• Chagas disease.

Contraindicated in:

• Hypersensitivity to benznidazole or other nitroimidazole derivatives (cross-sensitivity may occur)
• Current or previous use (in past 2 wk) of disulfiram
• Concurrent use of products containing alcohol or propylene glycol
• Cockayne syndrome (↑ risk of hepatotoxicity and death)
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Rep: Women of reproductive potential
• Pedi: Children <2 yr and >12 yr (safety and effectiveness not established).

Derm: rash, ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS, ERYTHEMA MULTIFORME, TOXIC EPIDERMAL NECROLYSIS, urticaria.

GI: abdominal pain, ↓ appetite, ↑ liver enzymes, diarrhea, nausea, vomiting.

GU: ↓ fertility (males).

Hemat: anemia, eosinophilia, leukopenia, neutropenia, thrombocytopenia.

Metab: ↓ weight.

MS: arthralgia.

Neuro: dizziness, headache, peripheral neuropathy, tremor.

Drug-Drug:

• Concurrent use with disulfiram may result in psychotic reactions; concurrent use and use of disulfiram in past 2 wk contraindicated.
• Disulfiram-like reaction may occur with ingestion of products containing alcohol or propylene glycol; use during and ≥3 days after therapy contraindicated.

(Generic available)

• Tablets: 12.5 mg; 100 mg;

• PO (Children 2–12 yr and ≥60 kg): 200 mg every 12 hr for 60 days.
• PO (Children 2–12 yr and 40–59 kg): 150 mg every 12 hr for 60 days.
• PO (Children 2–12 yr and 30–39 kg): 100 mg every 12 hr for 60 days.
• PO (Children 2–12 yr and 20–29 kg): 75 mg every 12 hr for 60 days.
• PO (Children 2–12 yr and 15–19 kg): 62.5 mg every 12 hr for 60 days.
• PO (Children 2–12 yr and <15 kg): 50 mg every 12 hr for 60 days.

• Disrupts DNA, RNA, and protein synthesis in susceptible organisms.

• Resolution of infection.

Spectrum:

• Active against Trypanosoma cruzi.

Therapeutic Classification: antiprotozoals

Pharmacologic Classification: imidazoles

Absorption: Rapidly and completely absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Metabolic pathway unknown; excreted in urine and feces.

Half-life: 13 hr.

(plasma levels)

• Instruct patient and parents to take benznidazole as directed for 60 days.
• Caution patient to avoid intake of alcoholic beverages or preparations containing alcohol during and for at least 3 days after treatment with benznidazole. May cause a disulfiram-like reaction (flushing, nausea, vomiting, headache, abdominal cramps).
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for at least 5 days after last dose and to avoid breast feeding during therapy. Inform male patients that benznidazole may impair fertility.

benz-NID-a-zole

NDC Code^*

• 0642- Exeltis USA, Inc.
  • 0642-7463- Benznidazole
    • 0642-7463-12- 1 BOTTLE in 1 CARTON (0642-7463-12) > 100 TABLET in 1 BOTTLE

• 0642- Exeltis USA, Inc.
  • 0642-7464- Benznidazole
    • 0642-7464-10- 1 BOTTLE in 1 CARTON (0642-7464-10) > 100 TABLET in 1 BOTTLE