Drug Catalog - Product Detail
LIDOCAINE HCL 2% VISC SOL 100ML
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
00603-1393-64 | PAR PHARMACEUTICALS | 100ML | 2% | SOLUTION |
PACKAGE FILES
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Description
DESCRIPTION SECTION 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 HCl, 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 C14H22N2O. The molecular weight is 234.34. COMPOSITION OF SOLUTION Each mL contains 20 mg of lidocaine HCl, artificial cherry flavor, methylparaben, propylparaben, saccharin sodium, sodium carboxymethylcellulose, and sodium hydroxide in purified water. The pH is adjusted to 5.0 to 7.0 with hydrochloric acid and/or sodium hydroxide. image description
How Supplied
HOW SUPPLIED SECTION Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) (NDC 0603-1393-64) is available in 100 mL polyethylene squeeze bottles. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
INDICATIONS & USAGE SECTION Lidocaine hydrochloride oral topical solution USP, 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
Dosage and Administration
DOSAGE & ADMINISTRATION SECTION 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 HCl 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 tablespoonful 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.