Benznidazole
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.
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:
- abdominal pain
- rash
- decreased weight
- headache
- nausea
- vomiting
- neutropenia
- urticaria
- pruritus
- eosinophilia
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.
- 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?[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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