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Potential for Cognitive and Motor Impairment
Somnolence was a commonly reported adverse event associated with RISPERDAL ® treatment, especially when ascertained by direct questioning of patients. This adverse event s dose-related, and in a study utilizing a checklist to detect adverse events, 41% of the high-dose patients ( RISPERDAL ® 16 mg/ day) reported somnolence compared to 16% of placebo patients. Direct questioning is more sensitive for detecting adverse events than spontaneous reporting, by which 8% of RISPERDAL ® 16 mg/ day patients and 1% of placebo patients reported somnolence as an adverse event. Since RISPERDAL ® has the potential to mpair 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. Priapism Rare cases of priapism have been reported. While the relationship of the events to RISPERDAL ® use has not been established, other drugs with alpha-adrenergic blocking effects have been reported to nduce priapism, and it is possible that RISPERDAL ® may share this capacity. Severe priapism may require surgical intervention. Text Continues Below
Thrombotic Thrombocytopenic Purpura ( TTP) A single case of TTP was reported in a 28 year-old female patient receiving RISPERDAL ® in a large, open premarketing experience ( approximately 1300 patients) . She experienced jaundice, fever, and bruising, but eventually recovered after receiving plasmapheresis. The relationship to RISPERDAL ® therapy is unknown. Antiemetic Effect Risperidone has an antiemetic effect in animals; this effect may also occur n humans, and may mask signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye' s syndrome, and brain tumor. Body Temperature Regulation Disruption of body temperature regulation has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral RISPERDAL ® use. Caution is advised when prescribing for patients who will be exposed to temperature extremes. Suicide The possibility of a suicide attempt s inherent n schizophrenia, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for RISPERDAL ® should be written for the smallest quantity of tablets, consistent with good patient management, in order to reduce the risk of overdose. Use in Patients With Concomitant Illness Clinical experience with RISPERDAL ® in patients with certain concomitant systemic illnesses is limited. Caution is advisable in using RISPERDAL ® in patients with diseases or conditions that could affect metabolism or hemodynamic responses. 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. Page: << Prev | 1 | 2 | 3 | 4 | 5
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