Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions), 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 to 773) mg/kg (as the salt) in non-fasted female rats and 214 (159 to 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.
Apply lidocaine patch 5% 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. (See HANDLING AND DISPOSAL) 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 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.
Hands should be washed after the handling of lidocaine patch 5%, and eye contact with lidocaine patch 5% 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. Lidocaine patch 5% should be kept out of the reach of children.
Lidocaine patch 5% is available as the following:
Carton of 30 patches, packaged into individual child-resistant envelopes.
Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature].
For more information, call Actavis at 1-800-272-5525.
Actavis Laboratories UT, Inc.
Salt Lake City, UT 84108 USA
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Revised: February 2015
Each adhesive patch contains:
Lidocaine, 700 mg (50 mg per gram adhesive) in an aqueous base.
Inactive components: non-woven polyethylene terephthalate (PET) backing, glycerin, D-sorbitol,
propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium,
gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben
(preservative), propylparaben (preservative), edetate disodium, and a PET release liner.
Usual dosage: For dosage and full prescribing information, read accompanying product information.
Store at 20° to 25°C [See USP Controlled Room Temperature].
WARNING: Keep used and unused patches out of the reach of children, pets and others.
30 Patches(30 Envelopes Containing 1 Patch Each)
Menthol USP 6%
Keep out of reach of children
Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches
For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.
Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.
aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol
The packaging for Elemar Patch is shown below.
|ELEMAR PATCH lidocaine kit|
|Labeler — V2 Pharma, LLC (102457346)|
|Actavis Pharma, Inc.||079589880||manufacture (0591-3525)|
|SOMBRA COSMETICS INC.||097464309||manufacture (61577-3235), label (61577-3235)|
|V2 Pharma, LLC||102457346||label (72835-502)|
Revised: 02/2023 V2 Pharma, LLC
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