artemether and lumefantrine
Drug Details
- Generic Name
- artemether and lumefantrine
- Brand Names
- COARTEM
- Application Number
- NDA022268
- Sponsor
- Novartis Pharmaceuticals Corporation
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- ARTEMETHER, LUMEFANTRINE
Indications and Usage
1 INDICATIONS AND USAGE Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria. Coartem Tablets are not approved for the prevention of malaria. Coartem Tablets are a combination of artemether and lumefantrine, both antimalarials, indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. ( 1 ) Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported. ( 1 ) Limitations of Use: ( 1 ) Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria . Coartem Tablets are not approved for the prevention of malaria.