Neonatal Drug Therapy Manual

Sildenafil

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Updated October 24, 2024 - 2:29pm

Alternate Name(s): 
Sildenafil Citrate, Revatio, Viagra
Classification: 
Phosphodiesterase Type-5 Inhibitor
Original Date: 
December 2008
Revised Date: 
October 2024
Indications: 
  • Treatment of persistent pulmonary hypertension of the newborn (PPHN) refractory to treatment with inhaled nitric oxide
Administration: 
  • IV continuous infusion with loading dose
    • ​Loading dose: over 3 hours
  • IV intermittent infusion
    • Infuse over 1 hour (reported range is 15 minutes to 3 hours). Longer infusion times are commonly used to minimize risk of hypotension 
  • PO
    • ​Dilute in small amount of water or feeds
Dosage: 
  • IV
    • Continuous Infusion: loading dose of 0.4 mg/kg over 3 hours, followed by a continuous infusion of 1.6 mg/kg/day
    • Intermittent IV infusion:
      • Initial dose of 0.125- 0.5 mg/kg/dose every 6-8 hours. Titrate by 0.125- 0.5 mg/kg/dose to a recommended max of 1 mg/kg/dose
  • PO
    • Initial recommended dose: 0.5-1 mg/kg/dose every 6-8 hours
    • Range: 0.5- 2 mg/kg/dose every 6-8 hours 
    • Maximum: 2 mg/kg/dose PO Q4h
Side Effects: 
  • CVS: hypotension, tachycardia
  • Dermatologic: rash
  • GI: diarrhea, dyspepsia
Parameters to Monitor: 
  • BP, HR
Reconstitution and Stability: 
  • IV formulation may be administered at a concentration of 0.8 mg/mL undiluted
Compatibility: 
  •  Solution Compatible : D5W
  •  Y-Site Compatible: SMOF
Notes: 
  • A 10 mg dose of the injection is predicted to have an effect equal to a 20 mg oral dose taking into consideration the parent drug and active metabolite
References: 
  • Steinhorn RH, Kinsella JP, Pierce C, et al. Intravenous Sildenafil in The Treatment of Neonates with Persistent Pulmonary Hypertension.  J Pediatr 2009; 155: 841-7
  • Baquero H, Soliz A, Neira F, Veneqas ME, Sola A. Oral sildenafil in infants with persistent pulmonary hypertension of the newborn: a pilot randomized blinded study. Pediatrics 2006; 117: 1077-83
  • Herrea J, Castillo R, Concha E, Soliz A. Oral sildenafil treatment as an alternative to inhaled NO therapy for persistent pulmonary hypertension of the newborn. In: E-PAS 2006: 59: 3724.3
  • Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook 20th Edition. Hudson: Lexi-Comp Inc.; 2013
  • Chen J, Lau E (Editors). Drug Handbook and Formulary - The Hospital for Sick Children 2013-14. Toronto: Lexi-Comp Inc; 2013
  • Abman SH, Hansmann G, Archer SL, et al. Pediatric pulmonary hypertension: guidelines from the American Heart Association and American Thoracic Society. Circulation. 2015;132(21):2037-2099. 
  • Ahsman MJ, Witjes BC, Wildschut ED, et al. Sildenafil exposure in neonates with pulmonary hypertension after administration via a nasogastric tube. Arch Dis Child Fetal Neonatal Ed. 2010;95(2):F109-F114.  
  • Al Omar S, Salama H, Al Hail M, et al. Effect of early adjunctive use of oral sildenafil and inhaled nitric oxide on the outcome of pulmonary hypertension in newborn infants. A feasibility study. J Neonatal Perinatal Med. 2016;9(3):251-259. 
  • El-Ghandour M, Hammad B, Ghanem M, Antonios MAM. Efficacy of milrinone plus sildenafil in the treatment of neonates with persistent pulmonary hypertension in resource-limited settings: results of a randomized, double-blind trial. Paediatr Drugs. 2020;22(6):685-693.  
  • Hussain AS, Ali R, Ahmed S, Naz F, Haroon A. Oral sildenafil use in neonates with persistent pulmonary hypertension of newborn. J Ayub Med Coll Abbottabad. 2017;29(4):677-680.
  • Kamran A, Rafiq N, Khalid A, et al. Effectiveness of oral sildenafil for neonates with persistent pulmonary hypertension of newborn (PPHN): a prospective study in a tertiary care hospital. J Matern Fetal Neonatal Med. 2022;35(25):6787-6793.
  • Chetan C, Suryawanshi P, Patnaik S, et al. Oral versus intravenous sildenafil for pulmonary hypertension in neonates: a randomized trial. BMC Pediatr. 2022;22(1):311.
  • Darland LK, Dinh KL, Kim S, et al. Evaluating the safety of intermittent intravenous sildenafil in infants with pulmonary hypertension. Pediatr Pulmonol. 2017;52(2):232-237.
  • Fender RA, Hasselman TE, Wang Y, Harthan AA. Evaluation of the tolerability of intermittent intravenous sildenafil in pediatric patients with pulmonary hypertension. J Pediatr Pharmacol Ther. 2016;21(5):419-425.
  • Sharma C, Burns J, Kulkarni A, Cerise JE, Molina Berganza F, Hayes DA. Continuous and intermittent administration of intravenous sildenafil in critically ill infants with pulmonary hypertension. Pediatr Pulmonol. 2021;56(9):2973-2978. 
  • Stultz JS, Puthoff T, Backes C Jr, Nahata MC. Intermittent intravenous sildenafil for pulmonary hypertension management in neonates and infants. Am J Health Syst Pharm. 2013;70(5):407-413. 

Special thanks to Kristina Toppari, Pharmacy Student, for work on this monograph.

 

The information contained on this website is provided for informational purposes only, as a guide to assist physicians, nurses and other healthcare providers in deciding on the appropriate care required for a particular patient. At all times, physicians, nurses and other healthcare providers must exercise their independent clinical judgment, based on their knowledge, training and experience, taking into account the specific facts and circumstances of each patient, when deciding on the appropriate course of investigation and/or treatment to recommend in a particular clinical situation.

CHEO has made every effort to ensure that the information contained on this website is as current and accurate as possible. However, changes can occur due to ongoing research and the constant influx of new information. Where possible, hospitals and healthcare practitioners should verify the information before acting on it.

Reliance on any information in this website is at the user's own risk. CHEO is not responsible or liable for any harm, loss or other consequences from the use or misuse of the information on this website.