Physicians are advised to discuss the following issues with patients for whom they prescribe RISPERDAL/RISPERDAL CONSTA and their caregivers.
Orthostatic Hypotension: Patients and caregivers should be advised about the risk of orthostatic hypotension, especially during the period of initial dose titration, and instructed in nonpharmacologic interventions that help to reduce the occurrence of orthostatic hypotension (e.g., sitting on the edge of the bed for several minutes before attempting to stand in the morning and slowly rising from a seated position) [see Precautions].
Interference with Cognitive and Motor Performance: Because RISPERDAL/RISPERDAL CONSTA has the potential to impair judgment, thinking, or motor skills, patients and caregivers should be cautioned about operating hazardous machinery, including automobiles, until patients are reasonably certain that treatment with RISPERDAL/RISPERDAL CONSTA does not affect them adversely [see Precautions].
Concomitant Medication: Patients and caregivers should be advised to inform their physicians if patients are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Interactions].
Alcohol: Patients should be advised to avoid alcohol during treatment with RISPERDAL/RISPERDAL CONSTA [see Interactions].
Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with RISPERDAL/RISPERDAL CONSTA. Advise patients that RISPERDAL/RISPERDAL CONSTA may cause extrapyramidal and/or withdrawal symptoms in a neonate.
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to RISPERDAL during pregnancy [see Use in Pregnancy & Lactation].
Lactation: Advise breastfeeding women using RISPERDAL/RISPERDAL CONSTA to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Pregnancy & Lactation].
Infertility: Advise females of reproductive potential that RISPERDAL/RISPERDAL CONSTA may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Pregnancy & Lactation].
Risperdal: Metabolic Changes: Inform patients and caregivers that treatment with RISPERDAL can be associated with hyperglycemia and diabetes mellitus, dyslipidemia, and weight gain [see Precautions].
Tardive Dyskinesia: Inform patients and caregivers about the risk of tardive dyskinesia [see Precautions].