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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  03/02/2020
 
Trade Name:  Cafcit Injection
 
Generic Name or Proper Name (*):  caffeine citrate
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *Expanded indication to include a broader gestational age (GA) range of premature infants. The lower and upper GA limits were removed from the Indications and Usage; previously indicated for the short-term use in infants between 28 - <32 weeks gestational age. *The term "short-term" was removed from the Indications and Usage section allowing for a longer treatment duration. *In a published randomized, placebo-controlled, clinical trial that studied the use of caffeine citrate in apnea of prematurity in approximately 2000 patients, necrotizing enterocolitis was not more common in caffeine treated patients compared to placebo. *Information on dosing, adverse reactions, and clinical trial. *Off-patent Written Request.
 
BPCA(B):  B
 
Sponsor:  Hikma Pharmaceuticals International Limited
 
NNPS:  FALSE
 
Therapeutic Category:  Bronchial smooth muscle relaxant
 
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