Limited data exist regarding sildenafil pharmacokinetics and pharmacodynamics in neonates. Studies suggest significantly longer elimination half-lives compared to adults, potentially reaching 70-100 hours. This prolonged elimination is largely due to immature hepatic and renal function. Consequently, clinicians must carefully adjust dosing regimens to prevent potential adverse effects.
The primary pharmacodynamic effect, vasodilation, is likely also altered in neonates. Reduced vascular responsiveness might require higher doses for therapeutic efficacy in certain conditions, but this warrants further research and careful monitoring.
Lower doses and extended dosing intervals are generally recommended to minimize the risk of adverse reactions such as hypotension and apnea. Close monitoring of vital signs, including blood pressure, heart rate, and respiratory rate, is paramount.
Individual patient factors, including gestational age, postnatal age, and underlying disease states, significantly influence sildenafil’s pharmacokinetics and pharmacodynamics. Therefore, individualized treatment plans are necessary. Thorough assessment before initiating therapy and continuous monitoring during treatment are critical for optimal safety and efficacy.
Further research is needed to establish clearer pharmacokinetic and pharmacodynamic parameters specific to neonatal populations and various disease indications. This research should include larger, well-designed clinical trials to provide more robust data on optimal dosing and safety profiles.
