Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
LLC Federal Solutions
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
ORAL
PRESCRIPTION DRUG
INDICATIONS AND USAGE Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions. CONTRAINDICATIONS Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution. Pediatric use Dosages in children should be reduced, commensurate with age, body weight and physical condition. (See DOSAGE AND ADMINISTRATION).
HOW SUPPLIED Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 20 mL unit dose cups. One-hundred (100) cups per box. SHAKE WELL BEFORE USE. Repackaged by: Safecor Health, LLC 317 New Boston St. Woburn, MA 01801 Rev 101-00 07/2013 Distributed by: LLC Federal Solutions Miami, FL 33132
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION LLC FEDERAL SOLUTIONS ---------- A Topical Anesthetic for the Mucous Membranes of the Mouth and Pharynx. FOR ORAL USE ONLY. RX ONLY DESCRIPTION Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6-dimethylphenyl)- , monohydrochloride and has the following structural formula: The molecular formula of lidocaine is C H N O. The molecular weight is 234.34. Each mL contains 20 mg of lidocaine HCl. In addition each mL contains the following inactive ingredients: Carboxymethylcellulose sodium, methylparaben, natural orange flavor, propylparaben, purified water, saccharin sodium. The pH is adjusted to 5.0 to 7.0 by means of hydrochloric acid and/or sodium hydroxide. 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. 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. The net effect is normally a modest hypotension when the recommended dosages are not exceeded. PHARMACOKINETICS AND METABOLISM: Lidocaine is absorbed following topical administration to mucous membranes, its rate and extent of absorption being dependent 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 gastrointestinal tract, but little Lugege kogu dokumenti