Application Site Reactions
During or immediately after treatment with LIDODERM
(lidocaine patch 5%), the skin at the site of application may develop blisters,
bruising, burning sensation, depigmentation, dermatitis, discoloration, edema,
erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or
may be the locus of abnormal sensation. These reactions are generally mild and
transient, resolving spontaneously within a few minutes to hours.
Allergic and anaphylactoid reactions associated with
lidocaine, although rare, can occur. They are characterized by angioedema,
bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus,
shock, and urticaria. If they occur, they should be managed by conventional
means. The detection of sensitivity by skin testing is of doubtful value.
Other Adverse Events
Due to the nature and limitation of spontaneous reports
in postmarketing surveillance, causality has not been established for
additional reported adverse events including:
Asthenia, confusion, disorientation, dizziness, headache,
hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea,
nervousness, pain exacerbated, paresthesia, somnolence, taste alteration,
vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and
Systemic (Dose-Related) Reactions
Systemic adverse reactions following appropriate use of
LIDODERM are unlikely, due to the small dose absorbed (see CLINICAL
PHARMACOLOGY, Pharmacokinetics). Systemic adverse effects of
lidocaine are similar in nature to those observed with other amide local
anesthetic agents, including CNS excitation and/or depression
(light-headedness, 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). Excitatory CNS reactions may be brief or not occur at
all, in which case the first manifestation may be drowsiness merging into
unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension
and cardiovascular collapse leading to arrest.
LIDODERM should be used with caution in patients
receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since
the toxic effects are additive and potentially synergistic.
When LIDODERM is used concomitantly with other products
containing local anesthetic agents, the amount absorbed from all formulations
must be considered.