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Benznidazole Dosage

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Trypanosomiasis

US CDC Recommendations: 5 to 7 mg/kg/day orally in 2 divided doses for 60 days

Comments:
-Up to 50 years with chronic Trypanosoma 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.

Usual Pediatric Dose for Trypanosomiasis

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

As calculated for tablets:
Less than 15 kg: 50 mg orally twice a day
15 to less than 20 kg: 62.5 mg orally twice a day
20 to less than 30 kg: 75 mg orally twice a day
30 to less than 40 kg: 100 mg orally twice a day
40 to less than 60 kg: 150 mg orally twice a day
60 kg or more: 200 mg orally twice a day

Duration of therapy: 60 days

Comments:
-Doses should be separated by about 12 hours.

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.

US CDC Recommendations:
Less than 12 years: 5 to 7.5 mg/kg/day orally in 2 divided doses
12 years or older: 5 to 7 mg/kg/day orally in 2 divided doses
Duration of therapy: 60 days

Comments:
-Antiparasitic therapy is recommended for all cases of acute/reactivated Chagas disease and for chronic T cruzi infection in children up to 18 years; congenital infections are considered acute disease.
-Current guidelines should be consulted for additional information.

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

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 females of reproductive 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.

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).
-Do not consume alcoholic beverages or propylene glycol-containing products during therapy and for at least 72 hours after the last dose.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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