Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Trifluent Pharma LLC
TOPICAL
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.
Tridacaine™ is available as the following: Carton of 15 patches, packaged into individual child-resistant envelopes. NDC 73352-825-15 Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. For more information, call Trifluent Pharma at 210-944-6920 Distributed by: Trifluent Pharma San Antonio, TX 78213 Revised 01/2024
Abbreviated New Drug Application
TRIDACAINE- LIDOCAINE PATCH TRIFLUENT PHARMA LLC ---------- LIDOCAINE PATCH A200675 LIDOCAINE PATCH 5% RX ONLY DESCRIPTION Tridacaine™ is comprised of an adhesive material containing 5% lidocaine, USP, 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, USP 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, USP (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. 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 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 is directly related to both the duration of application and the surface area over which it is applied. In a pharmacokinetic study, three lidocaine 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 NOR Lees het volledige document