Generic

Orlistat

Therapeutic Class

Anti-obesity

Pack Size

Xenobese 120 mg capsule: Each box contains 21 capsules (1 x 21's) in Alu-PVC / PVDC blister pack.

Indications

Adults: Xenobese is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI)>30 kg/m2 and overweight patients (BMI >28 kg/m2) with associated risk factors such as type II diabetes, hyperlipidemia and hypertension. Treatment with Xenekal® should be discontinued after 12 weeks in patients who have not lost at least 5% of their body weight as measured at the start of drug therapy. Adolescents (12 years & older) Obese adolescents should be treated with Xenekal® only if an adequate reduction of body weight cannot be achieved by means of diet & increased physical activity. Treatment with orlistat should be considered in particular if complications of obesity are present.

Therapeutic Class

Anti-obesity

Dosage & Administration

The recommended dose of Xenobese is one 120 mg cap to be taken immediately before, during, or up to one hour after each main meal. If a meal is missed or contains no fat the dose to Xenobese should be omitted. Doses of Xenekal® above 120 mg three times daily have not been shown to provide additional benefits. The effect of Xenekal® results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours. Safety & efficacy of Xenekal® were investigated in clinical studies lasting up to 4 years. The recommended dose of Xenekal® for adolescents is as same as adults.

Contraindications

Xenobese is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.

Side Effects

Undesirable effects of Xenobese are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc. Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensit ivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, louboutin heels, angioedema and anaphylaxis.

Pregnancy & Lactation

No clinical data are available on pregnancies exposed to Xenobese. As it is not known whether Xenobese is excreted in breast milk. Xenobese should not be used during breastfeeding.

Precautions

In clinical trial, the decrease in body weight with Xenobese therapy was less in type II diabetic patents than in nondiabetic patients. Antidiabetic drug treatment should be closely monitored during Xenekal® therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted. Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Xenekal® is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta-carotene may be low in obese patients compared with non-obese patients.

Storage Conditions

Store in a cool and dry place below 30°C. Keep out of reach of children.