Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
Lidocaine hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)
Cardinal Health
Lidocaine hydrochloride
Lidocaine hydrochloride 20 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application
XYLOCAINE- LIDOCAINE HYDROCHLORIDE JELLY CARDINAL HEALTH ---------- XYLOCAINE® 2% JELLY (LIDOCAINE HYDROCHLORIDE) DESCRIPTION Xylocaine (lidocaine HCl) 2% Jelly is a sterile aqueous product that contains a local anesthetic agent and is administered topically. (See INDICATIONS for specific uses.) Xylocaine 2% Jelly contains lidocaine HCl which is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula: Xylocaine 2% Jelly also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of Xylocaine 2% Jelly 30 mL and 5 mL tubes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0−7.0. 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 OF ACTION: The onset of action is 3−5 minutes. It is ineffective when applied to intact skin. 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. PHARMACOKINETICS AND METABOLISM: Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug may appear i Izlasiet visu dokumentu