Lidocaine Viscous (Page 3 of 3)

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.

The first step in the management of convulsions consist of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen. In situations where trained personnel are readily available, ventilation should be maintained and oxygen should be delivered by 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 indicated 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.

The oral LD 50 of lidocaine in non-fasted female rats is 459 (346 to 773) mg/kg (as the salt) and 214 (159 to 324) mg/kg (as the salt) in fasted female rats.

DOSAGE AND ADMINISTRATION

Adult

The maximum recommended single dose of lidocaine for healthy adults should be such that the dose of lidocaine 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 15 mL 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 should not exceed 75 to 100 mg (3.7 to 5 mL of lidocaine).

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 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.

HOW SUPPLIED

Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP) is supplied as a clear, colorless, viscous solution. Due to the viscous nature of this product, an overage is added to each unit dose container.

Overbagged with 5 cups per bag, NDC 55154-5789-5

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

Dispense in a child-resistant container as defined in the USP/NF.

SHAKE WELL BEFORE USE.

PACKAGED BY

Pharmaceteutical Associates, Inc.

Greenville, SC 29605

Distributed By:

Cardinal Health

Dublin, OH 43017

L57298010721

R05/20

PRINCIPAL DISPLAY PANEL — 15 mL Cup

Lidocaine Viscous

(Lidocaine Hydrochloride Oral Topical Solution USP)

2%

5 Cups

bag label
(click image for full-size original)
LIDOCAINE VISCOUS
lidocaine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5789(NDC:0121-0903)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
PROPYLPARABEN
SACCHARIN SODIUM
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5789-5 5 CUP, UNIT-DOSE in 1 BAG contains a CUP, UNIT-DOSE
1 15 mL in 1 CUP, UNIT-DOSE This package is contained within the BAG (55154-5789-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088802 04/26/1985
Labeler — Cardinal Health 107, LLC (118546603)

Revised: 12/2022 Cardinal Health 107, LLC

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