Indomethacin (Intravenous)

This injection treats heart disorders in premature babies and is an option for treatment when other methods of medical care for PDA do not work.

Overview

Indomethacin is an injection that treats PDA (patent ductus arteriosus) for infants who are premature (newborn babies who were born earlier than they should) with a weight ranging from 500 to 1750 grams. PDA is a condition where a blood vessel within the heart (ductus arteriosus) does not close properly after the baby is born. Babies only use this blood vessel before they are born, and it is not required after birth.

This injection helps the PDA narrow, which aids the blood vessel in closing. This medication is an option for treatment when other methods of medical care for PDA do not work after a 48-hour period. It is administered in a medical care setting as the injection can only be given by a trained health care professional.

This medication can only be obtained with a valid prescription from your physician. It is only available in powder form for injection solution.

This medication is manufactured under the US brand name Indocin.

Condition treated

  • Infant patent ductus arteriosus

Type of medicine

  • Nonsteroidal anti-Inflammatory drug

Side Effects

In addition to the benefits indomethacin may provide, it may also cause undesirable side effects in the same way that other medications can. While it is not typical for each side effect to occur, the patient could require medical care if any of the below side effects do take place.

Consult with your nurse or doctor right away if the patient experiences any of the side effects below.

More Common Side Effects (Medical Care Required)

  • Weight loss
  • Weakness or tiredness (unusual)
  • Vomiting or nausea
  • Vomiting blood or other type of substances with a similar appearance to coffee grounds
  • Tingling or numbness in the lips, feet, or hands
  • Thirst increase
  • Tarry, black stools (bloody)
  • Swelling of hands, ankles, or face
  • Stomach pain (severe)
  • Stomach or abdominal pain
  • Reduced output of urine
  • Nervousness
  • Muscle cramps or pain
  • Heaviness or weakness of legs
  • Heartbeat irregularity or quickness
  • Heartbeat irregularity
  • Headache (severe, sudden)
  • Dizziness
  • Convulsions
  • Constipation
  • Confusion
  • Coma
  • Breathing difficulty
  • Breath shortness
  • Breath odor (ammonia-like)
  • Appetite loss

Less Common Side Effects (Medical Care Required)

  • Weight gain
  • Vomiting blood or other type of substances with a similar appearance to coffee grounds
  • Vomiting (severe)
  • Vision blurred
  • Unusual bleeding or bruising
  • Swelling of lower legs, feet, hands, or fingers
  • Stomach pressure
  • Stomach pain or abdominal pain, burning, or cramping (severe)
  • Stomach or abdominal area swelling
  • Speech slurring
  • Shakiness
  • Seizures
  • Rattled, noisy breathing
  • Pale, cool skin
  • Nightmares
  • Indigestion
  • Increased hunger
  • Heartburn
  • Difficulty breathing while resting
  • Depression
  • Constipation (severe)
  • Cold sweats
  • Chills
  • Bloated or full feeling
  • Anxiety

Additional side effects that were not included above could also take place for certain patients. If other effects are observed, be sure to consult with your doctor.

Contact your doctor if you are seeking medical advice regarding side effects. The FDA also accepts side effects reports, and they can be reached by calling 1-800-FDA-1088.

Dosage

A medical care professional such as a doctor or nurse will give this injection to the patient. The medication is administered by placing a needle into one of the baby's veins.

The recommended dose for indomethacin injection will vary depending on how old the baby is when they need the medication. One complete therapy course for indomethacin is three doses given through IV between 12 and 24 hours apart. Urine output should be monitored closely. If an output of urine is less than 0.6 mL per kg per hour when the second or third dose is given, the patient should not have any additional doses until urinary functions are normal.

The injection should be mixed with 1-2 mL of Sterile Sodium Chloride Injection, and 0.9% of Sterile Water for Injection (preservative-free). There has been an association of toxicity in neonates with benzyl alcohol (as preservative).

If there is any medication remaining after the injection, it needs to be discarded because the vial does not contain any preservative. Be sure to prepare a fresh vial of solution every time before administration.

Infusion should be given over the course of 20 to 30 minutes.

Interactions

Drug Interactions

While some medications should never be taken at the same time, in other instances two medications can be combined despite the chance that an interaction may take place. Under these circumstances, the physician may choose to reduce the dose, or they may decide to take other precautions to protect the patient. When receiving this injection, it is imperative that the medical care professional is aware if your child is already taking any of the medications below. The following list of interactions have been chosen due to their potential significance, however the list below is not completely all-inclusive.

Taking this injection with the following medications is not suggested. The physician may choose not to prescribe indomethacin or they may adjust the other medications the patient is prescribed to take.

  • Ketorolac

It is not typically suggested to take this medication with the medications below, however certain circumstances may require it. If the pediatrician chooses to prescribe both medications, they may lower the frequency or dose for either or both medications.

  • Xipamide
  • Warfarin
  • Vortioxetine
  • Vorapaxar
  • Vilazodone
  • Venlafaxine
  • Vasopressin
  • Valdecoxib
  • Trolamine Salicylate
  • Trimipramine
  • Trichlormethiazide
  • Triamterene
  • Treprostinil
  • Tolmetin
  • Tolfenamic Acid
  • Tirofiban
  • Tinzaparin
  • Ticlopidine
  • Ticagrelor
  • Tiaprofenic Acid
  • Tianeptine
  • Tenoxicam
  • Tacrolimus
  • Sulindac
  • Sulfasalazine
  • Spironolactone
  • Sodium Salicylate
  • Sibutramine
  • Sertraline
  • Salsalate
  • Salicylic Acid
  • Salicylamide
  • Rofecoxib
  • Rivaroxaban
  • Reviparin
  • Reboxetine
  • Protriptyline
  • Protein C
  • Proquazone
  • Propyphenazone
  • Proglumetacin
  • Probenecid
  • Prednisone
  • Prednisolone
  • Prasugrel
  • Pralatrexate
  • Potassium
  • Polythiazide
  • Piroxicam
  • Piketoprofen
  • Phenylbutazone
  • Phenyl Salicylate
  • Phenprocoumon
  • Phenindione
  • Pentoxifylline
  • Pentosan Polysulfate Sodium
  • Pemetrexed
  • Paroxetine
  • Parnaparin
  • Parecoxib
  • Paramethasone
  • Oxyphenbutazone
  • Oxaprozin
  • Opipramol
  • Olsalazine
  • Nortriptyline
  • Nimesulide Beta Cyclodextrin
  • Nimesulide
  • Niflumic Acid
  • Nepafenac
  • Nefazodone
  • Naproxen
  • Nadroparin
  • Nabumetone
  • Morniflumate
  • Milnacipran
  • Metolazone
  • Methylprednisolone
  • Methyclothiazide
  • Methotrexate
  • Mesalamine
  • Meloxicam
  • Melitracen
  • Mefenamic Acid
  • Meclofenamate
  • Meadowsweet
  • Magnesium Salicylate
  • Lumiracoxib
  • Loxoprofen
  • Lornoxicam
  • Lofepramine
  • Lithium
  • Levomilnacipran
  • Lepirudin
  • Ketoprofen
  • Indapamide
  • Imipramine
  • Iloprost
  • Ibuprofen
  • Hydroflumethiazide
  • Hydrocortisone
  • Hydrochlorothiazide
  • Heparin
  • Gossypol
  • Ginkgo
  • Fondaparinux
  • Fluvoxamine
  • Flurbiprofen
  • Fluoxetine
  • Fluocortolone
  • Flufenamic Acid
  • Floctafenine
  • Feverfew
  • Feprazone
  • Fepradinol
  • Fenoprofen
  • Felbinac
  • Etoricoxib
  • Etofenamate
  • Etodolac
  • Escitalopram
  • Eptifibatide
  • Epoprostenol
  • Eplerenone
  • Enoxaparin
  • Edoxaban
  • Duloxetine
  • Droxicam
  • Doxepin
  • Dothiepin
  • Dipyrone
  • Dipyridamole
  • Digoxin
  • Diflunisal
  • Dibenzepin
  • Diazoxide
  • Dexketoprofen
  • Dexibuprofen
  • Dexamethasone
  • Desvenlafaxine
  • Desirudin
  • Desipramine
  • Deflazacort
  • Danaparoid
  • Dalteparin
  • Dabigatran Etexilate
  • Cyclosporine
  • Cyclopenthiazide
  • Cortisone
  • Clopidogrel
  • Clopamide
  • Clonixin
  • Clomipramine
  • Citalopram
  • Cilostazol
  • Choline Salicylate
  • Choline Magnesium Trisalicylate
  • Chlorthalidone
  • Chlorothiazide
  • Certoparin
  • Celecoxib
  • Cangrelor
  • Bumetanide
  • Bufexamac
  • Budesonide
  • Bromfenac
  • Bivalirudin
  • Bismuth Subsalicylate
  • Betamethasone
  • Beta Glucan
  • Benzthiazide
  • Bendroflumethiazide
  • Bemiparin
  • Balsalazide
  • Aspirin
  • Argatroban
  • Ardeparin
  • Apixaban
  • Anagrelide
  • Amtolmetin Guacil
  • Amoxapine
  • Amitriptylinoxide
  • Amitriptyline
  • Amineptine
  • Amiloride
  • Acenocoumarol
  • Acemetacin
  • Aceclofenac
  • Abciximab

Having this medication with any of the medications below can cause a heightened chance of some side effects, however the combination of both prescriptions may be the most optimal form of treatment for the patient. If the pediatrician chooses to prescribe both medications, they may reduce the dose or frequency for either one or possibly both medications.

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

Other Interactions

Some prescriptions should not be taken around mealtime due to the possibility of interactions. Consult with the pediatrician to see if any type of milk or formula may impact the effectiveness of this medication.

Medical Interactions

Other medical issues the patient may have could impact the usefulness of this medication. Ensure that the physician is aware of other medical issues, specifically:

  • Bleeding (stomach bleeding or brain hemorrhage)
  • Bleeding issues (thrombocytopenia)
  • Congenital heart disease
  • Infection (untreated)
  • Kidney issues
  • Inflamed intestine, known or suspected (necrotizing enterocolitis). Infants with these conditions should not have this injection
  • Liver disease (take caution; side effects could be increased due to slower removal of the medication from the body)

Warnings

When choosing whether or not a child should take a certain medication, the parents or caregivers and the doctor should carefully compare the likely benefits against the potential risks. Consider the following aspects for this medication.

This injection could impact how well the body can defend itself if an infection takes place. Your child's physician will watch carefully for infection signs, including chills, fever, or other types of abnormal behavior.

This medication may impact how platelets act, and platelets are imperative for proper blood clotting within the body. This could mean that your child may experience increased bleeding. Parents or caregivers and the pediatrician should monitor the child for bruising or bleeding that is unusual, stools or urine that is dark in color, or any other symptoms of bleeding.

This medication may reduce the total volume of urine your child produces. This could raise the likelihood of your child developing kidney issues or having low sodium levels within the blood (this condition is known as hyponatremia). Urine and blood tests should be conducted to monitor for potential signs of risks.

Liver issues can take place while your infant is receiving this injection. Discontinue indomethacin use and consult with your infant's pediatrician immediately if your child is experiencing one or more of the following symptoms: abdominal tenderness or pain; stools that are clay-colored; urine that is dark in color; lower appetite than usual; headache; fever; yellow skin or eyes; weakness or tiredness (unusual); swelling of the lower legs or feet; skin rash; vomiting and nausea; or loss of appetite.

Only take this medication as prescribed by your child's pediatrician. Do not take indomethacin in combination with other medications unless previously approved by your physician. This refers to nonprescription and prescription medications including vitamin and herbal supplements.

Allergies

Be sure to inform your physician if you experience any allergic or unusual reactions to this medication or other drugs. Also inform your child's medical care professional if they have any kind of allergy, including allergies to animals, preservatives, dyes, or foods. Always carefully read the package label ingredients summary carefully for all products that are not prescribed by your physician (non-prescription drugs).

Specific Demographic Use

Pediatric

Current research has not yet shown any correlation between the pediatric problem and issues with indomethacin that would limit the effectiveness of this medication for babies who are premature.

Geriatric

There has not yet been research demonstrating any effects different from adult side effects for elderly patients taking the indomethacin injection.

Pregnancy

Research has proven that there is a danger to the unborn baby during the third trimester of a woman's pregnancy. However, in a situation that may be life-threatening patients may benefit more from taking the medication to provide therapeutic effects.

Breastfeeding

No research has been conducted regarding whether or not breastfeeding while taking this medication will cause potential risk for the infant. Mothers should compare the potential benefits of taking indomethacin against the possible danger that the medication could cause.

Storage

Your medical care professional will ensure that this medication is stored properly as it must be administered in a medical facility such as a hospital or doctor's office.

Summary

Indomethacin is a medication that treats PDA for infants born prematurely weighing 500 to 1750 grams. PDA causes a blood vessel within the heart to close improperly after the baby is born. Babies only use this blood vessel before they are born, and it is not needed after birth.

This medication aids the PDA in becoming narrower, and this aids the blood vessel in closing. This injection is only prescribed when other methods of care for PDA are ineffective after a 48-hour period. This vaccine is given in a medical setting as it can only be given by a trained medical care professional.