Supplement-A treatment for apnea
Roxane Laboratories and Boehringer Ingelheim Pharmaceuticals in Columbus, OH, recently announced Food and Drug Administration approval of CAFCIT (caffeine citrate) Injection for the short-term treatment of apnea of prematurity in infants between 28 and 33 weeks gestational age. CAFCIT is the only product approved for the treatment of apnea of prematurity, a condition that causes cessation of breathing in preterm infants, and one of only three drugs approved for neonatal use.
Results from a multicenter, randomized, double-blind, placebo-controlled trial of 85 preterm infants with apnea of prematurity demonstrated that CAFCIT significantly reduced apnea events on day two of treatment by 26.7% vs. 8.1% for placebo. The mean number of days with no apnea events was 3.0 in the CAFCIT group vs. 1.2 in the placebo group. The mean number of days with a 50% reduction from baseline apnea events was 6.8 in the CAFCIT group and 4.6 in the placebo group. Overall, adverse events were similar between CAFCIT and placebo in the clinical trial.
For prescribing information, call Roxanne Labora tories at (800) 962-8364.
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