Last update April 18, 2022

R05CB02

Compatible

Safe substance and/or breastfeeding is the best option.

Bromhexine is metabolized into Ambroxol (Schaefer 2007 p72). Effectiveness of this drug has not been established (Prescrire 2017, INSALUD 2001). Oral administration two to three times a day.

At latest update, relevant published data on excretion into breast milk were not found.

Because of high serum protein-binding capacity (AEMPS 2016), excretion into breast milk in significant amount is seemingly unlikely.

Its low oral bioavailability (AEMPS 2016) causes a poor absorption into infant's serum as from breast milk, except in prematures and in the early neonatal period in which intestinal absorption may be increased.

Known adverse reactions are rare and mild. Ambroxol is used in children, infants and newborns. (Wei 2022, Kantar 2020, Xiang 2019, AEMPS 2016)

Secretion of prolactin and other hormones have not been affected by taking this medication. (Tuimala 1981)

Expert authors consider it safe during breastfeeding. (Schaefer 2007 p644)


See below the information of this related product:

  • Ambroxol (Safe substance and/or breastfeeding is the best option.)

Alternatives

  • Acetylcysteine (Safe substance and/or breastfeeding is the best option.)
  • Ambroxol (Safe substance and/or breastfeeding is the best option.)

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.

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Other names

R05CB02 is Bromhexine in ATC Code/s.

Is written in other languages:

R05CB02 is also known as

Group

R05CB02 belongs to this group or family:

Tradenames

Main tradenames from several countries containing R05CB02 in its composition:

List of 52 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 20 - 25 %
Molecular weight 413 daltons
Protein Binding 95 - 99 %
pKa 19.9 -
Tmax 1 hours
T½ 7 - 15 hours

References

  1. Wei Y, Liu X, Yuan J, Shi J, Zhang X, Wang D, Zhang L, Xie C. Coronavirus disease-2019 (COVID-19) infection in a 3-month-old infant: Clinical features, treatment and probable route of transmission. IDCases. 2020;22:e00937. Abstract
  2. Kantar A, Klimek L, Cazan D, Sperl A, Sent U, Mesquita M. An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children. Multidiscip Respir Med. 2020 Mar 3;15(1):511. Abstract
  3. Xiang J, Wang P. Efficacy of pulmonary surfactant combined with high-dose ambroxol hydrochloride in the treatment of neonatal respiratory distress syndrome. Exp Ther Med. 2019 Jul;18(1):654-658. Abstract
  4. Redaction Prescrire. Pour mieux soigner, des médicaments à écarter : bilan 2018. Prescrire.org. 2018 Full text (link to original source) Full text (in our servers)
  5. AEMPS-Sanofi. Bromhexina. Ficha técnica. 2016 Full text (in our servers)
  6. INSALUD. Área de Gestión de Farmacia. Subdirección General de Atención Primaria. Instituto Nacional de la Salud. Utilidad terapéutica de los medicamentos financiados por el Sistema Nacional de Salud. . 2001 Full text (in our servers)
  7. Vergin H, Bishop-Freudling GB, Miczka M, Nitsche V, Strobel K, Matzkies F. [The pharmacokinetics and bioequivalence of various dosage forms of ambroxol]. Arzneimittelforschung. 1985;35(10):1591-5. German. Abstract
  8. Bechgaard E, Nielsen A. Bioavailability of bromhexine tablets and preliminary pharmacokinetics in humans. Biopharm Drug Dispos. 1982 Oct-Dec;3(4):337-44. Abstract
  9. Tuimala RJ, Kauppila AJ, Viinikka L, Ylikorkala O. Maternal hormone levels during Na 872 infusion in late pregnancy. Horm Metab Res. 1981 Abstract

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