Lidocaine (patch)
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
- 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:
- 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.
Pharmacodynamics
- Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses.
- The penetration of lidocaine into intact skin after application of LIDODERM is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.
Pharmacokinetics
Absorption
- The amount of lidocaine systemically absorbed from LIDODERM is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three LIDODERM patches were applied over an area of 420 cm2 of intact skin on the back of normal volunteers for 12 hours. Blood samples were withdrawn for determination of lidocaine concentration during the application and for 12 hours after removal of patches. The results are summarized in Table 1.
- When LIDODERM is used according to the recommended dosing instructions, only 3 ± 2% of the dose applied is expected to be absorbed. At least 95% (665 mg) of lidocaine will remain in a used patch. Mean peak blood concentration of lidocaine is about 0.13 µg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias). Repeated application of three patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the lidocaine concentration does not increase with daily use. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1.
- Figure 1
Mean lidocaine blood concentrations after three consecutive daily applications of three LIDODERM patches simultaneously for 12 hours per day in healthy volunteers (n = 15).
Distribution
- When lidocaine is administered intravenously to healthy volunteers, the volume of distribution is 0.7 to 2.7 L/kg (mean 1.5 ± 0.6 SD, n = 15). At concentrations produced by application of LIDODERM, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4 µg/mL of free base), the plasma protein binding of lidocaine is concentration dependent. Lidocaine crosses the placental and blood brain barriers, presumably by passive diffusion.
Metabolism
- It is not known if lidocaine is metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine. A minor metabolite, 2,6-xylidine, has unknown pharmacologic activity but is carcinogenic in rats. The blood concentration of this metabolite is negligible following application of LIDODERM (lidocaine patch 5%). Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of lidocaine concentrations, respectively.
Excretion
- Lidocaine and its metabolites are excreted by the kidneys. Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15). The systemic clearance is 0.33 to 0.90 L/min (mean 0.64 ± 0.18 SD, n = 15).
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.