RISPERDAL ® has not been evaluated or used to any appreciable extent n patients with a recent history of myocardial nfarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product' s premarket testing. Increased plasma concentrations of risperidone and 9-hydroxyrisperidone occur n patients with severe renal mpairment ( creatinine clearance < 30 mL/ min/ 1.73 m 2 ) , and an increase in the free fraction of risperidone is seen in patients with severe hepatic impairment. A lower starting dose should be used in such patients ( see DOSAGE AND ADMINISTRATION) . Information for Patients Physicians are advised to discuss the following issues with patients for whom they prescribe RISPERDAL ® : Orthostatic Hypotension Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration. Interference With Cognitive and Motor Performance Since RISPERDAL ® has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that RISPERDAL ® therapy does not affect them adversely. Pregnancy Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Nursing Patients should be advised not to breast-feed an infant if they are taking RISPERDAL ® . Concomitant Medication Patients should be advised to nform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions. Alcohol Patients should be advised to avoid alcohol while taking RISPERDAL ® . Phenylketonurics Phenylalanine is a component of aspartame. Each 2 mg RISPERDAL ® M-TAB Orally Disintegrating Tablet contains 0.56 mg phenylalanine; each 1 mg RISPERDAL ® M-TAB Orally Disintegrating Tablet contains 0. 28 mg phenylalanine; and each 0.5 mg RISPERDAL ® M-TAB Orally Disintegrating Tablet contains 0.14 mg phenylalanine. Laboratory Tests No specific laboratory tests are recommended. | ||||
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