Indocin (Intravenous)

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 issue where a blood vessel, called the ductus arteriosus, does not close as it should after birth. This blood vessel is only needed before birth, and is not necessary after the baby is born. Indomethacin injection works by making the PDA constrict, which closes the blood vessel. This medicine is used when other treatments for PDA do not work after 48 hours.

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

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

This medicine may affect the action of platelets, which are needed for blood clotting. This may increase the risk 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 output. This may increase the chance of 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 contact your baby's doctor right away if your baby has 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.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a choice you will make with your doctor. For this medicine, you should think about the following:

Allergies

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

Pediatric

Studies so far have not shown any specific problems in children that would limit the use of indomethacin injection in premature babies.

Geriatric

There is no information available on how age affects the effects of indomethacin injection in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and may not include all possible interactions.

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 necessary 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
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bivalirudin
• Budesonide
• Bumetanide
• Cangrelor
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Cilostazol
• Citalopram
• Clomipramine
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Diazoxide
• Dibenzepin
• Diflunisal
• Digoxin
• Dipyridamole
• Dothiepin
• Doxepin
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Feverfew
• Fluocortolone
• Fluoxetine
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Glucagon
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Inotersen
• Ketoprofen
• Lepirudin
• Levoketoconazole
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Macimorelin
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Polythiazide
• Potassium
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Probenecid
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Vasopressin
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Acebutolol
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Gentamicin
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Active bleeding (e.g., brain hemorrhage or stomach bleeding) or
• Bleeding problems (e.g., thrombocytopenia) or
• Congenital heart disease or
• Untreated infection or
• Kidney problem or
• Known or suspected necrotizing enterocolitis (an inflamed intestine)—Should not be used in babies with these conditions.

• Liver disease—Use with caution. Effects may be increased because the medicine may be removed from the body more slowly.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

More common

• Abdominal or stomach pain
• ammonia-like breath odor
• bloody or black, tarry stools
• coma
• confusion
• constipation
• convulsions
• decreased urine output
• difficult breathing
• dizziness
• fast or irregular heartbeat
• headache, sudden, severe
• increased thirst
• irregular heartbeat
• loss of appetite
• muscle pain or cramps
• nausea and vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• severe stomach pain
• shortness of breath
• swelling of the face, ankles, or hands
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weakness or heaviness of the legs
• weight loss

Less common

• Anxiety
• blurred vision
• chills
• cold sweats
• cool, pale skin
• depression
• full or bloated feeling
• heartburn
• increased hunger
• indigestion
• nightmares
• noisy, rattling breathing
• pressure in the stomach
• seizures
• severe abdominal or stomach pain, cramping, or burning
• severe constipation
• severe vomiting
• shakiness
• slurred speech
• swelling of the abdominal or stomach area
• swelling of the fingers, hands, feet, or lower legs
• troubled breathing at rest
• unusual bruising or bleeding
• vomiting of material that looks like coffee grounds, severe and continuing
• 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.

In the U.S.

• Indocin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

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.

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