Colfosceril; Cetyl Alcohol; Tyloxapol suspension

What is colfosceril?

COLFOSCERIL, CETYL ALCOHOL, TYLOXAPOL (Exosurf®) is a lung surfactant, a medicine that will help the lungs to function normally. This product is a combination of three ingredients that together imitate the natural fluid present in the lungs essential for the correct flow of oxygen from the air into the body. It is administered to premature babies whose lung tissue has not fully developed, or to small babies who show signs of breathing difficulties and develop what is known as respiratory distress syndrome (RDS). It is only administered under careful supervision and in a hospital setting soon after birth, by direct application into the babies trachea (windpipe). Exosurf® is a suspension that must be prepared immediately before use in single-use vials. Exosurf® is also referred to as colfosceril. This product is not available generically.

What should my health care professional know before use of Exosurf®?

They need to know if you have any of these conditions:

• the possibility that breathing difficulties are caused by some condition other than respiratory distress syndome must be ruled out before treatment begins. The baby may be given an x-ray to determine the cause of breathing difficulties.

How should I use this medicine?

Exosurf® is only for the treatment or prevention of respiratory distress syndrome in newborn infants. It is given by under a prescriber's supervision in a hospital setting.

What if I miss a dose?

This does not apply.

What drug(s) may interact with Exosurf®?

There are no known interactions with other medicines.

What should I watch for while taking Exosurf®?

This does not apply.

What side effects may I notice from using Exosurf®?

There are few side effects directly caused by use of Exosurf®. There is a possibility that the baby will be deprived of oxygen during administration of Exosurf® as the suspension flows into the lungs. There is also the possibility that if the lungs recover very rapidly too much oxygen will enter the blood stream. These conditions require that the baby remains under constant supervision during, and for some time after, Exosurf® administration and remains connected to an artificial ventilator (on oxygen).

Where can I keep my medicine?

Before preparation of the suspension, store between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture.