מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
APP Pharmaceuticals, LLC
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 40 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application
XYLOCAINE-MPF- LIDOCAINE HYDROCHLORIDE SOLUTION APP PHARMACEUTICALS, LLC ---------- 4% XYLOCAINE-MPF (LIDOCAINE HCL) STERILE SOLUTION Rx only DESCRIPTION 4% Xylocaine-MPF (lidocaine HCl) Sterile Solution (Methylparaben Free) contains a local anesthetic agent and is administered topically or by injection. See INDICATIONS for specific uses. 4% Xylocaine-MPF Sterile Solution contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6- dimethylphenyl)-mono-hydrochloride and has the following structural formula: 4% Xylocaine-MPF Sterile Solution in 5 mL ampules may be autoclaved repeatedly if necessary. Composition of 4% Xylocaine-MPF Sterile Solution Each mL contains lidocaine HCl, 40 mg, and sodium hydroxide and/or hydrochloric acid to adjust pH to 5.0 to 7.0. A sterile, aqueous solution. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. ONSET AND DURATION OF ANESTHESIA The onset of action is rapid. For retrobulbar injection, 4 mL of 4% Xylocaine-MPF Sterile Solution provides an average duration of action of 1 to 1½ hours. This duration may be extended for ophthalmic surgery by the addition of epinephrine, the usual recommended dilution being 1:50,000 to 1:100,000. HEMODYNAMICS Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. The net effect is normally a modest hypotension when the recommended dosages are not exceeded. PHARMACOKINETICS AND METABOLISM Information derived from other formulations, concentrations and usages reveals that lidocaine is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon such factors such as the site of administration and the pre קרא את המסמך השלם