Last update Jan. 15, 2026

C43 H68 ClNO11

Compatible

Safe product and/or breastfeeding is the best option.

An immunomodulator and calcineurin inhibitor related to tacrolimus. Used in the treatment of atopic dermatitis. Used topically as a cream and orally in research studies.

Since the last update we have not found published data on its excretion in breastmilk.

Its pharmacokinetic data (moderately high molecular weight, high percentage of protein binding and very little systemic absorption with topical use (less than 2 micrograms/L in plasma) (AEMPS 2013, FDA 2001) make it unlikely that will be transferred to milk in significant quantities. (AEMPS 2013)

Do not apply on the breast in order to prevent the infant from swallowing it (AEMPS 2013, Barret 2013, Butler 2014); if necessary, apply after a feed and clean well with water before the next feed. (Deleuran 2024, Vestergaard 2019)

It is advisable to avoid the application of creams, gels and other local application products containing paraffin (mineral oil) on the nipple so that the infant does not absorb them. (Noti 2003, Concin 2008)

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.

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Other names

C43 H68 ClNO11 is Pimecrolimus in Molecular formula.

Is written in other languages:

Groups

C43 H68 ClNO11 belongs to these groups or families:

Tradenames

Main tradenames from several countries containing C43 H68 ClNO11 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. Dermat: baja - poor %
Molecular weight 811 daltons
Protein Binding 74 - 99.6 %
Tmax 2 hours
T½ 100 hours

References

  1. Deleuran M, Dézfoulian B, Elberling J, Knutar I, Lapeere H, Lossius AH, Schuttelaar MLA, Stockman A, Wikström E, Bradley M, de Bruin-Weller M, Gutermuth J, Mandelin JM, Schmidt MC, Thyssen JP, Vestergaard C. Systemic anti-inflammatory treatment of atopic dermatitis during conception, pregnancy and breastfeeding: Interdisciplinary expert consensus in Northern Europe. J Eur Acad Dermatol Venereol. 2024 Jan;38(1):31-41. Abstract Full text (link to original source)
  2. Vestergaard C, Wollenberg A, Barbarot S, Christen-Zaech S, Deleuran M, Spuls P, Flohr C, Trzeciak M, von Kobyletzki L, Seneschal J, Paul C, Bieber T, Werfel T, Fölster-Holst R, Darsow U, Gieler U, Svensson Å, Cork M, Stalder JF, De Raeve L, Kunz B, Simon D, et al. European task force on atopic dermatitis position paper: treatment of parental atopic dermatitis during preconception, pregnancy and lactation period. J Eur Acad Dermatol Venereol. 2019 Sep;33(9):1644-1659. Abstract Full text (link to original source)
  3. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  4. Barrett ME, Heller MM, Fullerton Stone H, Murase JE. Dermatoses of the breast in lactation. Dermatol Ther. 2013 Abstract
  5. AEMPS. Pimecrolimus. Ficha técnica. 2013 Full text (in our servers)
  6. Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Fessler S, Windbichler G, Zeimet A, Ulmer H, Siegl H, Rieger K, Concin H, Grob K. Mineral oil paraffins in human body fat and milk. Food Chem Toxicol. 2008 Abstract
  7. Scott G, Osborne SA, Greig G, Hartmann S, Ebelin ME, Burtin P, Rappersberger K, Komar M, Wolff K. Pharmacokinetics of pimecrolimus, a novel nonsteroid anti-inflammatory drug, after single and multiple oral administration. Clin Pharmacokinet. 2003 Abstract
  8. Noti A, Grob K, Biedermann M, Deiss U, Brüschweiler BJ. Exposure of babies to C15-C45 mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003 Abstract
  9. FDA. Pimecrolimus. Drug Summary. 2001 Full text (in our servers)

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