Product Elements:
Dermacinrx phn pak lidocaine lidocaine lidocaine lidocaine lidocaine
Drug Interactions:
Drug interactions antiarrhythmic drugs: lidocaine patch 5% should be used with caution in patients receiving class i antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. local anesthetics : when lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Indications and Usage:
Indication and usage highlights of prescribing information these highlights do not include all the information needed to use lidocaine patch 5% safely and effectively. see full prescribing information for lidocaine patch 5%. lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. it should be applied only to intact skin. lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. it should be applied only to intact skin.
Warnings:
Warnings
General Precautions:
General hepatic disease: patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally. allergic reactions: patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. however, lidocaine patch 5% should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. non-intact skin: application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. lidocaine patch 5% is only recommended for use on intact skin. external heat sources: placement of external heat sources, such as heating pads or electric blankets, over lidocaine patch 5% is not recommended as this has not been evaluated and may increase plasma lidocaine levels. eye exposure: the contact of lidocaine patc
Read more...h 5% with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. if eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Dosage and Administration:
Dosage and administration 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.
Contraindications:
Contraindications lidocaine patch 5% 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.
Adverse Reactions:
Adverse reactions
Drug Interactions:
Drug interactions antiarrhythmic drugs: lidocaine patch 5% should be used with caution in patients receiving class i antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. local anesthetics : when lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Use in Pregnancy:
Pregnancy teratogenic effects: pregnancy category b. lidocaine patch 5% has not been studied in pregnancy. reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously 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, lidocaine patch 5% should be used during pregnancy only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Overdosage:
Overdosage 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.
Description:
Description lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (pet) material backing and covered with a transparent pet release liner. the release liner is removed prior to application to the skin. the size of the patch is 10 cm x 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: glycerin, d-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium. lidocaine-structure
Clinical Pharmacology:
Clinical pharmacology
Pharmacodynamics:
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 lidocaine patch is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.
Pharmacokinetics
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility carcinogenesis: a minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. the blood concentration of this metabolite is negligible following application of lidocaine patch 5%. mutagenesis: lidocaine hcl is not mutagenic in salmonella/mammalian microsome test nor clastogenic in chromosome aberration assay with human lymphocytes and mouse micronucleus test. impairment of fertility: the effect of lidocaine patch 5% on fertility has not been studied.
Clinical Studies:
Clinical studies single-dose treatment with lidocaine patch 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. lidocaine patch performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours. multiple-dose, two-week treatment with lidocaine patch 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 lidocaine patch prior to the study. the constant type of pain was evaluated but not the pain induced by sensory stimuli (dysesthesia). statistically significant differences favoring lidocaine patch were observed in terms of time to exit from the trial (14 versus 3.8 days at p-value <0.001), dail
Read more...y average pain relief, and patientâs preference of treatment. about half of the patients also took oral medication commonly used in the treatment of post-herpetic neuralgia. the extent of use of concomitant medication was similar in the two treatment groups.
How Supplied:
How supplied lidocaine patch 5% is available as the following: carton of 15 patches, ndc 59088-396-82 carton of 30 patches, ndc 59088-396-54 each patch is packaged into an individual child-resistant envelope (ndc 59088-396-84). store at 20o to 25oc (68o to 77of) [see usp controlled room temperature]. for more information, call actavis at 1-800-272-5525. manufactured by: actavis laboratories ut, inc. salt lake city, ut 84108 usa distributed by: puretek corporation san fernando, ca 91340 usa rev. 37780 02/16
Package Label Principal Display Panel:
Principal display panel ndc 59088-807-00 dermacinrx® phn pak⢠[lidocaine patch 5% and moisturizing complex cream] rx only packaged in the usa by: puretek corporation, san fernando, ca 91340 usa for question or information, call toll-free: 877-921-7873 vist: dermacinrx.com dermacinrx phn pak