Last update May 10, 2021

Emedastine Fumarate

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is an antihistamine with a benzimidazole structure.
Indicated in the treatment of allergic rhinitis and conjunctivitis.
Ophthalmic administration in eye drops or oral in two daily doses.

It is excreted in human milk in clinically insignificant amounts and no short-term or long-term problems have been observed in an infant whose mother took 2 mg once daily (Saito 2020).

The small dose and poor plasma absorption of most topical ophthalmological preparations make it unlikely that significant amounts will transfer into breastmilk.
The small dose and poor plasma absorption of most topical ophthalmological preparations make it unlikely that significant amounts will transfer into breast milk.
Ophthalmic use of emedastine usually does not produce measurable plasma concentrations: following ophthalmic administration of emedastine, plasma drug concentrations were between 0.3 and 0.5 ng / ml or were below the limit of quantification, 0.3 ng / ml (EMA 2009).

Alternatives

We do not have alternatives for Emedastine Fumarate since it is relatively safe.

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

Emedastine Fumarate in other languages or writings:

Groups

Emedastine Fumarate belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Emedastine Fumarate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 %
Molecular weight 535 daltons
pKa 8.68 -
Tmax 3 hours
7 - 10 hours
Theoretical Dose 0.000009 - 0.000066 mg/Kg/d
Relative Dose 0.0025 - 0.02 %

References

  1. Saito J, Yakuwa N, Sasaki A, Kawasaki H, Suzuki T, Yamatani A, Sago H, Murashima A. Emedastine During Pregnancy and Lactation: Emedastine Levels in Maternal Serum, Cord Blood, Breast Milk, and Neonatal Serum. Breastfeed Med. 2020 Dec;15(12):809-812.
  2. AEMPS. Emedastina (Rhidate). Ficha técnica. 2013 Full text (in our servers)
  3. EMA. Emedastina (Emadine). Ficha técnica. 2009 Full text (in our servers)

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