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Dental Tribune U.S.Edition No.5, 2017

A10 I N DUST RY N EWS Dental Tribune U.S. Edition | May 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 2017 CDA Presents the Art and Science of Dentistry in Anaheim, Calif., you can visit booth No. 2144 to place an order. At the American Academy of Pediatric Dentistry 2017 annual session in Wash- ington, D.C., you can visit booth No. 131, 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. AD “It is a sig- nificant mo- ment in den- tistry as a new delivery method for pain management is now available,” said Steve Merrick, chief executive offi- cer of St. Renatus. “For decades, nee- dles have been the mainstay for deliver- ing dental anesthesia; now dentists have the option to offer patients a regional anesthesia via a nasal spray for restor- ative procedures in the smile zone.” For full prescribing and important safety information, visit www.kovanaze. com. To place an order, you can contact your dental dealer or call the Kovanaze Support Line at (800) 770-9400. Additional prescribing-information These highlights do not include all in- Approved by the U.S. Food and Drug Administration last year, 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 CDA BOOTH NO. 2144 AAPD BOOTH NO. 131 formation needed to use Kovanaze safely and effectively. See the pack- tetracaine and 0.088 mg oxymetazo- line) in each 0.2 mL spray. age insert 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 • 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.

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