Benznidazole
BENZNIDAZOLE- benznidazole tablet
Exeltis USA, Inc.
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).
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 tablets | ||
Greater than or equal to 60 kg | 200 mg | 2 tablets |
2.3 Assessment Prior to Initiating Benznidazole Tablets
Obtain a pregnancy test in females of reproductive potential prior to therapy with Benznidazole Tablets [see Use is Specific Populations ( 8.3)] .
2.4 Preparation of Slurry as an Alternative Method of Administration
A. Preparation of Slurry Using Benznidazole Tablets 12.5 mg for the Pediatric Population with Body Weight Less Than 30 kg
Benznidazole Tablets 12.5 mg may be made into slurry in a specified volume of water for the pediatric population with body weight less than 30 kg (see Table 2). The 12.5 mg tablet slurry is prepared by the following method:
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Body Weight Range (kg) | Dose (mg) | Number of Benznidazole Tablets 12.5 mg | Quantity of Water for Preparing the Slurry |
Less than 15 kg | 50 mg | 4 tablets | 40 mL |
15 kg to less than 20 kg | 62.5 mg | 5 tablets | 50 mL |
20 kg to less than 30 kg | 75 mg | 6 tablets | 60 mL |
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B. Preparation of Slurry Using Benznidazole Tablets 100 mg for the Pediatric Population with Body Weight (30 kg or greater)
Benznidazole Tablets 100 mg may be made into a slurry in a specified volume of water for the pediatric population with body weight of 30 kg or greater (see Table 3). The 100 mg tablet slurry is prepared as follows:
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Body Weight Range (kg) | Dose (mg) | Number of Benznidazole Tablets 100 mg | Quantity of Water for Preparing the Slurry |
30 kg to less than 40 kg | 100 mg | 1 tablet | 80 mL |
40 kg to less than 60 kg | 150 mg | 1 ½ tablets | 120 mL |
Greater than or equal to 60 kg | 200 mg | 2 tablets | 160 mL |
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