What is this medication?

INDOMETHACIN (in doe METH a sin) injection is a nonsteroidal antiinflammatory 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.

COMMON BRAND NAME(S): Indocin

What should I tell my care team before I take this medication?

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 indomethacin, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care provider in a hospital. It is usually given as three doses given at 12 to 24 hour intervals.

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 medication?

•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 medication?

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 healthcare provider if you have any concerns.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

What side effects may I notice from receiving this medication?

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

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• blurred vision OR changes in vision
• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)
• heart failure (trouble breathing; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired)
• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)
• increase in blood pressure
• kidney injury (trouble passing urine or change in the amount of urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• seizures
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)

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

• diarrhea
• dizziness
• feeding problems
• feeling faint or lightheaded, falls
• headache
• skin irritation where injected
• stomach pain
• vomiting

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 medication?

This medicine is only given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.