Xenical Special Precautions

The majority of patients in long-term studies of up to 4 years of treatment had vitamins A, D, E and K and β-carotene levels with normal range. In order to ensure adequate nutrition, the use of a multivitamin supplement could be considered.
Patients should be advised to adhere to the dietary guidelines (see Dosage & Administration). The possibility of experiencing gastrointestinal events (see Adverse Reactions) may increase when Xenical is taken with a diet high in fat (eg, in a 2000-kcal/day diet, >30% of calories from fat equates to >67 g of fat). The daily intake of fat should be distributed over 3 main meals. If Xenical is taken with any 1 meal very high in fat, the possibility of gastrointestinal effects may increase. Weight loss induced by Xenical is accompanied by improved metabolic control in type 2 diabetics which might allow or require reduction in the dose of hypoglycemic medication eg, sulfonylureas.
A reduction in cyclosporin plasma levels has been observed when Xenical is co-administered. Therefore, it is recommended to monitor more frequently than usual the cyclosporin plasma levels when Xenical is co-administered (see Interactions).
In a PK study, oral administration of amiodarone during orlistat treatment demonstrated a 25-30% reduction in the systemic exposure to amiodarone and desethylamiodarone. Due to the complex pharmacokinetics of amiodarone, the clinical effect of this is unclear. The effect of commencing orlistat treatment in patients on stable amiodarone therapy has not been studied. A reduced therapeutic effect of amiodarone is possible.
Laboratory Tests: Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants.
Renal and Hepatic Impairment: Clinical investigations in patients with renal and/or hepatic impairment have not been undertaken.
Use in pregnancy: In animal reproductive studies, no embryotoxic or teratogenic effects were observed with orlistat. In absence of teratogenic effect in animals, no malformative effect is expected in human beings. However, Xenical is not recommended for use during pregnancy in the absence of clinical data.
Use in lactation: The secretion of orlistat in human breast milk has not been investigated. Xenical should not be taken during breastfeeding.
Use in children: Clinical investigations in children <12 years have not been undertaken.