Dental Tribune U.S.Edition No.4, 2017

a6 I N DUST RY N EWS XXXXX Dental Tribune U.S. Edition | April 2017 Nasal spray is first 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 first FDA-approved, needle-free, regional dental anesthesia for the maxillary arch, is available for order. At the Ameri- can Academy of Cosmetic Dentistry An- nual Scientific Session in Las Vegas, 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 significant moment in dentistry as a new delivery method for pain man- agement is now available,” said Steve Merrick, chief executive officer of St. Re- AD natus. “For de- cades, needles have been the mainstay for delivering dental anesthesia; now den- tists have the option to offer patients a regional anesthesia via a nasal spray for restorative pro- cedures 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. 737 in the exhib- it hall at the AAACD Scientific Session in Las Vegas, 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 Apprjved by the U.S. Fjjd and Drug Administratijn in June, Kjvanaze is indicated fjr regijnal anesthesia when perfjrming a restjrative prjcedure jn teeth #4-13 and A-J in adults and children whj weigh 40 kg jr mjre. Photo/Provided by St. Renatus AACD BOOTH NO. 737 for full prescribing details. • Indications and usage: Kovanaze contains tetracaine HCl, an ester local 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-filled, 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- line) in each 0.2 mL spray. • 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.

Dental Tribune U.S.Edition No.4, 2017

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