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RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed The Time To Relapse In Patients With Bipolar I Disorder

drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL(R) CONSTA(R). Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL(R) CONSTA(R) elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Orthostatic Hypotension: RISPERDAL(R) CONSTA(R) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL(R) CONSTA(R) should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension. Potential for Cognitive and Motor Impairment: RISPERDAL(R) CONSTA(R) has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL(R) CONSTA(R) does not affect them adversely. Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold. Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia. Priapism has been reported. Severe priapism may require surgical intervention. Thrombotic Thrombocytopenic Purpura (TTP) has been reported. Administration: Care should be taken to avoid inadvertent injection into a blood vessel. Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy. Increased sensitivity in patients with Parkinson"s disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS. Use Risperdal Consta with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses. (e.g. Recent Myocardial infarction or unstable cardiac disease) Extrapyramidal Symptoms (EPS): The overall incidence of EPS-related adverse events in patients treated with 25 mg and 50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%). -- Akathisia and restlessness -- Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia Weight Gain: In a 12-week trial, the percentage of patients experiencing weight gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R). Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment. Commonly Observed Adverse Reactions for RISPERDAL(R) CONSTA(R): The most common adverse reactions in clinical trials in patients with schizophrenia (greater than or equal to 5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth. The most common adverse reactions in clinical trials in patients with bipolar disorder trials were weight increase (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy trial). Janssen

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