Last update July 5, 2022

N06AX03

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Tetracyclic antidepressant with marked sedative action. Inhibits norepinephrine reuptake.

Single nightly dose oral administration.

It is excreted in human milk in a clinically insignificant amount and the plasma or urine levels of infants whose mothers took it were either very low or below the limit of detection. (Buist 1993)

It is not recommended to share a bed with the baby if this drug is being taken. (UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006)

Due to the sedative action on the mother and because there is less published experience than with other antidepressant drugs, known safer alternatives might be preferable, especially during the neonatal period and in the event of prematurity.


See below the information of these related products:

  • Maternal Depression (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)
  • Mirtazapine (Safe substance and/or breastfeeding is the best option.)

Alternatives

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

N06AX03 is Mianserin Hydrochloride in ATC Code/s.

Is written in other languages:

Groups

N06AX03 belongs to these groups or families:

Tradenames

Main tradenames from several countries containing N06AX03 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 20 - 30 %
Molecular weight 301 daltons
Protein Binding 90 %
Tmax 3 hours
T½ 40 (21 - 61) hours
M/P ratio 3.6 -
Theoretical Dose 0.003 - 0.012 mg/Kg/d
Relative Dose 0.5 - 1.4 %

References

  1. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  2. UNICEF. Ball H, Blair PS. (For UNICEF UK). Caring for your baby at night. Health professional´s guide. 2017 Full text (link to original source) Full text (in our servers)
  3. UNICEF UK. Statement on co-sleeping following publication of new NICE postnatal guidance. Infosheet. 2014 Full text (link to original source) Full text (in our servers)
  4. UNICEF UK Baby Friendly Initiative statement on Bed-sharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case-control studies. None 2013 Full text (link to original source) Full text (in our servers)
  5. L.Landa Rivera, M.Díaz-Gómez, A.Gómez Papi, J.M.Paricio Talayero, C.Pallás Alonso, M.T.Hernández Aguilar, J.Aguayo Maldonado, J.M.Arena Ansotegui, S.Ares Segura, A.Jiménez Moya, J.J.Lasarte Velillas, J.Martín Calama, M.D.Romero Escós. El colecho favorece la práctica de la lactancia materna y no aumenta el riesgo de muerte súbita del lactante. Dormir con los padres. Rev Pediatr Aten Primaria. 14:53-60 2012 Full text (link to original source) Full text (in our servers)
  6. ABM - The Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #6: Guideline on Co-Sleeping and Breastfeeding. Breastfeeding Medicine 2008 Abstract Full text (link to original source) Full text (in our servers)
  7. ABM - Comité de protocolos de la Academia médica de lactancia materna (Academy of Breastfeeding Medicine). Protocolo Clínico de la ABM #6: Lineamientos sobre la práctica de dormir al bebé junto con la madre y la lactancia materna Revisión, marzo de 2008. Breastfeeding Medicine 2008 Full text (link to original source) Full text (in our servers)
  8. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  9. Buist A, Norman TR, Dennerstein L. Mianserin in breast milk. Br J Clin Pharmacol. 1993 Aug;36(2):133-4. No abstract available. Abstract

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