Lidocaine Patch 5% Available from Mylan
Mylan Lidocaine Patch 5%
Intended for U.S. healthcare professionals only.
Mylan Lidocaine Patch 5%

Mylan Lidocaine Patch 5%

A Generic Version of LIDODERM®*
(lidocaine patch 5%)

Patch size 10 cm x 14 cm
(Each adhesive patch contains 140 mg of lidocaine, USP)
INDICATION

Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia (PHN). It should be applied only to intact skin.

Selected Safety Information

  • Lidocaine patch 5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product
  • Excessive dosing by applying Lidocaine patch 5% 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
  • Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally.
  • Lidocaine patch 5% 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.
  • See additional Important Safety Information below

For patients using LIDODERM® for the relief of pain associated with PHN, now there is an option from Mylan.

  • Mylan Lidocaine Patch 5% is the first available lidocaine topical patch manufactured as a thin, lightweight pigmented film1
  • Do not touch the adhesive side of the patch during the application
  • After placing the patch on the affected area, hold in place and apply gentle pressure for 10-15 seconds1
  • Make sure the patch is fully adhered to the skin. The patch should be in good contact with the application site, especially around the edges. Additional pressure should be applied to the edges of the patch as necessary to ensure the entire perimeter of the patch is adhered1.
  • If desired, a hypoallergenic surgical tape can be used along the edges of the patch. Dispose of tape and patch so that children and pets cannot get to them.

Mylan Lidocaine Patch 5% is thin and lightweight.


Properties of Mylan Lidocaine Patch 5%
Not actual size
Properties of Mylan Lidocaine Patch 5% include:
Properties
Mylan Lidocaine Patch 5%
LIDODERM®
Thickness
0.27 mm
1.59 mm
Weight
3.50 g
15.57g
Appearance
Pigmented film
White felt
Adhesive
Non-water-based
Water-based

Approximate thickness and weight based on sample of lots tested (expirations July 2015 & November 2015).

Mylan Lidocaine Patch 5% contains 140 mg of lidocaine (versus 700 mg in LIDODERM®).

Mylan Lidocaine Patch 5% is approved by the FDA as a therapeutic equivalent to LIDODERM®.. While the total drug content in the two patches differs, they each contain 50 mg of lidocaine per gram of adhesive.1,2*

Only a small, equivalent portion of the drug contained in either patch is delivered to the patient. Both patches contain an excess of lidocaine drug. The excess lidocaine drug is greater for the brand LIDODERM® (i.e., at least 665 mg remaining in the patch) than for Mylan Lidocaine Patch 5% (i.e., at least 115 mg remaining in the patch).

Considerations for application and removal

  • Patient treatment can be customized:
    • -
      Apply up to 3 patches to intact skin, only once for up to 12 hours within a 24-hour period
    • -
      Patches may be cut into smaller sizes with scissors prior to removal of the release liner
  • Applying to smaller areas of treatment is recommended in a debilitated patient, or a patient with impaired elimination
  • If irritation or a burning sensation occurs during application, remove the patch(es) and do not reapply until the irritation subsides
  • Hands should be washed after the handling of Mylan Lidocaine Patch 5%, and eye contact with the patch should be avoided
  • Apply immediately after removal from the protective envelope
  • Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them
  • Mylan Lidocaine Patch 5% should be kept out of the reach of children

Mylan Lidocaine Patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering.

Developed by Mylan, a leading manufacturer of engineered drug delivery technology products.

  • Mylan prescription transdermal patches are either the #1 or #2 most dispensed products—brand or generic—in their respective drug classes
  • Mylan Lidocaine Patch 5%—the first topical patch from Mylan—benefits from 20 years of patch drug delivery technology experience

       *LIDODERM® is a registered trademark of Endo Pharmaceuticals Inc.
         IMS Health, NPA™, Dispensed Moving Annual Total (MAT)
          Prescriptions, July 2014 through June 2015.
Order Mylan Lidocaine Patch 5% by calling Mylan Customer Relations at 1.800.796.9526

(NDC number: 0378-9055-93, 30 patches per package)

Review full instructions for applying and removing Mylan Lidocaine Patch 5%.

See the Mylan Lidocaine Patch 5% Patient Brochure.

Download >>
INDICATION

Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. Apply only to intact skin.

IMPORTANT SAFETY INFORMATION

Lidocaine patch 5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

Even a used lidocaine patch 5% contains a large amount of lidocaine (at least 115 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch 5%, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of lidocaine patch 5% out of the reach of children, pets and others.

Excessive dosing by applying lidocaine patch 5% 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.

Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally.

Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, lidocaine patch 5% should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.

Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. Lidocaine patch 5% is only recommended for use on intact skin.

Placement of external heat sources, such as heating pads or electric blankets, over lidocaine patch 5% patches is not recommended as this has not been evaluated and may increase plasma lidocaine levels.

The contact of lidocaine patch 5% with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

Patients should wash their hands after handling of lidocaine patch 5%.

Lidocaine patch 5% 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 lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Lidocaine patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering.

Lidocaine patch 5% should be used with caution in pregnant (including labor and delivery) or nursing mothers.

During or immediately after treatment with 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. Other reactions may include dizziness, headache, and nausea.

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.

Discard used patches by folding used patch so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.


Click here for full Prescribing Information for Mylan Lidocaine Patch 5%.

IMPORTANT SAFETY INFORMATION AND INDICATION

SEE MORE SEE LESS

Lidocaine patch 5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

Even a used lidocaine patch 5% contains a large amount of lidocaine (at least 115 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used lidocaine patch 5%, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of lidocaine patch 5% out of the reach of children, pets and others.

Excessive dosing by applying lidocaine patch 5% 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.

Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally.

Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, lidocaine patch 5% should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.

Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. Lidocaine patch 5% is only recommended for use on intact skin.

Placement of external heat sources, such as heating pads or electric blankets, over lidocaine patch 5% patches is not recommended as this has not been evaluated and may increase plasma lidocaine levels.

The contact of lidocaine patch 5% with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

Patients should wash their hands after handling of lidocaine patch 5%.

Lidocaine patch 5% 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 lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Lidocaine patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering. 

Lidocaine patch 5% should be used with caution in pregnant (including labor and delivery) or nursing mothers.

During or immediately after treatment with 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. Other reactions may include dizziness, headache, and nausea.

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.

Discard used patches by folding used patch so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

INDICATION

Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. Apply only to intact skin.