Generic Name and Formulations:
Tetracaine HCl, oxymetazoline HCl 6mg/0.1mg; per spray; aqueous soln for intranasal use.
St. Renatus, LLC
Indications for KOVANAZE :
Regional anesthesia for restorative procedures on Teeth 4–13 and A–J in adults and children weighing ≥40kg.
≥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.
<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.
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.
Topical anesthetic + sympathomimetic.
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.
Rhinorrhea, nasal congestion, nasal discomfort, oropharyngeal pain, increased lacrimation; transient BP increase, epistaxis, methemoglobinemia, anaphylaxis.
Single-dose nasal spray (0.2mL)—30
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