Lucinactant (Intratracheal)

Lucinactant injection is used to prevent respiratory distress syndrome (RDS) in premature infants who are at risk for RDS. RDS is a lung problem that is more common in premature infants because their lungs do not produce enough surfactant. Surfactant is a liquid made naturally in the lungs that helps an infant breathe air normally.

This medicine should only be given by a doctor or under the direct supervision of a doctor.

It is very important that your child's doctor monitors your child's progress closely while receiving the medicine. This will help the doctor determine if the medicine is working properly and decide if your child should continue to receive it.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the usefulness of lucinactant injection in premature infants.

Geriatric

There is no information available on how age affects the effects of lucinactant injection in older patients.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or take other precautions. Let your healthcare professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around meal times, or with certain types of food, due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Acute respiratory distress syndrome—Surfaxin® is not indicated for use in patients with this condition.

• Airway blockage or
• Bradycardia (slow heartbeat)—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bluish lips or skin
• cough
• coughing up blood
• fast heartbeat
• fever or chills
• pale skin
• rapid, shallow breathing
• shortness of breath
• slow heartbeat
• sneezing
• troubled breathing
• wheezing

Incidence not known

• Blue or white in color
• heart may stop
• no oxygen to lungs
• patient unresponsive

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to suggest ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• clay-colored stools
• coma
• convulsions
• dark urine
• decreased urine output
• fruit-like breath odor
• loss of appetite
• rapid, deep breathing
• rash
• restlessness
• sweating
• swelling of the face, ankles, or hands
• unusual bleeding or bruising
• vomiting of blood
• yellow eyes or skin

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.

In the U.S.

• Surfaxin

Available Dosage Forms:

• Suspension

Therapeutic Class: Lung Surfactant

A doctor or other trained health professional will give your child this medicine in a hospital. This medicine is given directly into your child's lungs through his endotracheal (breathing) tube.