Atovaquone and Proguanil Hydrochloride Pediatric
Drug Details
- Generic Name
- Atovaquone and Proguanil Hydrochloride Pediatric
- Brand Names
- Atovaquone and Proguanil Hydrochloride Pediatric
- Application Number
- ANDA091211
- Sponsor
- Glenmark Pharmaceuticals Inc.,USA
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ATOVAQUONE, PROGUANIL HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.