Lidocaine (patch)

Lidocaine (patch)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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

Dosage

• Apply LIDODERM to intact skin to cover the most painful area. Apply the prescribed number of patches (maximum of 3), 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.Clothing may be worn over the area of application. Smaller areas of treatment are 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.

• When LIDODERM is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

• LIDODERM may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lidocaine (patch) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lidocaine (patch) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Lidocaine (patch) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lidocaine (patch) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lidocaine (patch) in pediatric patients.

Contraindications

There is limited information regarding Lidocaine (patch) Contraindications in the drug label.

Warnings

There is limited information regarding Lidocaine (patch) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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 Reactions

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 tremor.

Systemic (Dose-Related) Reactions

Systemic adverse reactions following appropriate use of LIDODERM are unlikely, due to the small dose absorbed. 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.

Postmarketing Experience

There is limited information regarding Lidocaine (patch) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Lidocaine (patch) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Lidocaine (patch) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lidocaine (patch) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Lidocaine (patch) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Lidocaine (patch) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Lidocaine (patch) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Lidocaine (patch) in geriatric settings.

Gender

There is no FDA guidance on the use of Lidocaine (patch) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Lidocaine (patch) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Lidocaine (patch) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Lidocaine (patch) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Lidocaine (patch) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Lidocaine (patch) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Lidocaine (patch) Administration in the drug label.

Monitoring

There is limited information regarding Lidocaine (patch) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Lidocaine (patch) and IV administrations.

Overdosage

• Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose , drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdose with lidocaine.

• In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics.

• The oral LD50 of lidocaine HCl is 459 (346-773) mg/kg (as the salt) in non-fasted female rats and 214 (159-324) mg/kg (as the salt) in fasted female rats, which are equivalent to roughly 4000 mg and 2000 mg, respectively, in a 60 to 70 kg man based on the equivalent surface area dosage conversion factors between species.

Pharmacology

There is limited information regarding Lidocaine (patch) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Lidocaine (patch) Mechanism of Action in the drug label.

Structure

There is limited information regarding Lidocaine (patch) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Lidocaine (patch) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Lidocaine (patch) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Lidocaine (patch) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Lidocaine (patch) Clinical Studies in the drug label.

How Supplied

• LIDODERM (lidocaine patch 5%) is available as the following:

• Carton of 30 patches, packaged into individual child-resistant envelopes

NDC 63481-687-06

Storage

• Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Lidocaine (patch) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Lidocaine (patch) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Lidocaine (patch) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Lidocaine (patch) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.