A Topical Anesthetic for the Mucous Membranes of the Mouth and Pharynx. For Oral Use Only
BOXED WARNING (WHAT IS THIS?)
WARNING: 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.
To decrease the risk of serious adverse events with use of Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous), instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.
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DESCRIPTION
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 ...
COMPOSITION OF SOLUTION
Each mL contains 20 mg of lidocaine hydrochloride and following inactive ingredients: banana flavor NAT WONF, carboxymethylcellulose sodium, methylparaben, propylparaben, saccharin sodium and ...
CLINICAL PHARMACOLOGY
Mechanism of Action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic ...
INDICATIONS AND USAGE
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 ...
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.
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 ...
PRECAUTIONS
Information for Patients: Parents and caregivers should be cautioned about the following: For patients under 3 years of age, special care must be given to accurately measuring the prescribed ...
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 ...
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 ...
CARDIOVASCULAR SYSTEM:
Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.
ALLERGIC:
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 ...
OVERDOSAGE
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics (see - ADVERSE REACTIONS ...
DOSAGE AND ADMINISTRATION
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 ...
HOW SUPPLIED
Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) is a clear, colorless , viscous solution supplied in 100 mL low density polyethylene squeeze bottles ...
SPL UNCLASSIFIED SECTION
Distributed by: Advagen Pharma Ltd - 666 Plainsboro Road - Suite 605Plainsboro, NJ 08536, USA. Revised: 12/2021
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% - NDC 72888-125-26 -100 mL Bottle Label
INGREDIENTS AND APPEARANCE
Product Information