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Odistad 60
OTC

Orlistat inhibits dietary fat absorption by inhibiting lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat into absorbable forms.

Pack size Box of 30 capsules, 42 capsules, 60 capsules
Shelf-life 36 months
Composition Orlistat (as orlistat pellets 50%)
Dosage forms and strengths Hard-gelatin capsule: 60 mg
Product code :

PRESCRIBING INFORMATION

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

  • Recommended: 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.
  • Orlistat is not recommended for use during pregnancy and lactation.
  • Orlistat has no influence on the ability to drive and use machines.