Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)
Akorn
TOPICAL
PRESCRIPTION DRUG
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 Lidocaine HCl 2% Jelly.
Lidocaine HCl 2% Jelly is supplied in the listed dosage forms. A detachable applicator cone and a key for expressing the contents are included in the 30 mL carton. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 LD00N Rev. 02/20
Abbreviated New Drug Application
LIDOCAINE- LIDOCAINE HYDROCHLORIDE JELLY AKORN ---------- LIDOCAINE HYDROCHLORIDE JELLY USP, 2% RX ONLY DESCRIPTION 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). Lidocaine HCl 2% Jelly contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula: Its molecular formula is C H N O • HCl and its molecular weight is 270.80. Lidocaine HCl 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 Lidocaine HCl 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 Přečtěte si celý dokument