Label: LIDOCAINE HYDROCHLORIDE solution

A Topical Anesthetic for the Mucous Membranes of the Mouth and Pharynx.
For Oral Use Only

Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:

The molecular formula of lidocaine is C 14H 22N 2O. The molecular weight is 234.34.

Each mL contains 20 mg of lidocaine hydrochloride and following inactive ingredients: banana flavor NAT WONF, carboxymethylcellulose sodium, methylparaben, propylparaben, saccharin sodium and purified water. The pH is adjusted to 5.0 to 7.0 by means of hydrochloric acid and/or sodium hydroxide.

Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) 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.

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.

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 Hydrochloride Oral Topical Solution 2% (Viscous) when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) 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.

Methemoglobinemia

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 signs of methemoglobinemia is recommended.

Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood.
Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

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:

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 occur as a consequence of rapid absorption.

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to the methylparaben and/or propylparaben used in this formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).

Adult:

The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) 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 one 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 determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg (3.7 to 5 mL of Lidocaine Hydrochloride Oral Topical Solution 2% Viscous).

For infants and in children under 3 years of age, the solution should be accurately measured and no more than 1.2 mL be applied to the immediate area with a cotton-tipped applicator. Wait at least 3 hours before giving the next dose; a maximum of four doses may be given in a 12-hour period. Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) should only be used if the underlying condition requires treatment with a volume of product that is less than or equal to 1.2 mL.

Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) is a clear, colorless , viscous solution supplied in 100 mL low density polyethylene squeeze bottles. Supplied with press-in bottle adapter.

NDC 72888-125-26

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

SHAKE WELL BEFORE USE.

Distributed by:

Advagen Pharma Ltd.,

East Windsor, NJ 08520, USA

Revised: 00, 10/2024

Lidocaine Hydrochloride Oral Topical Solution, USP Each ml contains 2% Lidocaine Instructions for Use Read these instructions carefully to learn how to use the medicine dispensing system correctly.
The Medicine Dispensing System
There are 2 parts to the dispensing system:
	A plastic adapterthat you push into the neck of the bottle the first time that you open the bottle. The adapter must always stay in the bottle. A bottle containing the medicine with a child resistant cap. Always replace the cap after use.
Preparing the Bottle
	Remove the child-resistant cap by pushing it firmly down and turning it counterclockwise - to the left (as shown on the top of the cap).      Note:Save the cap so you can close the bottle after each use. Hold the open bottle upright on a table and push the plastic adapter firmlyinto the neck of the bottle as far as you can. Replace the cap to be sure that the adapter has been fully forced into the neck of the bottle.     Note:You may not be able to push the adapter fully down, but it will be forced into the bottle when you screw the cap back on.    The adapter must always stay in the bottle. The child-resistant cap should seal the bottle in between use.
Taking the Medicine
	Shake the bottle well. Prepare the dose right away. Push and turn the child-resistant cap to open the bottle.    Note:Always replace the cap after use. Squeeze bottle to dispense contents. Replace the child-resistant cap after use.

Distributed by:

Advagen Pharma Ltd.,

East Windsor, NJ 08520, USA

Revised: 00, 10/2024

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% - NDC 72888-125-26 -100 mL Bottle Label

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% - NDC 72888-125-26 -100 mL Carton Label