WARNINGS
Priscoline stimulates gastric secretion and may activate stress ulcers. Through this mechanism, it can produce significant hypochloremic alkalosis. Pretreatment of infants with antacids may prevent gastrointestinal bleeding.
Patients should be observed closely for signs of systemic hypotension, and supportive therapy should be instituted if needed.
In patients with mitral stenosis, parenterally administered Priscoline may produce a rise or fall in pulmonary artery pressure and total pulmonary resistance; therefore, it must be used with caution in patients with known or suspected mitral stenosis.
PRECAUTIONS
General
The effects of Priscoline on pulmonary vessels may be pH dependent. Acidosis may decrease the effect of Priscoline.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies in animals have not been performed with Priscoline.
Pregnancy Category C
Animal reproduction studies have not been conducted with Priscoline. It is also not known whether Priscoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Priscoline should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Priscoline is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
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