Lampit

What is Lampit?

Lampit is a prescription medicine used to treat Chagas disease caused by the parasite Trypanosoma cruzi in children less than 18 years of age weighing at least 5.5 pounds (2.5 kg).

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

Description

LAMPIT contains nifurtimox, an antiprotozoal. The chemical name is (E)-N-(3-Methyl-1,1-dioxidothiomorpholin-4-yl)-1-(5-nitro-2-furyl)methanimine.

The molecular weight is 287.29 and the molecular formula is C10 H13 N3 O5 S. The structural formula is:

LAMPIT (nifurtimox) tablets are yellow round, biconvex tablets, each containing 30 mg or 120 mg of nifurtimox, intended for oral use. The 30 mg tablets are functionally scored on one side and marked with ‘30’ on the other side. The 120 mg tablets are functionally scored on one side and marked with ‘120’ on the other side.

The inactive ingredients of the tablets are as follows: calcium hydrogen phosphate dihydrate, magnesium stearate, maize starch, silica colloidal anhydrous and sodium lauryl sulfate.

Who should not take Lampit?

Do not take Lampit if you:

• are allergic to nifurtimox, or any of the ingredients in Lampit. See the end of this Patient Information guide for a complete list of ingredients in Lampit.
• plan to drink alcohol during treatment with Lampit.

What should I tell my healthcare provider before taking Lampit?

Before taking Lampit, tell your healthcare provider about all your medical conditions, including if you:

• have a history of brain injury, seizures, mental health problems, or behavior changes.
• have kidney problems or are on dialysis.
• have liver problems.
• have a genetic problem called porphyria. Taking Lampit can make your symptoms of porphyria including dark urine, severe stomach pain, muscle pain, tingling, numbness, mental changes or skin sensitivity to light worse.
• are pregnant, plan to become pregnant, or think you may be pregnant. Lampit can harm your unborn baby.
  • For females who are able to become pregnant:
    • Your healthcare provider should do a pregnancy test before you start taking Lampit to make sure that you are not pregnant.
    • You should use effective forms of birth control during treatment with Lampit and for 6 months after your last dose of Lampit. Talk to your healthcare provider about what forms of birth control may be right for you.
    • Call your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Lampit
  • For males:
    • Lampit may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
    • You should use a condom with female partners who are able to become pregnant, during treatment with Lampit and for 3 months after your last dose of Lampit.
• are breastfeeding or plan to breastfeed. Lampit can pass into breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Lampit. If you take Lampit and breastfeed, monitor your baby for vomiting, rash, decreased appetite, fever, and irritability.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take Lampit?

See the detailed Instructions for Use that comes with Lampit for information about how to split Lampit tablets and how to take Lampit if whole tablets or half tablets cannot be swallowed.

• Take Lampit exactly as your healthcare provider tells you.
• Your healthcare provider may change your dose if needed. Take your prescribed dose of Lampit 3 times a day with food.
• Lampit tablets are marked with a scored line. Lampit tablets can be taken whole or split at the scored line.
• Lampit tablets should be split by hand at the scored line. Do not split Lampit tablets using a tablet splitting device.
• If you cannot swallow Lampit tablets or you are giving Lampit to a child who cannot swallow the tablets, be sure to read the Instructions for Use that come with Lampit. Lampit tablets can be dissolved in water if whole tablets or half tablets cannot be swallowed.
• If you miss a dose of Lampit, take it as soon as possible with food. If it is within 3 hours of your next scheduled dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses to make up for a missed dose.

What are the possible side effects of Lampit?

Lampit may cause serious side effects, including:

• Worsening of symptoms related to brain injury, seizures, mental health problems or behavior changes in people with a history of these problems. Call your healthcare provider right away if any of these problems get worse during treatment with Lampit.
• Allergic reactions. Allergic reactions can happen when taking nifurtimox, the active ingredient in Lampit, or with changes in your immune system caused by Chagas disease during treatment with Lampit. These allergic reactions can include low blood pressure, swelling of the face and tongue (angioedema), shortness of breath, itching, rash or other skin problems. Call your healthcare provider or get emergency medical help if you get any of these signs and symptoms of an allergic reaction during treatment with Lampit.
• Loss of appetite and weight loss. Your healthcare provider should check your weight every 14 days to see if your dose of Lampit may need to be changed.

The most common side effects of Lampit include:

• headache
• vomiting
• nausea
• rash
• decreased appetite
• abdominal pain
• fever

These are not all the possible side effects of Lampit.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Lampit

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Lampit for a condition for which it was not prescribed. Do not give Lampit to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Lampit that is written for health professionals.

How should I store Lampit?

• Store Lampit at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Lampit in the bottle that it comes in with the child-resistant cap on the bottle. Do not remove the packet that helps to keep your medicine dry (desiccant).
• Keep the bottle tightly closed and protect from moisture.

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

What are the ingredients in Lampit?

Active ingredient: nifurtimox

Inactive ingredients: calcium hydrogen phosphate dihydrate, magnesium stearate, maize starch, silica colloidal anhydrous, and sodium lauryl sulfate.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 50419-750-01
• Rx only
• Lampit
• (nifurtimox) tablets
• 30 mg
• Oral use
• 100 tablets

 

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 50419-751-01
• Rx only
• Lampit
• (nifurtimox) tablets
• 120 mg
• Oral use
• 100 tablets

SRC: NLM .