Flavalta Lidocaine Hydrochloride and Epinephrine 20 mg/mL; .01 mg/mL Injection, Solution, 50 cartridges — NDC 0362-1200-50 (Billing 00362-1200-50)
This is a package of 50 cartridges of Flavalta Lidocaine Hydrochloride and Epinephrine 20 mg/mL; .01 mg/mL Injection, Solution from Septodont, Inc., marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1293648
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the alpha-Adrenergic Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- This combination is used in two main ways. When given as an injection by a healthcare provider, it numbs a specific part of your body — for example, during surgery, a dental proced...
- Some lightheadedness, drowsiness, or tingling around the mouth can happen if a little more drug than expected gets into your bloodstream — those are early warning signs your care t...
- Will I feel any side effects from the injection?
- Make sure your provider knows about all your medications — especially antidepressants called MAO inhibitors or tricyclics, any beta-blocker blood pressure medications, and anything...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00362-1200-50 You're viewing this Main listing | 50 CARTRIDGE in 1 CARTON / 1.7 mL in 1 CARTRIDGE | 2026-03-19 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lidocaine 20 mg/mL; .01 mg/mL 00362-0898-05 | Septodont, | 50 cartridges | — | — | FDA listed | — |
| Lignospan Standard 20 mg/mL; .01 mg/mL 00362-1095-60 | Septodont, | 10 cartridges | — | — | FDA listed | — |
| Flavalta 20 mg/mL; .01 mg/mLthis 00362-1200-50 | Septodont, | 50 cartridges | — | — | FDA listed | — |
| Lidocaine 20 mg/mL; .01 mg/mL 00404-6512-05 | Henry | 50 cartridges | — | — | FDA listed | — |
| Lidocaine 20 mg/mL; .01 mg/mL 43128-0105-15 | NDC, | 50 cartridges | — | — | FDA listed | — |
| Lidocaine 20 mg/mL; .01 mg/mL 50227-1030-05 | Patterson | 50 cartridges | — | — | FDA listed | — |
| Lidocaine 20 mg/mL; .01 mg/mL 51004-2105-00 | Novocol | 50 cartridges | — | — | FDA listed | — |
| Xylocaine 20 mg/mL; 10 ug/mL 66312-0176-16 | Dentsply | 50 cartridges | — | — | FDA listed | — |
| Lidocaine 20 mg/mL; .01 mg/mL 66467-9730-05 | Darby | 50 cartridges | — | — | FDA listed | — |
| Lidocaine 20 mg/mL; .01 mg/mL 66975-0425-51 | Benco | 50 cartridges | — | — | FDA listed | — |
| Lidocaine 20 mg/mL; .01 mg/mL 67239-0240-00 | Safco | 50 cartridges | — | — | FDA listed | — |
| Lidocaine 20 mg/mL; .01 mg/mL 71347-0210-50 | The | 50 cartridges | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.25 mg / 1 mL
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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1.2 mg / 1 mL
UNII 65OE787Q7W
Potassium metabisulfite is a chemical salt used as a preservative and antioxidant in medicines and foods. It helps prevent spoilage and discoloration by protecting the product from oxidation and microbial growth.
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20 mg / 1 mL
UNII 452VLY9402
Serine is an amino acid, a building block of proteins. In medications, it functions as a buffering agent and stabilizer to help maintain the product's pH balance and protect active ingredients during storage.
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6.5 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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0.9 mg / 1 mL
UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for recommended dosages and administration information for adult and pediatric patients.
2.1Important Dosage and Administration Information Visually inspect this product for particulate matter and discoloration prior to administration. Solution that is discolored and/or contains particulate matter should not be used and any unused portion of a cartridge of FLAVALTA should be discarded. Local anesthetic procedures should not be performed when there is inflammation and/or sepsis in the region of the proposed injection.
The dosage of FLAVALTA (lidocaine HCl and epinephrine) depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia used. The least volume of solution that results in effective local anesthesia should be administered; time should be allowed between injections to observe the patient for manifestations of an adverse reaction. Mixing or the prior or intercurrent use of any other local anesthetic with FLAVALTA is not recommended because of insufficient data on the clinical use of such mixtures.
Administration Precautions FLAVALTA should be in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise. Use FLAVALTA only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Warnings and Precautions (5.1) , Adverse Reactions (6) , Overdosage (10) ].
The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with FLAVALTA [see Warnings and Precautions (5.1) , Drug Interactions (7.1) , Overdosage (10) ]. Aspirate for blood prior to injecting FLAVALTA, both the initial dose and all subsequent doses, to avoid intravascular injection.
However, a negative aspiration for blood does not ensure against an intravascular injection [see Warnings and Precautions (5.9) ]. Avoid rapid injection of a large volume of FLAVALTA and use fractional (incremental) doses when feasible. Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness after each local anesthetic injection.
Use FLAVALTA in carefully restricted quantities in areas that may have compromised blood supply [see Warnings and Precautions (5.7) ].
2.2Recommended Concentration and Dosages of FLAVALTA Adult: For normal healthy adults, the amount of lidocaine HCl administered should be kept below 500 mg and should not exceed 7 mg/kg of body weight. Dosage requirements should be determined on an individual basis. In oral infiltration and/or mandibular block, initial dosages of 1 mL to 5 mL (½ to 2 ½ cartridges) of FLAVALTA (lidocaine HCl 2% solution with a 1:100,000 epinephrine concentration) are usually effective.
Pediatric: For pediatric patients who have a normal lean body mass and normal body development, the dose of lidocaine HCl is determined by the child’s body weight. The lowest effective dose should be used. The maximum dose of lidocaine hydrochloride should not exceed 7 mg/kg.
In children under 10 years of age, it is rarely necessary to administer more than one-half cartridge (0.9 mL to 1 mL or 18 mg to 20 mg of lidocaine) per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice for the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug will allow treatment of the teeth of an entire quadrant.
Aspiration is re… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and epinephrine 1:100,000 (0.017 mg/1.7 mL) (0.01 mg/mL) as a clear, colorless solution in single-dose glass cartridges Injection: lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and epinephrine 1:100,000 (0.017 mg/1.7 mL) (0.01 mg/mL) as a clear, colorless solution in single-dose glass cartridges
⛔ Contraindications ▾
4 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 Cautions ▾
5 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). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and, possibly, death.
Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use [see Adverse Reactions (6) ] . The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.
Use the lowest dosage of FLAVALTA that results in effective anesthesia to avoid high plasma levels and serious adverse effects. Avoid rapid injection of a large volume of FLAVALTA solution and administer fractional (incremental) doses when feasible. Injection of repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose due to slow accumulation of the drug or its metabolites, or to slow metabolic degradation.
Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status.
5.2Methemoglobinemia 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 sig… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 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 i… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG 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 Ane… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: Dosages in pediatric population should be reduced, commensurate with body weight and physical condition. ( 8.4 ) Geriatric Use: Elderly patients should be given reduced doses commensurate with their age and physical condition ( 8.5 ) Hepatic Impairment: Consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with hepatic impairment ( 8.6 )
8.1Pregnancy Risk Summary Available published data and decades of clinical use with lidocaine in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone and cardiac function (see Clinical Considerations ). In published reproduction studies, performed in rats, lower fetal body weights were reported when dosed up to 9.7 times the maximum recommended daily dose during the period of organogenesis and developmental delays in neonates when dosed 0.1 times the maximum recommended daily dose on Gestation Day 11 (see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Maternal Adverse Reactions During treatment of systemic toxicity, which may appear as maternal hypotension or fetal bradycardia, the parturient should be maintained in the left lateral decubitus position if possible or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient’s legs will also help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable.
Data Animal Data Reproduction studies with lidocaine have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. In a published study, lidocaine administered to pregnant rats by continuous subcutaneous infusion during the period of organogenesis at 100, 250, and 500 mg/kg/day, did not produce any structural abnormalities, but did result in lower fetal weights at 500 mg/kg/day dose (approximately 9.7 times the maximum daily dose [MDD] of 500 mg on a mg/m2 basis) in the absence of maternal toxicity.
In a published study, lidocaine containing 1:100,000 epinephrine at a dose of 6 mg/kg (approximately 0.1 times the MDD for lidocaine on a mg/m2 basis) injected into the masseter muscle of the jaw or into the gum of the lower jaw of pregnant Long-Evans hooded rats on Gestation Day 11 resulted in developmental delays in the neonates. Developmental delays were observed for negative geotaxis, static righting reflex, visual discrimination response, sensitivity and response to thermal and electrical shock stimuli, and water maze acquisition.
The developmental delays of the neonatal animals were transient, with responses becoming comparable to untreated animals later in life. The clinical relevance of these animal data is uncertain.
8.2Lactation Risk Summary Published data report the presence of lidocaine and its metabolites in human milk in low amounts, along with poor oral bioavailability. There are no data on the effect of lidocaine on the breastfed infant or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FLAVALTA and any potential adverse effects on the breastfed child from FLAVALTA or from the underlying maternal condition.
8.4Pediatric Use Dosages in pediatric population should be reduced, commen… [Excerpted — this section continues on DailyMed.]
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Clinical Presentation Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution [see Warnings and Precautions (5) , Adverse Reactions (6) ]. If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plus myocardial depression from the direct effects of lidocaine may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest.
Respiratory abnormalities, including apnea, may occur. If cardiac arrest should occur, successful outcome may require prolonged resuscitative efforts.
10.2Management of local anesthetic emergencies The first step in the management of systemic toxic reactions consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Endotracheal intubation, using drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask if difficulty is encountered in the maintenance of a patent airway, or if prolonged ventilatory support (assisted or controlled) is indicated.
A bolus intravenous dose of a benzodiazepine will counteract central nervous system stimulation related to FLAVALTA. Immediately after the institution of ventilatory measures, evaluate the adequacy of circulation. Supportive treatment of circulatory depression may require Advanced Cardiac Life Support measures.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby effecting local anesthetic action. Epinephrine is a vasoconstrictor added to lidocaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration
12.2Pharmacodynamics Onset and duration of anesthesia When used for infiltration anesthesia in dental patients, the time of onset averages less than two minutes for FLAVALTA. FLAVALTA (lidocaine HCl 2% solution with a 1:100,000 epinephrine concentration) provides an average pulp anesthesia of at least 60 minutes with an average duration of soft tissue anesthesia of approximately 2½ hours. When used for nerve blocks in dental patients, the time of onset for FLAVALTA averages 2 - 4 minutes.
FLAVALTA (lidocaine HCl 2% solution with a 1:100,000 epinephrine concentration) provides pulp anesthesia averaging at least 90 minutes with an average duration of soft tissue anesthesia of 3 to 3½ hours. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 μg free base per mL.
Hemodynamics Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system and/or the beta-adrenergic receptor stimulating action of epinephrine when present.
12.3Pharmacokinetics Absorption Information derived from diverse formulations, concentrations and usages reveals that lidocaine is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent. Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration. Distribution The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration.
At concentration of 1 to 4 μg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-l-acid glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.
Elimination The elimination half-life of lidocaine hydrochloride following an intravenous bolus injection is typically 1.5 to 2 hours. Metabolism Lidocaine is metabolized rapidly by the liver. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation.
N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Excretion Lidocaine metabolites and the unchanged drug are excreted by the kidneys.
Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. Specific Populations Patients with Hepatic Impairment Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics.
The half-life may be prolonged two-fold or more in patients with liver dysfunction. Patients with Renal Impairment Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING FLAVALTA (lidocaine hydrochloride and epinephrine injection) contains lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and epinephrine 1:100,000 (0.017 mg/1.7 mL) (0.01 mg/mL) supplied in cardboard boxes containing five blisters of ten 1.7 mL single-dose cartridges. The solution is clear and colorless (NDC is 0362-1200-50). Store at 20° - 25°C (68° - 77°F).
Excursions between 15° and 30°C (59° and 86°F) are allowed. Protect from light. Do not freeze.
BOXES: For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the end flap. Do not use if color is pinkish or darker than slightly yellow or if it contains a precipitate.
Sterilization Storage and Technical Procedures Cartridges should not be autoclaved, because the closures employed cannot withstand autoclaving temperatures and pressures. If chemical disinfection of anesthetic cartridges is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solution of ethyl alcohol not of U.S.P grade, contain denaturants that are injurious to rubber and, therefore, are not to be used.
It is recommended that chemical disinfection be accomplished just prior to use by wiping the cartridge cap thoroughly with a pledge of cotton that has been moistened with recommended alcohol. Certain metallic ions (mercury, zinc, copper, etc.) have been related to swelling and edema after local anesthesia in dentistry. Therefore, chemical disinfectants containing or releasing these ions are not recommended.
Antirust tablets usually contain sodium nitrite or some similar agents that may be capable of releasing metal ions. Because of this, aluminium sealed cartridges should not be kept in such solution. Quaternary ammonium salts, such as benzalkonium chloride, are electrolytically incompatible with aluminium.
Cartridges of FLAVALTA are sealed with aluminium caps and therefore should not be immersed in any solution containing these salts. To avoid leakage of solution during injection, be sure to penetrate the center of the rubber diaphragm when loading the syringe. An off-center penetration produces an oval shaped puncture that allows leakage around the needle.
Other causes of leakage and breakage include badly worn syringes, aspirating syringes with bent harpoons, the use of syringes not designed to take 1.7 mL cartridges, and inadvertent freezing. Cracking of glass cartridges is most often the result of an attempt to use a cartridge with an extruded plunger. An extruded plunger loses its lubrication and can be forced back into the cartridge only with difficulty.
Cartridges with extruded plungers should be discarded. Store at 20° - 25°C (68° - 77°F). Excursions between 15° and 30°C (59° and 86°F) are allowed.
📋 Description ▾
11 DESCRIPTION FLAVALTA is a clear and colorless sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and is administered parenterally by injection. FLAVALTA is available in single dose cartridges of 1.7 mL [see Indications and Usage (1) ]. FLAVALTA solution contains lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula: C 14 H 22 N 2 0 • HCl • H 2 0 M.W.
288.8 Epinephrine is ( - )-3,4-Dihydroxy- α -[(Methylamino) methyl] benzyl alcohol and has the following structural formula: C 9 H 13 NO 3 M.W. 183.21 Each mL of FLAVALTA contains 20 mg lidocaine hydrochloride (equivalent to 17.31 mg lidocaine), and 0.01 mg epinephrine (equivalent to 0.018 mg epinephrine bitartrate) with 0.25 mg edetate disodium, 1.2 mg potassium metabisulfite, 6.5 mg sodium chloride and 1 mL water for injections q.s. ad. The flavoring agents are 20.0 mg L-serine and 0.9 mg sodium saccharin.
The pH of the FLAVALTA solution is adjusted with sodium hydroxide to 3.3 – 5.5. Lidocaine Hydrochloride Epinephrine
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lidocaine and epinephrine. Mutagenesis The mutagenic potential of lidocaine and epinephrine has not been determined. Impairment of Fertility In a published study, female Sprague-Dawley rats were treated subcutaneously with lidocaine via osmotic pumps starting two weeks prior to mating, and reproductive effects were assessed.
Rat doses up to the high dose of 500 mg/kg/day (approximately 9.7 times the maximum daily dose of 500 mg on a mg/m2 basis) showed no effects on copulatory rate, pregnancy rate, or the numbers of corpora lutea or implantations.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 1.7 mL Cartridge Carton FOR DENTAL BLOCK AND INFILTRATION ANESTHESIA NDC 0362-1200-50 Flavalta (Lidocaine Hydrochloride and Epinephrine Injection, USP) Lidocaine Hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 Store at 20°C to 25°C (68°F to 77°F). DO NOT FREEZE 50 single-dose cartridges: 1.7 mL each Manufactured for SEPTODONT, Inc. 205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601 by Novocol Pharmaceutical of Canada, Inc.
25 Wolseley Court, Cambridge, Ontario N1R 6X3, Canada PRINCIPAL DISPLAY PANEL - 1.7 mL Cartridge Carton
1.7mL Cartridge Label Flavalta 1.7 mL (Lidocaine Hydrochloride and Epinephrine Injection, USP) Lidocaine Hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 SEPTODONT Canada 2 0 0 5 8 - 1 1.7 mL Cartridge Label
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