Alprostadil - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Alprostadil. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used where ventilatory assistance is immediately available.
WARNINGS See WARNING box.
NOTE : Alprostadil injection must be diluted before it is administered.
See dilution instructions in DOSAGE AND ADMINISTRATION section.
The administration of alprostadil injection to neonates may result in gastric outlet obstruction secondary to antral hyperplasia.
This effect appears to be related to duration of therapy and cumulative dose of the drug.
Neonates receiving alprostadil injection at recommended doses for more than 120 hours should be closely monitored for evidence of antral hyperplasia and gastric outlet obstruction.
Alprostadil injection should be infused for the shortest time and at the lowest dose that will produce the desired effects.
The risks of long-term infusion of alprostadil injection should be weighed against the possible benefits that critically ill infants may derive from its administration.
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