Last update: March 29, 2016

Raloxifene Hydrochloride

High Risk for breastfeeding


Poorly safe. Evaluate carefully.
Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives).
Read the Comment.

Selective estrogen receptor modulator. Estrogen agonist in bone and estrogen receptor antagonist in breast and uterine tissue.
Indicated in treating osteoporosis and preventing breast cancer.

Raloxifene does not alter prolactin secretion in premenopausal women but increases levels of estradiol and sex-hormone binding globulin (BGSH).

At last update no published data on excretion in breast milk were found.
Pharmacokinetic data (large volume of distribution, moderately high molecular weight and high percentage of protein binding) make it unlikely milk passage of significant amounts.
Low oral bioavailability hinders the passage into infant plasma from ingested milk except in preterm neonates and immediate neonatal period, because an increased intestinal permeability can appear.

Although short-term treatments may be of low risk during breastfeeding, the anti-estrogenic effect on breast tissue, a prolonged use is not recommended.

Alternatives

We do not have alternatives for Raloxifene Hydrochloride.

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.

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.

Other names

Raloxifene Hydrochloride in other languages or writings:

Tradenames

Main tradenames from several countries containing Raloxifene Hydrochloride in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 2 %
Molecular weight 510 daltons
Protein Binding 98 - 99 %
VD 2348 l/Kg
Tmax 6 hours
T1/2 27,7 - 32,5 hours

References

  1. EMA. Raloxifene. Drug Summary. 2010 Full text (in our servers)
  2. Faupel-Badger JM, Prindiville SA, Venzon D, Vonderhaar BK, Zujewski JA, Eng-Wong J. Effects of raloxifene on circulating prolactin and estradiol levels in premenopausal women at high risk for developing breast cancer. Cancer Epidemiol Biomarkers Prev. 2006 Abstract Full text (link to original source) Full text (in our servers)
  3. Heringa M. Review on raloxifene: profile of a selective estrogen receptor modulator. Int J Clin Pharmacol Ther. 2003 Abstract

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