For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Trade name Nuplazid.

About one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease.

An estimated 40 percent of Parkinson’s patients have Parkinson’s disease psychosis, a debilitating condition that is characterized by hallucinations and delusions, is associated with significant caregiver burden, and is a major reason for nursing home placement among patients.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

The drug is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.

An atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Prolongs the QT interval, and should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.

Should be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.

The most common adverse reactions are peripheral edema, nausea, confusional, hallucination, constipation and gait disturbance.

Strong CYP3A4 inhibitors, such as ketoconazole, increase drug concentrations.

Reducing the dose by one-half is recommended.

Strong CYP3A4 inducers may reduce its exposure, and an increased in dosage may be needed.

No dosage adjustment is needed in patients with mild to moderate renal impairment.

Safety and efficacy have not been established in pediatric patients.

Dosage and Administration: Recommended dose: 34 mg per day, taken orally as two 17 mg tablets once daily, without titration.

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