Lidoderm

Lidoderm

Lidoderm Recall

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Questions & Answers

Side Effects & Adverse Reactions

Accidental Exposure in Children

Even a used LIDODERM 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 for patients to store and dispose of LIDODERM out of the reach of children, pets and others. (See HANDLING AND DISPOSAL)

Excessive Dosing

Excessive dosing by 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 (see ADVERSE REACTIONS, Systemic Reactions). Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 µg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine. With recommended dosing of LIDODERM, the average peak blood concentration is about 0.13 µg/mL, but concentrations higher than 0.25 µg/mL have been observed in some individuals.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

LIDODERM is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

History

There is currently no drug history available for this drug.

Other Information

LIDODERM (lidocaine patch 5%) is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm × 14 cm.

Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:

Lidocaine structure

Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, and urea.

Lidoderm Manufacturers


  • Rebel Distributors Corp.
    Lidoderm (Lidocaine) Patch [Rebel Distributors Corp.]
  • Physicians Total Care, Inc.
    Lidoderm (Lidocaine) Patch [Physicians Total Care, Inc.]
  • Stat Rx Usa Llc
    Lidoderm (Lidocaine) Patch [Stat Rx Usa Llc]
  • Dispensing Solutions, Inc.
    Lidoderm (Lidocaine) Patch [Dispensing Solutions, Inc.]
  • H.j. Harkins Company, Inc.
    Lidoderm (Lidocaine) Patch [H.j. Harkins Company, Inc.]
  • Stat Rx Usa Llc
    Lidoderm (Lidocaine) Patch [Stat Rx Usa Llc]
  • Unit Dose Services
    Lidoderm (Lidocaine) Patch [Unit Dose Services]
  • Aidarex Pharmaceuticals Llc
    Lidoderm (Lidocaine) Patch [Aidarex Pharmaceuticals Llc]
  • Endo Pharmaceuticals Inc.
    Lidoderm (Lidocaine) Patch [Endo Pharmaceuticals Inc.]
  • Bryant Ranch Prepack
    Lidoderm (Lidocaine) Patch [Bryant Ranch Prepack]

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