The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, USP 4% should be such that the dose of lidocaine hydrochloride is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.
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 hydrochloride should not exceed 75 to 100 mg when calculated according to Clark’s rule. In any case, the maximum dose of Lidocaine Hydrochloride with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride administered should be such that the dose of lidocaine is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.
Lidocaine Hydrochloride Topical Solution, USP 4% is supplied in 50 mL bottle (NDC 60432-465-50) and packaged in a carton (NDC 60432-465-51). An aqueous solution for topical application. NOT FOR INJECTION.
Product No.: 8465
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053
Wockhardt USA, LLC
Parsippany, NJ 07054
NOT FOR INJECTION
TOPICAL USE ONLY
NET: 1 ⅔ fl oz (50 mL)
|LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride solution|
|Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)|
|Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)|
|Morton Grove Pharmaceuticals, Inc.||801897505||ANALYSIS (60432-465), MANUFACTURE (60432-465), PACK (60432-465)|
|Societa Italiana Medicinali Scandicci S.I.M.S. SrL — Italy||428994180||API MANUFACTURE (60432-465)|
Revised: 03/2022 Morton Grove Pharmaceuticals, Inc.
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