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Benznidazole

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Overview

What is Benznidazole?

Benznidazole Tablets contain benznidazole, a nitroimidazole antimicrobial. The chemical name of benznidazole is N-benzyl-2-(2-nitro-1H-imidazol-1-yl) acetamide. The empirical formula is CHNO and the molecular weight is 260.246 g/mol. The structural formula is:

Benznidazole is a yellowish, practically crystalline powder that is practically insoluble in water, sparingly soluble in acetone and ethanol, and slightly soluble in methanol.

Benznidazole Tablets are white round tablets each containing 12.5 mg or 100 mg of benznidazole, for oral use. The 100 mg white tablets are round and functionally scored twice as a cross on both sides debossed with “E” on one side of each quarter portion. The 12.5 mg white tablets are round and unscored debossed with “E” on one side.

The inactive ingredients are as follows: magnesium stearate, NF; microcrystalline cellulose, NF; monohydrate lactose, NF; pre-gelatinized corn starch, NF; and sodium croscarmellose, NF.



What does Benznidazole look like?



What are the available doses of Benznidazole?

Benznidazole Tablets are available as 100 mg and 12.5 mg tablets.

The 100 mg white tablets are round and functionally scored twice as a cross on both sides, debossed with “E” on one side of each quarter portion.

The 12.5 mg white tablets are round and unscored, debossed with “E” on one side.

What should I talk to my health care provider before I take Benznidazole?

Lactation: Breastfeeding is not recommended ().

How should I use Benznidazole?

Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by .

This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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What interacts with Benznidazole?

Sorry No Records found


What are the warnings of Benznidazole?

Sorry No Records found


What are the precautions of Benznidazole?

Sorry No Records found


What are the side effects of Benznidazole?

Sorry No records found


What should I look out for while using Benznidazole?

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4.3


What might happen if I take too much Benznidazole?

Sorry No Records found


How should I store and handle Benznidazole?

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) [See USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture.Product: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2447NDC: 50090-2447-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2447-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2448NDC: 50090-2448-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2448-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2449NDC: 50090-2449-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2449-1 90 TABLET, FILM COATED in a BOTTLEProduct: 50090-2451NDC: 50090-2451-0 30 TABLET, FILM COATED in a BOTTLENDC: 50090-2451-1 90 TABLET, FILM COATED in a BOTTLE


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Benznidazole is a nitroimidazole antimicrobial drug .

Non-Clinical Toxicology
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4.3

Drug interaction studies with mycophenolate mofetil have been conducted with acyclovir, antacids, cholestyramine, cyclosporine, ganciclovir, oral contraceptives, sevelamer, trimethoprim/sulfamethoxazole, norfloxacin, and metronidazole. Drug interaction studies have not been conducted with other drugs that may be commonly administered to renal, cardiac or hepatic transplant patients. Mycophenolate mofetil has not been administered concomitantly with azathioprine.

Genotoxicity

Genotoxicity of benznidazole has been demonstrated in humans, in vitro in several bacterial species and mammalian cell systems, and in vivo in rodents .

A study evaluating the cytogenetic effect of benznidazole in pediatric patients ranging from 11 months to 11 years of age (the safety and effectiveness of Benznidazole Tablets in patients less than 2 years old has not been established) with Chagas disease demonstrated a two-fold increase in chromosomal aberrations. In pediatric patients with Chagas disease who were treated with benznidazole, the median incidence of micronucleated interphase lymphocytes in 20 patients increased 2 fold compared to pre-dose values. In the same study, the mean incidence of chromosomal aberrations in 10 patients also increased 2 fold compared to pre-dose values.

Carcinogenicity

Carcinogenicity has been observed in mice and rats treated chronically with nitroimidazole agents which are structurally similar to benznidazole. Similar data have not been reported for benznidazole . It is not known whether benznidazole is associated with carcinogenicity in humans.

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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