Last update May 14, 2024

A11HA04; S01XA26

Compatible

Safe product and/or breastfeeding is the best option.

Riboflavin is a water-soluble vitamin that is essential for the utilization of energy from food. It is found in milk, meat, eggs, nuts, and vegetables (MedlinePlus 2020). It is used to correct vitamin B2 deficiency or aryboflavinosis. At high doses it is used to prevent migraine attacks. Riboflavin is also a food coloring (E101).

The riboflavin concentration in human milk depends on dietary intake of this vitamin being higher in well-nourished women (NIH prof 2022, Allen 2012, Sakurai 2005); it is also higher in transitional and mature milk than in colostrum. (Ren 2015)

The recommended daily allowance (RDA) of vitamin B2 for lactating women is 1.6 mg (NIH 2022, Sauberan 2019, Ares 2015, Hall 2010). Supplementation is not necessary in healthy, well-nourished women. (Thomas 1980, Nail 1980)

Up to 50% of the riboflavin in donated milk is destroyed in bottles or nasogastric tubes exposed to daylight or phototherapy, which may contribute to the high incidence of riboflavin deficiency in premature infants receiving donated breast milk without vitamin supplements. (Bates 1985)

Given its rapid elimination from the body when consumed in excess, no studies have reported significant adverse effects in humans from excessive consumption of riboflavin through food or supplements (Lee 2023). No upper limit (UL) of daily tolerability or toxic dose of this vitamin has been established in humans (Sauberan 2019, EFSA 2006). It is recognized as generally safe by the FDA. (FDA 2023)
With an adequate diet it is not necessary to take supplements of this vitamin. 

Various medical societies and expert authors consider the use of this medication safe during breastfeeding. (Hale, Briggs 2015)

Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs: compatible with Breastfeeding. (WHO 2002). American Academy of Pediatrics: medication usually compatible with breastfeeding.(AAP 2001)

Alternatives

We do not have alternatives for A11HA04; S01XA26 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.

Tradenames

Main tradenames from several countries containing A11HA04; S01XA26 in its composition:

  • 102 Plus™. Contains other elements than A11HA04; S01XA26 in its composition
  • Anemidox™. Contains other elements than A11HA04; S01XA26 in its composition
  • B2-400
  • B2-ASmedic
  • Cyto B2
  • Elevit™. Contains other elements than A11HA04; S01XA26 in its composition
  • Goteborg™. Contains other elements than A11HA04; S01XA26 in its composition
  • Hemamina™. Contains other elements than A11HA04; S01XA26 in its composition
  • Jetshemamina™. Contains other elements than A11HA04; S01XA26 in its composition
  • Multibionta Complex™. Contains other elements than A11HA04; S01XA26 in its composition
  • Nectar Vit™. Contains other elements than A11HA04; S01XA26 in its composition
  • Pharmaton Matruelle™. Contains other elements than A11HA04; S01XA26 in its composition
  • Photrexa
  • Pilopeptan Woman comprimidos™. Contains other elements than A11HA04; S01XA26 in its composition
  • Seidibion Embarazo™. Contains other elements than A11HA04; S01XA26 in its composition
  • Seidibion Mater preparto, posparto y lactancia™. Contains other elements than A11HA04; S01XA26 in its composition
  • Seidibion Prime Embarazo™. Contains other elements than A11HA04; S01XA26 in its composition
  • Supradyn Forte™. Contains other elements than A11HA04; S01XA26 in its composition
  • Supradyn Prenatal™. Contains other elements than A11HA04; S01XA26 in its composition
  • Supradyn Pronatal™. Contains other elements than A11HA04; S01XA26 in its composition
  • Vitafarm™. Contains other elements than A11HA04; S01XA26 in its composition

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 60 %
Molecular weight 376 daltons
Protein Binding 60 %
Tmax 1.5 - 2 hours
3.9 hours
Theoretical Dose 0.00006 mg/Kg/d
Relative Dose 0.35 %
Ped.Relat.Dose 0.4 %

References

  1. Lee TY, Farah N, Chin VK, Lim CW, Chong PP, Basir R, Lim WF, Loo YS. Medicinal benefits, biological, and nanoencapsulation functions of riboflavin with its toxicity profile: A narrative review. Nutr Res. 2023 Nov;119:1-20. Consulted on Dec. 16, 2023 Abstract
  2. FDA. U.S. Food & Drug Administration Part 184.1- Substances added directly to human food affirmed as generally recognized as safe (GRAS). CFR. 2023 Consulted on Dec. 12, 2023 Full text (link to original source) Full text (in our servers)
  3. NIH. Riboflavin. Fact Sheet for Health Professionals. 2022 Full text (link to original source)
  4. NIH. Riboflavina. Hoja informativa para consumidores. 2022 Full text (link to original source)
  5. NIH. Riboflavin. Fact Sheet for Consumers. 2022 Full text (link to original source)
  6. MedlinPlus. Riboflavin. Health topics. 2020 Full text (link to original source)
  7. MedlinePlus. Riboflavina. Temas de salud. 2020 Full text (link to original source)
  8. Sauberan JB. High-Dose Vitamins. Breastfeed Med. 2019 Apr 30. Abstract
  9. Ren X, Yang Z, Shao B, Yin SA, Yang X. B-Vitamin Levels in Human Milk among Different Lactation Stages and Areas in China. PLoS One. 2015 Abstract Full text (link to original source) Full text (in our servers)
  10. Ares Segura S, Arena Ansótegui J, Díaz-Gómez NM; en representación del Comité de Lactancia Materna de la Asociación Española de Pediatría. La importancia de la nutrición materna durante la lactancia, ¿necesitan las madres lactantes suplementos nutricionales? [The importance of maternal nutrition during breastfeeding: Do breastfeeding mothers need nutritional supplements?] An Pediatr (Barc). 2015 Abstract Full text (link to original source) Full text (in our servers)
  11. Allen LH. B vitamins in breast milk: relative importance of maternal status and intake, and effects on infant status and function. Adv Nutr. 2012 Abstract Full text (link to original source) Full text (in our servers)
  12. Hall Moran V, Lowe N, Crossland N, Berti C, Cetin I, Hermoso M, Koletzko B, Dykes F. Nutritional requirements during lactation. Towards European alignment of reference values: the EURRECA network. Matern Child Nutr. 2010 Oct;6 Suppl 2:39-54. Abstract Full text (link to original source) Full text (in our servers)
  13. EFSA. European Food Safety Authority. Tolerable upper intake levels for vitamins and minerals. Scientific Committee on Food. 2006 Full text (link to original source) Full text (in our servers)
  14. Sakurai T, Furukawa M, Asoh M, Kanno T, Kojima T, Yonekubo A. Fat-soluble and water-soluble vitamin contents of breast milk from Japanese women. J Nutr Sci Vitaminol (Tokyo). 2005 Abstract
  15. 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)
  16. 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)
  17. Zempleni J, Galloway JR, McCormick DB. Pharmacokinetics of orally and intravenously administered riboflavin in healthy humans. Am J Clin Nutr. 1996 Jan;63(1):54-66. Abstract
  18. Bates CJ, Liu DS, Fuller NJ, Lucas A. Susceptibility of riboflavin and vitamin A in breast milk to photodegradation and its implications for the use of banked breast milk in infant feeding. Acta Paediatr Scand. 1985 Jan;74(1):40-4. Abstract
  19. Nail PA, Thomas MR, Eakin R. The effect of thiamin and riboflavin supplementation on the level of those vitamins in human breast milk and urine. Am J Clin Nutr. 1980 Abstract
  20. Thomas MR, Sneed SM, Wei C, Nail PA, Wilson M, Sprinkle EE 3rd. The effects of vitamin C, vitamin B6, vitamin B12, folic acid, riboflavin, and thiamin on the breast milk and maternal status of well-nourished women at 6 months postpartum. Am J Clin Nutr. 1980 Abstract

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