DentiPatch (Page 3 of 3)

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.

DOSAGE AND ADMINISTRATION

When the DentiPatch® system is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

Isolate the procedure area with cotton rolls and use suction as appropriate. Dry the tissue with air or gauze. Remove the DentiPatch® system from its packaging and peel off the clear protective liner. Immediately apply the DentiPatch® system using firm pressure. Allow the patch to remain in place until the desired anesthetic effect is produced but not for longer than 15 minutes. Experience in children is inadequate to recommend a pediatric dose at this time.

HOW SUPPLIED

DentiPatch® system (46.1 mg/unit) — each 2.0 cm2 system contains 46.1 mg of lidocaine USP.

Dispenser carton of 50 systems NDC 57616-041-12

Do not store above 25°C.
Keep out of the reach of children.

May 1999
Package Insert
Noven Parmaceuticals, Inc.
100956-1

Manufactured by:
Noven Pharmaceuticals, Inc.
Miami, Florida 33186

DENTIPATCH
lidocaine patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57616-041
Route of Administration BUCCAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine (Lidocaine) Lidocaine 46.1 mg
Inactive Ingredients
Ingredient Name Strength
Karaya Gum
Glycerin
Dipropylene Glycol
Lecithin
Propylene Glycol
Aspartame
Spearmint Flavor
Polyester Flm Laminate
Polyester-Rayon Fabric
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57616-041-12 50 PATCH (50 PATCH) in 1 BOX None
Labeler — Noven Parmaceuticals, Inc.

Revised: 07/2006 Noven Parmaceuticals, Inc.

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