Flavalta™

Local dental anesthesia by nerve block or infiltration.

• Flavalta™ when used for infiltration will have an average onset time of less than two minutes and a duration of about 60 minutes. When used for nerve blocks the average onset time is 2 to 4 minutes and will provide about 90 minutes of pulpal anesthesia.
• Contains  sodium saccharin and L-Serine as flavoring agents
• No-methylparaben formulation to avoid allergic reactions on sensitive patients.
• No natural rubber latex components to help reduce allergic responses.
• Terminal sterilization of product/cartridges for safe use.
• Mylar label covered glass cartridges to minimize risk of wound in the event of a cartridge breakage.
• Cartridges packed 10 to a blister tray to avoid glass to glass contact, hence reducing breakage.

Item# 99379 – Box containing 5 blisters of 10 x 1.7ml glass cartridges

FLAVALTA is contraindicated in patients with a known hypersensitivity to lidocaine, other amide-type local anesthetics, or any component of FLAVALTA. The safety and effectiveness of FLAVALTA depends on proper dosage, correct technique and adequate precautions.

Use of FLAVALTA may result in serious dose-related toxicities, which show possible early warning signs of central nervous system (CNS) toxicity and cardiovascular effects. Patients should be monitored for changes in cardiovascular and respiratory status and level of consciousness following administration. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. Methemoglobinemia has been reported with local anesthetic use and may be life-threatening if not promptly treated. The clinical signs may include cyanosis, headache, fatigue, or shortness of breath.

FLAVALTA contains potassium metabisulfite, a sulfite which may cause allergic-type reactions, including anaphylaxis symptoms and life-threatening or less severe asthmatic episodes, particularly in susceptible individuals. Unintended intravascular injection may result in systemic toxicity, including CNS toxicity, cardiorespiratory depression, coma, or respiratory arrest. Dental practitioners and/or clinicians who employ local anesthetic should be well versed in diagnosis and management of emergencies that may arise from their use. Use with certain drugs (e.g., monoamine oxidase inhibitors, tricyclic antidepressants, nonselective beta-blockers, and ergot type oxytocics) may increase the risk of severe hypertension, arrhythmias, or other cardiovascular effects. Patients with hepatic impairment, cardiovascular disease, or compromised blood flow may be at increased risk for toxicity and require careful dosing and monitoring.

The most common adverse reactions are related to the central nervous system and cardiovascular system and may include dizziness, nervousness, drowsiness, confusion, tremors, convulsions, hypotension, bradycardia, arrhythmias, or cardiac arrest. Allergic reactions, including rash, urticaria, edema, or anaphylactoid reactions, have been reported. Refer to package insert for full prescribing information.

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