Prescription Drug Information: Lidocaine Hydrochloride (Page 2 of 2)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of lidocaine HCl in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Use in Pregnancy

Teratogenic Effects. Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine HCl. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine HCl to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

Labor and Delivery

Lidocaine HCl is not contraindicated in labor and delivery. Should Lidocaine Hydrochloride Topical Solution, 4% be used concomitantly with other products containing lidocaine HCl, the total dose being administered must be kept in mind.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine HCl is administered to a nursing woman.

Pediatric Use

Dosages in children should be reduced, commensurate with age and body weight (see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

Adverse experiences following the administration of lidocaine HCl 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:

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 vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

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 or to other ingredients in the formulation. Allergic reactions as a result of sensitivity to lidocaine HCl are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

OVERDOSAGE

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).

Management of Local Anesthetic Emergencies

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic administration. At the first sign of change, oxygen should be administered.

The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine HCl.

The intravenous LD50 of lidocaine HCl in female mice is 26 (21 to 31) mg/kg and the subcutaneous LD50 is 264 (203 to 304) mg/kg.

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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