Benznidazole

What is Benznidazole?

• Benznidazole a nitroimidazole antimicrobial, is indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease.

What are the uses of this medicine?

• Benznidazole is used in pediatric patients 2 to 12 years of age for the treatment of Chagas disease.

How does this medicine work?

• Benznidazole is a nitroimidazole antimicrobial drug.
• Benznidazole inhibits the synthesis of DNA, RNA, and proteins within the T. cruzi parasite.
• Studies suggest that benznidazole is reduced by a Type I nitroreductase (NTR) enzyme of T. cruzi producing a series of short-lived intermediates that may promote damage to several macromolecules including DNA.
• In mammalian cells, however, benznidazole is metabolized by reduction of the nitro group to an amino group by a Type II NTR enzyme. The precise mechanism of action is not known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of hypersensitivity reaction to benznidazole or other nitroimidazole derivatives.
• who have taken disulfiram within the last two weeks. Psychotic reactions may occur in patients who are using benznidazole and disulfiram concurrently.

What drug interactions can this medicine cause?

• Benznidazole Tablets should not be given to patients who have taken disulfiram within the last two weeks.
• Benznidazole Tablets are not expected to cause alcohol aversion or a disulfiram-like reaction as a result of ethanol ingestion.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosage in Pediatric Patients (2 to 12 Years of Age)ː

• The total daily dose 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.

Administration

• Benznidazole Tablets (12.5 mg and 100 mg) are for oral use and may be taken with or without food
• 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.
• Benznidazole Tablets 12.5 mg and 100 mg can be made into slurry as an alternative method of administration.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 100 mg (functionally scored).
• Tablets: 12.5 mg

This medicine is available in fallowing brand namesː

• Benznidazole

What side effects can this medication cause?

The most common side effects of this medicine include:

• abdominal pain
• rash
• decreased weight
• headache
• nausea
• vomiting
• neutropenia
• urticaria
• pruritus
• eosinophilia

What special precautions should I follow?

• Genotoxicity of benznidazole has been demonstrated.
• Benznidazole Tablets can cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended for females of reproductive potential. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
• Hypersensitivity skin reactions have been reported with benznidazole. In case of skin reactions, presenting with additional symptoms of systemic involvement such as lymphadenopathy, fever and/or purpura, discontinuation of treatment is recommended.
• Treatment with Benznidazole Tablets can potentially cause paresthesia or symptoms of peripheral neuropathy. In cases where neurological symptoms occur, immediate discontinuation of treatment is recommended.
• There have been hematological manifestations of bone marrow depression, such as neutropenia, thrombocytopenia, anemia, and leukopenia.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal studies, Benznidazole Tablets may cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Benznidazole Tablets have been established in pediatric patients 2 to 12 years of age for the treatment of Chagas disease.
• Safety and effectiveness in pediatric patients below the age of 2 years and above the age of 12 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient:

BENZNIDAZOLE

• Inactive ingredients:
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• LACTOSE MONOHYDRATE
• STARCH, CORN
• CROSCARMELLOSE SODIUM

Who manufactures and distributes this medicine?

• Packager: Exeltis USA, Inc.

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Benznidazole
• FDA Benznidazole

Benznidazole Resources
Latest articles Most recent articles Ongoing trials	Wikipedia