Classes
DEA Class; Rx
Common Brand Names; Benznidazole
- Antiparasitic Agents
Description
Antiprotozoal
Used for the treatment of Chagas disease or American trypanosomiasis, a parasitic infection caused by Trypanosoma cruzi
Only approved for pediatric patients 2 to 12 years, although used off-label in patients of all ages
Indications
Indicated for the treatment of American trypanosomiasis (Chagas disease).
Contraindications
Patients who have taken disulfiram within the last 2 weeks; psychotic reactions may occur
Patients with Cockayne syndrome
History of hypersensitivity reaction to benznidazole or other nitroimidazole derivatives; severe skin and soft tissue reactions reported
Adverse Effects
- Abdominal pain (25%)
- Rash or skin lesions (11-16%)
- Weight decreased (13%)
- Nausea (5%)
- Vomiting (5%)
- Increased AST/ALT (5%)
- Diarrhea (4%)
- Dizziness (4%)
- Peripheral neuropathy (2%)
- Tremor (2%)
Warnings
Genotoxicity of benznidazole has been demonstrated in humans, in vitro in several bacterial species and mammalian cell systems, and in vivo in rodent
Carcinogenicity observed in mice and rats treated chronically with nitroimidazole agents which are structurally similar to benznidazole
Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes reported after initiation of metronidazole, another nitroimidazole drug, structurally related to benznidazole in patients with Cockayne syndrome
Embryofetal toxicity may occur (see Pregnancy)
Pregnancy and Lactation
Based on findings from animal studies, can cause fetal harm when administered to pregnant women
Obtain pregnancy test in females of reproductive potential before initiating treatment
Because of the potential for serious adverse reactions and transmission of Chagas disease, advise patients that breastfeeding is not recommended during treatment
Maximum Dosage
Safety and efficacy have not been established; however, doses up to 7 mg/kg/day PO have been used off-label.
Safety and efficacy have not been established; however, doses up to 7 mg/kg/day PO have been used off-label.
Safety and efficacy have not been established; however, doses up to 7 mg/kg/day PO have been used off-label.
2 to 12 years: 8 mg/kg/day PO (Usual Max: 400 mg/day).
younger than 2 years: Safety and efficacy have not been established; however, doses up to 7.5 mg/kg/day PO have been used off-label.
Safety and efficacy have not been established; however, doses up to 7.5 mg/kg/day PO have been used off-label.
Safety and efficacy have not been established.
How supplied
Benznidazole
tablet
- 12.5mg
- 100mg (functionally scored)
