Dosage Form: Tablets
Date of Approval: August 29, 2017
Company: Chemo Research, S. L.
Treatment for: Chagas Disease
FDA Approves Benznidazole
The U.S. Food and Drug Administration has granted accelerated approval to benznidazole, a nitroimidazole antimicrobial drug indicated for the treatment of Chagas disease (American trypanosomiasis) in children ages 2 to 12 years.
Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is benznidazole?
Benznidazole is an antiprotozoal medicine.
It is used treat an infection called American trypanosomiasis (Chagas disease) in children 2 to 12 years of age.
What is the most important information I should know about benznidazole?
This medication must be taken for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.
Do not drink alcohol while you are taking benznidazole, and for at least three days after you stop taking it. You may have unpleasant side effects such as abdominal cramps, nausea, vomiting, headaches, and flushing.
Always check the labels of any medicines or food products you use to make sure they do not contain alcohol or propylene glycol.
What should I discuss with my healthcare provider before taking benznidazole?
You should not use this medication if you are allergic to benznidazole or any of the other ingredients in the tablets.
You should not use this medicine if you are pregnant, or plan to become pregnant. Benznidazole may harm your unborn baby. Your doctor may recommend a pregnancy test to confirm you are not pregnant before you start treatment. If you may become pregnant you should use effective birth control during treatment, and for five days after the last dose.
Before you start treatment, tell your doctor if you are allergic to any drugs, or if you have:
- liver disease;
- kidney disease
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
Benznidazole can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breastfeeding a baby.
How should I take benznidazole?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
The tablets are usually taken two times a day for a duration of 60 days.
The tablets can be taken with or without food.
If you cannot swallow the tablets, you can mix them with water to form a slurry. To prepare the slurry, you must measure the correct amount of water for your dose. If you are unsure, ask your pharmacist or healthcare provider.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include nausea, vomiting, dizziness, loss of balance or coordination, numbness and tingling, or seizures (convulsions).
What should I avoid while taking benznidazole?
Do not drink alcohol while you are taking benznidazole and for at least 3 days after you stop taking it. You may have unpleasant side effects such as abdominal cramps, nausea, vomiting, headaches, and flushing.
Check the labels of any medicines or food products you use to make sure they do not contain alcohol or propylene glycol.
Benznidazole side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- skin reactions
- unusual bleeding or bruising
- numbness or tingling in your hands or feet
Less serious side effects may include:
- stomach pain
- decreased weight
- abnormal white blood cell count
- urticaria (hives)
- pruritus (itching)
- decreased appetite
What other drugs will affect benznidazole?
Tell your doctor about all other medicines you use, especially:
- disulfiram (Antabuse). You may experience a severe psychotic reaction if you take disulfiram while you are taking benznidazole. Do not take benznidazole if you have taken disulfiram within the past two weeks.
This list is not complete and other drugs may interact with benznidazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
How do I store this medicine?
Store the tablets at room temperature between 68°F and 77°F (20°C to 25°C). Protect from moisture.
Keep all medicines out of the reach of children and pets.
General Information about the safe and effective use of benznidazole.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients in benznidazole tablets?
Active ingredient: benznidazole
Inactive ingredients: magnesium stearate, microcrystalline cellulose, monohydrate lactose, pre-gelatinized corn starch, and sodium croscarmellose.