Last update: May 1, 2016

Hydroxychloroquine Sulfate

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

Antimalarial drug used as anti-inflammatory and immunomodulating agent on tissue diseases such as arthritis or lupus.

It is excreted in breast milk in clinically non-significant amount which is much lower than the dose used in infants. Problems related to clinical features, development, vision or hearing issues have not been observed in infants whose mothers have received this medication.

When the mother takes 400 mg per day only 1 mg appears for every liter of milk, which is not considered dangerous to the infant, since a preventive dose for malaria in infants is 5 mg per kilo of weight once a week.

American Academy of Pediatrics states that it is usually compatible with breastfeeding medication.

Alternatives

We do not have alternatives for Hydroxychloroquine Sulfate since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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

Hydroxychloroquine Sulfate in other languages or writings:

Group

Hydroxychloroquine Sulfate belongs to this group or family:

Tradenames

Main tradenames from several countries containing Hydroxychloroquine Sulfate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 74 %
Molecular weight 434 daltons
Protein Binding 63 %
VD 580 - 815 l/Kg
Tmax 1 - 2 hours
T1/2 768 - 1200 hours
M/P ratio 5,5 -
Theoretical Dose 0,06 - 0,2 mg/Kg/d
Relative Dose 0,9 - 3 %
Relat.Ped.Dose 0,4 - 6,6 %

References

  1. 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
  2. SEFH - Sociedad Española de Farmacia Hospitalaria. Procedimientos de farmacia hospitalaria para la gestión del tratamiento con antivirales en la enfermedad por el nuevo coronavirus sars-cov-2 (COVID-19). Recomendaciones de la Sociedad Española de Farmacia Hospitalaria. 2020 Full text (in our servers)
  3. Noviani M, Wasserman S, Clowse ME. Breastfeeding in mothers with systemic lupus erythematosus. Lupus. 2016 Aug;25(9):973-9. Abstract
  4. Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, Arthanari S, Cunningham J, Flanders L, Moore L, Crossley A, Purushotham N, Desai A, Piper M, Nisar M, Khamashta M, Williams D, Gordon C, Giles I; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016 Sep;55(9):1693-7. Abstract Full text (link to original source) Full text (in our servers)
  5. Levy RA, de Jesús GR, de Jesús NR, Klumb EM. Critical review of the current recommendations for the treatment of systemic inflammatory rheumatic diseases during pregnancy and lactation. Autoimmun Rev. 2016 Abstract
  6. 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)
  7. Costedoat-Chalumeau N, Dunogué B, Morel N, Le Guern V, Guettrot-Imbert G. Hydroxychloroquine: a multifaceted treatment in lupus. Presse Med. 2014 Abstract
  8. 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
  9. Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014 Abstract
  10. Jain V, Gordon C. Managing pregnancy in inflammatory rheumatological diseases. Arthritis Res Ther. 2011 Abstract
  11. Zrour-Hassen S, Jguirim M, Aouam K, Korbaa W, Younes M, Bejia I, Touzi M, Bergaoui N. [Safety of rheumatic disease drugs at childbearing age]. Therapie. 2010 Abstract
  12. Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Breastfeeding travelers: precautions and recommendations. J Travel Med. 2010 Jan-Feb;17(1):32-47. Abstract Full text (link to original source) Full text (in our servers)
  13. Weber JC, Kuhnert C. Traitements de fond des affections inflammatoires systémiques au cours de l’allaitement. [Breastfeeding and drug management in connective tissue and rheumatic diseases]. Rev Med Interne. 2008 Abstract
  14. Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007 Abstract
  15. Østensen M, Khamashta M, Lockshin M, Parke A, Brucato A, Carp H, Doria A, Rai R, Meroni P, Cetin I, Derksen R, Branch W, Motta M, Gordon C, Ruiz-Irastorza G, Spinillo A, Friedman D, Cimaz R, Czeizel A, Piette JC, Cervera R, Levy RA, et al. Anti-inflammatory and immunosuppressive drugs and reproduction. Arthritis Res Ther. 2006 Abstract Full text (link to original source) Full text (in our servers)
  16. Costedoat-Chalumeau N, Amoura Z, Huong DL, Lechat P, Piette JC. Safety of hydroxychloroquine in pregnant patients with connective tissue diseases. Review of the literature. Autoimmun Rev. 2005 Abstract
  17. Costedoat-Chalumeau N, Amoura Z, Le Thi Huong D, Wechsler B, Piette JC. [Pleading to maintain hydroxychloroquine throughout Lupus pregnancies]. Rev Med Interne. 2005 Abstract
  18. Motta M, Tincani A, Faden D, Zinzini E, Lojacono A, Marchesi A, Frassi M, Biasini C, Zatti S, Chirico G. Follow-up of infants exposed to hydroxychloroquine given to mothers during pregnancy and lactation. J Perinatol. 2005 Abstract Full text (link to original source) Full text (in our servers)
  19. Temprano KK, Bandlamudi R, Moore TL. Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum. 2005 Abstract
  20. Cimaz R, Brucato A, Meregalli E, Muscará M, Sergi P. Electroretinograms of children born to mothers treated with hydroxychloroquine during pregnancy and breast-feeding: comment on the article by Costedoat-Chalumeau et al. Arthritis Rheum. 2004 Abstract Full text (in our servers)
  21. Al-Herz A, Schulzer M, Esdaile JM. Survey of antimalarial use in lupus pregnancy and lactation. J Rheumatol. 2002 Abstract
  22. Motta M, Tincani A, Faden D, Zinzini E, Chirico G. Antimalarial agents in pregnancy. Lancet. 2002 Abstract Full text (link to original source) Full text (in our servers)
  23. Tincani A, Faden D, Lojacono A et al. Hydroxychloroquine in pregnant patients with rheumatic disease. Arthritis Rheum. 2001;44 (Suppl 9):S397. Abstract 2065. 2001 Full text (in our servers)
  24. 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)
  25. Canadian rheumatology association. Canadian Consensus Conference on hydroxychloroquine. J Rheumatol. 2000 Abstract
  26. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med. 2000 Abstract Full text (link to original source) Full text (in our servers)
  27. Fulton B, Moore LL. Antiinfectives in breastmilk. Part II: Sulfonamides, tetracyclines, macrolides, aminoglycosides and antimalarials. J Hum Lact. 1992 Dec;8(4):221-3. Review. No abstract available. Abstract
  28. Byron MA. Treatment of rheumatic diseases. Br Med J (Clin Res Ed). 1987 Abstract Full text (link to original source) Full text (in our servers)
  29. Ostensen M, Brown ND, Chiang PK, Aarbakke J. Hydroxychloroquine in human breast milk. Eur J Clin Pharmacol. 1985 Abstract
  30. Nation RL, Hackett LP, Dusci LJ, Ilett KF. Excretion of hydroxychloroquine in human milk. Br J Clin Pharmacol. 1984 Abstract Full text (link to original source) Full text (in our servers)

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