" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
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Survanta Patient Information Including Side Effects
Brand Names: Survanta Intratracheal
Generic Name: beractant (Pronunciation: ber AK tant)
- What is beractant (Survanta)?
- What are the possible side effects of beractant (Survanta)?
- What is the most important information I should know about beractant (Survanta)?
- What should I discuss with my health care provider before my child receives beractant (Survanta)?
- How is beractant given (Survanta)?
- What happens if my child misses a dose (Survanta)?
- What happens if my child receives an overdose (Survanta)?
- What should be avoided after my child receives beractant (Survanta)?
- What other drugs will affect beractant (Survanta)?
- Where can I get more information?
What is beractant (Survanta)?
Beractant is a lung surface acting agent, or "surfactant." It helps the lungs function normally. Beractant is similar to the natural fluid in the lungs that helps maintain effective breathing.
Beractant is used to treat or prevent respiratory distress syndrome (RDS) in a premature baby whose lungs have not fully developed.
Beractant may also be used for purposes not listed in this medication guide.
What are the possible side effects of beractant (Survanta)?
There is a possibility that the baby will have breathing difficulties during the beractant treatment, and these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with beractant.
Tell your child's caregivers at once if the child has any of these serious side effects:
- pale skin;
- slow heartbeat;
- breathing that stops;
- urinating less than usual; or
- blood in the urine.
Less serious side effects include:
- noisy breathing;
- feeding or bowel problems; or
- bleeding around the endotracheal tube.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Survanta (beractant) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about beractant (Survanta)?
Your baby will receive this medication in a neonatal intensive care unit (NICU) or similar hospital setting.
Beractant is given directly into the baby's lungs through a breathing tube that is also connected to a ventilator (a machine that moves air in and out of the lungs to help your baby breathe easier and get enough oxygen).
Your baby will remain under constant supervision during treatment with beractant.
Follow your doctor's instructions about any restrictions on feeding or other medications after your child has been treated with beractant.
Additional Survanta Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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