Dental Tribune U.S.Edition No.3, 2017

Dental Tribune U.S. Edition | March 2017 I N DUST RY N EWS A7 Nasal spray is irst FDA-approved, needle-free, regional dental anesthesia for maxillary arch From St. Renatus: Kovanaze (tetracaine HCI and oxymetazoline HCl) Nasal Spray By St. Renatus Staff St. Renatus recently announced that Kovanaze™ (tetracaine HCl and oxy- metazoline HCl) Nasal Spray, the irst FDA-approved, needle-free, regional dental anesthesia for the maxillary arch, is available for order. At the Hin- man Dental Meeting in Atlanta, you can visit booth No. 525 to place an order. Approved by the U.S. Food and Drug Administration (FDA) on June 29, 2016, Kovanaze is indicated for regional an- esthesia when performing a restorative procedure on teeth #4-13 and A-J in adults and children who weigh 40 kg or more. “It is a signiicant moment in dentistry as a new delivery method for pain man- agement is now available,” said Steve Merrick, St. Renatus, chief executive oficer. “For decades, needles have been the mainstay for deliver- ing dental an- esthesia; now dentists have the option to of- fer patients a regional an- esthesia via a nasal spray for restor- ative procedures in the smile zone.” For full prescribing and important safety information, visit www.kovanaze. com. To learn more or to place an order, you can visit booth No. 525 in the exhib- it hall at the Hinman Dental Meeting in Atlanta, contact your dental dealer or call the Kovanaze Support Line at (800) 770-9400. Additional prescribing-information These highlights do not include all in- formation needed to use Kovanaze safe- ly and effectively. See the package insert Approved by the U.S. Food and Drug Administra- tion in June, Kovanaze is indicated for regional anesthesia when performing a restorative procedure on teeth #4-13 and A-J in adults and children who weigh 40 kg or more. Photo/Provided by St. Renatus HINMAN BOOTH NO. 525 for full prescribing information. line) in each 0.2 mL spray. • Indications and usage: Kovana- ze contains tetracaine HCl, an ester lo- cal anesthetic, and oxymetazoline HCl, a vasoconstrictor. • Dosage and administration: Kova- naze is for intranasal use only. Admin- ister Kovanaze ipsilateral (on the same side) to the maxillary tooth on which the dental procedure will be performed. • Dosage forms and strengths: Nasal spray in pre-illed, single-use sprayer: 6 mg tetracaine HCl and 0.1 mg oxy- metazoline HCl (equivalent to 5.27 mg tetracaine and 0.088 mg oxymetazo- • Contraindications: Known hyper- sensitivity to tetracaine, benzyl alcohol, other ester local anesthetics, p-amino- benzoic acid (PABA), oxymetazoline, or any other component of the product. • Adverse reactions: The most com- mon adverse reactions occurring in less than 10 percent of patients include rhi- norrhea, nasal congestion, lacrimation increased, nasal discomfort and oro- pharyngeal pain. Transient, asymptom- atic elevations in systolic blood pressure and diastolic blood pressures have been reported. AD

Dental Tribune U.S.Edition No.3, 2017

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