St. Renatus Kovanaze

St. Renatus has announced that Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray, the first FDA-approved, needle-free, regional dental anesthesia for the maxillary arch, is available for order.

Approved by the U.S. Food and Drug Administration (FDA) on June 29, 2016, 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.

“It is a significant moment in dentistry as a new delivery method for pain management is now available,” said Steve Merrick, St. Renatus, chief executive officer. “For decades, needles have been the mainstay for delivering dental anesthesia; now dentists have the option to offer patients a regional anesthesia via a nasal spray for restorative 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 exhibit hall at the Hinman Dental Meeting in Atlanta, contact your dental dealer or call the Kovanaze Support Line at (800) 770-9400.

These highlights do not include all information needed to use Kovanaze safely and effectively. See the package insert for full prescribing information.

• Indications and usage: Kovanaze contains tetracaine HCl, an ester local anesthetic, and oxymetazoline HCl, a vasoconstrictor.
• Dosage and administration: Kovanaze is for intranasal use only. Administer 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 oxymetazoline HCl (equivalent to 5.27 mg tetracaine and 0.088 mg oxymetazoline) in each 0.2 mL spray.
• Contraindications: Known hypersensitivity to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product.
• Adverse reactions: The most common adverse reactions occurring in less than 10 percent of patients include rhinorrhea, nasal congestion, lacrimation increased, nasal discomfort and oropharyngeal pain. Transient, asymptomatic elevations in systolic blood pressure and diastolic blood pressures have been reported.