Xenical Special Precautions

General: A reduction in cyclosporine plasma levels has been observed when Orlistat (Xenical) is co-administered. Therefore it is recommended to monitor more frequently than usual the cyclosporine plasma levels when Orlistat (Xenical) is co-administered (see Interactions).
The majority of patients in long-term studies of up to 4 years of treatment had vitamin A, D, E and K and beta-carotene levels within normal range. In order to ensure adequate nutrition, the use of a multivitamin supplement should be considered.
Patients should be advised to adhere to dietary guidelines (see Dosage & Administration). The possibility of experiencing gastrointestinal events (see Adverse Reactions) may increase when Orlistat (Xenical) is taken with a diet high in fat (e.g. 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 three main meals. If Orlistat (Xenical) is taken with any one meal very high in fat, the possibility of gastrointestinal effects may increase. Weight loss induced by Orlistat (Xenical) is accompanied by improved metabolic control in type 2 diabetics which might allow or require reduction in the dose of hypoglycemic medication (e.g. sulfonylureas).
Laboratory Tests: Coagulation parameters, such as international normalised ratio (INR) values, should be monitored in patients treated with concomitant oral anticoagulants.
Renal Impairment: Clinical investigations in patients with renal and/or hepatic impairment have not been undertaken.
Hepatic Impairment: Clinical investigations in patients with hepatic and/or renal impairment have not been undertaken.
Use in Children: Clinical investigations in children under the age of 12 have not been undertaken.