Country: United States
Language: English
Source: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Ingenus 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 available in 35.44 g (1¼ oz) and 50.00 g (1¾ oz) laminate tubes with a child-resistant cap. NDC numbers for different packaging sizes are as following: Store at 25ºC (77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Made in Canada Rev. 11/18 IN-30635.R2 ingenus
Abbreviated New Drug Application
LIDOCAINE- LIDOCAINE OINTMENT INGENUS PHARMACEUTICALS, LLC ---------- LIDOCAINE OINTMENT USP, 5% DO NOT USE IN THE EYES RX ONLY DESCRIPTION Lidocaine Ointment 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment 5% contains lidocaine, which is chemically designated as acetamide, 2- (diethylamino)-_N_-(2,6-dimethylphenyl)-, and has the following structural formula: Composition of Lidocaine Ointment 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 3-5 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. 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, cleavage of the amide Read the complete document