Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Lake Erie Medical DBA Quality Care Products LLC
LIDOCAINE
LIDOCAINE 50 mg in 1 g
CUTANEOUS
PRESCRIPTION DRUG
LIDODERM 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 patch 5%) is available as the following: Carton of 30 patches, packaged into individual child-resistant envelopes NDC 49999-419-30 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. For more information, call Endo Pharmaceuticals at 1-800-462-3636. Manufactured for: Endo Pharmaceuticals Inc. Malvern, PA 19355 LIDODERM® is a registered trademark of Hind Health Care, Inc. © 2015 Endo Pharmaceuticals Inc. All rights reserved. 114957 / January 2015
New Drug Application
LIDODERM- LIDOCAINE PATCH LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- LIDODERM® (LIDOCAINE PATCH 5%) R ONLY DESCRIPTION LIDODERM (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. CLINICAL PHARMACOLOGY 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 LIDODERM is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block. PHARMACOKINETICS _ABSORPTION_The amount of lidocaine systemically absorbed from LIDODERM is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three LIDODERM patches were applied over an area of 420 cm of intact skin on the back of normal volunteers for 12 hours. Blood samples were withdrawn for determination of lidocaine concentration X 2 during the application and for 12 hours after removal of patches. The results are summarized in Table 1. TABLE 1 ABSORPTION OF LIDOCAINE FROM LIDODERM NORMAL VOLUNTEERS (N = Прочитајте комплетан документ