- Approval Id
- b578ef80a507318d
- Drug Name
- XENICAL CAPSULE 120MG
- Product Name
- XENICAL CAPSULE 120MG
- Approval Number
- SIN13046P
- Approval Date
- 2005-01-31
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PHARMACY ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>3.2 Posology and method of administration</strong><br>
The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.</p>
<p>The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30 % of calories from fat. It is recommended that the diet should be rich in fruit and vegetables. The daily intake of fat, carbohydrate and protein should be distributed over three main meals.</p>
<p>Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.</p>
<p>The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours. The safety and effectiveness of Xenical beyond 4 years have not been determined at this time; therefore, the duration of treatment with Xenical should not be longer than 4 years.</p>
<p><strong>Special populations</strong><br>
The effect of Xenical in patients with hepatic and/or renal impairment, children and elderly patients has not been studied. Xenical is not intended to be used in children.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>3.1 Therapeutic indications</strong><br>
Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m<sup>2</sup>, or overweight patients (BMI ≥ 28 kg/m<sup>2</sup>) with associated risk factors.</p>
<p>Treatment with Xenical should be discontinued after 12 weeks if patients have been unable to lose at least 5% of their body weight as measured at the start of drug therapy.</p>
<p>In type 2 diabetic patients who are overweight (BMI ≥ 28kg/m<sup>2</sup>) or obese (BMI ≥ 30kg/m<sup>2</sup>), clinical studies conducted over one year showed Xenical, in conjunction with a mildly hypocaloric diet, provides additional glycemic control when used in combination with anti-diabetic agents such as metformin, sulfonylurea and/or insulin. No studies have been done in patients receiving concomitant treatment with thiazolidinedione. The efficacy of Xenical as a monotherapy treatment for type 2 diabetes has not been established.</p>
- Contraindications
- <p><strong>3.3 Contraindications</strong></p>
<ul class="dash">
<li>Chronic malabsorption syndrome</li>
<li>Cholestasis</li>
<li>Breastfeeding</li>
<li>Hypersensitivity to the active substance or to any of the excipients. Xenical is not recommended for use during pregnancy.</li>
</ul>
- Atc Code
- A08AB01
- Atc Item Name
- orlistat
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
