Ibuprofen Lysine Solution for injection

What is this medicine?

IBUPROFEN LYSINE (eye BYOO proe fen LAHY seen) is a nonsteroidal anti-inflammatory drug (NSAID). It is used to close a heart defect called patent ductus arteriosus (PDA) in a baby who was born early.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding problems

• heart problems

• infection

• kidney disease

• liver disease

• stomach problems

• an unusual reaction to ibuprofen, other NSAIDs, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care provider in a hospital.

This drug is specifically for use in newborns.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

• aspirin and aspirin-like medicines

• certain antibiotics

• digoxin

• diuretics

• medicines that treat or prevent blood clots like warfarin

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your baby's condition will be watched closely while this treatment is given. Your baby will also receive regular blood tests and exams. Talk with your doctor or health care professional if you have any concerns.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• change in amount or color of urine

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• trouble breathing

• unusual bleeding, bruising

• yellowing of eyes, skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• feeding problems

• skin irritation where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is only given in a hospital and will not be stored at home.