THERAPEUTIC INDICATIONS: reversible inhibitor of lipases (auxiliary exogenous obesity.)
REDUSTAT ® is indicated for the treatment of obesity, for weight loss and maintenance treatment with a hypocaloric diet control. It is also indicated in patients who have risk factors associated with obesity, hypercholesterolemia, type 2 diabetes mellitus, hyperinsulinemia, glucose intolerance and hypertension.
REDUSTAT ® is indicated as an additional control
blood glucose in patients with type 2 diabetes mellitus are overweight or obese, BMI = 28 kg/m2 were treated with hypocaloric diet control and oral hypoglycemic drugs or insulin.
In patients treated with orlistat has been shown to significantly improve cardiovascular risk factors like blood pressure and lipid profile
CONTRAINDICATIONS: REDUSTAT ® is contraindicated in persons with hypersensitivity to orlistat or any other part of the formula, in patients with chronic malabsorption syndrome and those with cholestasis.
CAUTIONS: The levels of vitamins A, D, E, K and beta-carotene is maintained in patients (handling up to 2 years) within the normal range. In order to assure adequate nutrition, it could be the use of a multivitamin, which should take at least two hours after administration of REDUSTAT ®.
REDUSTAT ® should be used with caution in patients with diets high in fat because it can increase gastrointestinal events.
Weight loss induced by REDUSTAT ® is accompanied by improved metabolic control in type 2 diabetes, which may allow or require reduction in dosage of oral hypoglycemic medication (eg sulfonylureas). The plasma levels of cyclosporine may decrease when administered concomitantly with orlistat. Coagulation parameters should be monitored in patients receiving concomitant oral anticoagulants.
RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION: Not established security REDUSTAT ® use during pregnancy.
Therefore not be administered during pregnancy. Orlistat is in category B pregnancy risk. It is not known whether orlistat passes into breast milk, which is not recommended during lactation.
DOSAGE AND ADMINISTRATION: Oral
The recommended dose of orlistat for the treatment of obesity in adults and adolescents over18 years of age is one capsule of 60 mg orally 3 times daily with meals. The same dose isused in adults and adolescents (over 18 years of age). We recommend taking the dose during meals or up to 1hr after maximum. Nutritional intake during treatment with orlistat should be approximately 30% of calories from fat in food. Doses greater than 60 mg three times dailyhave shown no additional benefit. You do not need dose adjustment in elderly patients with renal or hepatic function.
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