Last update July 2, 2022

7-Chloro-1,5-dihydro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4(3H)-dione

Likely Compatibility

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

Long-acting benzodiazepine indicated in It is used in the treatment of epilepsy and anxiety disorders. Oral administration once a day.

According to an study from 1978, it is excreted in breastmilk in small amounts, but which could be significant. (Schaefer 2007 p728, Bennett 1996 p 409)

A 25-day-old infant whose mother was taking clobazam and levetiracetam presented sedation, vomiting and weight loss (Paret 2014). No adverse effects were reported in a newborn whose mother was taking tiagabine, clobazam and oxcarbazepine daily. (Tomson 2007)

It is advisable to monitor drowsiness and the adequate feeding of the infant during maternal treatment with clobazam. (Bar-Oz 2012)

In general, occasional and low dose use of benzodiazepines is compatible with breastfeeding. (Kelly 2012, Rubin 2004, Iqbal 2002, Hägg 2000, McElhatton 1994, Lee 1993, Bennet 1996, Kanto 1982)

It is advisable to choose short-acting benzodiazepines and use the minimum effective dose (Rowe 2013), especially during the neonatal period and in cases of prematurity because they can accumulate in the infant during chronic use. (Sachs 2013)

It is advisable to monitor drowsiness and the adequate feeding of the infant. It is not recommended to share a bed with the baby if this medication is being taken due to an increased risk of suffocation or sudden infant death. (ABM 2020, UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006)


See below the information of this related product:

  • Maternal Epilepsy (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

Alternatives

  • Carbamazepine (Safe product and/or breastfeeding is the best option.)
  • Clonazepam (Safe product and/or breastfeeding is the best option.)
  • Gabapentin (Safe product and/or breastfeeding is the best option.)
  • Lorazepam (Safe product and/or breastfeeding is the best option.)
  • Valproate, Valproic Acid (Safe product 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

7-Chloro-1,5-dihydro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4(3H)-dione is Clobazam in Chemical name.

Is written in other languages:

Group

7-Chloro-1,5-dihydro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4(3H)-dione belongs to this group or family:

Tradenames

Main tradenames from several countries containing 7-Chloro-1,5-dihydro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4(3H)-dione in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 87 %
Molecular weight 301 daltons
Protein Binding 80 - 90 %
VD 0.87 - 1.8 l/Kg
pKa 9 -
Tmax 1 - 2 hours
17 - 31 hours
M/P ratio 0.13 - 0.36 -
Theoretical Dose 0.019 - 0.05 mg/Kg/d
Relative Dose 3.8 - 9.9 %

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. Sanofi Aventis. Clobazam. Ficha técnica. 2017 Full text (in our servers)
  5. Ludbeck. Clobazam. Drug Summary. 2016 Full text (in our servers)
  6. 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)
  7. 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)
  8. Paret N, Gouraud A, Bernard N, Bruel M, Cottin J, Descotes J, Vial T. Long-term follow-up of infants exposed to levetiracetam during breastfeeding: Comparison to a control group. (The 2nd International OTIS-ENTIS Conference at The Hospital for Sick Children, Toronto, Canada) Birth Defects Res A Clin Mol Teratol. 2014;100:537-8. Abstract 38. DOI: doi:10.1002/bdra.23258 2014
  9. 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)
  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. 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)
  12. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012 Sep;161(3):448-51. Abstract
  13. 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)
  14. 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)
  15. 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)
  16. Tomson T, Palm R, Källén K, Ben-Menachem E, Söderfeldt B, Danielsson B, Johansson R, Luef G, Ohman I. Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation. Epilepsia. 2007 Jun;48(6):1111-6. Epub 2007 Mar 22. Abstract Full text (link to original source) Full text (in our servers)
  17. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, second edition. London. 2007
  18. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  19. 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
  20. 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)
  21. Bar-Oz B, Nulman I, Koren G, Ito S. Anticonvulsants and breast feeding: a critical review. Paediatr Drugs. 2000 Mar-Apr;2(2):113-26. Review. Abstract
  22. Hägg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000 Jun;22(6):425-40. Review. Abstract
  23. Bennett PN. Drugs and human lactation, 2nd ed. Amsterdam. Elsevier. 1996. 1996
  24. McElhatton PR. The effects of benzodiazepine use during pregnancy and lactation. Reprod Toxicol. 1994 Nov-Dec;8(6):461-75. Review. Abstract
  25. 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)
  26. 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

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