Midazolam oral solution (Ozalin®): a profile of its use for procedural sedation or premedication before anaesthesia in children
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Ozalin®, a novel oral solution of 0.2% midazolam, is an effective option for moderate sedation prior to a therapeutic or diagnostic procedure, and as premedication before anaesthesia, in infants, children and adolescents. Orally administered midazolam has a rapid onset and short duration of action, with well-established favourable efficacy, tolerability, safety and acceptability profiles in these indications. To overcome the problems of bitter taste and inconsistent bioavailability associated with extemporaneous formulations of oral midazolam, Ozalin, a commercially prepared oral midazolam formulation, contains the inert excipient γ-cyclodextrin, which forms inclusion complexes with midazolam, thereby enhancing the solubility and stability of midazolam solutions, and masking its bitter taste. Ozalin is administered at the lowest dose of midazolam (i.e. 0.25 mg/kg) that has been shown to be effective, with this dose providing sedative effects consistent with the historical data for midazolam at doses that were the same or higher (i.e. 0.5–1.5 mg/kg).
The manuscript was reviewed by: H. Dupont, Pôle Anesthésie-Réanimation, CHU Amiens-Picardie, and INSERM U1088, Amiens, France; F. Marçon, Pharmacie à Usage Intérieur, CHU Amiens-Picardie, Amiens, France; N. Najafi, Department of Anaesthesiology and Perioperative Medicine, Vrije Universiteit Brussel-Universitair Ziekenhuis Brussel, Brussels, Belgium; M. Vittinghoff, Department of Anesthesiology and Intensive Care, Medical University Graz, Graz, Austria. During the peer review process, Primex Pharmaceuticals, the marketing-authorization holder of Ozalin, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with ethical standards
The preparation of this review was not supported by any external funding.
Conflicts of interest
K.A. Lyseng-Williamson is an employee of Adis/Springer, is responsible for the article content and declares no conflicts of interest.
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