Last update Oct. 30, 2024

3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride

Compatible

Safe product and/or breastfeeding is the best option.

Second-generation antihistamine that does not cross the blood-brain barrier, state devoid of sedative or antimuscarinic effects (AEMPS 2015). It is used in allergic rhinoconjunctivitis and cutaneous pruritus Administration orally or as eye drops. 

It is excreted in breast milk in a clinically insignificant amount and no problems have been observed in infants whose mothers took it. Plasma levels in these infants were below the limit of detection. (Iwasa 2019)

The 2nd generation antihistamines are considered safe during lactation because of their lack of sedative effect due to their failure to cross the blood-brain barrier.

The small dose and poor plasma absorption of most topical ophthalmic preparations make passage of significant amount into breast milk unlikely. Ophthalmic Epinastine achieves a negligible plasma concentration: 0.042 ng/ml (Allergan 2018 and 2012). In ophthalmic administration, absorption can be minimized by pressing the tear duct (inner canthus of the eye) with the finger for 1 minute. Its ophthalmic use is also compatible with breastfeeding.

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

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Other names

3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride is Epinastine Hydrochloride in Chemical name.

Is written in other languages:

Groups

3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride belongs to these groups or families:

Tradenames

Main tradenames from several countries containing 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride in its composition:

List of 19 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 40 %
Molecular weight 286 daltons
Protein Binding 64 %
VD 5.96 l/Kg
pKa 8.77 -
Tmax 2 hours
T½ 8 - 12 hours
M/P ratio 0.8 - 3.4 -
Theoretical Dose 0.001 - 0.0096 mg/Kg/d
Relative Dose 0.3 - 2.8 %

References

  1. Iwasa C, Zaima K, Metori K, Harikai N, Tanaka Y, Hamada J, Shinomiya K, Hayashi H. Transfer of epinastine to infants through human breast milk. Pharmazie. 2019 Dec 1;74(12):732-736. Abstract
  2. Allergan. Epinastina. Ficha técnica. 2018 Full text (in our servers)
  3. Allergan. Epinastine. Drug Summary. 2012 Full text (in our servers)
  4. Pradhan S, Abhishek K, Mah F. Epinastine: topical ophthalmic second generation antihistamine without significant systemic side effects. Expert Opin Drug Metab Toxicol. 2009 Abstract

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