displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lidocaine Hydrochloride Topical Solution, USP 4% contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses.
Lidocaine Hydrochloride Topical Solution USP 4% contains lidocaine hydrochloride monohydrate, which is chemically designated as 2-(Diethylamino)-2′,6′-acetoxylidide monohydrochloride monohydrate and has the following structural formula:
C14H22N2O ∙ HCl ∙ H20 M.W. 288.81
Inactive Ingredients: methylparaben, propylene glycol and purified water. It may also contain sodium hydroxide for pH adjustment. The pH range is between 5.0 and 7.0.
An aqueous solution for topical use only. NOT FOR INJECTION.
Each mL contains:
|Lidocaine Hydrochloride Monohydrate, USP
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Lidocaine Hydrochloride Topical Solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of Lidocaine Hydrochloride Topical Solution.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS MUST BE IMMEDIATELY AVAILABLE WHEN LOCAL ANESTHETIC AGENTS, SUCH AS LIDOCAINE, ARE ADMINISTERED TO MUCOUS MEMBRANES.
Lidocaine Hydrochloride Topical Solution USP 4% should be used with extreme caution if there is sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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:
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (see
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
When Lidocaine Hydrochloride Topical Solution, USP 4% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.
The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine Hydrochloride is quite low, caution should be exercised, particularly when employing large volumes, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.
The dosages recommended below are for normal, healthy adults:
When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of Lidocaine Hydrochloride Topical Solution is 1 to 5 mL (40 to 200 mg lidocaine hydrochloride), i.e., 0.6 to 3.0 mg/kg or 0.3 to 1.5 mg/lb body weight.
NOTE: The solution may be applied with a sterile swab which is discarded after a single use and never reused under any circumstances. When spraying, transfer the solution from the original container to an atomizer.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine Hydrochloride Topical Solution, USP 4% is supplied in 50 mL (NDC 60432-465-50). An aqueous solution for topical application. NOT FOR INJECTION.
PRINCIPAL DISPLAY PANEL – 50 mL Bottle Label
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NOT FOR INJECTION
TOPICAL USE ONLY
NET: 1 ⅔ fl oz (50 mL)