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).

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 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:

Table 2: Preparation and Administration of Slurry Using Benznidazole Tablets 12.5 mg for the Pediatric Population with Body Weight of Less than 30 kg
  • Place the prescribed dose of Benznidazole Tablets 12.5 mg into a cup.
  • Add the specified volume of water per number of 12.5 mg tablets as shown below.

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

  • Allow the tablets to disintegrate in the cup over a period of approximately 1-2 minutes.
  • Shake the contents of the cup gently to mix.
  • Drink the contents of the cup (slurry of tablets with water) immediately.
  • Rinse the cup with an additional 10 mL of water and drink the whole amount.

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:

Table 3: Preparation and Administration of Slurry Using Benznidazole Tablets 100 mg for the Pediatric Population with Body Weight 30 kg or greater
  • Place the prescribed dose of Benznidazole Tablets 100 mg tablets into a cup.
  • Add the specified volume of water per number of 100 mg tablets as shown below.

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

  • Allow the tablet(s) to disintegrate in the cup over a period of approximately 1- 2 minutes.
  • Shake the contents of the cup gently to mix.
  • Drink the contents of the cup (slurry of tablet(s) with water) immediately.
  • Rinse the cup by adding 80 mL of water and drink the whole amount. Repeat this rinse with 80 mL of water and drink again.

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