Is Bilastine compatible with breastfeeding? Do we have alternatives for Bilastine?

Bilastine

June 11, 2018 (Low Risk)

It is a second-generation antihistamine drug without sedative or antimuscarinic effects (AEMPS 2016, Wolthers 2013, Scaglione 2012, Conen 2011, Church 2011).

At latest update, relevant data on its excretion into breast milk were not found.

Due to a lack of sedative effect since it does not break through the blood-brain barrier (Scaglione 2012, Church 2011), and, a favorable pharmacokinetic profile (Togawa 2016, AEMPS 2016, Sádaba 2013), -high protein-binding capacity, and a medium oral bioavailability-, the risk for problems in the nursing infant is very low. However, until more and reliable data on this drug concerning breastfeeding is available, known safer options should be preferred, especially for breastfeeding mothers in the first month after birth or in case of prematurity.

Alternatives

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

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

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Writings

  • Μπιλαστίνη (Greek)
  • بيلاستين (Arabic)
  • Биластин (Cyrillic)
  • 比拉斯汀 (Chinese)
  • ビラスチン (Japanese)
  • Bilastine (French)
  • C28H37N3O3 (Molecular formula)
  • p-(2-{4-[1-(2-Ethoxyethyl)-2-benzimidazolyl]piperidino}ethyl)-α-methylhydratropic acid (Chemical name)
  • R06AX29 (ATC Code/s)

Drug trade names

References

  1. Togawa M, Yamaya H, Rodríguez M, Nagashima H. Pharmacokinetics, Pharmacodynamics and Population Pharmacokinetic/Pharmacodynamic Modelling of Bilastine, a Second-Generation Antihistamine, in Healthy Japanese Subjects. Clin Drug Investig. 2016Abstract Full text (link to original source) Full text (in our servers)
  2. AEMPS. Bilastina. Ficha técnica 2016 Full text (in our servers)
  3. Sádaba B, Gómez-Guiu A, Azanza JR, Ortega I, Valiente R. Oral availability of bilastine. Clin Drug Investig. 2013Abstract
  4. Wolthers OD. Bilastine: a new nonsedating oral H1 antihistamine for treatment of allergic rhinoconjunctivitis and urticaria. Biomed Res Int. 2013Abstract Full text (link to original source) Full text (in our servers)
  5. Scaglione F. Safety profile of bilastine: 2nd generation H1-antihistamines. Eur Rev Med Pharmacol Sci. 2012Abstract Full text (link to original source) Full text (in our servers)
  6. Conen S, Theunissen EL, Van Oers AC, Valiente R, Ramaekers JG. Acute and subchronic effects of bilastine (20 and 40 mg) and hydroxyzine (50 mg) on actual driving performance in healthy volunteers. J Psychopharmacol. 2011Abstract
  7. Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011Abstract