Last update Jan. 21, 2021

N05BA14

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

Long-acting benzodiazepine with anxiolytic effect. It is metabolised to N-desmethyldiazepam/nordazepam (Janbroers 1984, Pacifici 1984 y 1977).
Indicated in the control of anxiety.
Oral administration every 6 to 8 hours.

It is excreted in breast milk in small amounts, but its metabolite, N-desmethyldiazepam, has been detected in human milk at concentrations that could be significant for up to three days after a single dose (Pacifici 1977).

Its pharmacokinetic data does not make it easy to accurately predict possible transfer to breastmilk, because while its high percentage of protein binding and large volume of distribution would prevent it, the long half-life of its active metabolite (Jochemsen 1984) would facilitate it.

It has very few bibliographical references, and is marketed in few countries

The occasional use and low doses of benzodiazepines are compatible with breastfeeding (Kelly 2012, Rubin 2004, Iqbal 2002, Hägg 2000, McElhatton 1994, Lee 1993, Kanto 1982).

It is advisable to choose a short-acting benzodiazepine and minimal effective dose as possible (Rowe 2013), especially in the neonatal period and in case of prematurity because they can accumulate in the infant during chronic use (Sachs 2013).

It is advisable to monitor drowsiness and adequate feeding of the infant.
It is not recommended to share a bed (co-sleeping, bed-sharing) with the baby if this drug is being taken, due to increased risk of asphyxia or sudden infant death (UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006).


See below the information of this related product:

  • Nordazepam ( Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.)

Alternatives

  • Lorazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Oxazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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.

Other names

N05BA14 is Pinazepam in ATC Code/s.

Is written in other languages:

Group

N05BA14 belongs to this group or family:

Tradenames

Main tradenames from several countries containing N05BA14 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. Alta - Hig %
Molecular weight 309 daltons
Protein Binding 89 %
VD 10.9 l/Kg
Tmax 1.8 ± 0.1 hours
15.7 .Metabolit: 65 (36 - 200) hours
Theoretical Dose 0.001-0.002. Metab:0.004-0.013 mg/Kg/d
Relative Dose 0. 6 - 1.1. Metabolit: 2.3 - 8 %

References

  1. (ABM): Blair PS, Ball HL, McKenna JJ, Feldman-Winter L, Marinelli KA, Bartick MC; Academy of Breastfeeding Medicine.. Bedsharing and Breastfeeding: The Academy of Breastfeeding Medicine Protocol #6, Revision 2019. Breastfeed Med. 2020 Jan;15(1):5-16. Abstract Full text (link to original source) Full text (in our servers)
  2. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  3. 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)
  4. 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)
  5. 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)
  6. Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. Abstract Full text (link to original source) Full text (in our servers)
  7. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  8. AEMPS. Pinazepam. Ficha técnica. 2012 Full text (in our servers)
  9. 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)
  10. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012 Sep;161(3):448-51. Abstract
  11. 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)
  12. 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)
  13. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  14. Rubin ET, Lee A, Ito S. When breastfeeding mothers need CNS-acting drugs. Can J Clin Pharmacol. 2004 Fall;11(2):e257-66. Epub 2004 Dec 8. Abstract
  15. Iqbal MM, Sobhan T, Ryals T. Effects of commonly used benzodiazepines on the fetus, the neonate, and the nursing infant. Psychiatr Serv. 2002 Jan;53(1):39-49. Review. Abstract Full text (in our servers)
  16. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  17. McElhatton PR. The effects of benzodiazepine use during pregnancy and lactation. Reprod Toxicol. 1994 Nov-Dec;8(6):461-75. Review. Abstract
  18. Lee JJ, Rubin AP. Breast feeding and anaesthesia. Anaesthesia. 1993 Jul;48(7):616-25. Review. Abstract Full text (link to original source) Full text (in our servers)
  19. Pacifici GM, Cuoci L, Guarneri M, Fornaro P, Arcidiacono G, Cappelli N, Moggi G, Placidi GF. Placental transfer of pinazepam and its metabolite N-desmethyldiazepam in women at term. Eur J Clin Pharmacol. 1984;27(3):307-10. Abstract
  20. Janbroers JM. Pinazepam: review of pharmacological properties and therapeutic efficacy. Clin Ther. 1984;6(4):434-50. Abstract
  21. Kanto JH. Use of benzodiazepines during pregnancy, labour and lactation, with particular reference to pharmacokinetic considerations. Drugs. 1982 May;23(5):354-80. Review. Abstract
  22. Pacifici GM, Placidi GF. Rapid and sensitive electron-capture gas chromatographic method for the determination of pinazepam and its metabolites in human plasma, urine and milk. J Chromatogr. 1977 May 11;135(1):133-9. Abstract

Total visits

1,098

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2006 of United States of America

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM