DailyMed Label: Lidocan

DailyMed Label: Lidocan

2023

DailyMed Prescription

Lidocan

Lidocaine 5%

PURETEK CORPORATION

NDC: 59088-905

NDC: 59088-905

LIDOCAN™ 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 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: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.

LIDOCAN™ is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

Apply LIDOCAN™ 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 LIDOCAN™ is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. LIDOCAN™ may not stick if it gets wet. Avoid contact with water, such as bathing, swimming, or showering.

LIDOCAN™ 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.

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, LIDOCAN™ 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. LIDOCAN™ 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 LIDOCAN™ 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.

Antiarrhythmic Drugs LIDOCAN™ 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 LIDOCAN™ is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Drugs That May Cause Methemoglobinemia When Used with LIDOCAN™ Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Example Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine

LIDOCAN™ is available as the following: Carton of 30 patches....................................................................................NDC 5 9088-905-54 (packaged into individual child-resistant envelope) Single patch............................................................................................. NDC 59088-905-84 (packaged into individual child-resistant envelope) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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 a lidocaine patch 5% is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.

Single-dose treatment with lidocaine patch 5% 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 5% performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours. Multiple-dose, two-week treatment with lidocaine patch 5%, 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 5% 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 5% were observed in terms of time to exit from the trial (14 versus 3.8 days at p-value <0.001), daily average pain relief, and patient's 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.