Dosing & Uses
Dosage Forms & Strengths
transdermal patch
- 5%; 700mg/patch (Lidoderm; Rx)
- 1.8%; 36mg/patch (ZTlido; Rx)
- 4% (Lidocare Patch; OTC)
Postherpetic Neuralgia Pain
Lidoderm 5% or ZTlido 1.8%
- Lidoderm 5% transdermal patch: Apply to intact skin to cover the most painful area
- Apply up to 3 patches, only once for up to 12 hr within a 24-hr 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
- Also see Administration
Temporary Pain Relief
Indicated for temporary pain relief in adults and adolescents aged ≥12 yr
Lidocare 4% transdermal patch: Apply patch to affected area q8-12hr prn
May leave patch on skin for up to 8, but no more than 12 hr
Dosing Considerations
One ZTlido (lidocaine topical system) 1.8% provides equivalent lidocaine exposure to one Lidoderm (lidocaine patch 5%)
If used concomitantly with other products containing local anesthetic agents, the total amount of drug absorbed from all formulations must be considered
Dosage Forms & Strengths
transdermal patch
- 4% (Lidocare Patch; OTC)
Temporary Pain Relief
Indicated for temporary pain relief in adults and adolescents aged ≥12 yr
Lidocare 4% transdermal patch: Apply patch to affected area q8-12hr prn
May leave patch on skin for up to 8, but no more than 12 hr
Adverse Effects
Frequency Not Defined
Allergic and anaphylactoid reactions (rare) may be characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria
Application site reactions may occur (eg, blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or abnormal sensation
Postmarketing Reports
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, eye irritation, and tremor
Warnings
Contraindications
Known history of sensitivity to local anesthetics of the amide type, or to any other component of the product
Cautions
Patients allergic to para-aminobenzoic acid (PABA) derivatives (eg, procaine, tetracaine, benzocaine) have not shown cross-sensitivity to lidocaine; however, be aware of the potential for cross-sensitivity in patients allergic to PABA derivatives, especially if the etiologic agent is uncertain
If irritation or a burning sensation occurs during application, advise patients to remove patch and do not reapply until the irritation subsides
When used concomitantly with other products containing local anesthetic agents, the amount of lidocaine absorbed from all formulations must be considered
Dispose of used lidocaine patches properly to avoid toxicity in small children or pets; used lidocaine patches contains a large amount of lidocaine
Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption; apply only to intact skin
External heat sources (eg, heating pads, electric blanket), longer duration of application, application of more than recommended number of patches, smaller patients, impaired elimination may contribute to increase systemic absorption from transdermal patch; advice patients of proper application and duration
Severe hepatic impairment may decrease systemic elimination of lidocaine
If eye contact occurs, immediately wash out eye with water or saline and protect the eye until sensation returns
Pregnancy & Lactation
Pregnancy
There are no available data regarding use in pregnant women
Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg SC and have revealed no evidence of harm to the fetus due to lidocaine
There are, however, no adequate and well-controlled studies in pregnant women
Because animal reproduction studies are not always predictive of human response, should be used during pregnancy only if clearly needed
Lactation
There are no available data regarding use in breastfeeding women; caution if administered
Lidocaine is excreted in human milk, and the milk: plasma ratio of lidocaine is 0.4
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Elicits local anesthesia; stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action
Absorption
Peak plasma time (transdermal patch): 11 hr
Peak plasma concentration (3 transdermal patches): 0.13 mcg/mL
Distribution
Protein bound: 70% (transdermal patch)
Vd: 0.7-2.7 L/kg (transdermal patch)
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
Administration
Transdermal Administration
Instruct patients to wash hands immediately after handling patch and to avoid contact with eyes
Patch may not stick if it gets wet; advise patients to avoid contact with water (eg, bathing, swimming, or showering) during the 12 hr when the patch is worn
Advise patients not to apply external heat sources (eg, heating pads or electric blankets) directly to lidocaine transdermal patches because plasma lidocaine levels are increased
The patch can be applied, however, to the administration site after moderate heat exposure (eg, 15 minutes of heating pad exposure on a medium setting)
May be used during moderate exercise (eg, biking for 30 minutes)
Topical systems that have lifted at the edges may be reattached by pressing firmly on the edges; if a patch comes off completely and will not stick to patient’s skin, it should be thrown away and a new patch should be applied for a total duration of 12 hr of used and new patched together
Dispose of properly
- Instruct patients to, after use, fold used patch so that the adhesive side sticks to itself and safely discard the used patch or pieces of cut patch where children and pets cannot get to them
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Store inside original sealed package and to apply immediately after removal from the package
Store out of the reach of children, pets, and others
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Formulary
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