Indomethacin sodium trihydrate
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Indomethacin IV Mylan. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of Indomethacin IV Mylan against the benefits they expect it will have for your baby.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Indomethacin IV Mylan is used for
Indomethacin IV Mylan is used in premature babies to close the patent ductus arteriosus.
While a baby is inside its mother's womb it does not need to use its lungs. An unborn baby has a blood vessel called a 'ductus arteriosus' near the heart which allows the baby's blood to bypass its lungs and circulate to the rest of its body.
When the baby is born and starts using its lungs the ductus arteriosus normally closes up.
However, in some cases this does not happen. This can cause heart problems in the baby.
The doctor has prescribed Indomethacin IV Mylan for your baby because your baby has a ductus arteriosus which has not closed properly. Indomethacin IV Mylan can help close this blood vessel.
If the ductus arteriosus remains open, blood intended for the body may be returned to the lungs, overloading the lung's blood vessels, making the lungs and heart work harder to pump blood to the rest of the body. This can lead to failure to gain weight, shortness of breath, a fast heart rate, frequent chest infections, and sometimes heart failure.
In premature infants the extra blood flow to the lungs may interfere with the functioning of the heart and, even more significantly, with that of the lungs which are immature. In these cases, fluid restriction, Indomethacin IV Mylan, or surgery may be used to close the ductus.
Indomethacin IV Mylan belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
It is not known exactly how Indomethacin IV Mylan works, but it is believed that it stops the production of prostaglandin.
Prostaglandin is a naturally occurring chemical in the body which keeps the ductus arteriosus open.
Indomethacin IV Mylan is not addictive.
Before your baby receives Indomethacin IV Mylan
When your baby must not be given it
Indomethacin IV Mylan should not be given to your baby if:
your baby has proven or suspected infection that is not being treated
your baby has bleeding, especially in the brain or stomach
your baby has a low blood platelet count
your baby has blood clotting problems
your baby has or is suspected of having an intestinal problem, called necrotising enterocolitis
your baby has significantly impaired kidney function.
your baby has heart disease at birth and it is necessary for them to have a patent ductus arteriosus for satisfactory blood flow in the lungs and throughout the body.
your baby has a peptic ulcer (ie stomach or duodenal ulcer), a recent history of one, or has had peptic ulcers before
Indomethacin IV Mylan should not be given if:
the packaging is torn or shows signs of tampering
the expiry date (EXP) printed on the pack has passed.
If the medicine is given after the expiry date has passed, it may not work.
Your baby's doctor will be aware of these, but if you are worried or confused, talk to the doctor treating your baby.
Before your baby is given it
There are other things regarding Indomethacin IV Mylan which the baby's doctor should know about. These include, if:
1. your baby has any allergies to:
any other medicines including aspirin or other NSAID medicines
any other substances, such as foods, preservatives or dyes
2. your baby has or has had any medical conditions, especially the following:
kidney or liver disease
heart disease
heart failure
high blood pressure
build-up of fluid
3. your baby currently has an infection
If Indomethacin IV Mylan is used while your baby has an infection, it may hide some of the signs of an infection. This may make you think, mistakenly, that your baby is better or that the infection is less serious than it might be.
These are things that your baby's doctor will look out for.
Taking other medicines
There are certain medicines, which if given together with Indomethacin IV Mylan, may cause unwanted effects. These include:
aspirin, salicylates or other NSAID
medicines
digoxin, a medicine used to treat heart failure
diuretics, also called fluid or water tablets
certain blood pressure medicines
gentamicin or amikacin, antibiotics used to treat infection
These medicines may be affected by Indomethacin IV Mylan, or may affect how well it works. Your baby may need to take different amounts of medicine, or may need to take different medicines.
Your baby's doctor will be aware of the effects Indomethacin IV Mylan and these medicines can have on each other, but if you are worried or confused, you should talk to the doctor.
How Indomethacin IV Mylan is given
Babies with patent ductus arteriosus are cared for in a special newborn intensive care unit where the baby's condition is closely monitored. Your baby will be given Indomethacin IV Mylan injection by a doctor or nurse, who will know how to make up the injection. They will do this by adding sterile water or saline (salt and water) to the vial.
The doctor will decide what dose and how long your baby will receive Indomethacin IV Mylan. This depends on their condition and other factors, such as their age and weight.
Side effects
Tell the doctor or nurse as soon as possible if your baby appears unwell while receiving Indomethacin IV Mylan
Indomethacin IV Mylan helps most babies with patent ductus arteriosus but it may have unwanted side effects in a few babies.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. Your baby may need medical treatment if they get some of the side effects.
Ask the doctor or, nurse to answer any questions you may have.
Tell the doctor or nurse if your baby has any of the following and they worry:
oozing from the skin after needle puncture
Tell the doctor or nurse immediately if your baby has any of the following:
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
vomiting blood or material that looks like coffee grounds
any other unusual bleeding or bruising
vomiting, stomach bloating, diarrhoea
fluid retention, weight gain
passing less urine than is normal
These are serious side effects. Your baby may need urgent medical attention.
Other side effects have been reported in adults taking indomethacin for the treatment of different types of arthritis and shoulder pain, and may occur in babies given Indomethacin IV Mylan These include:
constipation
signs of liver problems, including, yellowing of the skin and eyes, stomach swelling, and dark coloured urine
convulsions, coma
asthma, wheezing, shortness of breath
sudden or severe itching, skin rash, hives
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing.
Other side effects not listed above may also occur in some patients. Tell the baby's doctor if you notice any other effects.
Do not be alarmed by this list of possible side effects. Your baby may not experience any of them.
Storage
Indomethacin IV Mylan will be stored in the hospital pharmacy or on the ward.
It is kept in a cool dry place where it is protected from light and where the temperature stays below 25°C.
Product description
What it looks like
Indomethacin IV Mylan comes as a white to yellow lyophilised powder or plug in a single dose vial. It is made up into a solution for injection before being given to your baby.
Ingredients
Active ingredient:
Indomethacin sodium trihydrate, equivalent to indomethacin 1 mg per vial
