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Risperdal

Generic Name: Risperidone
Drug Category: Atypical Antipsychotic
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 5 years old for a maximum duration of 2 years.

Approved Uses

Indicated for:

Schizophrenia: (adults and adolescents ages 13 to 17 years)

Bipolar Mania:

• Monotherapy (adults, children, and adolescents ages 10 to 17 years): For the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

• Adjunctive therapy (adults): Adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Irritability Associated with Autistic Disorder: (children and adolescents ages 5 to 17 years)

• Treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

Safety and effectiveness of RISPERDAL in children less than 13 years of age with schizophrenia have not been established.

Safety and effectiveness of RISPERDAL in children less than 10 years of age with bipolar I disorder have not been established.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL is not approved for the treatment of patients with dementia-related psychosis.

The safety of doses above 16 mg per day for adults and 6 mg per day for adolescents (13 to 17 years) with schizophrenia has not been evaluated in clinical trials. 

The safety of doses above 6 mg per day for adults and 6 mg per day for adolescents (10 to 17 years) with bipolar I disorder has not been evaluated in clinical trials. 

Somnolence, postural hypotension, motor and sensory instability have been reported with the use of antipsychotics, including RISPERDAL, which may lead to falls and, consequently, fractures or other fall-related injuries. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Antipsychotic drugs including RISPERDAL can cause a potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS). Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome.

Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain.

Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics including RISPERDAL.

RISPERDAL is associated with higher levels of prolactin elevation than other antipsychotic agents.

Events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents, including RISPERDAL.

RISPERDAL should be used cautiously in patients with a history of seizures.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer’s dementia.

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.

Priapism has been reported during postmarketing surveillance. Severe priapism may require surgical intervention.

When RISPERDAL is co-administered with enzyme inducers (e.g., carbamazepine), the dose of RISPERDAL should be increased up to double the patient’s usual dose. Similar effect may be expected with co-administration of RISPERDAL with other enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital).

When fluoxetine or paroxetine is co-administered with RISPERDAL, the dose of RISPERDAL should be reduced. The RISPERDAL dose should not exceed 8 mg per day in adults when co-administered with these drugs.

Based on the pharmacologic action of risperidone (D2 receptor antagonism), treatment with RISPERDAL may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential.

Neonates exposed to antipsychotic drugs (including RISPERDAL) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Adequate and well controlled studies with RISPERDAL have not been conducted in pregnant women. Animal studies: death, decreased bone length and density, decreased weight and impaired learning and memory performance.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in neonates following in utero exposure to antipsychotics in the third trimester. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Because of the potential for serious adverse reactions in nursing infants from risperidone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

There are reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to risperidone.

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Off-label Uses

•  Use in children under the age of 13 for schizophrenia, use in children under the age of 10 for bipolar disorder and use in children under the age of 5 for irritability associated with autistic disorder. GoToSource

• Dosage greater than 16 mg per day for adults and 6 mg per day for adolescents (10 to 17 years) for  schizophrenia without renal or hepatic impairment. GoToSource

• Dementia. GoToSource

• Attention-deficit hyperactivity disorder, anxiety, dementia, depression, eating disorders, insomnia, obsessive-compulsive disorder, personality disorder, post-traumatic stress disorder, substance use and dependence disorders and tourette’s syndrome. GoToSource

Adverse Events

Exacerbation of working memory impairments. GoToSource

Sedation, sexual dysfunction, postural hypotension (drop in blood pressure due to change in body position), cardiac arrhythmia and sudden cardiac death. GoToSource

Pathological gambling, hypersexuality and compulsive eating and shopping. GoToSource

Tardive dyskinesia (involuntary movements). GoToSource

Severe arterial hypertension resulting in posterior reversible cerebral edema syndrome. GoToSource 

Acute eosinophilic pneumonia (eosinophil, a type of white blood cell, accumulates in the lung). GoToSource

A 3-fold increased risk for type 2 diabetes. GoToSource

Weight gain. GoToSource

Priapism (persistent erection). GoToSource

Deep vein thrombosis (blood clot forms in one or more of the deep veins in body) and pulmonary embolism (blockage in one of the pulmonary arteries in lungs). GoToSource

Iron depletion and deficiency. GoToSource

Activation of mania. GoToSource

Restless legs syndrome. GoToSource

Rabbit syndrome (rhythmic motion of the mouth and lips). GoToSource

Use in patients with dementia increases risk of cerebrovascular adverse events such as stroke and transient ischemic attacks, including fatalities. GoToSource

Increased levels of prolactin causing gynecomastia (enlargement of male breast tissue) and galactorrhea (milky nipple discharge). GoToSource

Neuroleptic malignant syndrome (life-threatening neurological disorder). GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Pituitary tumors. GoToSource

Leukopenia (decreased number of white blood cells). GoToSource

Neutropenia (low level of neutrophils a type of white blood cell). GoToSource

Agranulocytosis (lowered white blood cell count). GoToSource

Seizures. GoToSource

Dysphagia (difficulty swallowing). GoToSource

Litigation

Lawsuits filed for gynecomastia, diabetes, bone loss, sexual dysfunction, pituitary tumors, tardive dyskinesia, neuroleptic malignant syndrome, heart attacks, pancreatitis and death.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024