Xenical - an inhibitor of gastrointestinal lipases; drug for the treatment of obesity.
Release form and composition
Dosage form of Xenical - gelatin capsules No. 1: solid, opaque, turquoise, with the words "ROCHE" on the lid and "XENICAL 120" - on the body; the contents are white or almost white pellets (21 pieces in blisters, 1, 2 or 4 blisters in carton packs).
Composition 1 capsule:
- Active ingredient: orlistat - 120 mg, in the form of pellets (240 mg), containing carboxymethyl starch sodium (primogel), povidone K-30, sodium lauryl sulfate and microcrystalline cellulose;
- Auxiliary component: talc;
- Shell composition: gelatin, titanium dioxide and indigo carmine.
Indications for use
In combination with a moderate hypocaloric diet, Xenical is used for the long-term treatment of overweight and obese patients (adults and children over 12 years old), including having obesity-associated risk factors.
In combination with a moderate hypocaloric diet or hypoglycemic agents (sulfonylurea derivatives, metformin and / or insulin), it is prescribed to treat obesity or overweight in adult patients with type 2 diabetes.
- Chronic malabsorption syndrome;
- Children under 12 years of age (the efficacy and safety of Xenical has not been studied);
- Hypersensitivity to the drug.
Dosing and Administration
Xenical prescribed 1 capsule with each main meal (breakfast, lunch and dinner). Take the drug at meal time or within an hour after meals.
During treatment, you must follow a balanced, moderately low-calorie diet, containing no more than 30% of calories in the form of fat. The daily volume of proteins, carbohydrates and fats should be divided into 3 main meals.
If the food does not contain fat, you can not take the capsule.
According to clinical studies, adverse reactions caused by Xenical, occurred mainly on the part of the gastrointestinal tract (GIT), due to the pharmacological action of orlistat, which prevents the absorption of fat from food. It was often noted: imperative urge to have a bowel movement, more frequent bowel movements, pain or discomfort in the abdomen, flatulence, gas with some discharge, oily discharge from the rectum, and diarrhea. These side effects are usually mild and transient, usually occurring during the first 3 months of treatment. Their frequency increases with increasing fat content in the diet. The likelihood of these reactions can be reduced by following a low-fat diet.
Frequent reactions from the gastrointestinal tract: damage to the teeth and / or gums, pain or discomfort in the rectum, abdominal distension, fecal incontinence, loose stools.
The following side effects were also very often noted: flu, upper respiratory tract infections, headaches; often - urinary and lower respiratory tract infections, weakness, anxiety, dysmenorrhea.
In more than 2% of patients with type 2 diabetes, in addition, hypoglycemic states and abdominal distention occurred.
In the course of post-marketing surveillance, the following adverse reactions were rarely found:
- Bullous rash, increased alkaline phosphatase and transaminase activity. There are cases of serious hepatitis, however, a causal relationship with Xenical has not been established;
- Pancreatitis, diverticulitis, cholelithiasis, rectal bleeding, oxalate nephropathy;
- Allergic reactions such as itching, rash, urticaria, bronchospasm, angioedema, anaphylaxis;
- With the simultaneous use of antiepileptic drugs - convulsions;
- With simultaneous use of anticoagulants - a decrease in prothrombin, an increase in INR (international normalized ratio), a change in hemostatic parameters.
Xenical is effective in terms of long-term weight control (weight loss and the prevention of repeated weight gain). The drug reduces visceral fat and improves the profile of risk factors and diseases associated with obesity, including impaired glucose tolerance, type 2 diabetes mellitus, hyperinsulinemia, hypercholesterolemia and arterial hypertension.
Increasing the dose of Xenical above the recommended (120 mg 3 times a day) does not enhance its therapeutic effect.
When using the drug in diabetic patients with obesity or overweight in combination with hypoglycemic agents such as insulin, metformin and sulfonylurea derivatives, in combination with a moderately low-calorie diet, Xenical provides an additional improvement in carbohydrate metabolism, which may require a reduction in the dose of hypoglycemic agent.
In clinical studies, it was found that in patients taking orlistat for 4 years, the concentrations of vitamins A, D, E, K and beta-carotene remained within the normal range. However, multivitamins can be taken to ensure adequate intake of all nutrients.
When using orlistat in combination with warfarin or other oral anticoagulants, no interaction was found, however, it is necessary to monitor the INR indicators.
With the concomitant appointment of multivitamins, they should be taken no earlier than 2 hours after taking Xenical or before bedtime, because orlistat can reduce betacarotene and vitamins D and E absorption.
Orlistat reduces the plasma concentration of cyclosporine, so when using such a combination, it is necessary to more often determine the content of this substance in the plasma.
When taking Xenical during treatment with amiodarone, a decrease in the therapeutic effect of amiodarone is believed to be possible.
It is not recommended to take orlistat simultaneously with acarbose, because pharmacokinetic studies of their interaction were not conducted.
There are cases of seizures in patients taking orlistat during treatment with antiepileptic drugs. Although a causal relationship with this drug has not been established, it is necessary to carefully monitor the condition of patients for possible changes in the severity and / or frequency of the convulsive syndrome.
Terms and conditions of storage
Store at temperatures up to 25 ºC in a place protected from moisture and out of reach of children.
Shelf life - 3 years.