Is Ketotifen Fumarate compatible with breastfeeding? Do we have alternatives for Ketotifen Fumarate?

Ketotifen Fumarate

January 29, 2017 (Low Risk)

1st-generation-antihistamine and piperidine-type drug with a minimal sedative effect.
Indicated on prophylaxis of asthma, rhinitis (oral administration) and conjunctivitis (administrated as eye drops).

At latest update relevant published data on excretion into breast milk were not found.
Pharmacokinetic data (large volume of distribution and moderately high molecular weight) make it unlikely that significant amounts of milk would pass through breastmilk.
Plasma levels following ophthalmic administration are undetectable (AEMPS 2011).
It is a medicine authorized for use in infants from 6 months of age on.
It does not influence prolactin levels (Dolecek 1984).

Until more published data on this drug related to breastfeeding is available, a safer and known alternative should be preferred during the neonatal period and in case of prematurity.
Ophthalmic administration is safe while breastfeeding.

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

  • Κετοτιφαίνη φουμαρική (Greek)
  • Кетотифена Фумарат (Cyrillic)
  • ケトチフェンフマル酸塩 (Japanese)
  • C19H19NOS,C4H4O4 (Molecular formula)

References

  1. AEMPS. Ketotifeno oral Ficha técnica. 2015 Full text (in our servers)
  2. AEMPS. Ketotifeno colirio Ficha técnica. 2011 Full text (in our servers)
  3. Novartis. Ketotifen (Zaditen). Drug Summary. 2011 Full text (in our servers)
  4. Grahnén A, Lönnebo A, Beck O, Eckernäs SA, Dahlström B, Lindström B. Pharmacokinetics of ketotifen after oral administration to healthy male subjects. Biopharm Drug Dispos. 1992Abstract
  5. Dolecek R, Janstová V, Halatová A. Growth hormone plasma levels in children treated for 6 months with ketotifen. Pharmatherapeutica. 1984Abstract