Benznidazole Generic Name & Formulations
Legal Class
Rx
General Description
Benznidazole 12.5mg, 100mg+; tabs; +scored.
Pharmacological Class
Nitroimidazole.
How Supplied
Tabs—100
Manufacturer
Benznidazole Indications
Indications
Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi.
Benznidazole Dosage and Administration
Adult
Not applicable.
Children
<2yrs: not established. 2–12yrs: 5–8mg/kg given daily in 2 divided doses (approx. 12hrs apart) for 60 days. Tabs can be made into slurry as an alternative administration method. See full labeling.
Benznidazole Contraindications
Contraindications
Within 2 weeks of disulfiram use. Cockayne syndrome.
Benznidazole Boxed Warnings
Not Applicable
Benznidazole Warnings/Precautions
Warnings/Precautions
Discontinue at first sign of serious cutaneous reactions (eg, AGEP, TEN, erythema multiforme, eosinophilic drug reaction), skin reactions presenting additional signs of systemic involvement (eg, lymphadenopathy, fever, purpura), or if neurological symptoms occur. Hematological manifestations of bone marrow depression: treat under strict medical supervision. Monitor CBC, total and differential leukocyte counts before, during and after therapy. Hepatic or renal impairment. Potential for genotoxicity. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for 5 days after the last dose. Nursing mothers: not recommended.
Benznidazole Pharmacokinetics
See Literature
Benznidazole Interactions
Interactions
See Contraindications. Psychotic reactions may occur when concomitant disulfiram.
Benznidazole Adverse Reactions
Adverse Reactions
Abdominal pain, rash, decreased weight, headache, nausea, vomiting, neutropenia, urticaria, pruritus, eosinophilia, decreased appetite; hypersensitivity skin reactions, paresthesia, peripheral neuropathy, infertility (in males).
Benznidazole Clinical Trials
See Literature
Benznidazole Note
Not Applicable
Benznidazole Patient Counseling
See Literature