Country: United States
Language: English
Source: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
PLUM VALLEY PHARMA LLC
TOPICAL
PRESCRIPTION DRUG
Lidocaine Ointment USP, 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 USP, 5%.
Lidocaine Ointment USP, 5% is available in the following: 50.0 g (1 ¾ oz) jar with a child-resistant cap, NDC 82226-040-05 Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature] Do not permit to freeze. Manufactured by: Plum Valley Pharma, Dearborn, MI 48120 Rev.10/2018
unapproved drug other
ZILOVAL 5%- ZILOVAL 5% PLUM VALLEY PHARMA LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- ZILOVAL 5% FOR TOPICAL USE ONLY DO NOT USE IN THE EYES Rx Only LIDOCAINE 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, 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 glycol 300 and polyethylene glycol 1450. LIDOCAINE 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 USP, 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 b Read the complete document