Last update Jan. 29, 2025

Azelastine Hydrochloride

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Second generation antihistamine with minimal sedative effect. Indicated for allergic and vasomotor rhinitis and allergic conjunctivitis. Oral, nasal and ophthalmic administration.

At the time of last update, no published data on breastfeeding were available.

Pharmacokinetic data (large volume of distribution, moderately high molecular weight and high percentage of plasma protein binding) make passage into breast milk unlikely in clinically significant quantities.

It is a very bitter product that could, if excreted into breast milk, alter its taste and cause rejection by the infant. (Hale).

The small dose and low plasma absorption of most topical nasal or ophthalmologic preparations make passage of significant amounts into breast milk unlikely, so they are considered safe during breastfeeding

For oral administration, until further published data on this drug in relation to breastfeeding is known, safer alternatives may be preferable, especially during the neonatal period and in case of prematurity. (LactMed, So 2010).

Alternatives

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.

Other names

Azelastine Hydrochloride in other languages or writings:

Tradenames

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

Pharmacokinetics

Variable Value Unit
Oral Bioavail. oral: 80. Intranasal 40 %
Molecular weight 418 daltons
Protein Binding 88 - 97 %
VD 14.5 l/Kg
pKa 9.5 -
Tmax 2 - 3 hours
22 (metabolit: 54) hours

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  3. So M, Bozzo P, Inoue M, Einarson A. Safety of antihistamines during pregnancy and lactation. Can Fam Physician. 2010 May;56(5):427-9. Abstract Full text (link to original source) Full text (in our servers)

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