Classes
DEA Class; Rx
Common Brand Names; Lampit
- Antiprotozoal Agents
Description
Antiprotozoal agent
Mechanism of action is not fully understood
May react with the nucleic acids of the parasite and inhibits trypanothione reductase, a parasite-specific antioxidant defense enzyme
Indications
Orphan designation for Chagas Disease (American Trypanosomiasis)
Contraindications
Hypersensitivity to nifurtimox or any of the excipients
Alcohol consumption during treatment
Adverse Effects
- Vomiting (14.6%)
- Abdominal pain (13.2%)
- Headache (12.8%)
- Decreased appetite (10.5%)
- Nausea (8.2%)
- Pyrexia (7.3%)
- Rash (5.5%)
- Diarrhea (4.6%)
- Decreased weight (2.7%)
- Dizziness (2.7%)
- Anemia (2.7%)
- Urticaria (2.3%)
- Eosinophilia (2.3%)
Warnings
Genotoxicity has been demonstrated in humans, in vitro in several bacterial species and mammalian cell systems, and in vivo in rodents; a study in treated children with Chagas disease aged 7 months to 14 years demonstrated a 13-fold increase in chromosomal aberrations
Carcinogenicity has been observed in mice and rats treated chronically with nitrofuran agents which are structurally similar to nifurtimoximilar data have not been reported; association with carcinogenicity is unknown
May cause fetal harm when administered to pregnant females
May worsen conditions in patients with history of brain injury, seizures, psychiatric disease, or serious behavioral alterations; closely monitor these patients and in patients who develop neurological disturbances or psychiatric drug reactions during treatment
Cases of hypersensitivity reported; reaction may be induced by nifurtimox or an immune response triggered by Chagas disease during treatment; at first sign of serious hypersensitivity, discontinue treatment
Decreased appetite and weight loss were reported; patients can lose their appetite or experience nausea/vomiting which can result in weight loss; check body weight every 14 days and adjust dose accordingly
Nitrofuran derivatives may precipitate acute attacks of porphyria; administer tablets under close medical supervision in patients with porphyria
Pregnancy and Lactation
Based on animal studies, may cause fetal harm when administered to pregnant females
Antiprotozoal agent
Mechanism of action is not fully understood
May react with the nucleic acids of the parasite and inhibits trypanothione reductase, a parasite-specific antioxidant defense enzyme
Maximum Dosage
8-10 mg/kg/day PO divided q6-8hr for 90-120 days
How supplied
Nifurtimox
tablet
- 30mg
- 120mg