Lidoderm Information
Lidoderm (Lidocaine)
Lidoderm (Lidocaine) Description
Lidoderm (Lidocaine) (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.
Lidoderm (Lidocaine) Clinical Pharmacology
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 (Lidocaine) is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.
Lidoderm (Lidocaine) Clinical Studies
Single-dose treatment with Lidoderm (Lidocaine) was compared to treatment with vehicle patch (without lidocaine), and to no treatment (observation only) in a double-blind, crossover clinical trial with 35 post-herpetic neuralgia patients. Pain intensity and pain relief scores were evaluated periodically for 12 hours. Lidoderm (Lidocaine) performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours.
Multiple-dose, two-week treatment with Lidoderm (Lidocaine) was compared to vehicle patch (without lidocaine) in a double-blind, crossover clinical trial of withdrawal-type design conducted in 32 patients, who were considered as responders to the open-label use of Lidoderm (Lidocaine) prior to the study. The constant type of pain was evaluated but not the pain induced by sensory stimuli (dysesthesia). Statistically significant differences favoring Lidoderm (Lidocaine) were observed in terms of time to exit from the trial (14 versus 3.8 days at p-value
Lidoderm (Lidocaine) Indication And Usage
Lidoderm (Lidocaine) is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to .
Lidoderm (Lidocaine) Contraindications
Lidoderm (Lidocaine) 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.
Lidoderm (Lidocaine) Adverse Reactions
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.
Lidoderm (Lidocaine) Overdosage
Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see ), 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 LD 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.
Lidoderm (Lidocaine) Dosage And Administration
Apply Lidoderm (Lidocaine) to intact skin to cover the most painful area. Apply up to three patches, 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. (See ) 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 (Lidocaine) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Lidoderm (Lidocaine) Handling And Disposal
Hands should be washed after the handling of Lidoderm (Lidocaine) , and eye contact with Lidoderm (Lidocaine) should be avoided. Do not store patch outside the sealed envelope. 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. Lidoderm (Lidocaine) should be kept out of the reach of children.
Lidoderm (Lidocaine) How Supplied
Lidoderm (Lidocaine) (lidocaine patch 5%) is available as the following:
Carton of 30 patches (NDC 42549-576-30), packaged into individual child-resistant envelopes (NDC 42549-576-01).
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
Lidoderm (Lidocaine)
Lidoderm (Lidocaine)
