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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="citation_inbook_title" content="Drugs and Lactation Database (LactMed®) [Internet]" /><meta name="citation_title" content="Clobazam" /><meta name="citation_publisher" content="National Institute of Child Health and Human Development" /><meta name="citation_date" content="2024/10/15" /><meta name="citation_pmid" content="30000914" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK501854/" /><meta name="citation_keywords" content="Clobazam" /><meta name="citation_keywords" content="Chlorepin" /><meta name="citation_keywords" content="Frisium" /><meta name="citation_keywords" content="Urbanyl" /><meta name="citation_keywords" content="Clorepin" /><meta name="citation_keywords" content="Urbadan" /><meta name="citation_keywords" content="Clobazamum" /><meta name="citation_keywords" content="Onfi" /><meta name="citation_keywords" content="Caastilium" /><meta name="citation_keywords" content="Noiafren" /><meta name="citation_keywords" content="Urbanil" /><meta name="citation_keywords" content="Odipam" /><meta name="citation_keywords" content="HR 376" /><meta name="citation_keywords" content="LM-2717" /><meta name="citation_keywords" content="UNII-2MRO291B4U" /><meta name="citation_keywords" content="RU-4723" /><meta name="citation_keywords" content="CCRIS 7506" /><meta name="citation_keywords" content="LM 2717" /><meta name="citation_keywords" content="2MRO291B4U" /><meta name="citation_keywords" content="DEA No. 2751" /><meta name="citation_keywords" content="NSC 336279" /><meta name="citation_keywords" content="EINECS 244-908-7" /><meta name="citation_keywords" content="H-4723" /><meta name="citation_keywords" content="H 4723" /><meta name="citation_keywords" content="HSDB 8343" /><meta name="citation_keywords" content="BRN 0758410" /><meta name="citation_keywords" content="5-24-08-00034 (Beilstein Handbook Reference)" /><meta name="citation_keywords" content="7-chloro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4-dione" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Clobazam" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="National Institute of Child Health and Human Development" /><meta name="DC.Date" content="2024/10/15" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK501854/" /><meta name="description" content="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 sedation, poor feeding and poor weight gain.[1,2]" /><meta name="og:title" content="Clobazam" /><meta name="og:type" content="book" /><meta name="og:description" content="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 sedation, poor feeding and poor weight gain.[1,2]" /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK501854/" /><meta name="og:site_name" content="NCBI Bookshelf" /><meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-lactmed-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/lactmed/LM938/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK501854/" /><link rel="stylesheet" href="/corehtml/pmc/css/figpopup.css" type="text/css" media="screen" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_print.min.css" type="text/css" /><style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} </style><script type="text/javascript" src="/corehtml/pmc/js/jquery.hoverIntent.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/common.min.js?_=3.18"> </script><script type="text/javascript">window.name="mainwindow";</script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/book-toc.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/books.min.js"> </script>
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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. </p></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK501854_"><span class="title" itemprop="name">Clobazam</span></h1><p class="small">Last Revision: <span itemprop="dateModified">October 15, 2024</span>.</p><p><em>Estimated reading time: 2 minutes</em></p></div><div class="body-content whole_rhythm" itemprop="text"><p>CASRN: 22316-47-8</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/134994740" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=134994740" alt="image 134994740 in the ncbi pubchem database" /></a><div id="LM938.Drug_Levels_and_Effects"><h2 id="_LM938_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM938.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>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 sedation, poor feeding and poor weight gain.[<a class="bk_pop" href="#LM938.REF.1">1</a>,<a class="bk_pop" href="#LM938.REF.2">2</a>]</p></div><div id="LM938.Drug_Levels"><h3>Drug Levels</h3><p>In published reports of anticonvulsant use during breastfeeding, most women were taking a combination of anticonvulsants. Some other anticonvulsants (e.g., phenytoin, carbamazepine) stimulate the metabolism of other drugs including anticonvulsants, whereas others (e.g., valproic acid) inhibit the metabolism of other drugs. Therefore, the relationship of the maternal dosage to the concentration in breastmilk can be quite variable, making calculation of the weight-adjusted percentage of maternal dosage less meaningful than for other drugs</p><p>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.</p><p><i>Maternal Levels.</i> 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.[<a class="bk_pop" href="#LM938.REF.3">3</a>] Because of the lower potency and longer half-life of N-desmethylclobazam, these values probably overestimate the pharmacologic impact of clobazam in breastmilk.</p><p><i>Infant Levels.</i> Relevant published information was not found as of the revision date.</p></div><div id="LM938.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>No adverse effects were reported in 10 newborns who were 4 to 23 days old who were breastfed during maternal intake of levetiracetam 1000 to 3000 mg daily. One mother was also taking tiagabine 30 mg daily, clobazam 45 mg daily and oxcarbazepine 600 mg daily.[<a class="bk_pop" href="#LM938.REF.4">4</a>]</p><p>The infants (including 3 preterm) of 18 nursing mothers who were taking levetiracetam and called the Pharmacovigilance Center in Lyon, France. One 25-day-old infant whose mother was taking levetiracetam 3000 mg daily plus clobazam was hospitalized for sedation, vomiting, and weight loss, and improved rapidly after breastfeeding discontinuation. Another infant exposed to levetiracetam and clobazam had poor weight gain, but it appeared to be caused by poor milk production.[<a class="bk_pop" href="#LM938.REF.5">5</a>]</p></div><div id="LM938.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM938.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p>(Seizure Disorder) <a href="/books/n/lactmed/LM400/">Carbamazepine</a>, <a href="/books/n/lactmed/LM437/">Divalproex</a>, <a href="/books/n/lactmed/LM358/">Gabapentin</a>, <a href="/books/n/lactmed/LM399/">Lamotrigine</a>, <a href="/books/n/lactmed/LM376/">Oxcarbazepine</a>, <a href="/books/n/lactmed/LM402/">Phenytoin</a>, <a href="/books/n/lactmed/LM403/">Valproic Acid</a></p></div><div id="LM938.References"><h3>References</h3><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="LM938.REF.1">Bar-Oz
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B, Nulman
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I, Koren
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G, et al.
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Anticonvulsants and breastfeeding. A critical review.
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Paediatr Drugs
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2000;2:113-26.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/10937463" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10937463</span></a>]</div></dd><dt>2.</dt><dd><div class="bk_ref" id="LM938.REF.2">Hägg
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S, Spigset
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O. Anticonvulsant use during lactation.
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Drug Saf
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2000;22:425-40.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/10877037" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10877037</span></a>]</div></dd><dt>3.</dt><dd><div class="bk_ref" id="LM938.REF.3">Bennett PN. Drugs and human lactation, 2nd ed. Amsterdam: Elsevier; 1996</div></dd><dt>4.</dt><dd><div class="bk_ref" id="LM938.REF.4">Tomson
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T, Palm
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R, Kallen
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K, et al.
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Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation.
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Epilepsia
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2007;48:1111-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/17381438" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17381438</span></a>]</div></dd><dt>5.</dt><dd><div class="bk_ref" id="LM938.REF.5">Paret
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N, Gouraud
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A, Bernard
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N, et al.
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Long-term follow-up of infants exposed to levetiracetam during breastfeeding: Comparison to a control group.
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Birth Defects Res A Clin Mol Teratol
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2014;100:537-8. doi:10.1002/bdra.23258 [<a href="http://dx.crossref.org/10.1002/bdra.23258" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl></div></div><div id="LM938.Substance_Identification"><h2 id="_LM938_Substance_Identification_">Substance Identification</h2><div id="LM938.Substance_Name"><h3>Substance Name</h3><p>Clobazam</p></div><div id="LM938.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>22316-47-8</p></div><div id="LM938.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Anticonvulsants</p><p>Benzodiazepines</p></div></div><div><dl class="temp-labeled-list small"><dt></dt><dd><div><p class="no_top_margin"><p><b>Disclaimer: </b>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.</p></p></div></dd></dl></div><div id="bk_toc_contnr"></div></div></div>
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