Source: FDA, National Drug Code (US) Revision Year: 2020
NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
The recommended dose of NUPLAZID is 34 mg taken orally once daily, without titration.
NUPLAZID can be taken with or without food [see Clinical Pharmacology (12.3)].
NUPLAZID capsules can be taken whole, or opened and the entire contents sprinkled over a tablespoon (15 mL) of applesauce, yogurt, pudding, or a liquid nutritional supplement. Consume the drug/food mixture immediately without chewing; do not store for future use.
Coadministration with Strong CYP3A4 Inhibitors: The recommended dose of NUPLAZID when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole) is 10 mg, taken orally as one tablet once daily [see Drug Interactions (7.1)].
Coadministration with Strong or Moderate CYP3A4 Inducers: void concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID [see Drug Interactions (7.1)].
The pre-marketing clinical trials involving NUPLAZID in approximately 1200 subjects and patients do not provide information regarding symptoms with overdose. In healthy subject studies, dose-limiting nausea and vomiting were observed.
There are no known specific antidotes for NUPLAZID. In managing overdose, cardiovascular monitoring should commence immediately and should include continuous ECG monitoring to detect possible arrhythmias [see Warnings and Precautions (5.2)]. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine should not be used, as they have the potential for QT-prolonging effects that might be additive to those of NUPLAZID [see Drug Interactions (7.1)]. Consider the long plasma half-life of pimavanserin (about 57 hours) and the possibility of multiple drug involvement. Consult a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice.
34 mg Capsule: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. To prevent potential capsule color fading, protect from light.
10 mg Tablet: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
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