Benznidazole (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- BENZNIDAZOLE
Indications and Usage
Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies ( 14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Adverse Reactions
The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Potential for Genotoxicity, Carcinogenicity, and Mutagenicity [see Warnings and Precautions ( 5.1)] Hypersensitivity Skin Reactions [see Warnings and Precautions ( 5.3)] Central and Peripheral Nervous System Effects [see Warnings and Precautions ( 5.4)] Hematological Manifestations of Bone Marrow Depression [see Warnings and Precautions ( 5.5)]
Mechanism of Action
Benznidazole is a nitroimidazole antimicrobial drug [see Microbiology ( 12.4)] .