Last update Jan. 28, 2021

M04AC01

Compatible

Safe substance and/or breastfeeding is the best option.

It is used for treatment of Gout, Familial Mediterranean Fever. As well as for other conditions like Amyloidosis, Behçet's Syndrome, Pericarditis, Primary Biliary Cirrhosis and Pyoderma gangrenosum.
Used experimentally in the treatment of the COVID-19 coronavirus (Cumhur 2020).
Oral administration once or twice a day.

It is excreted in breast milk in quantities that differ according to different published studies, from no clinically significant in some (Ben-Chetrit 1996, Milunsky 1991), until being important in others (Guillonneau 1995), but there have been no problems in infants whose mothers were treated, even after months (Duman 2019 y 2016, Herscovici 2015, Diav-Citrin 2010, Ben-Chetrit 1996, Guillonneau 1995, Milunsky 1991), with undetectable urine levels in these infants (Guillonneau 1995).

The concomitant use of macrolide antibiotics and fruit juices (both the mother and the infant) , especially grape-fruit, is not recommended since they may interfere with bile excretion and greatly increase toxicity (Finkelstein 2010, Goldbart 2000).

Several medical societies, experts authors and expert consensus, consider the use of this medication to be safe during breastfeeding (Sammaritano 2020, Götestam 2016, Yanmaz 2014, Finkelstein 2010, Stankovic 2008, Ben-Chetrit 1998).
The American Academy of Breastfeeding rates it as compatible with breastfeeding (AAP 2001).
List of Essential Medicines of WHO (2002): compatible with breastfeeding (WHO 2002)

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

M04AC01 is Colchicine in ATC Code/s.

Is written in other languages:

Group

M04AC01 belongs to this group or family:

Tradenames

Main tradenames from several countries containing M04AC01 in its composition:

List of 31 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 47 ± 14 %
Molecular weight 399 daltons
Protein Binding 10 - 39 %
VD 6.7 l/Kg
pKa 15.06 -
Tmax 1 - 2 hours
T½ 30 - 58 hours
M/P ratio 1 -
Theoretical Dose 0.0004 - 0.005 mg/Kg/d
Relative Dose 1 - 30 %
Ped.Relat.Dose < 1 %

References

  1. Cumhur Cure M, Kucuk A, Cure E. Colchicine may not be effective in COVID-19 infection; it may even be harmful? Clin Rheumatol. 2020 Jul;39(7):2101-2102. Consulted on July 30, 2020 Abstract
  2. Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. Abstract Full text (link to original source)
  3. Götestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, da Silva J, Nelson-Piercy C, Cetin I, Costedoat-Chalumeau N, Dolhain R, Förger F, Khamashta M, Ruiz-Irastorza G, Zink A, Vencovsky J, Cutolo M, Caeyers N, Zumbühl C, Østensen M. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Abstract Full text (link to original source) Full text (in our servers)
  4. Herscovici T, Merlob P, Stahl B, Laron-Kenet T, Klinger G. Colchicine use during breastfeeding. Breastfeed Med. 2015 Abstract
  5. Yanmaz MN, Özcan AJ, Savan K. The impact of familial Mediterranean fever on reproductive system. Clin Rheumatol. 2014 Abstract
  6. AEMPS. Colchicina. Ficha técnica. 2014 Full text (in our servers)
  7. Finkelstein Y, Aks SE, Hutson JR, Juurlink DN, Nguyen P, Dubnov-Raz G, Pollak U, Koren G, Bentur Y. Colchicine poisoning: the dark side of an ancient drug. Clin Toxicol (Phila). 2010 Abstract
  8. Diav-Citrin O, Shechtman S, Schwartz V, Avgil-Tsadok M, Finkel-Pekarsky V, Wajnberg R, Arnon J, Berkovitch M, Ornoy A. Pregnancy outcome after in utero exposure to colchicine. Am J Obstet Gynecol. 2010 Aug;203(2):144.e1-6. Abstract
  9. Colchicine. Drug Summary 2009 Full text (in our servers)
  10. Stankovic K, Hentgen V, Grateau G. [Auto-inflammatory syndromes and pregnancy]. Presse Med. 2008 Abstract
  11. Ben-Chetrit E, Levy M. Reproductive system in familial Mediterranean fever: an overview. Ann Rheum Dis. 2003 Abstract Full text (link to original source) Full text (in our servers)
  12. 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)
  13. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  14. Goldbart A, Press J, Sofer S, Kapelushnik J. Near fatal acute colchicine intoxication in a child. A case report. Eur J Pediatr. 2000 Abstract
  15. Ben-Chetrit E, Levy M. Colchicine: 1998 update. Semin Arthritis Rheum. 1998 Abstract
  16. Ferron GM, Rochdi M, Jusko WJ, Scherrmann JM. Oral absorption characteristics and pharmacokinetics of colchicine in healthy volunteers after single and multiple doses. J Clin Pharmacol. 1996 Abstract
  17. Ben-Chetrit E, Scherrmann JM, Levy M. Colchicine in breast milk of patients with familial Mediterranean fever. Arthritis Rheum. 1996 Abstract
  18. Guillonneau M, Aigrain EJ, Galliot M, Binet MH, Darbois Y. Colchicine is excreted at high concentrations in human breast milk. Eur J Obstet Gynecol Reprod Biol. 1995 Abstract Full text (link to original source) Full text (in our servers)
  19. Rochdi M, Sabouraud A, Girre C, Venet R, Scherrmann JM. Pharmacokinetics and absolute bioavailability of colchicine after i.v. and oral administration in healthy human volunteers and elderly subjects. Eur J Clin Pharmacol. 1994 Abstract
  20. Milunsky JM. Breast-feeding during colchicine therapy for familial Mediterranean fever. J Pediatr. 1991 Abstract

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