatorrhea, increased bowel movement and fecal incontinence (as a rule, these phenomena are transient in nature and occur in the first 3 months of treatment); rarely, pain or discomfort in the abdomen, flatulence, loose stools, pain or discomfort in the rectum.
Allergic reactions: skin rash, itching, angioedema, Anaphylactic reactions.

Special notes

Increasing the dose of orlistat over the recommended (120 mg 3 times a day) does not lead to an increase in its therapeutic effect.

The efficacy and safety of the drug Xenical in patients with impaired liver and / or kidney function, as well as in patients of middle age and childhood (under 12 years of age) have not been studied.

During Xenical therapy, the patient should receive a balanced, moderately low-calorie diet containing no more than 30% of calories in the form of fat. With a higher fat content in the diet increases the likelihood of adverse reactions from the gastrointestinal tract.

Reducing the body weight of patients can improve metabolism in patients with diabetes mellitus and require a reduction in the dose of oral antidiabetic drugs.

In clinical studies in most patients who received Xenical for 2 full years, the concentrations of Vitamins A, D, E, K and beta-carotene remained within the normal range. In some cases, for adequate intake of all nutrients into the body, you can assign multivitamins, which should be taken no less than 2 hours after taking Xenical or before going to bed.

Drug Interactions

No interaction was found with Amitriptyline, Atorvastatin, biguanides, Digoxin, fibrates, Fluoxetine, Losartan, phenytoin, oral contraceptives, phentermine, pravastatin, Warfarin, Nifedipine GITS (gastrointestinal therapeutic system), and in the case of the same i'yo, i'yo, i'yo, i'm using ipitine, Heparin, pyroxetine, phenocarcinoma research on drug interactions). However, it is necessary to monitor the performance of MNO with concomitant therapy with warfarin or other oral anticoagulants.
When taken simultaneously with Xenical, a decrease in the absorption of vitamins D, E and beta-carotene was noted. If multivitamins are recommended, they should be taken at least 2 hours after taking Xenical or before going to bed.

While taking the drug Xenical and cyclosporine, there was a decrease in plasma concentrations of cyclosporine, therefore more frequent determination of plasma cyclosporine concentrations while taking cyclosporine and Xenical is recommended.

Oral administration of Amiodarone during therapy with Xenical showed a decrease in systemic exposure of amiodarone and dezethylamidone (by 25-30%), however, due to the complex pharmacokinetics of amiodarone, the clinical significance of this phenomenon is not clear. The addition of the drug Xenical to long-term therapy with amiodarone may lead to a decrease in the therapeutic effect of amiodarone (no studies have been conducted).
It is necessary to avoid simultaneous administration of the drug Xenical and acarbose, due to the lack of data from pharmacokinetic studies.

While taking orlistat and antiepileptic drugs, there have been cases of seizures. The causal relationship between the development of seizures and therapy with orlistat has not been established. However, patients should be monitored for possible changes in the frequency and / or severity of the convulsive syndrome.

Storage conditions

Store at a temperature not exceeding 25 ° C in a place protected from moisture and inaccessible to children.

3 years.