Warnings and Precautions

warningWarnings and Precautions.

  • Hypertension and Thyroid Disease — shown to increase blood pressure in some clinical trial patients. Monitor blood pressure. Use in patients with inadequately controlled hypertension or active thyroid disease is not advised
  • Epistaxis — use is not recommended in patients with a history of frequent nose bleeds ( ≥ 5 per month). If a decision to use is made, monitor these patients carefully
  • Dysphagia — carefully monitor patients for sensation of difficulty in swallowing
  • Methemoglobinemia — May cause methemoglobinemia, particularly when used with methemoglobin-inducing agents. Use in patients with history of congenital or idiopathic methemoglobinemia not advised. If central cyanosis unresponsive to oxygen therapy occurs, suspect methemoglobinemia, confirm diagnosis with co-oximetry, and treat with a standard clinical regimen
  • Anaphylactic Reactions — If an anaphylactic reaction occurs, seek emergency help

warningAdverse Reactions.

  • The most common adverse reactions occurring in >10% of patients include runny nose, nasal congestion, nasal discomfort, sore throat and watery eyes.
  • Transient, asymptomatic elevations in systolic blood pressure (≥25 mm Hg from baseline) and diastolic blood pressures (≥15mm Hg from baseline) have been reported.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.

warningDrug Interactions.

  • Monoamine oxidase inhibitors (MAOIs): Concomitant use of MAOIs, nonselective beta adrenergic antagonists, or tricyclic antidepressants may cause hypertension and is not recommended
  • Oxymetazoline-containing products: Discontinue use 24 hours prior to Kovanaze administration
  • Intranasal products: Avoid concomitant use

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Important Safety Information

IMPORTANT SAFETY INFORMATION: Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Allergic or anaphylactic reactions can occur. If an allergic reaction occurs, seek emergency help immediately. KOVANAZE® is contraindicated in patients with a history of allergy to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product. Some clinical trial patients experienced an increase in blood pressure, so blood pressure should be monitored. In addition, patients should be carefully monitored for dysphagia. KOVANAZE® is not recommended for use in patients with a history of frequent nose bleeds. Concomitant use of monoamine oxidase inhibitors, nonselective beta adrenergic antagonist, or tricyclic antidepressants may cause hypertension and is not recommended. Discontinue use of oxymetazoline-containing products 24 hours prior to KOVANAZE® administration. Avoid concomitant use of intranasal products. The most common adverse reactions to KOVANAZE® occurring in >10% of patients include a runny nose, nasal congestion, nasal discomfort, sore throat, and watery eyes.

Click here for full Prescribing Information: Package Insert

IMPORTANT SAFETY INFORMATION: Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Allergic or anaphylactic reactions can occur. If an allergic reaction occurs, seek emergency help immediately. KOVANAZE® is contraindicated in patients with a history of allergy to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product. Some clinical trial patients experienced an increase in blood pressure, so blood pressure should be monitored. In addition, patients should be carefully monitored for dysphagia. KOVANAZE® is not recommended for use in patients with a history of frequent nose bleeds. Concomitant use of monoamine oxidase inhibitors, nonselective beta adrenergic antagonist, or tricyclic antidepressants may cause hypertension and is not recommended. Discontinue use of oxymetazoline-containing products 24 hours prior to KOVANAZE® administration. Avoid concomitant use of intranasal products. The most common adverse reactions to KOVANAZE® occurring in >10% of patients include a runny nose, nasal congestion, nasal discomfort, sore throat, and watery eyes.

Click here for full Prescribing Information: Package Insert