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.
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. G6PD deficiency. History of congenital or idiopathic methemoglobinemia: not recommended. Severe hepatic disease or pseudocholinesterase deficiency: monitor for toxicity. Pregnancy. Nursing mothers.
Topical anesthetic + sympathomimetic.
Increased risk of methemoglobinemia with concomitant sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, p-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine; monitor carefully. 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
Clinical Pain Advisor Articles
- Abuse-Deterrent Opioid Formulations: Barriers to Broader Use
- Women Frequently Prescribed High Doses of Opioids After Vaginal Delivery
- Notifications by PDMPs May Not Effectively Reduce Opioid Misuse
- Virtual Reality May Effectively Reduce Sensory, Affective, and Cognitive Pain During Labor
- Medical Cannabis Legalization Associated With Reduced Schedule III Opioid Prescriptions
- Neuropathic Pain Medications
- Higher Buprenorphine Dose May Not Increase Severity of Neonatal Abstinence Syndrome
- Terms Used for Addiction May Be Associated With Explicit, Implicit Bias
- Ketamine Infusions May Be Effective for Refractory Headache
- Physical, Psychosocial Activity May Be Protective Against Development of Chronic Pain in Older Adults
- Prioritizing Rest in Hospital Settings: Poor Sleep Increases Costs, Complications, and Mortality
- Pain Catastrophizing Decreases in Rheumatoid Arthritis After DMARD Initiation
- Addressing Commercial Incentives in the Medical Device Industry
- Cancer Patients Treated With Step III Opioids Often Have Sleep Disturbances
- Low Literacy Self-Management Program for Chronic Pain May Be Effective