Last update: May 22, 2019

R05CB06

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

It is a metabolite of Bromhexine (Schaefer 2007 p72).
Effectiveness of this drug has not been established (Prescrire 2017, DGF 2011, INSALUD 2001).
Oral administration two to three times a day.

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

Its high percentage of protein binding and high volume of distribution make it very unlikely that significant amounts will be transferred to milk.

The manufacturer confirms that it is unlikely that it could affect the breastfeed infant.

Known adverse reactions are rare and mild. Authorized for use in children.

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:

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
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Other names

R05CB06 is Ambroxol in ATC Code/s.

Is written in other languages:

R05CB06 is also known as

Group

R05CB06 belongs to this group or family:

Tradenames

Main tradenames from several countries containing R05CB06 in its composition:

List of 65 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 73 - 81 %
Molecular weight 415 daltons
Protein Binding 90 %
VD 1,5 l/Kg
pKa 9,0 - 15,3 -
Tmax 0,5 - 3 hours
T1/2 7 - 12 hours

References

  1. 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)
  2. AEMPS. Ambroxol. Ficha técnica. 2016 Full text (in our servers)
  3. MRI-CTS. Ambroxol. Drug Summary. 2015 Full text (in our servers)
  4. DGF. Dirección General de Farmacia. Servicio Canario de la Salud. Listado de fármacos considerados de Utilidad terapéutica Baja (UTB). 2011 Full text (in our servers)
  5. Área de Gestión de Farmacia. Subdirección General de Atención Primaria. Instituto Nacional de la Salud (INSALUD). Utilidad terapéutica de los medicamentos financiados por el Sistema Nacional de Salud. 2001 Full text (in our servers)
  6. 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
  7. Bechgaard E, Nielsen A. Bioavailability of bromhexine tablets and preliminary pharmacokinetics in humans. Biopharm Drug Dispos. 1982 Oct-Dec;3(4):337-44. Abstract
  8. 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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