nistration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Disulfiram
4.3 Alcohol and Products Containing Propylene Glycol
5 WARNINGS AND PRECAUTIONS
5.1 Potential for Genotoxicity and Carcinogenicity
5.2 Embryo-Fetal Toxicity
5.3 Hypersensitivity Skin Reactions
5.4 Central and Peripheral Nervous System Effects
5.5 Hematological Manifestations of Bone Marrow Depression
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
7.1 Disulfiram
7.2 Alcohol and Products Containing Propylene Glycol
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi.
This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
•Benznidazole Tablets (12.5 mg and 100 mg) are for oral use and may be taken with or without food [see Clinical Pharmacology (12.3)].
•Benznidazole Tablets are dosed by body weight (kg) [see Dosage and Administration (2.2)].
•Benznidazole Tablets 100 mg are functionally scored tablets which can be split into one-half (50 mg) or one-quarter (25 mg) at the scored lines to provide doses less than 100 mg [see INSTRUCTIONS FOR USE].
•Benznidazole Tablets 12.5 mg and 100 mg can be made into slurry as an alternative method of administration [see Dosage and Administration (2.4)].
2.2 Recommended Dosage in Pediatric Patients (2 to 12 Years of Age)
The total daily dose for pediatric patients 2 to 12 years of age is 5 mg/kg to 8 mg/kg orally administered in two divided doses separated by approximately 12 hours, for a duration of 60 days (see TABLE 1).
Table 1: Recommended Dosage of Benznidazole Tablets in Pediatric Patients (2 to 12 Years of Age)
Body Weight Range (kg)
Dose (mg)
Number of Benznidazole Tablets
12.5 mg
Number of Benznidazole Tablets
100mg
Duration and Frequency of Therapy
Less than 15 kg
50 mg
4 tablets
½ tablet
Administered twice daily approximately 12 hours apart for 60 days.
15 kg to less than 20 kg
62.5 mg
5 tablets
20 kg to less than 30 kg
75 mg
6 tablets
¾ tablet
30 kg to less than 40 kg
100 mg
1 tablet
40 kg to less than 60 kg
150 mg
1 ½ tab |
