Important Safety Information and Indication

Indication

LIDODERM® (lidocaine patch 5%) is indicated for relief of pain associated with post-herpetic neuralgia. Apply only to intact skin.

Important Safety Information

  • LIDODERM is contraindicated in patients with a history of sensitivity to local anesthetics (amide type) or any product component.
  • Even a used  LIDODERM (lidocaine patch 5%) patch contains a large amount of lidocaine (at least 665 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used LIDODERM patch, although the risk with this formulation has not been evaluated. It is important to store and dispose of LIDODERM out of the reach of children, pets, and others.
  • Excessive dosing, such as applying LIDODERM to larger areas or for longer than the recommended wearing time, could result in increased absorption of lidocaine and high blood concentrations leading to serious adverse effects.
  • Avoid contact of LIDODERM with the eye. If contact occurs, immediately wash the eye with water or saline and protect it until sensation returns. Avoid the use of external heat sources as this has not been evaluated and may increase plasma lidocaine levels.
  • Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally. 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. LIDODERM should also be used with caution in pregnant (including labor and delivery) or nursing mothers.
  • Allergic reactions, although rare, can occur.
  • During or immediately after LIDODERM treatment, 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. Other reactions may include dizziness, headache, and nausea.
  • When LIDODERM is used concomitantly with local anesthetic products, the amount absorbed from all formulations must be considered.
  • Immediately discard used patches or remaining unused portions of cut patches in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.

Before prescribing LIDODERM, please refer to the full Prescribing Information.

Localized Therapy With Very Little Lidocaine Absorption Into the Bloodstream When Using 3 Patches Daily1,2


Systemic adverse reactions following appropriate use of LIDODERM® (lidocaine patch 5%) are unlikely because very little lidocaine is absorbed into the bloodstream—even with 3 patches daily.1,2

In a pharmacokinetic study in which 15 healthy volunteers wore 3 LIDODERM patches for 12 hours on 3 successive days, lidocaine concentrations did not accumulate and stayed below the expected toxicity level of 5 micrograms per milliliter.2

SELECTED SAFETY INFORMATION

  • Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally. 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. LIDODERM should also be used with caution in pregnant (including labor and delivery) or nursing mothers.
  • When LIDODERM is used concomitantly with local anesthetic products, the amount absorbed from all formulations must be considered.
  • Longer duration of application, application of more than the number of recommended patches, smaller patients, or impaired elimination may all contribute to increasing concentrations of lidocaine.1
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