Alli is indicated in combination with a moderately low-calorie and low-fat diet in the treatment of overweight (Body Mass Index (BMI) ≥ 28 kg / m ²) in adults

Dosage

Adults

The recommended dosage for alli is one 60 mg capsule, taken three times a day. Do not take more than 3 capsules at 60 mg every 24 hours.

Diet and exercise are important parts of a weight loss program. It is recommended that a diet and a physical exercise program be initiated before the beginning of treatment with

During treatment with orlistat, the patient should be on a nutritionally well-balanced diet, moderately calorie-rich, containing about 30% calories from lipids (eg, in a diet, 2 000 kcal / day , This proportion corresponds to 67 g of lipids). The daily intake of lipids, carbohydrates and protein should be distributed over the three main meals.

Patient must continue to follow diet and exercise program after stopping treatment with

Treatment should not exceed 6 months.

Patients who have not lost weight after 12 weeks of treatment with alli should consult their doctor or pharmacist. It may be necessary to stop processing.

Populations, special

Elderly people (> 65 years)

Data on the use of orlistat in the elderly are limited. However, since the absorption of orlistat is minimal, it is not necessary to adjust the doses in the elderly.


The effect of orlistat has not been studied in patients with hepatic and / or renal insufficiency
However, as the absorption of orlistat is minimal, there is no need to adjust doses in patients with hepatic and / or renal impairment
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Population, pediatric

The safety and efficacy of alli in children under 18 years of age have not yet been established.
Administration mode

The capsule should be taken with water immediately before, during, or up to one hour after each major meal. If a meal is skipped or does not contain fat, orlistat must be taken out.

The capsule consists of a dark blue central band, a turquoise head and a body bearing the word "alli".

Pharmaco-therapeutic: Preparations, anti-obesity, excluding products of, diet, anti-obesity action agent, peripheral, ATC code A08AB01. >
Orlistat is a potent, specific and prolonged inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme can therefore no longer hydrolyze the triglycerides of food origin into free fatty acids and monoglycerides, which can be absorbed. The results of the clinical studies have shown that taking 60 mg orlistat three times a day blocks the absorption of about 25% of dietary fat. Orlistat causes an increase in the amount of fat in the stool 24 to 48 hours after taking. When stopping the treatment, the contents of the fat stools usually return to the initial values ​​in 48 to 72 hours.

Two randomized, double-blind, placebo-controlled studies in adults with a BMI ≥ 28 kg / m 2 are in favor of the efficacy of orlistat 60 mg three times daily in combination with; Low calorie diet low in fat. The main evaluation parameter, the change in body weight, relative to its initial value (at the time of randomization), was evaluated in terms of change in body weight over time (Table 1), and By the percentage of subjects who lost ≥ 5% or ≥ 10% of their initial body weight (Table 2). Although it was evaluated for 12 months of treatment in both studies, weight loss was predominantly observed in the first six months. >
Table 1: Effect of 6 months treatment on initial body weight

Group of processing

N

Average Relative Change (%)

Modification average (kg)

Study 1

Placebo

Orlistat 60; mg

204

216

-3,24

-5.55

-3,11

-5,20; a

Study 2

Placebo

Orlistat 60; mg

183

191

-1,17

-3,66

-1.05

-3.59; a

Data, grouped

Placebo

Orlistat 60; mg

387

407

-2.20

-4,60

-2,09

-4.40, a

A, p