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: KOVANAZE is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more. Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Tetracaine may cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents. Use of KOVANAZE in patients with a history of congenital or idiopathic methemoglobinemia is not advised. Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen therapy occurs, especially if methemoglobinemia-inducing agents have been used. Confirm diagnosis by measuring methemoglobin level with co-oximetry. Treat clinically significant symptoms of methemoglobinemia with a standard clinical regimen. 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 monamine 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: Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Tetracaine may cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents. Use of KOVANAZE in patients with a history of congenital or idiopathic methemoglobinemia is not advised. Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen therapy occurs, especially if methemoglobinemia-inducing agents have been used. Confirm diagnosis by measuring methemoglobin level with co-oximetry. Treat clinically significant symptoms of methemoglobinemia with a standard clinical regimen. 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 monamine 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