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Kovanaze Generic Name & Formulations
Legal Class
Rx
General Description
Tetracaine HCl, oxymetazoline HCl 6mg/0.1mg; per spray; aqueous soln for intranasal use.
Pharmacological Class
Topical anesthetic + sympathomimetic.
How Supplied
Single-dose nasal spray (0.2mL)—30
Manufacturer
Generic Availability
NO
Kovanaze Indications
Indications
Regional anesthesia for restorative procedures on Teeth 4–13 and A–J in adults and children weighing ≥40kg.
Kovanaze Dosage and Administration
Adult
≥18yrs: 2 sprays (0.2mL each) given 4–5mins apart, in the nostril ipsilateral to the maxillary tooth on which the dental procedure will be performed. Initiate dental procedure 10mins after the second spray. 1 additional spray can be given if inadequate response achieved 10mins after the second spray.
Children
<3yrs or <40kg: not recommended. ≥3yrs (≥40kg): 2 sprays (0.2mL each) given 4–5mins apart, in the nostril ipsilateral to the maxillary tooth on which the dental procedure will be performed. Initiate dental procedure 10mins after the second spray.
Kovanaze Contraindications
Not Applicable
Kovanaze Boxed Warnings
Not Applicable
Kovanaze Warnings/Precautions
Warnings/Precautions
Risk of methemoglobinemia (esp. in G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants <6 months of age, concurrent exposure to oxidizing agents or metabolites); monitor. Monitor for hypertension and dysphagia. Uncontrolled hypertension or uncontrolled active thyroid disease: not recommended. History of frequent nosebleeds (≥5/month); avoid or monitor carefully if used. Severe hepatic disease or pseudocholinesterase deficiency: monitor for toxicity. Pregnancy. Nursing mothers.
Kovanaze Pharmacokinetics
See Literature
Kovanaze Interactions
Interactions
Increased risk of methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, others. Increased risk of hypertension with MAOIs, nonselective beta adrenergic antagonists, TCAs: not recommended; use alternative anesthetic if unavoidable. Discontinue other oxymetazoline-containing products 24hrs prior to Kovanaze use. Avoid concomitant other intranasal products.
Kovanaze Adverse Reactions
Adverse Reactions
Rhinorrhea, nasal congestion, nasal discomfort, oropharyngeal pain, increased lacrimation; transient BP increase, epistaxis, methemoglobinemia, anaphylaxis.
Kovanaze Clinical Trials
See Literature
Kovanaze Note
Not Applicable
Kovanaze Patient Counseling
See Literature
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