CAPLYTA Capsule Ref.[10130] Active ingredients:

2.1 Recommended Dosage

The recommended dosage of CAPLYTA is 42 mg administered orally once daily with food. Dose titration is not required.

2.2 Dosage Recommendations for Concomitant Use with CYP3A4 Inducers and Moderate or Strong CYP3A4 Inhibitors

Coadministration with CYP3A4 Inducers

Avoid concomitant use of CAPLYTA with CYP3A4 inducers [see Drug Interactions (7.1)].

Coadministration with Moderate or Strong CYP3A4 Inhibitors

Avoid concomitant use of CAPLYTA with moderate or strong CYP3A4 inhibitors [see Drug Interactions (7.1)].

2.3 Dosage Recommendations for Patients with Hepatic Impairment

Avoid use of CAPLYTA in patients with moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.6)].

No specific antidotes for CAPLYTA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. In case of overdose, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org).

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