Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Indocin

Descriptions


Indomethacin injection is used to treat patent ductus arteriosus (PDA) in premature infants (babies born too early) who weigh between 500 and 1750 grams. PDA is a heart problem where a blood vessel, the ductus arteriosus, fails to close normally after birth. This blood vessel is only used before birth, and is no longer needed after the baby is born. Indomethacin injection works by causing the PDA to constrict, and this closes the blood vessel. This medicine is used when other medical treatment for PDA fails after 48 hours.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of indomethacin injection in premature babies.

Geriatric

No information is available on the relationship of age to the effects of indomethacin injection in geriatric patients.

Pregnancy

Information about this indomethacin-intravenous-route
Pregnancy Category Explanation
1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Apixaban
  • Ardeparin
  • Argatroban
  • Beta Glucan
  • Bivalirudin
  • Certoparin
  • Cilostazol
  • Citalopram
  • Clopidogrel
  • Clovoxamine
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Digoxin
  • Duloxetine
  • Enoxaparin
  • Eptifibatide
  • Erlotinib
  • Escitalopram
  • Femoxetine
  • Feverfew
  • Flesinoxan
  • Fluoxetine
  • Fondaparinux
  • Ginkgo
  • Gossypol
  • Heparin
  • Lepirudin
  • Levomilnacipran
  • Meadowsweet
  • Methotrexate
  • Milnacipran
  • Nadroparin
  • Nefazodone
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Potassium
  • Pralatrexate
  • Prasugrel
  • Protein C
  • Reviparin
  • Rivaroxaban
  • Sibutramine
  • Tacrolimus
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Acetohexamide
  • Alacepril
  • Alprenolol
  • Amiloride
  • Amlodipine
  • Arotinolol
  • Atenolol
  • Azilsartan Medoxomil
  • Azosemide
  • Befunolol
  • Bemetizide
  • Benazepril
  • Bendroflumethiazide
  • Benzthiazide
  • Bepridil
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Bucindolol
  • Bumetanide
  • Bupranolol
  • Buthiazide
  • Candesartan Cilexetil
  • Canrenoate
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Chlorothiazide
  • Chlorpropamide
  • Chlorthalidone
  • Cilazapril
  • Clopamide
  • Cyclopenthiazide
  • Delapril
  • Desvenlafaxine
  • Dilevalol
  • Diltiazem
  • Dipyridamole
  • Enalaprilat
  • Enalapril Maleate
  • Eprosartan
  • Esmolol
  • Ethacrynic Acid
  • Felodipine
  • Flunarizine
  • Fosinopril
  • Furosemide
  • Gallopamil
  • Gentamicin
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Imidapril
  • Indapamide
  • Irbesartan
  • Isradipine
  • Labetalol
  • Lacidipine
  • Landiolol
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Lithium
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Olmesartan Medoxomil
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Piretanide
  • Polythiazide
  • Pranidipine
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Spironolactone
  • Talinolol
  • Tasosartan
  • Telmisartan
  • Temocapril
  • Tertatolol
  • Timolol
  • Tolazamide
  • Tolbutamide
  • Torsemide
  • Trandolapril
  • Triamterene
  • Trichlormethiazide
  • Valsartan
  • Verapamil
  • Warfarin
  • Xipamide
  • Zofenopril

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Active bleeding (e.g., brain hemorrhage or stomach bleeding) or
  • Bleeding problems (e.g., thrombocytopenia) or
  • Congenital heart disease or
  • Infection, untreated or
  • Kidney problem or
  • Necrotizing enterocolitis, known or suspected (an inflamed intestine)—Should not be used in babies with these conditions.
  • Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use

A nurse or other trained health professional will give this medicine to your baby. This medicine is given through a needle placed in one of your baby's veins.

Precautions

Indomethacin injection may change how the body reacts during an infection. Your baby's doctor will monitor your baby for any signs of infection (e.g., fever, chills, or other unusual behavior).

This medicine may affect the action of platelets, which are necessary for clotting the blood. This may increase the chance of bleeding for your baby. Your baby's doctor will monitor your baby for any unusual bleeding or bruising, any dark-colored urine or stools, or other signs of bleeding in your baby.

This medicine may decrease your baby's urine volume. This may increase your baby's chance of having kidney problems or low sodium in the blood (hyponatremia). Blood and urine tests will be needed to check for any signs of these risks.

Liver problems may occur while your baby is receiving this medicine. Stop using this medicine and check with your baby's doctor right away if your baby is having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Abdominal or stomach pain
  2. ammonia-like breath odor
  3. bloody or black, tarry stools
  4. coma
  5. confusion
  6. constipation
  7. convulsions
  8. decreased urine output
  9. difficult breathing
  10. dizziness
  11. fast or irregular heartbeat
  12. headache, sudden, severe
  13. increased thirst
  14. irregular heartbeat
  15. loss of appetite
  16. muscle pain or cramps
  17. nausea and vomiting
  18. nervousness
  19. numbness or tingling in the hands, feet, or lips
  20. severe stomach pain
  21. shortness of breath
  22. swelling of the face, ankles, or hands
  23. unusual tiredness or weakness
  24. vomiting of blood or material that looks like coffee grounds
  25. weakness or heaviness of the legs
  26. weight loss

Less common

  1. Anxiety
  2. blurred vision
  3. chills
  4. cold sweats
  5. cool, pale skin
  6. depression
  7. full or bloated feeling
  8. heartburn
  9. increased hunger
  10. indigestion
  11. nightmares
  12. noisy, rattling breathing
  13. pressure in the stomach
  14. seizures
  15. severe abdominal or stomach pain, cramping, or burning
  16. severe constipation
  17. severe vomiting
  18. shakiness
  19. slurred speech
  20. swelling of the abdominal or stomach area
  21. swelling of the fingers, hands, feet, or lower legs
  22. troubled breathing at rest
  23. unusual bruising or bleeding
  24. vomiting of material that looks like coffee grounds, severe and continuing
  25. weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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