Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Lake Erie Medical DBA Quality Care Products LLC
LIDOCAINE
LIDOCAINE 25 mg in 1 g
PRESCRIPTION DRUG
Abbreviated New Drug Application
LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- LIDOCAINE 2.5% AND PRILOCAINE 2.5% CREAM FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION Lidocaine 2.5% and Prilocaine 2.5%, a topical anesthetic agent, is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 15 gram and 30 gram tubes. 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: Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol:water partition ratio of 25 at pH 7.4, and has the following structure: Each gram of lidocaine 2.5% and prilocaine 2.5% cream contains lidocaine 25 mg, prilocaine 25 mg, carboxypolymethylene (as a thickening agent), polyoxyethylene fatty acid esters (as emulsifiers), purified water to 1 gram, and sodium hydroxide to adjust pH (pH range 9.0-9.4). Lidocaine 2.5% and prilocaine 2.5% cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine 2.5% and prilocaine 2.5% cream is 1.00. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Lidocaine 2.5% and prilocaine 2.5% cream, applied to intact skin under occlusive dressing, provides dermal analgesia by the release of lidocaine and prilocaine from the cream into the epidermal and dermal layers of the skin and by the accumulation of lidocaine and prilocaine in the vicinity of dermal pain receptors and nerve endings. Lidocaine and prilocaine are amide-type local anesthetic agents. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local a Lue koko asiakirja