Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Mylan Pharmaceuticals Inc.
LIDOCAINE
LIDOCAINE 140 mg
CUTANEOUS
PRESCRIPTION DRUG
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.
Lidocaine Patch 5% is available containing 140 mg of lidocaine, USP (50 mg per gram adhesive in polyisobutylene adhesive matrix). The rectangular patch consists of a pigmented backing film randomly printed with “Lidocaine Patch 5%” in brown ink, an adhesive matrix layer and a clear removable release liner. They are available as follows: NDC 0378-9055-93 carton containing 30 patches, packaged into individual child-resistant pouches Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 11/2018 LIDO:R4
Abbreviated New Drug Application
LIDOCAINE- LIDOCAINE PATCH MYLAN PHARMACEUTICALS INC. ---------- DESCRIPTION Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, USP, which is applied to a pigmented polyethylene/polyester backing film printed with brown ink and covered with a silicone coated polyester 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 2-(Diethylamino)-2’,6’-acetoxylidide, has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure: Each adhesive patch contains 140 mg of lidocaine, USP (50 mg per gram adhesive) in a polyisobutylene adhesive matrix. 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 lidocaine patch 5% 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 lidocaine patch 5% is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three lidocaine patch 5% 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 during the application and for 12 hours after removal of patches. The results are summarized in Table 1. TABLE 1: ABSORPTION OF LIDOCAINE FROM LIDOCAINE PATCH 5% Normal volunteers (n = 15, 12-hour wearing time) Lidocaine Patch 5% Application Site Area (cm ) Dose Absorbed (mg) C (mcg/mL) T (hr) 3 patches Back 420 64 ± 32 0.13 ± 0.06 11 hr When lidocaine patch 5% is used according to the recommended dosing instructions, only 11 ± 4% of 2 2 max max the dose applied is e Прочитать полный документ