LIDOCAINE .01 mg/mL
Lidocaine Hydrochloride and Epinephrine Bitartrate · INJECTION, SOLUTION · NDC, Inc.
LIDOCAINE is a injection, solution containing lidocaine hydrochloride and epinephrine bitartrate at .01 mg/mL, taken submucosal. Manufactured by NDC, Inc..
Key Facts
- Brand Name
- LIDOCAINE
- Generic Name
- Lidocaine Hydrochloride and Epinephrine Bitartrate
- NDC Code (Product)
43128-105- Manufacturer
- NDC, Inc.
- Strength
- .01 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Marketing Status
- Application #
- ANDA088390
- Marketing Start
- 04/10/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adult The maximum recommended single dose of lidocaine for healthy adults should be such that the dose of lidocaine does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg. For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is 15 mL undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period. The dosage should be adjusted commensurate with the patient’s age, weight and physical condition (see PRECAUTIONS ). Pediatric Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing. It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determin…
Warnings
WARNINGS EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS. Lidocaine should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption. Life-threatening and fatal events in infants and young children Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Viscous 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed. Methemoglobinemi…
Contraindications
CONTRAINDICATIONS Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.
Drug Interactions
Drug Interactions 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: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine Antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, sodium valproate, phenobarbital Other drugs acetaminophen, metoclopramide, sulfasalazine, quinine
Adverse Reactions
ADVERSE REACTIONS Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by 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 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 o…
Frequently Asked Questions
What is LIDOCAINE used for?
LIDOCAINE contains Lidocaine Hydrochloride and Epinephrine Bitartrate. It is a injection, solution taken submucosal. Consult your doctor for specific uses.
Is LIDOCAINE a controlled substance?
LIDOCAINE is not classified as a controlled substance by the DEA.
What is the generic name for LIDOCAINE?
The generic name for LIDOCAINE is Lidocaine Hydrochloride and Epinephrine Bitartrate. There are 9 other brand versions of Lidocaine Hydrochloride and Epinephrine Bitartrate.
What is the NDC code for LIDOCAINE .01 mg/mL?
The NDC (National Drug Code) for LIDOCAINE .01 mg/mL is 43128-105, listed by NDC, Inc..