Lampit is an antiprotozoal medicine. Antiprotozoal medicines kill or prevent the growth of organisms known as protozoans.

Lampit is a prescription medicine used to treat Chagas disease, a condition caused by the parasite Trypanosoma cruzi. Chagas disease occurs most commonly in Mexico, Central America, and South America.

Lampit 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 this medicine.

It is not known if Lampit is safe and effective in children weighing less than 5.5 pounds (2.5 kg).

Do not drink alcohol while taking Lampit. Alcohol may increase the frquency and severity of side effects experienced when taking nifurtimox.

Before taking this medicine

Your child should not use Lampit if he or she is allergic to nifurtimox.

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. Sexually active females and males should use effective birth control.

• If you are female; you may need to have a pregnancy test before starting this treatment to make sure you are not pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are male; use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose. It may be harder for you to get a woman pregnant while you are using this medicine.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Lampit.

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

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

The usual dosage of Lampit 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 Lampit 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 is taking Lampit.

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

Your child should not use Lampit if he or she is allergic to nifurtimox.

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. Sexually active females and males should use effective birth control.

• If you are female; you may need to have a pregnancy test before starting this treatment to make sure you are not pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are male; use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose. It may be harder for you to get a woman pregnant while you are using this medicine.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Lampit.

If you are breastfeeding, tell your 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.

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

This medicine 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 to Lampit: hives, itching; feeling light-headed; difficult breathing; swelling of the face, lips, tongue, or throat.

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

Other drugs may interact with nifurtimox, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your child's current medicines and any medicine your child starts or stops using.