NOURIANZ Film-coated tablet Ref.[10315] Active ingredients:

2.1 Dosing Information

The recommended dosage of NOURIANZ is 20 mg administered orally once daily. The dosage may be increased to a maximum of 40 mg once daily, based on individual need and tolerability. Initial dose titration is not required.

NOURIANZ can be taken with or without food [see Clinical Pharmacology (12.3)].

2.2 Dosage Adjustment with Strong CYP 3A4 Inhibitors

The maximum recommended dosage of NOURIANZ with concomitant use of strong CYP3A4 inhibitors is 20 mg once daily [see Drug Interactions (7.1)].

2.3 Dosing with Strong CYP 3A4 Inducers

Avoid use of NOURIANZ with strong CYP3A4 inducers [see Drug Interactions (7.1)].

2.4 Dosage Adjustment in Patients with Hepatic Impairment

The maximum recommended dosage of NOURIANZ in patients with moderate hepatic impairment (Child-Pugh B) is 20 mg once daily. Closely monitor patients with moderate hepatic impairment for adverse reactions when on NOURIANZ treatment [see Adverse Reactions (6.1)]. Avoid use of NOURIANZ in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7)].

2.5 Dosage Adjustment for Tobacco Smokers

The recommended dosage of NOURIANZ in patients who use tobacco in amounts of 20 or more cigarettes per day (or the equivalent of another tobacco product) is 40 mg once daily [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

10.1 Human Experience

There is limited clinical experience regarding human overdosage with NOURIANZ. In clinical trials, one patient took 6 tablets (120 mg, 3 times the maximum recommended dosage) of istradefylline with alcoholic beverages and developed hallucinations, agitation, and worsening dyskinesia.

10.2 Management of Overdose

There are no known specific antidotes for NOURIANZ nor any specific treatment for istradefylline overdose. If an overdose occurs, NOURIANZ treatment should be discontinued and supportive treatment should be administered as clinically indicated. Consider the long terminal half-life of istradefylline (about 83 hours) and the possibility of multiple drug involvement.

Consult a Certified Poison Control Center for up-to-date guidance and advice.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].