Xenical Special Precautions

The majority of patients in up to 2 full years of treatment had vitamin A, D, E and K and β-carotene levels stayed within normal range. In order to ensure adequate nutrition, the use of a multivitamin supplement could 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 Xenical is taken with a diet high in fat (eg, in a 2000-calorie/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 oral 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.)
Use in pregnancy & lactation: In animal reproductive studies, no embryotoxic or teratogenic effects were observed with orlistat. In absence of a 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.
The secretion of orlistat in human breast milk has not been investigated. Xenical should not be taken during breastfeeding.
Use in children: The safety and efficacy of Xenical in children <18 years have not been established.