What is the recommended dose of Sildenafil (generic name) for neonates with secondary pulmonary hypertension?

From the Guidelines

For neonates with secondary pulmonary hypertension, the recommended dose of Sildenafil is 0.5–1 mg/kg 3 times daily orally, as stated in the guidelines from the American Heart Association and American Thoracic Society 1. This dose is recommended for neonates less than 1 year old, and it is essential to note that the dose should be adjusted based on the patient's weight, with a maximum dose of 10 mg 3 times daily orally for patients weighing less than 20 kg. The guidelines also emphasize the importance of avoiding higher dosing in children due to the increased risk of mortality noted in the STARTS-2 study 1. It is crucial to monitor patients closely during therapy, including continuous pulse oximetry, blood pressure measurements, and echocardiographic assessments to evaluate treatment response. Some key points to consider when using Sildenafil in neonates with secondary pulmonary hypertension include:

• The dose should be titrated based on clinical response and tolerance
• Patients should be monitored for common side effects such as hypotension, headache, and flushing
• Sildenafil should be used cautiously in neonates with cardiovascular instability, and dose adjustments may be necessary for patients with hepatic or renal impairment
• The use of Sildenafil in neonates should be guided by the latest clinical guidelines and expert recommendations, such as those from the American Heart Association and American Thoracic Society 1, 2.

From the Research

Recommended Dose of Sildenafil for Neonates

• The recommended dose of sildenafil for neonates with secondary pulmonary hypertension is not universally established, but several studies provide guidance on dosing.
• A study published in 2010 3 used a dose of 3 mg/kg of oral sildenafil every 6 hours in full-term infants with persistent pulmonary hypertension.
• A more recent study from 2022 4 started with a dose of 1 mg/kg/dose thrice a day and increased to 2 mg/kg/dose after 48 hours if the partial pressure of oxygen did not increase.
• Another study from 2013 5 used a starting dose of 0.5 mg/kg and increased it gradually to a maximum dose of 2 mg/kg in infants with moderate-to-severe pulmonary hypertension.

Considerations for Dosing

• The dose of sildenafil may need to be adjusted based on the individual patient's response to treatment, as well as their underlying medical condition.
• The studies suggest that sildenafil can be effective in improving oxygenation parameters and reducing mortality in neonates with pulmonary hypertension, but the optimal dosing regimen may vary depending on the specific patient population and clinical context.
• It is essential to monitor patients closely for adverse effects and adjust the dose accordingly, as noted in the study from 2015 6, which reported no serious adverse effects with sildenafil therapy in infants with bronchopulmonary dysplasia-associated pulmonary hypertension.