Benznidazole

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.

The benznidazole 100-mg tablets are scored so that they can easily be split into halves or quarters. 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.

If you are unable to swallow the tablets whole, you may dissolve them in water. Place the prescribed number of tablets (or portions of tablets) into a drinking cup. Add the amount of water as told by your doctor or pharmacist into the cup. Wait 1 to 2 minutes to allow the tablets to disintegrate in the cup, then gently shake the cup contents to mix. Drink the mixture immediately. Then rinse the cup with an additional amount of water as told by your doctor and drink the entire amount. Drink all of this mixture to be sure that you receive all of the medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Benznidazole is also sometimes used to treat Chagas disease in children older than 12 years of age and adults up to 50 years old who do not have advanced Chagas disease. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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). Your doctor may tell you not to take benznidazole if you are taking disulfiram or have taken it within the past two weeks.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any blood disorders or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. Females who can become pregnant must take a pregnancy test before starting this medication. You should use birth control to prevent pregnancy during your treatment and for 5 days after your final dose. If you become pregnant while taking benznidazole, call your doctor. Benznidazole can cause fetal harm.
• do not breastfeed while taking benznidazole.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking benznidazole.
• do not drink alcoholic beverages or take products with alcohol or propylene glycol while taking this medication and for at least 3 days after your treatment is finished. Alcohol and propylene glycol may cause nausea, vomiting, stomach cramps, headache, sweating, and flushing (redness of the face) when taken during treatment with benznidazole.

Unless your doctor tells you otherwise, continue your normal diet.

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

Some side effects can be serious. If you experience any of these symptoms, stop this medication and call your doctor immediately:

1. rash
2. swollen, red, peeling, or blistering skin
3. hives
4. itching
5. red- or purple-colored skin spots
6. fever
7. swollen lymph nodes
8. numbness, pain, burning, or tingling in your hands or feet

Benznidazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is very important that your doctor check your progress at regular visits to make sure benznidazole is working properly. Blood tests may be needed to check for unwanted effects.

Do not use benznidazole if you have taken disulfiram (Antabuse®) within the last two weeks. Also, do not take alcohol or alcoholic products (eg, propylene glycol) during treatment with benznidazole and for at least 3 days after your last dose.

Using benznidazole while you are pregnant can harm your unborn baby. 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. Some men using benznidazole have become infertile (unable to have children).

There is a possible risk of getting cancer with benznidazole. Talk with your doctor if you have any concerns about this risk.

Serious skin reactions can occur with benznidazole. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with benznidazole.

Check with your doctor right away if you have dizziness, headache, burning, numbness, tingling, or painful sensations, weakness in the arms, hands, legs, or feet, or unsteadiness or awkwardness. These may be signs of peripheral neuropathy.

Benznidazole may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. 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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• chest pain
• chills
• cough
• fever
• painful or difficult urination
• rash
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

• Burning, numbness, tingling, or painful sensations
• headache
• tremors
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

• Bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• dark urine
• diarrhea
• difficulty in moving
• general tiredness and weakness
• inability to concentrate
• itching
• light-colored stools
• muscle pain or stiffness
• nausea
• pain, swelling, or redness in the joints
• pinpoint red spots on the skin
• red, irritated eyes
• seizures
• swelling of the eyelid, arms, or legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• temporary disorientation
• temporary loss of memory
• trouble sleeping
• upper right abdominal pain
• vomiting
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased appetite
• decreased weight
• stomach pain

• Bone pain
• dry mouth
• loss of sense of taste
• loss of strength
• muscle aching or cramping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Disulfiram

Psychotic reactions have been reported in patients who are concurrently taking disulfiram and nitroimidazole agents (structurally related to Benznidazole, but not with Benznidazole). Benznidazole Tablets should not be given to patients who have taken disulfiram within the last two weeks [see Contraindications (4.2)].

Alcohol and Products Containing Propylene Glycol

Abdominal cramps, nausea, vomiting, headaches, and flushing may occur if alcoholic beverages or products containing propylene glycol are consumed during or following therapy with nitroimidazole agents which are structurally related to Benznidazole. Although no similar reactions have been reported with Benznidazole, discontinue alcoholic beverage or products containing propylene glycol during and for at least 3 days after therapy with Benznidazole Tablets [see Contraindications (4.3)].

Benznidazole
tablets, for oral use

Read this Instructions for Use before you start taking Benznidazole and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

Note:

100 mg treatment (take the whole tablet)

How to break your Benznidazole 100 mg tablet:

75 mg treatment (take one-half of the tablet and one-fourth of the tablet)

50 mg treatment (take one-half of the tablet)

25 mg treatment (take one-fourth of the tablet)

How should I store Benznidazole?

Keep Benznidazole and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by: Laboratorios Liconsa S.A., Guadalajara, Spain

Issued: August 2017

Carton Label - 100 mg

NDC 0642-7464-10

Tradename
Benznidazole tablets
100 mg

For oral use
Rx only
100 tablets

Exeltis
Rethinking healthcare

Keep out of the reach of children.

Store at controlled room temperature
20° to 25°C (68° to 77°F)
Keep bottle tightly closed and protect
from moisture.

Manufactured for Chemo Research, S.L.,
Madrid, Spain.

Manufactured by Laboratorios Liconsa S.A.,
Avenida Miralcampo 7,
Pol. Ind. Miralcampo, Azuqueca de Henares,
Guadalajara 19200, Spain.

Distributed by Exeltis USA, Inc.,
Florham Park, USA.

See prescribing information
for Dosage and
Administration.

Tradename
Benznidazole
tablets
100 mg

Tradename
Benznidazole tablets
100 mg

Lot No.:
Expiry date: MMM YYYY

Carton Label - 12.5 mg

NDC 0642-7463-12

Tradename
Benznidazole tablets
12.5 mg

For oral use
Rx only
100 tablets

Exeltis
Rethinking healthcare

Keep out of the reach of children.

Store at controlled room temperature
20° to 25°C (68° to 77°F)
Keep bottle tightly closed and protect
from moisture.

Manufactured for Chemo Research, S.L.,
Madrid, Spain.

Manufactured by Laboratorios Liconsa S.A.,
Avenida Miralcampo 7,
Pol. Ind. Miralcampo, Azuqueca de Henares,
Guadalajara 19200, Spain.

Distributed by Exeltis USA, Inc.,
Florham Park, USA.

See prescribing information
for Dosage and
Administration.

Tradename
Benznidazole
tablets
12.5 mg

Tradename
Benznidazole tablets
12.5 mg

Lot No.:
Expiry date: MMM YYYY

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Safety and efficacy have not been established in patients younger than 2 years or older than 12 years.

Consult WARNINGS section for dosing related precautions.

Administration advice:
-Before starting this drug, obtain a pregnancy test in females of reproductive potential.
-May administer without regard to food
-Can make the tablets into slurry as an alternative method of administration; after preparation, drink the contents of the cup at once. If less than 30 kg, rinse the cup with an additional 10 mL of water and drink the entire amount; if 30 kg or more, rinse the cup by adding 80 mL of water, drink the entire amount, repeat rinse with 80 mL of water, and drink again.

Storage requirements:
-Store at controlled room temperature 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
-Keep bottle tightly closed and protect from moisture.

Reconstitution/preparation techniques:
-The tablets may be made into a slurry; the manufacturer product information should be consulted regarding tablet strength, tablet quantity, and specified volume of water.
(a) Place the prescribed dose into a cup.
(b) Add the specified volume of water.
(c) Allow the tablets to disintegrate in the cup over about 1 to 2 minutes.
(d) Shake the contents of the cup gently to mix.

General:
-The 100-mg tablets can be split into 1/2 (50 mg) or 1/4 (25 mg) at the scored lines to provided doses less than 100 mg.

Monitoring:
-Hematologic: CBC; total and differential leukocyte counts (before, during, and after therapy)

Patient advice:
-Read the US FDA-approved patient labeling (Instructions for Use).
-Do not consume alcoholic beverages or propylene glycol-containing products during therapy and for at least 72 hours after the last dose.