lets
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 Benznidzole Tablets [see Use is Specific Populations (8.3)].
2.4 Preparation of Slurry as an Alternative Method of Administration
1.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.
1.
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.
3 DOSAGE FORMS AND STRENGTHS
Benznidazole Tablets are available as 100 mg and 12.5 mg tablets.
The 100 mg white tablets are round and functionally scored twice as a cross on both sides, debossed with “E” on one side of each quarter portion.
The 12.5 mg white tablets are round and unscored, debossed with “E” on one side.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Benznidazole Tablets are contraindicated in patients with a history of hypersensitivity reaction to benznidazole or other nitroimidazole derivatives. Reactions have include |
