Last update: June 1, 2020

N06BC01

Low Risk for breastfeeding


Moderately safe. Probably compatible.
Mild risk possible. Follow up recommended.
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Trimethylxanthine stimulant of the central nervous system which is present in many compounds like decongestant or pain relief drugs (50 to 100 mg per unit) ( (Mitchell 1999).
It is also present in many infusion beverages (coffee, tea, mate, guarana), in cocoa/chocolate and other drinks with cola or allegedly energizing properties (Barone 1996, Fulton 1990). See also Coffee, Caffeine (beverages).

It is excreted in human milk in variable amount (Calvaresi 2016, Stavchansky 1988, Ryu 1985, Bucher 1985, Berlin 1984, Findlay 1981, Tyrala 1979).

Moderate caffeine consumption does not produce significant plasma or urine levels in infants, and may be undetectable or below therapeutic levels in the neonatal period (Blanchard 1992, Fulton 1990, Berlin 1984, Hildebrandt 1983, Bailey 1982, Rivera 1977).

Doses greater than 300 - 500 mg per day can cause nervousness, irritability and insomnia in the infant (Santos 2012, Martin 2007, Clement 1989, Rustin 1989), as well as decreased iron levels in breast milk and anemia in the infant (Muñoz 1988 ). Also has been related to the Raynaud's phenomenon in the nipple of nursing women (McGuinness 2013).

One study found no problems in infants whose mothers consumed 500 mg of caffeine daily for 5 days (Ryu 1985).
There is insufficient evidence on the recommended amount of caffeine during lactation (McCreedy 2018).

Intravenous high doses used to treat post-epidural anesthesia headache within 2-3 days after delivery, before mature breast milk comes, are compatible with breastfeeding.

The elimination half-life, of a few hours in adults, can be 10 times longer in preterm infants and during the neonatal period, reaching adult values by 3-5 months of age. (McNamara 2004, Oo 1995).

The moderate use of caffeine during lactation is considered compatible or probably compatible by various experts (Hale 2019, Briggs 2017, Bordini 2016, Davanzo 2014, Rowe 2103).
American Academy of Pediatrics: Maternal Medication Usually Compatible With Breastfeeding (AAP 2001).


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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.

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Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

N06BC01 is Caffeine in ATC Code/s.

Is written in other languages:

N06BC01 is also known as

Group

N06BC01 belongs to this group or family:

Tradenames

Main tradenames from several countries containing N06BC01 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 194 daltons
Protein Binding 10 - 36 %
VD 0,6 l/Kg
Tmax 0,5 - 2 hours
T1/2 5 (3 - 7) hours
M/P ratio 0,1 - 0,8 -
Theoretical Dose 0,15 - 2,4 mg/Kg/d
Relative Dose 4 - 19 %
Relat.Ped.Dose 1,5 - 48 %

References

  1. Hale TW. Hale's Medications & Mothers' Milk. Springer Publishing Company. 2019
  2. McCreedy A, Bird S, Brown LJ, Shaw-Stewart J, Chen YF. Effects of maternal caffeine consumption on the breastfed child: a systematic review. Swiss Med Wkly. 2018 Sep 28;148:w14665. Abstract
  3. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. 11th edition (acces on line) 2017
  4. Bordini CA, Roesler C, Carvalho Dde S, Macedo DD, Piovesan É, Melhado EM, Dach F, Kowacs F, Silva Júnior HM, Souza JA, Maciel JA Jr, Carvalho JJ, Speciali JG, Barea LM, Queiroz LP, Ciciarelli MC, Valença MM, Lima MM, Vincent MB. Recommendations for the treatment of migraine attacks - a Brazilian consensus. Arq Neuropsiquiatr. 2016 Abstract Full text (link to original source) Full text (in our servers)
  5. Calvaresi V, Escuder D, Minutillo A, Bastons-Compta A, García-Algar O, Pallás Alonso CR, Pacifici R, Pichini S. Transfer of Nicotine, Cotinine and Caffeine Into Breast Milk in a Smoker Mother Consuming Caffeinated Drinks. J Anal Toxicol. 2016 Jul;40(6):473-7. Abstract
  6. Davanzo R, Bua J, Paloni G, Facchina G. Breastfeeding and migraine drugs. Eur J Clin Pharmacol. 2014 Abstract
  7. McGuinness N, Cording V. Raynaud's phenomenon of the nipple associated with labetalol use. J Hum Lact. 2013 Abstract Full text (link to original source)
  8. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  9. Santos IS, Matijasevich A, Domingues MR. Maternal caffeine consumption and infant nighttime waking: prospective cohort study. Pediatrics. 2012 Abstract Full text (link to original source) Full text (in our servers)
  10. Martín I, López-Vílchez MA, Mur A, García-Algar O, Rossi S, Marchei E, Pichini S. Neonatal withdrawal syndrome after chronic maternal drinking of mate. Ther Drug Monit. 2007 Abstract
  11. McNamara PJ, Abbassi M. Neonatal exposure to drugs in breast milk. Pharm Res. 2004 Abstract
  12. 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)
  13. Mitchell JL. Use of cough and cold preparations during breastfeeding. J Hum Lact. 1999 Abstract
  14. Barone JJ, Roberts HR. Caffeine consumption. Food Chem Toxicol. 1996 Abstract
  15. Oo CY, Burgio DE, Kuhn RC, Desai N, McNamara PJ. Pharmacokinetics of caffeine and its demethylated metabolites in lactation: predictions of milk to serum concentration ratios. Pharm Res. 1995 Abstract
  16. Blanchard J, Weber CW, Shearer LE. Methylxanthine levels in breast milk of lactating women of different ethnic and socioeconomic classes. Biopharm Drug Dispos. 1992 Apr;13(3):187-96. Abstract
  17. Fulton B. The galactopharmacopedia. Recreational drug use in the breastfeeding mother. Part 2: Licit drugs. J Hum Lact. 1990 Abstract
  18. Rustin J. Caffeine and babies. Br Med J. 1989;299:121. Full text (link to original source)
  19. Clement MI. Personl view: Caffeine and babies. Br Med J. 1989;298:1461. Full text (link to original source)
  20. Stavchansky S, Combs A, Sagraves R, Delgado M, Joshi A. Pharmacokinetics of caffeine in breast milk and plasma after single oral administration of caffeine to lactating mothers. Biopharm Drug Dispos. 1988 Abstract
  21. Muñoz LM, Lönnerdal B, Keen CL, Dewey KG. Coffee consumption as a factor in iron deficiency anemia among pregnant women and their infants in Costa Rica. Am J Clin Nutr. 1988 Abstract Full text (link to original source) Full text (in our servers)
  22. Ryu JE. Effect of maternal caffeine consumption on heart rate and sleep time of breast-fed infants. Dev Pharmacol Ther. 1985 Abstract
  23. Bucher HU, Gautschi K. [Detection of caffeine, theophylline and theobromine in the umbilical cord blood and breast milk]. Helv Paediatr Acta. 1985 Jul;40(2-3):163-7. German. Abstract
  24. Ryu JE. Caffeine in human milk and in serum of breast-fed infants. Dev Pharmacol Ther. 1985 Abstract
  25. Berlin CM Jr, Denson HM, Daniel CH, Ward RM. Disposition of dietary caffeine in milk, saliva, and plasma of lactating women. Pediatrics. 1984 Abstract
  26. Hildebrandt R, Gundert-Remy U. Lack of pharmacological active saliva levels of caffeine in breast-fed infants. Pediatr Pharmacol (New York). 1983 Abstract
  27. Bailey DN, Weibert RT, Naylor AJ, Shaw RF. A study of salicylate and caffeine excretion in the breast milk of two nursing mothers. J Anal Toxicol. 1982 Abstract
  28. Findlay JW, DeAngelis RL, Kearney MF, Welch RM, Findlay JM. Analgesic drugs in breast milk and plasma. Clin Pharmacol Ther. 1981 Abstract
  29. Tyrala EE, Dodson WE. Caffeine secretion into breast milk. Arch Dis Child. 1979 Abstract Full text (link to original source) Full text (in our servers)
  30. Rivera-calimlim L. Drugs in breast milk. Drug Ther (NY). 1977 Abstract

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