(indomethacin, MSD)

PLEASE READ ALL OF THIS LEAFLET CAREFULLY IF YOUR BABY HAS BEEN GIVEN OR WILL BE GIVEN INDOCID PDA INJECTION.

Keep this leaflet. You may want to read it again.

The active ingredient in Indocid PDA injection is indomethacin sodium USP. Each vial contains indomethacin sodium equivalent to 1.0 mg indomethacin as a sterile powder for reconstitution with sterile water.

There are no other ingredients.

Indocid PDA injection is available in cartons of three 1 ml vials.

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 the lungs and circulate to the rest of the 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. The medical term for this condition is 'patent ductus arteriosus', i.e. an unclosed ductus arteriosus. If the ductus arteriosus is not closed it can cause heart problems in your baby. Indocid PDA, when given to your baby, can help to close the ductus arteriosus.

It is not known exactly how indomethacin works, but it is believed that it closes a ductus arteriosus by inhibiting the production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus arteriosus open.

Indocid PDA is made by Merck Manufacturing Division, Merck & Co., Inc., West Point, Pennsylvania, USA, for Merck Sharp & Dohme Limited, Hertford Road Hoddesdon, Hertfordshire, who hold the Product Licence in the UK and Product Authorisation in Eire.

Your doctor has prescribed Indocid PDA for your baby because your baby has a ductus arteriosus which has not closed properly. Indocid PDA should close this vessel.

Indocid PDA should not be given to babies if:

1. they have an infection which has not been treated.
2. they are bleeding, especially if the bleeding is inside the skull or in the intestines.
3. they have other problems with their heart which require the ductus arteriosus to remain open so that adequate circulation of the blood is maintained.
4. they have problems with their blood clotting.
5. they have certain problems with their intestines.
6. they have kidney problems.

Your baby's doctor will be aware of these, but if you are worried or confused, talk to the doctor treating your baby.

There are other things regarding Indocid PDA which you should know about and these are given below.

Treatment with Indocid PDA should be stopped if your baby is suspected of having liver disease, signs and symptoms of which include yellowing of the skin and eyes.

Indomethacin may reduce the ability of your baby's blood to clot. Your baby should therefore be watched for signs of prolonged bleeding.

Indocid PDA should be carefully administered to your baby by the healthcare professional, to avoid damage to the skin and surrounding tissues.

Your baby may develop some bleeding from the intestines. To detect this, your baby's stools may be tested to determine if there is any blood present in them.

Premature babies may start bleeding inside the brain. As indomethacin may reduce the ability of your baby's blood to clot, the potential for your baby to start bleeding inside the brain may increase.

Indocid PDA may reduce the amount of urine your baby passes. If this is significant, your baby's treatment may be stopped until the volume of urine passed by your baby returns to normal. Serious kidney problems, including renal failure, may occur in some babies who receive Indocid PDA, however this is most likely to occur in babies who are already sick with other problems.

Your baby may develop low levels of sodium (a naturally occurring chemical in your baby's body) in the blood; therefore, your baby's kidney function and blood should be monitored.

If you are worried or confused by any of the above, you should talk to the doctor treating your baby.

There are certain medicines which, if given together with Indocid PDA, may cause unwanted effects. These are detailed below.

Your baby may have problems passing urine and may have been prescribed frusemide. Indocid PDA can reduce the effect of this drug.

Your baby may be given gentamicin or amikacin to treat an infection. Indocid PDA may increase the levels of these antibiotics in your baby's blood.

Your baby may have been given digitalis to help a heart disorder. Indocid PDA can prolong the effect of this drug. Your baby should therefore be frequently checked by an ECG (electrocardiogram), which is a technique used to monitor the heart, and the level of digitalis in the blood should be measured.

Your baby's doctor will be aware of the effect g Indocid PDA can have with these drugs, but if you are worried or confused, you should talk to the doctor treating your baby.

Babies with patent ductus arteriosus are often cared for in a special neonatal intensive care unit where your baby's condition can be closely monitored. Your baby will have been given or is about to be given Indocid PDA injection by a healthcare professional, who will know how to prepare the injection prior to administration.

Indocid PDA is usually given as a course of three injections, each injection being given at 12- to 24-hour intervals. The amount of Indocid PDA given depends close(y on the age and weight of your baby.

If your baby's ductus arteriosus is closed or significantly reduced in size 48 hours after the first course of therapy (i.e. 3 injections), no further treatment is necessary. If your baby's ductus arteriosus reopens, a second course of therapy may be given.