Last update Jan. 21, 2021

Prazepam

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 (Jochemsen 1984, Ochs 1984, Smith 1979).
Indicated in the control of anxiety.
Oral administration once or twice a day.

It is excreted in breast milk in clinically insignificant amounts (Brodie 1981).
The long elimination half-life of its active metabolite (Jochemsen 1984, Ochs 1984, Smith 1979) makes it inadvisable during breastfeeding.

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.

Group

Prazepam belongs to this group or family:

Tradenames

Main tradenames from several countries containing Prazepam in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 325 daltons
Protein Binding 70 %
VD 14.4 l/Kg
Tmax 6 (2.5 - 129 hours
63. Metabolit: 65 (36 - 200) hours
M/P ratio 0.1 -
Theoretical Dose 0.007 - 0.013 mg/Kg/d
Relative Dose 0.7 - 1.3 %

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. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012 Sep;161(3):448-51. Abstract
  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. 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)
  11. 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)
  12. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  13. 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
  14. 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)
  15. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  16. McElhatton PR. The effects of benzodiazepine use during pregnancy and lactation. Reprod Toxicol. 1994 Nov-Dec;8(6):461-75. Review. Abstract
  17. 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)
  18. Jochemsen R, Breimer DD. Pharmacokinetics of benzodiazepines: metabolic pathways and plasma level profiles. Curr Med Res Opin. 1984;8 Suppl 4:60-79. Abstract
  19. Ochs HR, Greenblatt DJ, Verburg-Ochs B, Locniskar A. Comparative single-dose kinetics of oxazolam, prazepam, and clorazepate: three precursors of desmethyldiazepam. J Clin Pharmacol. 1984 Oct;24(10):446-51. Abstract
  20. 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
  21. Brodie RR, Chasseaud LF, Taylor T. Concentrations of N-descyclopropylmethylprazepam in whole-blood, plasma, and milk after administration of prazepam to humans. Biopharm Drug Dispos. 1981 Jan-Mar;2(1):59-68. Abstract
  22. Smith MT, Evans LE, Eadie MJ, Tyrer JH. Pharmacokinetics of prazepam in man. Eur J Clin Pharmacol. 1979 Sep;16(2):141-7. No abstract available. Abstract

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