Usual Pediatric Dose for Trypanosomiasis

2 to 12 years: 5 to 8 mg/kg/day orally in 2 divided doses

As calculated for tablets:

• Weight less than 15 kg: 50 mg orally twice a day
• Weight 15 to less than 20 kg: 62.5 mg orally twice a day
• Weight 20 to less than 30 kg: 75 mg orally twice a day
• Weight 30 to less than 40 kg: 100 mg orally twice a day
• Weight 40 to less than 60 kg: 150 mg orally twice a day
• Weight 60 kg or more: 200 mg orally twice a day

Duration of therapy: 60 days

Comments:

• Doses should be separated by about 12 hours.
• Per US CDC: Antiparasitic therapy is recommended for all cases of acute/reactivated Chagas disease and for chronic Trypanosoma cruzi infection in children up to 18 years; congenital infections are considered acute disease.
• Current guidelines should be consulted for additional information.

Use: For the treatment of Chagas disease (American trypanosomiasis) due to T cruzi

• Approved under accelerated approval based on number of treated patients who became immunoglobulin G (IgG) antibody negative against recombinant antigens of T cruzi; continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Renal Dose Adjustments

Data not available

Comments:

• According to some experts, this drug is contraindicated in patients with severe renal dysfunction.

Liver Dose Adjustments

Data not available

Comments:

• According to some experts, this drug is contraindicated in patients with severe liver dysfunction.

Precautions

CONTRAINDICATIONS:

• History of hypersensitivity reaction to the active component or other nitroimidazole derivatives
• Use of disulfiram within the last 2 weeks
• Cockayne syndrome

Safety and efficacy have not been established in patients younger than 2 years or older than 12 years.

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Before starting this drug, obtain a pregnancy test in patients of childbearing potential.
• May administer without regard to food
• Can make the tablets into slurry as an alternative method of administration; after preparation, drink the contents of the cup at once. If less than 30 kg, rinse the cup with an additional 10 mL of water and drink the entire amount; if 30 kg or more, rinse the cup by adding 80 mL of water, drink the entire amount, repeat rinse with 80 mL of water, and drink again.

Storage requirements:

• Store at controlled room temperature 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Keep bottle tightly closed and protect from moisture.

Reconstitution/preparation techniques:

• The tablets may be made into a slurry; the manufacturer product information should be consulted regarding tablet strength, tablet quantity, and specified volume of water.

(a) Place the prescribed dose into a cup.
(b) Add the specified volume of water.
(c) Allow the tablets to disintegrate in the cup over about 1 to 2 minutes.
(d) Shake the contents of the cup gently to mix.

General:

• The 100-mg tablets can be split into 1/2 (50 mg) or 1/4 (25 mg) at the scored lines to provided doses less than 100 mg.
• Per US CDC:
• Use of this drug to treat a patient outside of the US FDA-approved age range (2 to 12 years) is based on clinical diagnosis and decision by treating physician under practice of medicine.
• Up to 50 years of age with chronic T cruzi infection without advanced Chagas cardiomyopathy: Treatment is strongly recommended.
• Older than 50 years with chronic T cruzi infection: Decision to treat with antiparasitic drugs should be individualized, weighing benefits/risks for each patient; factors such as patient age, clinical status, preference, and overall health should be considered.
• Current guidelines should be consulted for additional information.

Monitoring:

• Hematologic: CBC; total and differential leukocyte counts (before, during, and after therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Instructions for Use).