NUPLAZID CAPSULES Dosage & Rx Info

Nuplazid Capsules Generic Name & Formulations

Legal Class

General Description

Pimavanserin 34mg.

Pharmacological Class

Atypical antipsychotic.

How Supplied

Tabs, caps—30

Manufacturer

Acadia Pharmaceuticals

Generic Availability

Mechanism of Action

The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis is unclear. However, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors.

Nuplazid Capsules Indications

Indications

Treatment of hallucinations and delusions associated with Parkinson's disease (PD) psychosis.

Nuplazid Capsules Dosage and Administration

Adult

Caps: may be swallowed whole or opened and entire contents sprinkled over a tablespoon (15mL) of applesauce, yogurt, pudding, or a liquid nutritional supplement; consume mixture immediately without chewing. 34mg once daily without titration. Concomitant strong CYP3A4 inhibitors: 10mg once daily. Concomitant strong or moderate CYP3A4 inducers: avoid.

Children

Not established.

Nuplazid Capsules Contraindications

Not Applicable

Nuplazid Capsules Boxed Warnings

Boxed Warning

Increased mortality in elderly patients with dementia-related psychosis.

Nuplazid Capsules Warnings/Precautions

Warnings/Precautions

Elderly with dementia-related psychosis: increased risk of death. Not for treating patients with dementia who experience psychosis, unless their hallucinations/delusions are related to PD. Avoid in patients with known or congenital QT prolongation, history of cardiac arrhythmias, symptomatic bradycardia, hypokalemia, or hypomagnesemia. Severe renal impairment (CrCl <30mL/min), ESRD. Pregnancy. Nursing mothers.

Nuplazid Capsules Pharmacokinetics

Distribution

Mean apparent volume of distribution: 2173 L. Plasma protein bound: ~95%.

Metabolism

Hepatic (CYP3A4, CYP3A5, CYP2J2, CYP2D6, others).

Elimination

Fecal, renal.

Nuplazid Capsules Interactions

Interactions

Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, clarithromycin, indinavir); see Adults. Antagonized by strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John's wort) or moderate CYP3A4 inducers (eg, modafinil, thioridazine, efavirenz, nafcillin); see Adults. Avoid concomitant drugs known to prolong QT interval including Class 1A (eg, quinidine, procainamide, disopyramide) or Class 3 antiarrhythmics (eg, amiodarone, sotalol), certain antipsychotics (eg, ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (eg, gatifloxacin, moxifloxacin).

Nuplazid Capsules Adverse Reactions

Adverse Reactions

Peripheral edema, confusional state, nausea, hallucination, constipation, gait disturbance.

Nuplazid Capsules Clinical Trials

See Literature

Nuplazid Capsules Note