Indomethacin (Intravenous route)
- Powder for Solution
Acetic Acid (class)
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of indomethacin injection in premature babies.
No information is available on the relationship of age to the effects of indomethacin injection in geriatric patients.
|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.|
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.
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.
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.
- Beta Glucan
- Dabigatran Etexilate
- Pentosan Polysulfate Sodium
- Protein C
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.
- Azilsartan Medoxomil
- Candesartan Cilexetil
- Enalapril Maleate
- Ethacrynic Acid
- Olmesartan Medoxomil
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 of This Medicine:
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 While Using This Medicine:
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 of This Medicine:
- More common
- Abdominal or stomach pain
- ammonia-like breath odor
- bloody or black, tarry stools
- decreased urine output
- difficult breathing
- fast or irregular heartbeat
- headache, sudden, severe
- increased thirst
- irregular heartbeat
- loss of appetite
- muscle pain or cramps
- nausea and vomiting
- 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
- blurred vision
- cold sweats
- cool, pale skin
- full or bloated feeling
- increased hunger
- noisy, rattling breathing
- pressure in the stomach
- severe abdominal or stomach pain, cramping, or burning
- severe constipation
- severe vomiting
- 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
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:
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.
Last Updated: 11/4/2014