Last update Dec. 4, 2020

Clofazimine

Likely Compatibility

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

An antimicrobial indicated in the treatment of leprosy.
Daily oral administration over several months.

It is excreted in breastmilk in an amount that could be significant (Venkatesan 1997), but no adverse effects have been observed in infants whose mothers were taking it, with the exception of being able to cause a reddish discoloration of the skin of infants, reversible at the end of treatment. (Ozturk 2017, WHO 2002).

May turn milk bright pink (Waters 1969).

Known alternatives with faster elimination and less excretion in breastmilk should be considered, especially during the neonatal period and in cases of prematurity.

Alternatives

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

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

Clofazimine is also known as


Clofazimine in other languages or writings:

Group

Clofazimine belongs to this group or family:

Tradenames

Main tradenames from several countries containing Clofazimine in its composition:

List of 6 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 45 - 70 %
Molecular weight 473 daltons
pKa 8.51 -
Tmax 4 - 12 hours
T½ 1680 (600 - 2160) hours
M/P ratio 1.5 (1 - 1.7) -
Theoretical Dose 0.12 - 0.26 mg/Kg/d
Relative Dose 22 (14 - 30) %
Ped.Relat.Dose 20 %

References

  1. Algharably EA, Kreutz R, Gundert-Remy U. Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data. Pharmaceutics. 2023 Apr 13;15(4). pii: 1228. Abstract Full text (link to original source)
  2. Ozturk Z, Tatliparmak A. Leprosy treatment during pregnancy and breastfeeding: A case report and brief review of literature. Dermatol Ther. 2017 Jan;30(1). Abstract
  3. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Abstract Full text (link to original source) Full text (in our servers)
  4. Venkatesan K, Mathur A, Girdhar A, Girdhar BK. Excretion of clofazimine in human milk in leprosy patients. Lepr Rev. 1997 Sep;68(3):242-6. Abstract
  5. Waters MF. G 30 320 or B 663--lampren (Geigy). Lepr Rev. 1969 Jan;40(1):21-47. No abstract available. Abstract

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