Last update April 24, 2022

Διαζεπάμη

Likely Compatibility

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

Long-acting benzodiazepine with anticonvulsant, sedative, muscle relaxant and anxiolytic actions. It is metabolized to desmethyldiazepam (nordazepam), temazepam, and oxazepam. Oral, rectal, vaginal and parenteral administration 2 to 4 times a day.

It is excreted in milk in an amount that may be clinically significant. (Borgatta 1997, Dusci 1990, Wesson 1985, Brandt 1976, Cole 1975, Erkkola 1972, Patrick 1972)

Levels in infant plasma have been measured (Erkkola 1972), and found to be more than 5 times lower than the corresponding maternal levels. (Wesson 1985)

Some authors have not observed problems in infants whose mothers took it. (Kelly2012, Erkkola 1972)

Others have reported sedation and poor suctioning in the infant (Wesson 1985, Patrick 1972), especially with repeated or high doses and during the neonatal period (Davanzo 2013). There is an increased risk of weight loss and jaundice in newborns whose mothers are given doses of diazepam greater than 0.1 mg/kg. (Gilders 2021)

Vaginal administration has a lower bioavailability than oral, reaching low plasma levels, although with a longer elimination time. (Larish 2019) 

The long elimination half-life of its active metabolite, desmethyldiazepam (Jochemsen 1984), makes it inadvisable during breastfeeding.

The occasional use and low doses of benzodiazepines are compatible with breastfeeding (Kelly 2012, Rubin 2004, Iqbal 2002, WHO 2002, Hägg 2000, McElhatton 1994, Lee 1993, Kanto 1982)Diazepam at low and isolated doses and monitoring the infant does not contraindicate breastfeeding. (Uguz 2021)It is advisable to monitor drowsiness and adequate feeding of the infant.

Choose short-acting benzodiazepines and use the lowest effective dose (Rowe 2013, WHO 2002), especially during the neonatal period and in prematurity, as they can accumulate in the infant during chronic use. (Davanzo 2013, Sachs 2013, Amir 2011)

Bed-sharing with the baby is not recommended if this medicine is being taken due to increased risk of suffocation or sudden infant death. (UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006)


See below the information of these related products:

  • Nordazepam (Unsafe. Moderate/severe adverse effects. Compatible under certain circumstances. Follow-up recommended. Use safer alternative or discontinue breastfeeding from 5 to 7 T ½ . Read Commentary.)
  • Temazepam (Safe substance and/or breastfeeding is the best option.)

Alternatives

  • Lorazepam (Safe substance and/or breastfeeding is the best option.)
  • Midazolam (Safe substance and/or breastfeeding is the best option.)
  • Oxazepam (Safe substance and/or breastfeeding is the best option.)
  • Phenytoin (Safe substance and/or breastfeeding is the best option.)
  • Valproate, Valproic Acid (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.

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

Διαζεπάμη is Diazepam in Greek.

Is written in other languages:

Group

Διαζεπάμη belongs to this group or family:

Tradenames

Main tradenames from several countries containing Διαζεπάμη in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 (vaginal 71) %
Molecular weight 285 daltons
Protein Binding 99 %
VD 0.8 - 1 l/Kg
pKa 3.4 -
Tmax 1 - 1.5 (Vaginal: 3) hours
43 (Vag:82) Desmet: 65(36-200) hours
M/P ratio 0.9 -
Theoretical Dose 0.004 - 0.025 mg/Kg/d
Relative Dose 4 – 14.7 %
Ped.Relat.Dose 0.5 - 20.8 %

References

  1. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Abstract
  2. Gilder ME, Tun NW, Carter A, Tan FFSL, Min AM, Eh H, Aye P, Carrara VI, Angkurawaranon C, McGready R. Outcomes for 298 breastfed neonates whose mothers received ketamine and diazepam for postpartum tubal ligation in a resource-limited setting. BMC Pregnancy Childbirth. 2021 Feb 9;21(1):121. Abstract Full text (link to original source)
  3. (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)
  4. Larish AM, Dickson RR, Kudgus RA, McGovern RM, Reid JM, Hooten WM, Nicholson WT, Vaughan LE, Burnett TL, Laughlin-Tommaso SK, Faubion SS, Green IC. Vaginal Diazepam for Nonrelaxing Pelvic Floor Dysfunction: The Pharmacokinetic Profile. J Sex Med. 2019 Jun;16(6):763-766. Abstract
  5. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  6. 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)
  7. Veiby G, Bjørk M, Engelsen BA, Gilhus NE. Epilepsy and recommendations for breastfeeding. Seizure. 2015 May;28:57-65. Abstract Full text (link to original source)
  8. Soussan C, Gouraud A, Portolan G, Jean-Pastor MJ, Pecriaux C, Montastruc JL, Damase-Michel C, Lacroix I. Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014 Abstract
  9. 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)
  10. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  11. Davanzo R, Dal Bo S, Bua J, Copertino M, Zanelli E, Matarazzo L. Antiepileptic drugs and breastfeeding. Ital J Pediatr. 2013 Abstract Full text (link to original source) Full text (in our servers)
  12. 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)
  13. 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)
  14. Rapcencu AE, Lindhout D, Bulk S. Frequently asked questions on epilepsy, pregnancy and lactation: a EURAP-NL report. Seizure. 2012 Abstract Full text (link to original source) Full text (in our servers)
  15. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012 Sep;161(3):448-51. Abstract
  16. 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)
  17. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Sep;40(9):684-90. Review. Abstract Full text (link to original source) Full text (in our servers)
  18. 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)
  19. 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)
  20. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  21. 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
  22. 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)
  23. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Abstract Full text (link to original source) Full text (in our servers)
  24. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  25. Borgatta L, Jenny RW, Gruss L, Ong C, Barad D. Clinical significance of methohexital, meperidine, and diazepam in breast milk. J Clin Pharmacol. 1997 Mar;37(3):186-92. Abstract
  26. McElhatton PR. The effects of benzodiazepine use during pregnancy and lactation. Reprod Toxicol. 1994 Nov-Dec;8(6):461-75. Review. Abstract
  27. 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)
  28. Dusci LJ, Good SM, Hall RW, Ilett KF. Excretion of diazepam and its metabolites in human milk during withdrawal from combination high dose diazepam and oxazepam. Br J Clin Pharmacol. 1990 Jan;29(1):123-6. Abstract Full text (link to original source) Full text (in our servers)
  29. Wesson DR, Camber S, Harkey M, Smith DE. Diazepam and desmethyldiazepam in breast milk. J Psychoactive Drugs. 1985 Jan-Mar;17(1):55-6. No abstract available. Abstract
  30. Jochemsen R, Breimer DD. Pharmacokinetics of benzodiazepines: metabolic pathways and plasma level profiles. Curr Med Res Opin. 1984;8 Suppl 4:60-79. Abstract
  31. 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
  32. Brandt R. Passage of diazepam and desmethyldiazepam into breast milk. Arzneimittelforschung. 1976;26(3):454-7. Abstract
  33. Cole AP, Hailey DM. Diazepam and active metabolite in breast milk and their transfer to the neonate. Arch Dis Child. 1975 Abstract Full text (link to original source) Full text (in our servers)
  34. Erkkola R, Kanto J. Diazepam and breast-feeding. Lancet. 1972 Abstract
  35. Patrick MJ, Tilstone WJ, Reavey P. Diazepam and breast-feeding. Lancet. 1972 Abstract

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