Also known as Clobazamum, Frisium, Onfi, Urbanol
A 1,5-benzodiazepine and partial gamma-aminobutyric acid (GABA) receptor agonist, with anxiolytic, sedative, and anticonvulsant activities. Clobazam binds to a specific site, distinct from the inhibitory neurotransmitter GABA binding site, on the benzodiazepine-GABA-A-chloride ionophore receptor complex located in the central nervous system (CNS). This binding causes an allosteric modification of the receptor and enhances the affinity of GABA to the receptor leading to an increase in the opening of chloride-channels. This leads to an increase in chloride ion conductance, neuronal hyperpolarization, inhibition of the action potential and a decrease in neuronal excitability.
Originator: NCI Thesaurus | Source: The website of the National Cancer Institute (http://www.cancer.gov)
Can I take Clobazam while breastfeeding?
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
Clobazam has 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 In an older, unpublished study performed by the European manufacturer, clobazam and N-desmethylclobazam were measured in breastmilk using an assay that did not distinguish between the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
Clobazam has 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.
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.
4. Tomson T, Palm R, Kallen K B et al. Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation. Epilepsia. 2007;48:1111-6. PMID: 17381438
5. Paret N, Gouraud A, Bernard N et al. Long-term follow-up of infants exposed to levetiracetam during breastfeeding: Comparison to a control group. Birth Defects Res A Clin Mol Teratol. 2014 ;100:537-8. Abstract.
Last Revision Date
20150130
Disclaimer:Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
Source: LactMed – National Library of Medicine (NLM)