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warnings
WARNINGS IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS MUST BE IMMEDIATELY AVAILABLE WHEN LOCAL ANESTHETIC AGENTS, SUCH AS LIDOCAINE, ARE ADMINISTERED TO MUCOUS MEMBRANES. The DentiPatch® system should be used with extreme caution if there is sepsis or extremely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.
ADVERSE REACTIONS Localized Reactions: During controlled clinical trials with this dosage form, the area of patch application was evaluated for oral irritation following removal. In the majority of instances, no irritation was observed. Minimal to moderate redness was reported, however, in fewer than 15% of the applications of the patch and placebo. General Adverse Events: In controlled clinical trials, the percentage of subjects reporting adverse events was similar in the two treatment groups consisting of the 46.1 mg and placebo patches. Overall, the most frequently occurring adverse experiences irrespective of causality were taste perversion, stomatitis (including erythema and other types of mucosal reactions), headache and gingivitis. The incidence of drug-related (definite, probably/highly probably) events was low in both treatment groups, however. Other adverse experiences reported following the administration of lidocaine 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 the most common reported. Central nervous system: CNS manifestations are excitatory and/or depressant and may be characterized by lightheaded-ness, 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 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 are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.