Lidocaine Hydrochloride: Package Insert and Label Information (Page 2 of 2)

DOSAGE AND ADMINISTRATION

When Lidocaine Hydrochloride Topical Solution, 4% is used concomitantly with other products containing lidocaine HCl, 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. The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Although the incidence of adverse effects with Lidocaine Hydrochloride Topical Solution, 4% 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, 4% is 1 to 5 mL (40 to 200 mg lidocaine HCl), i.e., 0.6 to 3 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. When spraying, transfer the solution from the original container to an atomizer.

MAXIMUM RECOMMENDED DOSAGES

Normal Healthy Adults
The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, 4% should be such that the dose of lidocaine HCl is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

Children
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 of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example, in a child of five years weighing 50 lbs., the dose of lidocaine HCl should not exceed 75 to 100 mg when calculated according to Clark’s rule. In any case, the maximum dose of Lidocaine Hydrochloride Topical Solution, 4% with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride Topical Solution, 4% administered should be such that the dose of lidocaine HCl is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

HOW SUPPLIED

Lidocaine Hydrochloride Topical Solution USP, 4% (NDC 0527-6004-80) is available in 50 mL screw cap plastic bottles, individually cartoned. NOT FOR INJECTION.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

10-1207

Rev. 11/19

Lidocaine Hydrochloride

50 mL
(click image for full-size original)
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-6004(NDC:0603-1393)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
PROPYLPARABEN
SACCHARIN SODIUM
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM HYDROXIDE
WATER
HYDROCHLORIC ACID
Product Characteristics
Color Score
Shape Size
Flavor CHERRY (artificial cherry flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-6004-80 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (0527-6004-80)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040708 02/27/2007
Labeler — Lannett Company, Inc. (002277481)

Revised: 11/2019 Lannett Company, Inc.

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