http://orcid.org/0000-0003-0928-1577
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ABSTRACT
Introduction: Recently, an intravenous formulation of carbamazepine (CBZ) (sulphobutylether-7-beta-cyclodextrine carbamazepine, SBECD CBZ) has been developed and approved by the U.S. Food and Drug Administration. It is indicated as a short-term replacement therapy for oral CBZ formulations, when oral administration is temporarily not feasible and in adults with focal seizures with complex symptomatology as well as generalized tonic-clonic seizures and mixed seizure patterns.
Areas covered: This review focuses on the drug development, pharmacokinetics and pharmacodynamics of intravenous CBZ and provides a comprehensive overview of the studies assessing its clinical efficacy, tolerability and safety in adults with epilepsy.
Expert opinion: Intravenous CBZ has favorable pharmacokinetics and is well tolerated and safe when used as a short-term substitution for oral CBZ. Seizure control was unchanged after switching from oral to IV formulations. Overall, this new formulation represents a useful option to enhance continuity of care in adults with focal or generalized tonic-clonic seizures when oral CBZ administration is temporarily unfeasible. Further studies are needed to assess the efficacy and tolerability of IV CBZ used at larger doses (above 1600 mg/day), for a period longer than 7 days or for other indications not approved by FDA, such as prolonged convulsive seizures and status epilepticus.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.