Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Amneal Pharmaceuticals LLC
LIDOCAINE
LIDOCAINE 50 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Ointment 5%.
Lidocaine Ointment USP, 5% is supplied as a white to off-white color ointment. It is available as follows: 30 g laminate tubes with a child-resistant cap, NDC 65162-918-30. 35.44 g (1 ¼ oz) laminate tubes with a child-resistant cap, NDC 65162-918-38. 50 g (1 ¾ oz) double wall jar, with a child-resistant cap, NDC 65162-918-53. Pharmacist: If dispensed to a consumer, provide child resistant package for dispensing. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2018-08
Abbreviated New Drug Application
LIDOCAINE- LIDOCAINE OINTMENT AMNEAL PHARMACEUTICALS LLC ---------- LIDOCAINE OINTMENT USP, 5% FOR TOPICAL USE DO NOT USE IN THE EYES RX ONLY DESCRIPTION Lidocaine Ointment USP, 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment USP, 5% contains lidocaine USP, which is chemically designated as acetamide, 2-(diethylamino)-_N_-(2,6-dimethylphenyl)-,and has the following structural formula: Composition of Lidocaine Ointment USP, 5%: acetamide, 2-(diethylamino)-_N_-(2,6- dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycols. 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 ANESTHESIA Lidocaine Ointment 5% effects local, topical anesthesia. 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 the specific site of application, duration of exposure, concentration, and total dosage. 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 appears in the circulation because of biotransformation in the liver. Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation Прочетете целия документ