See Supplemental Patient Information
- Unapproved for use in patients with dementia-related psychosis [US Black Box Warning]
- Geriatrics are more prone to fatal death on treatment with antipsychotic drugs for dementia-related psychosis, most deaths are associated with either cardiovascular disease or infectious disease [US Black Box Warning]
- May increase mortality on treatment with conventional or atypical antipsychotics [US Black Box Warning]
- Risperidone naive patients should start PO form prior to initiating treatment with IM risperidone
- Fatal cerebrovascular adverse events including stroke have occurred in patients treated with the drug
- Fatal neuroleptic malignant syndrome (NMS) have occurred in association with antipsychotic drugs
- Carefully diagnose patients for serious medical illness (e.g. pneumonia, systemic infection, etc.), untreated or inadequately treated extrapyramidal signs and symptoms, central anticholinergic toxicity, heart stroke, drug fever, and primary central nervous system pathology
- Immediately discontinue antipsychotic drugs and other drugs not essential for concomitant therapy, provide intensive symptomatic treatment, carefully monitor patients and provide treatment for concomitant serious medical problems for management of NMS
- Carefully consider potential reintroduction of drug therapy in patients recovered from NMS requiring antipsychotic drug
- Geriatric women are more prone to irreversible, involuntary, dyskinetic movements, risk increases with prolong duration of treatment and with increase in total cumulative dose of antipsychotic drugs
- On discontinuance tardive dyskinesia may remit, partially or completely, drug partially suppress the signs and symptoms of tardive dyskinesia
- Reserve chronic antipsychotic treatment for patients suffering from chronic illness, use lowest dose for shortest duration in patients requiring chronic treatment, periodically reassessed need for continued treatment
- Discontinue the treatment on occurrence of signs and symptoms of tardive dyskinesia, with some exceptions
- Fatal death, extreme hyperglycemia, diabetes mellitus, ketoacidosis or hyperosmolar coma have occurred
- Periodically monitor diabetes mellitus patients on atypical antipsychotics for worsening of glucose control
- Perform fasting blood glucose test during initiation of the treatment and periodically during treatment in patients with risk factors for diabetes mellitus
- Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness
- Perform fasting blood glucose test in patients developing symptoms of hyperglycemia
- Resolution of hyperglycemia may or may not occur after discontinuing of treatment
- Elevates prolactin levels, results in reduced pituitary gonadotropin secretion and inhibits reproductive function by impairing gonadal steroidogenesis in both female and male patients, galactorrhea, amenorrhea, gynecomastia, impotence and Decreased bone density in both female and male patients have occurred
- Decreased bone density associated with hypogonadism in both female and male patients have occurred
- Orthostatic hypotension associated with dizziness, tachycardia and syncope have occurred
- Concomitant use of risperidone and other antihypertensive medication induces significant hypotension, monitor orthostatic vital signs and consider reduction in doses on occurrence of hypotension
- Agranulocytosis, leukopenia/neutropenia have occurred, patients with pre-existing low white blood cell count (WBC) and a history of drug-induced leukopenia/neutropenia are more prone, monitor CBC during first few months of therapy in patients with a history of a clinically significant low WBC or a drug-induced leukopenia/neutropenia
- Discontinue therapy on first sign of a clinically significant decline in WBC
- Carefully monitor neutropenic patients for fever or other symptoms or signs of infection and provide appropriate treatment, discontinue therapy in patients with severe neutropenia, monitor WBC until recovery
- Esophageal dysmotility, aspiration, thrombotic thrombocytopenic purpura (TTP), hyperthermia, hypothermia and seizures have occurred
- Inject into the deltoid or gluteal muscle, and take utmost care to avoid inadvertent injection into a blood vessel
- Masking of signs and symptoms of overdosage or of conditions such as intestinal obstruction, Reye’s syndrome, and brain tumor have occurred
- Supervision high-risk patients for attempting suicide
- Increased sensitivity to antipsychotic medications have occurred
- Plasma concentrations of risperidone and free fraction of risperidone have increased in patients with severe renal impairment and severe hepatic impairment respectively
- Titrate dose with oral risperidone before initiation of treatment of product in patients with renal or hepatic impairment
- Increase in a marker of cellular proliferation in renal tissue and renal tumor have occurred
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Cardiovascular disease
- diabetes mellitus
- History of diabetes mellitus
- History of myocardial infarction or ischemia
- Heart failure
- Hypotension
- Conduction abnormalities
- Cerebrovascular disease
- Dehydration
- Hypovolemia
- Dementia
- Parkinson's disease
- History of neuroleptic malignant syndrome
- History of seizures
- Aspiration pneumonia
- Impairment of body temperature regulation
- PKU
- Disease affecting metabolism
- Disease affecting hemodynamic responses
- History of drug-induced leukopenia or neutropenia
- Leukopenia
- Suicide risk
- Pediatrics
- Adolescent
- Geriatrics
- Concomitant CYP3A4 inducers: carbamazepine, phenytoin, rifampin, phenoparbital
- Concomitant CYP2D6 inhibitors: fluoxetine, paroxetine
Supplemental Patient Information
- Instruct patients to slowly arise from seating position
- Instruct patients to operate hazardous machinery, automobiles and engage in activities requiring mental alertness carefully
Pregnancy Category:C
Breastfeeding: Risperidone is excreted in breastmilk in low levels. Limited information indicates that maternal doses of up to 6 mg/day produce low levels in milk. Due to insufficient long term follow up data, other agents might be preferred. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 22 November 2010). Manufacturer advises that nursing women receiving therapy with risperidone should not breastfeed for at least 12 weeks after the last injection.
