Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)
Septodont, Inc.
Lidocaine Hydrochloride
LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
SUBMUCOSAL
PRESCRIPTION DRUG
LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended. LIGNOSPAN is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations.
- LIGNOSPAN FORTE (Lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges (NDC 0362-1096-70). - LIGNOSPAN STANDARD (Lidocaine hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges (NDC 0362-1095-60). Store at controlled room temperature, below 25°C (77°F). Protect from light. Do not permit to freeze. BOXES: For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the end flap. Do not use if color is pinkish or darker than slightly yellow or if it contains a precipitate.
Abbreviated New Drug Application
LIGNOSPAN STANDARD- LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION SEPTODONT, INC. ---------- LIGNOSPAN (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, U.S.P.) LIGNOSPAN FORTE (LIDOCAINE HCL 2% (34 MG/1.7 ML) (20 MG/ML) AND EPINEPHRINE 1:50,000 INJECTION) LIGNOSPAN STANDARD (LIDOCAINE HCL 2% (34 MG/1.7 ML) (20 MG/ML) AND EPINEPHRINE 1:100,000 INJECTION) RX ONLY SOLUTIONS FOR LOCAL ANESTHESIA IN DENTISTRY DESCRIPTION LIGNOSPAN FORTE and LIGNOSPAN STANDARD are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). LIGNOSPAN Solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula: C H N O • HCl • H 0 M.W. 288.8 Epinephrine is ( - )-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula: ® 14 22 2 2 C H NO M.W. 183.21 COMPOSITION OF THE LIGNOSPAN INJECTIONS BRAND NAME PRODUCT IDENTIFICATION FORMULA SINGLE DOSE CARTRIDGE LIDOCAINE HYDROCHLORIDE EPINEPHRINE (AS THE BITARTRATE) SODIUM CHLORIDE POTASSIUM METABISULFITE EDETATE DISODIUM CONCENTRATION % DILUTION (MG/ML) (MG/ML) (MG/ML) LIGNOSPAN FORTE 2 1:50,000 6.5 1.2 0.25 LlGNOSPAN STANDARD 2 1:100,000 6.5 1.2 0.25 The pH of the LIGNOSPAN FORTE and the LIGNOSPAN STANDARD solutions are adjusted to USP limits with sodium hydroxide. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby effecting local anesthetic action. ONSET AND DURATION OF ANESTHESIA When used for infiltration anesthesia in dental patients, the time of onset averages less than two minutes for each of the two forms of LIGNOSPAN. LIGNOSPAN FOR Lue koko asiakirja