Risperidone - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis.

Risperidone for Extended-Release Injectable Suspension is not approved for use in patients with dementia-related psychosis Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring Tardive Dyskinesia: Discontinue treatment if clinically appropriate Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk.

These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.

Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness.

Monitor glucose regularly in patients with diabetes or at risk for diabetes.

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.

Weight Gain: Significant weight gain has been reported.

Hyperprolactinemia: Risperidone treatment may elevate prolactin levels.

Long-standing hyperprolactinemia, when associated with hypogonadism, can lead to decreased bone density in men and women.

Orthostatic hypotension: associated with dizziness, tachycardia, bradycardia, and syncope can occur, especially during initial dose titration with oral risperidone.

Use caution in patients with cardiovascular disease, cerebrovascular disease, and conditions that could affect hemodynamic responses.

Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics, including Risperidone for Extended-Release Injectable Suspension.

Patients with history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood cell count (CBC) monitored frequently during the first few months of therapy and discontinuation of Risperidone for Extended-Release Injectable Suspension should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

Potential for cognitive and motor impairment: has potential to impair judgment, thinking, and motor skills.

Use caution when operating machinery, including automobiles.

Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the 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.

Avoid inadvertent administration into a blood vessel.

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.

Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.