Nifurtimox is used to treat Chagas disease, a condition caused by a parasite. Chagas disease occurs most commonly in Mexico, Central America, and South America.

Nifurtimox is for use in children from birth through their 17th year. A child must weigh at least 5.5 pounds (2.5 kilograms) before taking nifurtimox.

Nifurtimox may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your child's healthcare providers about all the medical conditions, allergies, and medicines the child uses.

Do not drink alcohol while taking nifurtimox.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your child's dose. Take the medicine exactly as directed.

The usual dosage of nifurtimox is 3 times per day with food, taken for 60 days. Follow the doctor's dosing instructions very carefully.

Each tablet should be swallowed whole or split in half. You may split a tablet by breaking it along scored line with your fingertip. Do not split a nifurtimox tablet using a tablet-cutting device.

If the child cannot swallow a tablet whole, place the tablet into 1/2 teaspoon of water. Allow the tablet to completely dissolve (in about 30 seconds). Give the mixture right away with food.

Nifurtimox doses are based on weight and may change if the child gains or loses weight. The doctor should check the child's weight every 2 weeks while the child takes nifurtimox.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Pediatric Dose for Trypanosomiasis:

BIRTH (TERM NEONATE) TO LESS THAN 18 YEARS:
Total Daily Dosage Based on Body Weight:
-Weight 2.5 to less than 40 kg: 10 to 20 mg/kg/day orally in divided doses 3 times a day
-Weight at least 40 kg: 8 to 10 mg/kg/day orally in divided doses 3 times a day

Individual Dosages Based on Body Weight:
-Weight 2.5 to 4.5 kg: 15 mg orally 3 times a day
-Weight 4.6 to less than 9 kg: 30 mg orally 3 times a day
-Weight 9 to less than 13 kg: 45 mg orally 3 times a day
-Weight 13 to less than 18 kg: 60 mg orally 3 times a day
-Weight 18 to less than 22 kg: 75 mg orally 3 times a day
-Weight 22 to less than 27 kg: 90 mg orally 3 times a day
-Weight 27 to less than 35 kg: 120 mg orally 3 times a day
-Weight 35 to less than 41 kg: 180 mg orally 3 times a day
-Weight 41 to less than 51 kg: 120 mg orally 3 times a day
-Weight 51 to less than 71 kg: 180 mg orally 3 times a day
-Weight 71 to less than 91 kg: 240 mg orally 3 times a day
-Weight at least 91 kg: 300 mg orally 3 times a day

Duration of Therapy: 60 days

Comments:
-During therapy, patients can lose their appetite or have nausea/vomiting which can lead to weight loss; body weight should be checked every 14 days and dose should be adjusted accordingly.

Use: For the treatment of Chagas disease (American trypanosomiasis) due to Trypanosoma cruzi

Nifurtimox should not be used if the child is allergic to it.

Tell your child's doctor if the child has ever had:

• a brain injury;

• a seizure;

• mental illness or psychosis;

• kidney disease (or if the child is on dialysis);

• liver disease; or

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Nifurtimox can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.

• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell the doctor right away if a pregnancy occurs.

It may be harder for you to get a woman pregnant while you are using this medicine.

If you are breastfeeding, tell the doctor if you notice symptoms in the nursing baby such as fussiness, decreased appetite, vomiting, rash, or fever.

Give the medicine as soon as you can, but skip the missed dose if your child's next dose is due in less than 3 hours. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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). Do not remove the desiccant (small packet that contains a substance that absorbs moisture to keep the medication dry).

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.

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

Follow your child's doctor's instructions about any restrictions on food, beverages, or activity.

nifurtimox may cause muscle weakness or tremors and may impair your child's reactions. Your child should avoid driving or hazardous activity until you know the effects of this medicine.

Get emergency medical help if the child has signs of an allergic reaction: hives, itching; feeling light-headed; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your child's doctor at once if the child has:

• a decreased appetite and weight loss;

• new or worsening symptoms of a pre-existing condition (such as a brain injury, seizures, behavior changes, or mental health problems); or

• worsening symptoms of porphyria (dark urine, severe stomach pain, muscle pain, numbness, tingling, mental changes, or skin sensitivity to light).

Common side effects of nifurtimox may include:

• stomach pain, nausea, vomiting;

• loss of appetite;

• fever;

• rash; or

• headache.

This is not a complete list of side effects and others may occur. Call your child's doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect nifurtimox, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell the doctor about all other medicines your child use.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.