Last update April 15, 2024

Sildénafil

Compatible

Safe product and/or breastfeeding is the best option.

A 5-phosphodiesterase inhibitor used in the treatment of pulmonary hypertension, erectile dysfunction in men, Raynaud's syndrome and in other treatments due to its vasodilatory effect on smooth muscle. Its use is authorized in small infants and neonates to treat pulmonary hypertension (Lakshminrusimha 2016, Krishnan 2010). Sildenafil and its metabolite N-desmethylsildenafil are excreted in breast milk in clinically insignificant amounts, much lower than the dose used in newborns and infants (Wollein 2016).

Alternatives

We do not have alternatives for Sildénafil since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Tradenames

Main tradenames from several countries containing Sildénafil in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 41 (25 - 63) %
Molecular weight 667 daltons
Protein Binding 96 %
VD 1.5 l/Kg
Tmax 1 (0.5 - 2) hours
4 (3 - 5) hours
Theoretical Dose 0.00003 - 0.00067 mg/Kg/d
Relative Dose 0.042 - 0.06 %

References

  1. Nauwelaerts N, Ceulemans M, Deferm N, Eerdekens A, Lammens B, Armoudjian Y, Van Calsteren K, Allegaert K, de Vries L, Annaert P, Smits A. Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project. Front Pharmacol. 2022 Jun 15;13:881084. Abstract Full text (link to original source)
  2. Wollein U, Schech B, Hardt J, Schramek N. Determination and quantitation of sildenafil and its major metabolite in the breast milk of a lactating woman. J Pharm Biomed Anal. 2016 Abstract
  3. Lakshminrusimha S, Mathew B, Leach CL. Pharmacologic strategies in neonatal pulmonary hypertension other than nitric oxide. Semin Perinatol. 2016 Abstract
  4. EMA. Sildenafilo. Ficha técnica. 2016 Full text (in our servers)
  5. EMA. Sildenafil. Drug Summary. 2016 Full text (in our servers)
  6. Krishnan U. Management of pulmonary arterial hypertension in the neonatal unit. Cardiol Rev. 2010 Abstract
  7. Molelekwa V, Akhter P, McKenna P, Bowen M, Walsh K. Eisenmenger's syndrome in a 27 week pregnancy--management with bosentan and sildenafil. Ir Med J. 2005 Abstract

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