Last update April 15, 2024

C08CA05

Compatible

Safe substance and/or breastfeeding is the best option.

It is a dihydropyridine calcium channel blocker, peripheral and coronary vasodilator, indicated for the treatment of angina pectoris and hypertension. Oral administration once or twice daily.

It is excreted into breast milk in non-significant amount (Malfará 2019, Taddio 1996, Manninen 1991, Ehrenkranz 1989, Penny 1989) with no problems among breastfed infants whose mothers were treated with this medication. (Wu 2012, O'Sullivan 2011, Page 2006, Anderson 2004, Garrison 2002, Lawlor 1997, Penny 1989)

No alteration on breast milk composition or production has been seen. (Magee 2005)

Shown to be effective at a dose of 10 - 20 mg three times-a-day for pain relief related to Raynaud phenomenon of the nipple. (Quental 2023, Deniz 2023, Di Como 2020, Barrett 2013, Anderson 2004, Garrison 2002)

Possible side effects (headache, hypotension) in the mother should be monitored. Gynecomastia may occur with the use of nifedipine and other calcium channel blockers. (Deepinder 2012, Tanner 1988)

Several medical societies, experts and expert consensus, consider the use of this medication to be safe or very probably safe during breastfeeding (Hale, LactMed, Malachias 2016, Briggs 2015, Schaefer 2015, Serrano 2015, Rowe 2013, Dennis 2012, Chen 2010, Ghanem 2008). American Academy of Pediatrics 2001: Maternal Medication Usually Compatible With Breastfeeding. (AAP 2001). Eleventh WHO Model List of Essential Drugs 2002: Compatible with breastfeeding. (WHO 2002)

Alternatives

We do not have alternatives for C08CA05 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

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Other names

C08CA05 is Nifedipine in ATC Code/s.

Is written in other languages:

Groups

C08CA05 belongs to these groups or families:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 45 - 68 %
Molecular weight 346 daltons
Protein Binding 92 - 98 %
VD 0.25 - 0.69 l/Kg
pKa 16.94 -
Tmax 0.75 - 4. 2 hours
T½ 2 - 5 hours
M/P ratio 1 -
Theoretical Dose 0.008 mg/Kg/d
Relative Dose 1.6 %
Ped.Relat.Dose 0.01 - 0.1 %

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  3. Quental C, Brito DB, Sobral J, Macedo AM. Raynaud Phenomenon of the Nipple: A Clinical Case Report. J Family Reprod Health. 2023 Jun;17(2):113-115. Abstract Full text (link to original source)
  4. Deniz S, Kural B. Nipple Vasospasm of Nursing Mothers. Breastfeed Med. 2023 Jun;18(6):494-498. Abstract
  5. Di Como J, Tan S, Weaver M, Edmonson D, Gass JS. Nipple pain: Raynaud's beyond fingers and toes. Breast J. 2020 Oct;26(10):2045-2047. Abstract
  6. Malfará BN, Benzi JRL, de Oliveira Filgueira GC, Zanelli CF, Duarte G, de Carvalho Cavalli R, de Moraes NV. ABCG2 c.421C>A polymorphism alters nifedipine transport to breast milk in hypertensive breastfeeding women. Reprod Toxicol. 2019 Apr;85:1-5. Abstract
  7. Malachias MV, Figueiredo CE, Sass N, Antonello IC, Torloni MR, Bortolotto MRF L. 7th Brazilian Guideline of Arterial Hypertension: Chapter 9 - Arterial Hypertension in pregnancy Arq Bras Cardiol. 2016 Abstract Full text (link to original source)
  8. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, Third Edition. 2015
  9. Serrano Aguayo P, García de Quirós Muñoz JM, Bretón Lesmes I, Cózar León MV. Tratamiento de enfermedades endocrinológicas durante la lactancia. [Endocrinologic diseases management during breastfeeding.] Med Clin (Barc). 2015 Jan 20;144(2):73-9. Abstract
  10. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  11. Barrett ME, Heller MM, Stone HF, Murase JE. Raynaud phenomenon of the nipple in breastfeeding mothers: an underdiagnosed cause of nipple pain. JAMA Dermatol. 2013 Abstract
  12. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  13. Wu M, Chason R, Wong M. Raynaud's phenomenon of the nipple. Obstet Gynecol. 2012 Abstract
  14. Deepinder F, Braunstein GD. Drug-induced gynecomastia: an evidence-based review. Expert Opin Drug Saf. 2012 Sep;11(5):779-95. Abstract
  15. Dennis AT. Management of pre-eclampsia: issues for anaesthetists. Anaesthesia. 2012 Sep;67(9):1009-20. Abstract Full text (link to original source) Full text (in our servers)
  16. O'Sullivan S, Keith MP. Raynaud phenomenon of the nipple: a rare finding in rheumatology clinic. J Clin Rheumatol. 2011 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. Ghanem FA, Movahed A. Use of antihypertensive drugs during pregnancy and lactation. Cardiovasc Ther. 2008 Abstract Full text (link to original source) Full text (in our servers)
  19. Page SM, McKenna DS. Vasospasm of the nipple presenting as painful lactation. Obstet Gynecol. 2006 Abstract
  20. Magee L, Sadeghi S. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2005 Abstract
  21. Anderson JE, Held N, Wright K. Raynaud's phenomenon of the nipple: a treatable cause of painful breastfeeding. Pediatrics. 2004 Abstract Full text (link to original source) Full text (in our servers)
  22. Garrison CP. Nipple vasospasms, Raynaud's syndrome, and nifedipine. J Hum Lact. 2002 Abstract
  23. 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)
  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. Kirsten R, Nelson K, Kirsten D, Heintz B. Clinical pharmacokinetics of vasodilators. Part II. Clin Pharmacokinet. 1998 Abstract
  26. Lawlor-Smith LS, Lawlor-Smith CL. Raynaud's phenomenon of the nipple: a preventable cause of breastfeeding failure? Med J Aust. 1997 Abstract
  27. Taddio A, Oskamp M, Ito S, Bryan H, Farine D, Rvan D, Koren G. Is nifedipine use during labour and breast-feeding safe for the neonate? Clin Investig Med. 1996;19:S11 Abstract Full text (link to original source)
  28. Manninen AK, Juhakoski A. Nifedipine concentrations in maternal and umbilical serum, amniotic fluid, breast milk and urine of mothers and offspring. Int J Clin Pharmacol Res. 1991 Abstract
  29. Ehrenkranz RA, Ackerman BA, Hulse JD. Nifedipine transfer into human milk. J Pediatr. 1989 Abstract
  30. Penny WJ, Lewis MJ. Nifedipine is excreted in human milk. Eur J Clin Pharmacol. 1989 Abstract
  31. Tanner LA, Bosco LA. Gynecomastia associated with calcium channel blocker therapy. Arch Intern Med. 1988 Abstract

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