Apnea of prematurity

Respiratory pause longer than 20 seconds or shorter with bradycardia and desaturation in preterm infants. Drug of choice per AAP is caffeine citrate; theophylline is used when caffeine is unavailable.

ICD-10 P28.41 drug

Also known as: AOP

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

FTheophyllineNot recommended · MethylxanthineIn apnea of prematurity, caffeine citrate is preferred: fewer adverse effects, a wider therapeutic window, no routine serum monitoring required. Theophylline is reserve therapy used only when caffeine is unavailable or not tolerated. A 2010 Cochrane meta-analysis showed comparable efficacy in apnea episode counts but less tachycardia, dyspepsia, and agitation with caffeine.

How to read tiers A–F

Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit