Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients as well as to reduce the risk for weight regain in patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI ≥ 28 kg/m²) with associated risk factors (e.g., hypertension, diabetes mellitus, hyperlipidemia).
The recommended dose of Odistad 60 is one capsule to be taken three times daily.
- The capsule should be taken with water immediately before, during or up to 1 hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.
- No more than 03 capsules should be taken in 24 hours.
- Treatment should not exceed 06 months.
- If patients have been unable to lose weight after 12 weeks of treatment with Odistad 60, they should consult their doctor or a pharmacist. It may be necessary to discontinue treatment.
- Diet and exercise are important parts of a weight loss programme. It is recommended that a diet and exercise programme is started before beginning treatment with Odistad 60.
- While taking orlistat, the patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat (e.g. in a 2,000 kcal/day diet, this equates to < 67 g of fat). The daily intake of fat, carbohydrate and protein should be distributed over 03 main meals.
- The diet and exercise programme should continue to be followed when treatment with Odistad 60 is stopped.
- Should not be used in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
- There are limited data on the use of orlistat in the elderly.
- The effect of orlistat in individuals with hepatic and/or renal impairment has not been studied. However, as orlistat is minimally absorbed, no dosage adjustment is necessary in elderly and in individuals with hepatic and/or renal impairment.