tafenoquine succinate
Drug Details
- Generic Name
- tafenoquine succinate
- Brand Names
- Krintafel
- Application Number
- NDA210795
- Sponsor
- GlaxoSmithKline LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- TAFENOQUINE SUCCINATE
Indications and Usage
1 INDICATIONS AND USAGE KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection [see Dosage and Administration ( 2.2 )] . Limitations of Use • KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. • Concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria [see Warnings and Precautions ( 5.6 )] . KRINTAFEL is an antimalarial indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection. ( 1 ) Limitations of Use • KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. ( 1 ) • The concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria. ( 1 , 5.6 )