Usual Pediatric Dose for Trypanosomiasis

BIRTH (TERM NEONATE) TO LESS THAN 18 YEARS:
Total Daily Dosage Based on Body Weight:

• Weight 2.5 to less than 40 kg: 10 to 20 mg/kg/day orally in divided doses 3 times a day
• Weight at least 40 kg: 8 to 10 mg/kg/day orally in divided doses 3 times a day

• Weight 2.5 to 4.5 kg: 15 mg orally 3 times a day
• Weight 4.6 to less than 9 kg: 30 mg orally 3 times a day
• Weight 9 to less than 13 kg: 45 mg orally 3 times a day
• Weight 13 to less than 18 kg: 60 mg orally 3 times a day
• Weight 18 to less than 22 kg: 75 mg orally 3 times a day
• Weight 22 to less than 27 kg: 90 mg orally 3 times a day
• Weight 27 to less than 35 kg: 120 mg orally 3 times a day
• Weight 35 to less than 41 kg: 180 mg orally 3 times a day
• Weight 41 to less than 51 kg: 120 mg orally 3 times a day
• Weight 51 to less than 71 kg: 180 mg orally 3 times a day
• Weight 71 to less than 91 kg: 240 mg orally 3 times a day
• Weight at least 91 kg: 300 mg orally 3 times a day

• During therapy, patients can lose their appetite or have nausea/vomiting which can lead to weight loss; body weight should be checked every 14 days and dose should be adjusted accordingly.

Renal Dose Adjustments

Data not available

Comments:

• This drug should be administered under close medical supervision.

Liver Dose Adjustments

Data not available

Comments:

• This drug should be administered under close medical supervision.

Precautions

CONTRAINDICATIONS:
Known hypersensitivity to the active component or any of the ingredients; consumption of alcohol during therapy

Safety and efficacy have not been established in pediatric patients weighing less than 2.5 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• This drug should be administered under close medical supervision.

Other Comments

Administration advice:

• Obtain a pregnancy test in patients of childbearing potential before starting this drug.
• Administer with food; complete full course of therapy to prevent recurrence of infection.
• Dose according to body weight of the patient; adjust dose accordingly if body weight decreases during therapy.
• The functionally scored tablets can be split into one-half at the scored lines by hand; do not break the tablets mechanically with a tablet splitting device.
• To split: Place the tablet on a flat surface with score line facing up; with tablet resting on the flat surface, apply sufficient downward pressure with index finger centered on top of the tablet to break it along the score line.
• The tablets can be made into a slurry (i.e., disperse tablets in water) as an alternative method of administration for patients unable to swallow whole or half tablets; after preparation, administer the slurry immediately with food.
• Discontinue consumption of alcohol during therapy.
• Consult the manufacturer product information regarding missed doses.

• Store at controlled room temperature 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Store tablets in original bottle; do not removed desiccant.
• Keep bottle tightly closed; protect from moisture.

• To make a slurry for patients unable to swallow whole or half tablets:
• Place about 2.5 mL of water into a spoon.
• Place the prescribed dose into the water.
• Allow the tablet(s) to disintegrate (usually less than 30 seconds), forming a slurry (liquid suspension).

• This indication was approved under accelerated approval based on the number of treated patients who became immunoglobulin G (IgG) antibody negative or who showed an at least 20% reduction in optical density on 2 different IgG antibody tests against antigens of T cruzi; continued approved may depend on verification and description of clinical benefit in confirmatory trial(s).

• General: For vomiting, rash, decreased appetite, fever, and irritability in infants exposed to this drug through breast milk; body weight (every 14 days during therapy)

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Avoid missing doses and complete the entire course of therapy.
• Patients of childbearing potential: Notify healthcare provider of known/suspected pregnancy; use effective contraception while taking this drug and for 6 months after the last dose.
• Males of reproductive potential with female partners: Use condoms during therapy and for 3 months after the last dose.
• Do not drink alcohol during therapy.
• Check body weight every 14 days as the dose may need to be adjusted.
• If muscle weakness or tremors occur during therapy, do no drive, cycle, or use any tools or machines.