Last update: Jan. 15, 2020

φαινυλεφρίνη

Low Risk for breastfeeding


Moderately safe. Probably compatible.
Mild risk possible. Follow up recommended.
Read the Comment.

A sympathomimetic with alpha-adrenergic activity. It produces peripheral vasoconstriction and increased blood pressure without stimulating effects on the central nervous system.

Used as a decongestant in topical nasal preparations at low concentrations, associated with other drugs, in oral preparations to treat respiratory colds (Nice 2000, Kanfer 1993) and in eye drops at concentrations of up to 10% as a mydriatic. It is also used subcutaneously or intramuscularly in severe hypotensive states and associated with topical anesthetics.

Since the last update we have not found published data on its excretion in breastmilk.

The low dose of phenylephrine in nasal, ophthalmic and topical preparations makes it unlikely to transfer into breastmilk in significant amounts. It is advised to press on the tear duct after administering eye drops in order to decrease absorption. Low plasma concentrations have been recorded at 10 minutes after ophthalmic administration and practically zero at one hour (AEMPS 2017).

Its pharmacokinetic data: very large volume of distribution and high percentage of protein binding (DrugBank online 2019), make transfer to breastmilk in significant amounts unlikely.

Its low oral bioavailability makes hinders transfer to infant plasma from breastmilk, except in premature infants and the immediate neonatal period when there may be greater intestinal permeability.

Nasal and ophthalmic use is authorized in children under one year of age (Pediamecum 2015) and has been used in premature infants (White 2013).

Avoid excessive or prolonged use when taken orally and use the minimum sufficient dose. A similar molecule, pseudoephedrine, can cause decreased milk production (Aljazaf 2003).

Some authors consider decongestant drugs administered orally and nasally to be non-essential medications, to be avoided in general, not only during breastfeeding, since they expose patients to serious risks (cardiovascular, neurological and intestinal) for the treatment of benign disorders such as nasal obstruction, which usually evolves favourably in a few days without medication (Prescrire 2018).


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Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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Other names

φαινυλεφρίνη is Phenylephrine in Greek.

Is written in other languages:

φαινυλεφρίνη is also known as

Tradenames

Main tradenames from several countries containing φαινυλεφρίνη in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 38 %
Molecular weight 204 daltons
Protein Binding 95 %
VD 2,6 - 7,8 l/Kg
pKa 8,8 -
Tmax 0,2 - 1 hours
T1/2 2 - 3,4 hours

References

  1. Redaction Prescrire. Pour mieux soigner, des médicaments à écarter : bilan 2018. Prescrire.org. 2018 Full text (link to original source) Full text (in our servers)
  2. AEMPS-M4Pharm. Fenilefrina Oftalmica. Ficha técnica. 2017 Full text (in our servers)
  3. Comité de Medicamentos de la Asociación Española de Pediatría. Fenilefrina. http://pediamecum.es/wp-content/farmacos/Fenilefrina.pdf Full text (link to original source) Full text (in our servers)
  4. FDA. Phenylephrine. Drug Summary. 2014 Full text (in our servers)
  5. White-Traut R, Shapiro N, Healy-Baker E, Menchavez L, Rankin K, Medoff-Cooper B. Lack of feeding progression in a preterm infant: a case study. Adv Neonatal Care. 2013 Jun;13(3):175-80. Abstract
  6. Aljazaf K, Hale TW, Ilett KF, Hartmann PE, Mitoulas LR, Kristensen JH, Hackett LP. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol. 2003 Abstract Full text (link to original source) Full text (in our servers)
  7. Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000 Nov;16(4):319-31. Review. Erratum in: J Hum Lact 2001 Feb;17(1):90. Abstract
  8. Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy. 1993 Abstract

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