Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987), prilocaine (UNII: 046O35D44R) (prilocaine - UNII:046O35D44R)
Physicians Total Care, Inc.
lidocaine
lidocaine 25 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Lidocaine and prilocaine cream, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: Lidocaine and prilocaine cream, 2.5%/2.5% 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 and prilocaine cream, 2.5%/2.5% is available as follows NDC 54868-5194-2 30 gram tube NDC 54868-5194-1 5 gram tube NDC 54868-5194-0 5 x 5 gram tube NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. WARNING: Keep out of reach of children. Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). E.FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 I2357/IF2357D R9/07 #42 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
LIDOCAINE AND PRILOCAINE - LIDOCAINE AND PRILOCAINE CREAM PHYSICIANS TOTAL CARE, INC. ---------- LIDOCAINE AND PRILOCAINE CREAM, 2.5%/2.5% NOT FOR OPHTHALMIC USE FOR EXTERNAL USE ONLY RX ONLY DESCRIPTION Lidocaine and prilocaine cream, 2.5%/2.5% 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 30 gram tubes and 5 gram tubes for hospital use. 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 and prilocaine cream, 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carbomer 934 (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water. Lidocaine and prilocaine cream, 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream, 2.5%/2.5% is approximately 1. CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Lidocaine and prilocaine cream, 2.5%/2.5%, 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 anesthet Lue koko asiakirja