País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
Lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987)
Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)
Lidocaine hydrochloride
Lidocaine hydrochloride 0.5 mg in 18 mL
TOPICAL
PRESCRIPTION DRUG
Xylocaine (lidocaine HCl) 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal). Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Xylocaine 2% Jelly.
Xylocaine (lidocaine HCl) 2% Jelly is supplied as follows: NDC 76478-479-05 2% (20 mg/mL) 5 mL aluminum tube packed individually. NDC 76478-479-30 2% (20 mg/mL) 30 mL aluminum tube packed individually. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AKORN Distributed by: Akorn, Inc. Lake Forest, IL 60045 OAK Mfd. for: Oak Pharmaceuticals, Inc. OPXY00N Rev. 10/18
New Drug Application
XYLOCAINE- LIDOCAINE HYDROCHLORIDE JELLY OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.) ---------- XYLOCAINE® 2% JELLY (LIDOCAINE HYDROCHLORIDE) Rx only DESCRIPTION: Xylocaine (lidocaine HCl) 2% Jelly is a sterile aqueous product that contains a local anesthetic agent and is administered topically (see INDICATIONS AND USAGE 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 to 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 to 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 gastr Leia o documento completo