praziquantel

FDA Drug Profile — Biltricide

Drug Details

Generic Name
praziquantel
Brand Names
Biltricide
Application Number
NDA018714
Sponsor
Bayer HealthCare Pharmaceuticals Inc.
NDC Codes
2
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
PRAZIQUANTEL

Indications and Usage

1 INDICATIONS AND USAGE Praziquantel tablets are indicated in patients aged 1 year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated) Praziquantel tablets are an anthelmintic indicated in patients aged one year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma (for example , Schistosoma mekongi , Schistosoma japonicum , Schistosoma mansoni and Schistosoma hematobium ), and, Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis and Opisthorchis viverrini