hepatitis
Skeletal Muscle
•Myalgia
•usculoskeletal pain
•Migratory arthritis
General/Constitutional Symptoms
•Fever
•Asthenia
•Fatigue
Lymphatic
•Generalized edema
•Eyelid edema
•Edema in the extremities
•Lymphadenopathy
Bone Marrow
•Thrombocytopenia
•Granulocytopenia
•Agranulocytosis
Metabolism/Laboratory
•Elevation of alkaline phosphatase
•Elevation of bilirubin
CLOSE
7 DRUG INTERACTIONS
7.1 Disulfiram
Psychotic reactions have been reported in patients who are concurrently taking disulfiram and nitroimidazole agents (structurally related to benznidazole, but not with benznidazole). Benznidazole Tablets should not be given to patients who have taken disulfiram within the last two weeks [see Contraindications (4.2)].
7.2 Alcohol and Products Containing Propylene Glycol
Abdominal cramps, nausea, vomiting, headaches, and flushing may occur if alcoholic beverages or products containing propylene glycol are consumed during or following therapy with nitroimidazole agents which are structurally related to benznidazole. Although no similar reactions have been reported with benznidazole, discontinue alcoholic beverage or products containing propylene glycol during and for at least 3 days after therapy with Benznidazole Tablets [see Contraindications (4.3)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from animal studies, Benznidazole Tablets may cause fetal harm when administered to a pregnant woman. Published postmarketing reports on benznidazole use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. There are risks to the fetus associated with Chagas Disease (see CLINICAL CONSIDERATIONS). In animal reproduction studies, benznidazole administered orally to pregnant rats and rabbits during organogenesis was associated with fetal malformations at doses approximately 1-3 times the MRHD in rats (anasarca, anophthalmia, and/or microphthalmia) and doses approximately 0.3-1.0 times the MRHD in rabbits (ventricular septal defect) (see DATA). Advise pregnant women of the potential risk to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations
Disease-associated Maternal and/or Embryo/Fetal Risk
Published data from case-control and observational studies on chronic Chagas disease during pregnancy are inconsistent in their findings. Some studies showed an increased risk of pregnancy loss, prematurity and neonatal mortality in pregnant women who have chronic Chagas disease while other studies did not demonstrate these findings. Chronic Chagas disease is usually not life-threatening. Since pregnancy findings are inconsistent, treatment of chronic Chagas disease during pregnancy is not recommended due to risk of embryo-fetal toxicity from Benznidazole Tablets.
Acute symptomatic Chagas disease is rare in pregnant women; however, symptoms may be serious or life-threatening.&nbs |
