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Benznidazole

    Brands

    DEA Class; Rx

    Common Brand Names; Benznidazole

    • Antiparasitic Agents

    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

    Indicated for the treatment of American trypanosomiasis (Chagas disease).

    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

    • 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%)

    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)

    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

    Adults

    Safety and efficacy have not been established; however, doses up to 7 mg/kg/day PO have been used off-label.

    Geriatric

    Safety and efficacy have not been established; however, doses up to 7 mg/kg/day PO have been used off-label.

    Adolescents

    Safety and efficacy have not been established; however, doses up to 7 mg/kg/day PO have been used off-label.

    Children

    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.

    Infants

    Safety and efficacy have not been established; however, doses up to 7.5 mg/kg/day PO have been used off-label.

    Neonates

    Safety and efficacy have not been established.

    Benznidazole 

    tablet

    • 12.5mg
    • 100mg (functionally scored)