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.
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.
Topical anesthetic + sympathomimetic.
Rhinorrhea, nasal congestion, nasal discomfort, oropharyngeal pain, increased lacrimation; transient BP increase, epistaxis, methemoglobinemia, anaphylaxis.
Single-dose nasal spray (0.2mL)—30
Sign Up for Free e-newsletters
Psychiatry Advisor Articles
- Adjunctive Therapies for Bipolar Disorder Show Promise, Need More Evidence
- Improving Performance of Everyday Activities Is Critical in Schizophrenia
- Analysis Finds Lithium Maintenance Most Effective as Monotherapy in Bipolar Disorder
- Web-Based Intervention Targets Parental Behaviors That May Affect Adolescent Anxiety, Depression
- Abnormalities of Cortical Thickness in Bipolar Disorder With Auditory Hallucinations
- The Way to the Head May Be Through the Gut: Probiotics for Depression
- Suicide-Screening Toolkit Can Help Identify Youths at High Risk for Suicide
- Agoraphobia: An Evolving Understanding of Definitions and Treatment
- Parental Pressure to Diet Linked With Long-term Harm in Adolescents
- Does Access to Medical Cannabis Reduce Risk for Opioid Abuse?
- Antidepressants Increase Seizure Risk in Youth and Severely Depressed
- Examining Associations Between Diabetes and Effects on Cognition
- Untreated Depression Common in Women of Childbearing Age
- Incidence of Psychiatric Disorders in Rheumatoid Arthritis
- Effect of Antidepressant Class, Dose on Pediatric Anxiety Disorders