Kovanaze

Last updated on RxList: 12/10/2018
Kovanaze Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/10/2018

Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray contains an ester local anesthetic and a vasoconstrictor and 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. Common side effects of Kovanase Nasal Spray include:

The dose of Kovanaze Nasal Spray in adults and children who weigh 40 kg or more is 2 sprays (0.2 mL per spray), 4 to 5 minutes apart. Adults over 18 years may receive 1 additional spray (0.2 mL) if adequate anesthesia has not been achieved 10 minutes after the second spray. Kovanase Nasal Spray may interact with monoamine oxidase inhibitors (MAOIs), nonselective beta-adrenergic antagonists, tricyclic antidepressants, products containing oxymetazoline, and other nasal sprays. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before receiving Kovanaze Nasal Spray. It is unknown if Kovanaze Nasal Spray passes into breast milk. Consult your doctor before breastfeeding.

Our Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

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Kovanaze Professional Information

SIDE EFFECTS

The following adverse reactions are described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The adverse reactions information described below is from Phase 3 randomized, controlled clinical trials [see Clinical Studies]. These data reflect exposure to KOVANAZE in 154 adult dental patients and 20 pediatric dental patients (aged 7 to 17 years) with a need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology. [see Clinical Studies].

Common Adverse Reactions In Adult Dental Patients And Pediatric Patients Weighing 40 kg Or More

The most common adverse reactions to occur in Phase 3 trials with KOVANAZE in adult dental patients and pediatric dental patients weighing 40 kg or more were rhinorrhea, nasal congestion, nasal discomfort, oropharyngeal pain, and lacrimation increased [Table 1].

No serious adverse events with KOVANAZE have occurred [see Clinical Studies].

Table 1: Common Adverse Reactions in ≥ 2% of Phase 3 Adult Dental Patients and Pediatric Patients Weighing 40 kg or More

SOC / Preferred Term KOVANAZE
(N=174)
Active Comparator*
(N=54)
Placebo
(N=88)
Respiratory System Disorders 141 (81%) 50 (93%) 18 (21%)
Rhinorrhea (runny nose) 91 (52%) 20 (37%) 3 (3%)
Nasal congestion 56 (32%) 34 (63%) 6 (7%)
Nasal discomfort 45 (26%) 7 (13%) 5 (6%)
Oropharyngeal pain (sore throat) 25 (14%) 5 (9%) 0 (0%)
Intranasal hypoesthesia 18 (10%) 8 (15%) 5 (6%)
Pharyngeal hypoesthesia (numb throat) 17 (10%) 10 (19%) 0 (0%)
Throat Irritation 15 (9%) 1 (2%) 0 (0%)
Rhinalgia 10 (6%) 3 (6%) 2 (2%)
Sneezing 7 (4%) 2 (4%) 1 (1%)
Epistaxis 4 (2%) 2 (4%) 0 (0%)
Nasal Dryness 4 (2%) 0 (0%) 1 (1%)
Nervous System Disorders 39 (22%) 5 (9%) 6 (7%)
Headache 18 (10%) 3 (6%) 4 (5%)
Dysgeusia 14 (8%) 1 (2%) 1 (1%)
Sinus headache 5 (3%) 0 (0%) 0 (0%)
Dizziness 5 (3%) 0 (0%) 1 (1%)
Sensory Disturbance 4 (2%) 0 (0%) 0 (0%)
Eye Disorders 29 (17%) 8 (15%) 4 (5%)
Lacrimation increased (watery eye) 23 (13%) 6 (11%) 4 (5%)
Gastrointestinal Disorders 16 (9%) 5 (9%) 3 (3%)
Oral Discomfort 4 (2%) 0 (0%) 0 (0%)
Investigations 12 (7%) 0 (0%) 4 (5%)
BP systolic increased 8 (5%) 0 (0%) 2 (2%)
BP diastolic increased 6 (3%) 0 (0%) 1 (1%)
Cardiac Disorders 8 (5%) 5 (9%) 1 (1%)
Bradycardia 5 (3%) 3 (6%) 1 (1%)
Vascular Disorders 6 (3%) 2 (4%) 1 (1%)
Hypertension 5 (3%) 1 (2%) 1 (1%)
* Active Comparator was tetracaine only spray used in two clinical studies in adults.

Intranasal ulcerations, some of which were transient, were noted to have occurred following treatment with KOVANAZE. In Phase 3 trials, 6 (3%) patients who received KOVANAZE, but no patients who received placebo, developed nasal ulcers that were present on exam the same day as KOVANAZE dosing. Three (2%) KOVANAZE and 2 (2%) placebo-treated patients without nasal ulcerations on the day of KOVANAZE or placebo dosing were observed to have nasal ulcerations at the next day follow-up visit.

Less Common Adverse Reactions In Phase 3 Clinical Trials Adult Dental Patients And Pediatric Dental Patients Weighing 40 kg Or More

Dysphagia (i.e., the sensation of difficult swallowing) is a notable adverse reaction reported in Phase 3 trials, occurring in 1.15% of patients.

For medical advice about adverse reactions, contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact St. Renatus, LLC at 1-800-865-4925 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch/.

Read the entire FDA prescribing information for Kovanaze (Tetracaine HCl and Oxymetazoline HC Nasal Spray)

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© Kovanaze Patient Information is supplied by Cerner Multum, Inc. and Kovanaze Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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