Odistad 60

OTC

Indications

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).

Dosage

The recommended dose of Odistad 60 is one capsule to be taken three times daily.

Usage

• 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.

• Known hypersensitive to any of the active substance or excipients.
• Chronic malabsorption syndrome or cholestasis.
• Pregnancy and lactation.

Common

• Gastrointestinal disturbances, including faecal urgency and incontinence, flatulence, and fatty stools. They may be minimised by limiting the amount of fat in the diet.
• Headache, anxiety, fatigue, and menstrual irregularities.
• A report of hypertension associated with orlistat therapy. Blood pressure decreased on stopping orlistat and increased again on rechallenge.

• Orlistat should be given with caution to patients with a history of hyperoxaluria or calcium oxalate nephrolithiasis.
• Adjustments to dosage of hypoglycaemics may be necessary in patients with type II diabetes because of improved metabolic control after weight loss in these patients.
• Supplements of fat-soluble vitamins may be necessary during long-term therapy, but they should be taken at least 2 hours before or after an orlistat dose or at bedtime.
• Hormonal contraceptive failure may occur in the event of severe diarrhoea with orlistat, and patients are advised to use an additional contraceptive method.
• Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine post marketing. Administer levothyroxine and orlistat at least 4 hours apart.