Benznidazole

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What is Benznidazole?[edit | edit source]

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


What are the uses of this medicine?[edit | edit source]

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


How does this medicine work?[edit | edit source]

  • 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 ?[edit | edit source]

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?[edit | edit source]

  • 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?[edit | edit source]

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


How should this medicine be used?[edit | edit source]

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?[edit | edit source]

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?[edit | edit source]

The most common side effects of this medicine include:


What special precautions should I follow?[edit | edit source]

  • 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?[edit | edit source]

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


Can this medicine be used in pregnancy?[edit | edit source]

  • 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?[edit | edit source]

  • 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?[edit | edit source]

  • Active ingredient:

BENZNIDAZOLE

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


Who manufactures and distributes this medicine?[edit | edit source]

  • Packager: Exeltis USA, Inc.


What should I know about storage and disposal of this medication?[edit | edit source]

  • 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.


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Contributors: Prab R. Tumpati, MD