Last update Jan. 29, 2021

P01BA02

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is an antimalarial drug with actions similar to those of chloroquine. It is used as anti-inflammatory and immunomodulating agent in the treatment and prophylaxis of malaria, in the management of systemic and discoid lupus erythematosus, rheumatoid arthritis, porphyria cutanea tarda, sarcoidosis and various skin disorders. It is also used in prophylaxis of venous thromboembolism.
Used experimentally in the treatment of the COVID-19 coronavirus (Elavarasi 2020, SEFH 2020).
Oral administration.

It is excreted in breast milk in clinically non-significant amount which is much lower than the dose used in infants (Peng 2019, Liu 2016, Cissoko 2010, Costedoat 2002, Ostensen 1985, Nation 1984).
Problems related to clinical features, development, vision or hearing issues have not been observed in infants whose mothers have received this medication (Peng 2019, Motta 2005 & 2002, Cimaz 2004, Tincani 2001).

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.

Several medical associations, experts and expert consensus consider the use of this medication to be compatible during breastfeeding (Hale, Sammaritano 2020, Briggs 2017, Flint 2016, Götestam 2016, Kavanaugh 2015, Schaefer 2015).

American Academy of Pediatrics states that it is usually compatible with breastfeeding medication (AAP 2001).


See below the information of these related products:

  • Lupus (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Maternal Rheumatoid arthritis (RA) (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

Alternatives

We do not have alternatives for P01BA02 since it is relatively safe.

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

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.

Group

P01BA02 belongs to this group or family:

Tradenames

Main tradenames from several countries containing P01BA02 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
768 - 1200 hours
M/P ratio 5.5 -
Theoretical Dose 0.06 - 0.2 mg/Kg/d
Relative Dose 0.9 - 3 %
Ped.Relat.Dose 0.4 - 6.6 %

References

  1. Elavarasi A, Prasad M, Seth T, Sahoo RK, Madan K, Nischal N, Soneja M, Sharma A, Maulik SK, Shalimar, Garg P. Chloroquine and Hydroxychloroquine for the Treatment of COVID-19: a Systematic Review and Meta-analysis. J Gen Intern Med. 2020 Nov;35(11):3308-3314. Consulted on Nov. 30, 2020 Abstract
  2. Ikram N, Eudy A, Clowse MEB. Breastfeeding in women with rheumatic diseases. Lupus Sci Med. 2021 Apr;8(1). pii: e000491. Abstract Full text (link to original source)
  3. 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)
  4. 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. None 2020 Full text (in our servers)
  5. Peng W, Liu R, Zhang L, Fu Q, Mei D, Du X. Breast milk concentration of hydroxychloroquine in Chinese lactating women with connective tissue diseases. Eur J Clin Pharmacol. 2019 Nov;75(11):1547-1553. 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. 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
  8. Noviani M, Wasserman S, Clowse ME. Breastfeeding in mothers with systemic lupus erythematosus. Lupus. 2016 Aug;25(9):973-9. Abstract
  9. 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)
  10. Kavanaugh A, Cush JJ, Ahmed MS, Bermas BL, Chakravarty E, Chambers C, Clowse M, Curtis JR, Dao K, Hankins GD, Koren G, Kim SC, Lapteva L, Mahadevan U, Moore T, Nolan M, Ren Z, Sammaritano LR, Seymour S, Weisman MH. Proceedings from the American College of Rheumatology Reproductive Health Summit: the management of fertility, pregnancy, and lactation in women with autoimmune and systemic inflammatory diseases. Arthritis Care Res (Hoboken). 2015 Mar;67(3):313-25. Abstract Full text (link to original source) Full text (in our servers)
  11. Costedoat-Chalumeau N, Dunogué B, Morel N, Le Guern V, Guettrot-Imbert G. Hydroxychloroquine: a multifaceted treatment in lupus. Presse Med. 2014 Abstract
  12. Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014 Abstract
  13. 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
  14. Jain V, Gordon C. Managing pregnancy in inflammatory rheumatological diseases. Arthritis Res Ther. 2011 Abstract Full text (link to original source)
  15. Mathieu O, Masson F, Thompson MA, Leplay M, Mazurier E, Hillaire-Buys D. (Abstracts of the 14th Annual Meeting of French Society of Pharmacology and Therapeutics, 77th Annual Meeting of Society of Physiology, 31th Pharmacovigilance Meeting, 11th APNET Seminar and 8th CHU CIC Meeting, 23-25 March 2010, Bordeaux, France). Case report: in utero exposure and safe breastfeeding in two premature twins of a chronically treated mother with high doses of zopiclone. Fundam Clin Pharmacol 2010;24 (Suppl. S1), 88. abst424. doi:10.1111/j.1472-8206.2010.00819.x
  16. 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
  17. 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)
  18. Cissoko H, Rouger J, Zahr N, Darrouzaina F, Jonville-Beraa AP, Autret-Lecaa E. Breast milk concentrations of hydroxychloroquine. 2010;24 (Suppl. 1):87. Abstract 420. doi:10.1111/j.1472-8206.2010.00819.x.
  19. 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 Dec;29(12):1017-23. Abstract
  20. Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007 Abstract
  21. 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)
  22. 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
  23. 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 Feb;25(2):86-9. Abstract Full text (link to original source) Full text (in our servers)
  24. Temprano KK, Bandlamudi R, Moore TL. Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum. 2005 Abstract
  25. 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
  26. 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 Sep;50(9):3056-7; author reply 3057-8. No abstract available. Abstract Full text (in our servers)
  27. Al-Herz A, Schulzer M, Esdaile JM. Survey of antimalarial use in lupus pregnancy and lactation. J Rheumatol. 2002 Abstract
  28. 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)
  29. Costedoat-Chalumeau N, Amoura Z, Aymard G, Le TH, Wechsler B, Vauthier D, Dermer ME, Darbois Y, Piette JC. Evidence of transplacental passage of hydroxychloroquine in humans. Arthritis Rheum. 2002 Apr;46(4):1123-4. No abstract available. Abstract
  30. 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)
  31. Tincani A, Faden D, Lojacono A, Zatti S, Palai N, Biasini C, Frassi M, Taglietti M, Gorla R, Balestrieri G, Vescovi F, Doria A, Gerosa M, Trespidi L, Meroni PL, Castellino G, Brucato A, Chirico G, Motta M. Hydroxychloroquine in pregnant patients with rheumatic disease. Arthritis Rheum. 2001;44 (Suppl 9):S397. Abstract 2065. 2001 Full text (in our servers)
  32. Canadian rheumatology association. Canadian Consensus Conference on hydroxychloroquine. J Rheumatol. 2000 Abstract
  33. 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)
  34. 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
  35. Ostensen M, Brown ND, Chiang PK, Aarbakke J. Hydroxychloroquine in human breast milk. Eur J Clin Pharmacol. 1985;28(3):357. Abstract
  36. Nation RL, Hackett LP, Dusci LJ, Ilett KF. Excretion of hydroxychloroquine in human milk. Br J Clin Pharmacol. 1984 Mar;17(3):368-9. No abstract available. Abstract Full text (link to original source) Full text (in our servers)

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