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Full Answer
What is benznidazole used to treat?
Benznidazole is used to treat Chagas disease, a potentially life-threatening parasitic disease. In October 2011, a CDC-sponsored Investigational New Drug (IND) treatment protocol went into effect to ensure benznidazole availability for eligible U.S. patients. What is added by this report?
Is benznidazole approved by the FDA?
In the absence of commercially available drugs approved by the Food and Drug Administration (FDA), benznidazole and nifurtimox have been available exclusively through CDC, under Investigational New Drug (IND) treatment protocols.
How should I take benznidazole?
Take benznidazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. The benznidazole 100-mg tablets are scored so that they can easily be split into halves or quarters.
How do you get benznidazole from a donor?
It can be transmitted by eating food contaminated with the parasite's feces or urine, blood transfusion from infected donors, organ transplant using organs from infected donors, or during pregnancy or childbirth. Benznidazole is available only with your doctor's prescription.
How do I get Benznidazole?
Benznidazole is approved by FDA for use in children 2–12 years of age and is available from www.benznidazoletablets.com . Lampit® (nifurtimox) is FDA approved for treatment of children from birth to younger than 18 years and is commercially available for pharmacies to purchase from several drug wholesalers.
Is Benznidazole FDA approved?
On August 29, 2017, FDA approved benznidazole (Chemo Research, SL, in care of Exeltis) for treatment of Chagas disease in children aged 2–12 years§ (4). On May 14, 2018, the FDA-approved benznidazole product became commercially available through an exclusive distributor, Foundation Care.
For what purpose ofloxacin is used?
Ofloxacin is used to treat certain bacterial infections in many different parts of the body. It may also be used for other problems as determined by your doctor. Ofloxacin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.
How do you pronounce Benznidazole?
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Is ofloxacin A antibiotic?
Ofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics such as ofloxacin will not work for colds, flu, or other viral infections.
What does Secnidazole treat?
Secnidazole is used to treat vaginal infection (vaginosis) caused by bacteria in adult women and trichomoniasis (an infection of the sex organs in men or women caused by protozoa).
When are Benznidazole Tablets prescribed?
Benznidazole Tablets are an antimicrobial indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease caused by Trypanosoma cruzi. 1 This indication received accelerated approval based on the number of treated patients who were successfully treated in clinical trials. 2
What is the clinical efficacy of Benznidazole Tablets?
The efficacy of Benznidazole Tablets for the treatment of Chagas disease in patients 6 to 12 years of age was established in 2 randomized, double-blind, placebo-controlled trials with more than 200 people. 1,*,† All patients had chronic indeterminate Chagas disease. 1 Results from both trials indicate a significantly higher percentage of seronegative patients by a nonconventional assay following treatment with Benznidazole Tablets vs placebo. 1
How do Benznidazole Tablets work?
Benznidazole exhibits antimicrobial activity against all 3 stages of the T cruzi parasite. 1 Resistance to Benznidazole Tablets may develop, but the clinical relevance of the mechanisms by which this may occur is not known. 1
What is nitroimidazole used for?
Benznidazole Tablets, a nitroimidazole antimicrobial, is indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi.
How long does benznidazole last?
Benznidazole is dosed by body weight. The total daily dose for pediatric patients 2 to 12 years of age is 5 mg/kg to 8 mg/kg orally, administered in 2 divided doses every 12 hours for 60 days. Alternatively, benznidazole may be dosed as a slurry.
How long after Benznidazole is given to use contraception?
Advise women of reproductive potential to use effective contraception during treatment with Benznidazole Tablets and for 5 days after the last dose.
What are the adverse reactions of benznidazole?
In Trial 3, a subset of 19 pediatric patients 2 to 6 years of age treated with benznidazole, 6 patients (32%) had the following adverse reactions: rash, leukopenia, urticaria, eosinophilia, decreased appetite, and neutropenia. These adverse reactions were similar to those observed in the overall population of 37 patients. 1,‡
What is benznidazole used for?
Expand Section. Benznidazole is used to treat Chagas disease (caused by a parasite) in children 2 to 12 years old. Benznidazole is in a class of medications called antiprotozoals. It works by killing the organism that can cause Chagas disease.
How to split benznidazole tablets?
If your doctor has told you to take only part of a tablet, hold the tablet between your thumb and index fingers close to the scored line and apply pressure to separate the number of parts needed for the dose. Only use a portion of a tablet that has been broken at the scored line.
How should this medicine be used?
Benznidazole comes as a tablet to take by mouth. It is usually taken with or without food twice a day for 60 days. Take benznidazole at around the same times every day and space your doses about 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take benznidazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
What to do if you are allergic to benznidazole?
Before taking benznidazole, tell your doctor and pharmacist if you are allergic to benznidazole, metronidazole (Flagyl, in Pylera), any other medications, or any of the ingredients in benznidazole tablets. Ask your pharmacist for a list of the ingredients. tell your doctor if you are taking or have taken disulfiram (Antabuse).
What are the side effects of benznidazole?
Benznidazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: 1 headache 2 dizziness 3 stomach pain 4 nausea 5 vomiting 6 diarrhea 7 loss of appetite 8 weight loss 9 uncontrollable shaking of a part of the body
Can you get pregnant while taking benznidazole?
If you become pregnant while taking benznidazole, call your doctor. Benznidazole can cause fetal harm.
What is Benznidazole used for?
BENZNIDAZOLE is used to treat Chagas disease in children 2 to 12 years of age.
What is a placebo pill?
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo. SUBGROUP: A subset of the population studied in a clinical trial.
WHO WAS IN THE CLINICAL TRIALS?
The FDA approved BENZNIDAZOLE based primarily on evidence from the two published clinical trials of 235 children with Chagas disease. Trial 1 was conducted from 1991-1995 in Argentina and Trial 2 from 1991-1995 in Brazil. Demographics of these two trials are presented in the Table 8 and Figures 1 and 2 below.
What is a comparator in clinical trials?
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested. EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
When was the Chagas trial conducted?
The trial was conducted from 2008-2010 in Argentina. Demographics of this trial are presented in the Table 9.
How old are the patients who were given benznidazole?
Only two patients were aged 2–12 years, the group for which FDA has approved the use of benznidazole.
What is benznidazole used for?
Benznidazole is used to treat Chagas disease, a potentially life-threatening parasitic disease. In October 2011, a CDC-sponsored Investigational New Drug (IND) treatment protocol went into effect to ensure benznidazole availability for eligible U.S. patients.
What is the treatment for Chagas disease?
The two drugs used for treating Chagas disease are benznidazole and nifurtimox ( 1, 2 ), which have been used in Latin America since the 1970s and 1960s, respectively.
How long does Trypanosoma cruzi last?
The acute phase, which can be life-threatening in immunosuppressed persons, typically lasts for several weeks or months. The subsequent chronic phase, which can be life-threatening (e.g., can cause sudden cardiac death) even in asymptomatic persons, is associated with an estimated 20%–30% lifetime risk of developing cardiac or gastrointestinal disease ( 1, 2 ). The number of chronically infected Latin American immigrants in the United States has been estimated to exceed 300,000 ( 5, 6 ). Blood-donor screening for serologic evidence of T. cruzi infection, which was introduced in the United States in 2007, has resulted in increased detection of asymptomatic, chronically infected persons and has helped raise awareness about Chagas disease, including the importance of diagnostic testing and appropriate antimicrobial therapy for infected persons.
When did the IND for benznidazole go into effect?
The CDC-sponsored IND for benznidazole went into effect in October 2011.
When did benznidazole become available?
On May 14, 2018, the FDA-approved benznidazole product became commercially available through an exclusive distributor, Foundation Care. Physician requests for benznidazole for treatment of Chagas disease in U.S. patients (not limited to patients aged 2–12 years) ( 7) should now be directed to Exeltis. Effective May 14, 2018, benznidazole is no ...
Is benznidazole FDA approved?
FDA’s approval of benznidazole and the commercial av ailability of the approved product in the United States likely will increase awareness of Chagas disease and facilitate access to therapy.
When did the CDC stop providing nifurtimox?
In response, the CDC has ended the IND program that exclusively provided benznidazole and nifurtimox for people in the United States who have Chagas disease and received the drugs during October 2011 to May 2018.
How old are Chagas patients?
Data from 365 patients were included in an intention-to-treat analysis. Median patient age was 42.9 years ( range, 0.1-76.0 years) and 8.8% were younger than19 years of age. Only 4 patients had acute-phase infections, all of whom were born in and infected with Chagas disease in the United States. The routes of infection for these 4 were solid organ transplants from Central American immigrants (2 individuals), congenital transmission from a Bolivian immigrant (1 individual), and presumed vector-borne transmission (1 individual). The remaining 361 patients had chronic-phase infections and were born in and acquired the infection in Latin America.
When did the IND program end?
The CDC has ended the IND program that exclusively provided benznidazole and nifurtimox for Chagas patients in the US from October 2011 to May 2018. The Centers for Disease Control and Prevention (CDC) announced recently in the Morbidity and Mortality Weekly Report that, effective May 14 2018, the CDC Investigational New Drug (IND) ...
Does the CDC have a Chagas disease test?
The CDC continues to provide reference diagnostic testing for Try panosoma cruzi, the causative agent of Chagas disease, through its website ( https://www.cdc.gov/dpdx) and also provides telephone consultation services regarding Chagas disease. Healthcare providers and health departments can contact CDC Parasitic Diseases Branch by telephone at 404-718-4745 or by e-mail at [email protected].
What is BI Cares?
The BI Cares Patient Assistance Program is a charitable program provided by the Boehringer Ingelheim Cares Foundation (BI Cares), an independent nonprofit organization, to improve patients’ health and lives.
Is Boehringer Ingelheim Cares affiliated with any third party?
The Boehringer Ingelheim Cares Foundation is not affiliated with any third party individual or organization that may charge patients a fee (s) to assist them in applying to our program or ordering refills through our program. These individuals or organizations are acting independently of the Boehringer Ingelheim Cares Foundation and do not have the Foundation’s consent.
What is benznidazole used for?
Benznidazole is used to treat Chagas disease (American trypanosomiasis) in children 2 to 12 years of age. Chagas disease is a potentially life-threatening disease caused by the protozoan parasite, Trypanosoma cruzi, also known as "kissing bug".
What to tell your doctor about benznidazole?
Tell your doctor if you have ever had any unusual or allergic reaction to benznidazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
How long after benznidazole can you get pregnant?
Use an effective form of birth control to keep from getting pregnant during treatment with benznidazole and for 5 days after the last dose. If you think you have become pregnant while using benznidazole, tell your doctor right away. If you plan to have children, talk with your doctor before using benznidazole.
How can benznidazole be transmitted?
It can be transmitted by eating food contaminated with the parasite's feces or urine, blood transfusion from infected donors, organ transplant using organs from infected donors, or during pregnancy or childbirth. Benznidazole is available only with your doctor's prescription.
How to avoid getting a bleed from benznidazole?
To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
How old is too old to take benznidazole?
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of benznidazole in children 2 to 12 years of age. Safety and efficacy have not been established in children younger than 2 years of age and older than 12 years of age.
How many times a day can you take Chagas?
For oral dosage form (tablets): For the treatment of Chagas disease: Children 2 to 12 years of age—Dose is based on body weight and is usually 5 to 8 milligram (mg) per kilogram (kg) given two times a day, 12 hours apart for 60 days.
