FDA

Flavalta

Approved 19 Mar 2026InjectionSolution

Indications

FLAVALTA solution is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques [see Dosage and Administration (2.2) ]. FLAVALTA solution is a combination of lidocaine, an amide local anesthetic, and epinephrine, an alpha and beta adrenergic agonist indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.

Contraindications

FLAVALTA is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations. Known history of hypersensitivity to lidocaine or to any local anesthetics of the amide-type or to other components of FLAVALTA ( 4 )

Warnings and precautions

Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of FLAVALTA. ( 5.1 ) Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks. ( 5.2 ) Allergic-Type Reactions to Sulfites in FLAVALTA and Anaphylactic Reactions: FLAVALTA contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people ( 5.4 ) Risk of Systemic Toxicities with Unintended Intravascular Injection: Unintended intravascular injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest.

Aspirate for blood prior to each dose ( 5.9 )

5.1Dose-Related Toxicity

The safety and effectiveness of FLAVALTA depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be performed after each local anesthetic injection. Possible early warning signs of central nervous system (CNS) toxicity are restlessness, anxiety, incoherent speech, lightheadedness, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness.

Signs and symptoms of depressed cardiovascular function may commonly result from a vasovagal reaction, particularly if the patient is in an upright position: placing the patient in the recumbent position is recommended when an adverse response is noted after injection of a local anesthetic. Vasovagal reactions may elicit a range of clinical manifestations, from prodrome signs of pre-syncope (e.g. lightheadedness, pallor, nausea, sweating, visual disturbances, weakness) to brief loss of consciousness (i.e. syncope).

At a glance

Brand name: Flavalta
Active substance: epinephrine bitartrate
Route: Injection
Dosage form: Solution
Applicant: Deproco
Status: Prescription
FDA approval: 19 Mar 2026
Application: NDA216564-001

Indications

Contraindications

Warnings and precautions

Aspirate for blood prior to each dose ( 5.9 )

5.1Dose-Related Toxicity

Interactions

Local Anesthetics: The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. ( 7.1 ) Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: Administration of FLAVALTA, which contains epinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension.

Concurrent use of these agents should generally be avoided. ( 5.3 , 7.2 ) Ergot-Type Oxytocic Drugs: Concurrent administration FLAVALTA, which contains epinephrine, and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. ( 5.3 , 7.3 ) Nonselective Beta-Adrenergic Antagonists: Administration of FLAVALTA (containing a vasoconstrictor, epinephrine), in patients receiving nonselective beta-adrenergic antagonist may cause severe hypertension and bradycardia.

Concurrent use of these agents should generally be avoided ( 5.3 , 7.4 ). Drugs Associated with Methemoglobinemia: Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. ( 7.5 ) Potent Inhalation Anesthetics: Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are used in patients during or following the administration of potent inhalation anesthetics.

( 5.10 , 7.6)

7.1Local Anesthetics

The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with FLAVALTA cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ].

7.2Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

The administration of local anesthetic solutions containing epinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential [see Warnings and Precautions (5.3) ].

7.3Ergot-Type Oxytocic Drugs

Concurrent administration of FLAVALTA and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Avoid use of FLAVALTA concomitantly with ergot-type oxytocic drugs [see Warnings and Precautions (5.3) ].

7.4Nonselective Beta-Adrenergic Antagonists Administration of

FLAVALTA solution (containing a vasoconstrictor, epinephrine), in patients receiving a nonselective beta-adrenergic antagonist may result in dose-dependent hypertension and bradycardia with possible heart block. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient’s blood pressure and heart rate is essential [see Warnings and Precautions (5.3) ].

7.5Drugs Associated with Methemoglobinemia

Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics [see Warnings and Precautions (5.2) ]. Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, isofamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine

7.6Potent Inhalation Anesthetics

Serious dose-related cardiac arrhythmias may occur if preparations containing epinephrine are used in patients during or following the administration of potent inhalation anesthetics [see Warnings and Precautions (5.10) ] .

7.7Phenothiazines and Butyrophenones Phenothiazines

and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of FLAVALTA and these agents should generally be avoided. In situation when concurrent therapy is necessary, careful patient monitoring is essential.

Adverse reactions

The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: Dose-Related Toxicity [see Warnings and Precautions (5.1) ] Methemoglobinemia [see Warnings and Precautions (5.2) ] Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions (5.3) ] Allergic-Type Reactions [see Warnings and Precautions (5.4) ] Systemic Toxicities with Unintended Intravascular Injection [see Warnings and Precautions (5.9) ] The following adverse reactions from voluntary reports or clinical studies have been reported with lidocaine or lidocaine and epinephrine.

Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions to FLAVALTA are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation.

The most commonly encountered acute adverse reactions that demand immediate counter measures were related to the CNS and the cardiovascular system. These adverse reactions were generally dose-related and due to high plasma levels which may have resulted from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. Persistent paresthesias of the lips, tongue, and oral tissues have been reported with the use of lidocaine, with slow, incomplete, or no recovery.

These adverse events have been reported primarily following nerve blocks in the mandible involving the trigeminal nerve and its branches. Nervous System Disorders Adverse reactions were characterized by excitation and/or depression of the central nervous system and included lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest.

The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. Neurologic effects following administration have included persistent anesthesia, paresthesia, weakness, paralysis, all with slow, incomplete, or no recovery.

Convulsions: Incidence varied with the procedure used and the total dose administered. The incidences of adverse neurologic reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Cardiac Disorders: High doses or unintentional intravascular injection have led to high plasma levels of lidocaine and related depression of the myocardium, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation, and cardiac arrest [see Warnings and Precautions (5.9) ].

In addition, the beta-adrenergic receptor stimulating action of epinephrine may lead to excitatory cardiovascular responses, such as tachycardia, palpitations, and hypertension. Vasovagal Reactions: dizziness, loss of consciousness, nausea, diaphoresis, syncope, and hypotension. Immune System Disorders Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to sulfites in epinephrine-containing solutions. [see Warnings and Precautions (5.4) ].

There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine. Hematologic Methemoglobinemia [see Warnings and Precautions (5.2) ]. Most common adverse reactions are related to the central nervous system and the cardiovascular system. To report SUSPECTED ADVERSE REACTIONS, contact Septodont at 1-888-888-1441 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Flavalta

Indications

Contraindications

Warnings and precautions

5.1Dose-Related Toxicity

At a glance

Two medicines in one question?

Flavalta

Indications

Contraindications

Warnings and precautions

5.1Dose-Related Toxicity

At a glance

Two medicines in one question?

5.2Methemoglobinemia Cases

5.3Risk of Adverse Reactions Due to Drug Interactions with

5.4Allergic-Type Reactions to Sulfites in

5.5Risk of Toxicity in Patients with Hepatic Impairment

5.6Risk of Use in Patients with Impaired Cardiovascular Function

5.7Risk of Ischemic Injury or Necrosis in Body Areas with Limited Blood Supply Use

Interactions

7.1Local Anesthetics

7.2Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

7.3Ergot-Type Oxytocic Drugs

7.4Nonselective Beta-Adrenergic Antagonists Administration of

7.5Drugs Associated with Methemoglobinemia

7.6Potent Inhalation Anesthetics

7.7Phenothiazines and Butyrophenones Phenothiazines

Adverse reactions

Composition

Official product information