Clobazam

Drug Levels and Effects:




Summary of Use during Lactation:


Limited information indicates that maternal doses of clobazam up to 30 mg daily produce low levels in milk. Short-term use would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. During long-term administration, monitor the infant for possible sedation and poor sucking.[1][2]


Drug Levels:


Clobazamhas a half-life of 36 to 42 hours and is metabolized to N-desmethylclobazam, which has about 20% of the activity of clobazam and a half-life of 71 to 82 hours.

Maternal Levels.

In an older, unpublished study performed by the European manufacturer, clobazam and N-desmethylclobazam were measured in breastmilk using an assay that did not distinguish between the two compounds. Six patients received oral clobazam 10 mg at 7 am and 20 mg at 3 pm daily for 5 days. Milk samples were taken 2 hours after each dose on days 2 and 5 of drug administration. Average clobazam plus N-desmethylclobazam milk levels were 0.125 mg/L on day 2 and 0.152 mg/L on day 5. The highest recorded clobazam plus N-desmethylclobazam milk levels were 0.33 mg/L on day 2 and 0.25 mg/L on day 5. The weight-adjusted infant dosages are an average of 4.6% of the maternal dosage and a maximum of 7.5% of the maternal dosage.[3] Because of the lower potency and longer half-life of N-desmethylclobazam, these values probably overestimate the pharmacologic impact of clobazam in breastmilk.

Infant Levels.

Relevant published information was not found as of the revision date.


Effects in Breastfed Infants:


Relevant published information was not found as of the revision date.


Possible Effects on Lactation:


Relevant published information was not found as of the revision date.


References:


1. Hagg S, Spigset O. Anticonvulsant use during lactation. Drug Saf. 2000;22:425-40. PMID:10877037
2. Bar-Oz B, Nulman I, Koren G, Ito S. Anticonvulsants and breastfeeding. A critical review. Paediatr Drugs. 2000 ;2:113-26. PMID:10937463
3. Bennett PN, ed. Drugs and human lactation, 2nd ed. Amsterdam. Elsevier. 1996;409-10.



Substance Identification:




Substance Name:

Clobazam

CAS Registry Number:

22316-47-8

Drug Class:


  • Anticonvulsants

  • Benzodiazepines


  • Administrative Information:




    LactMed Record Number:


    938


    Last Revision Date:


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