Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE BITARTRATE (UNII: 30Q7KI53AK) (EPINEPHRINE - UNII:YKH834O4BH)
Dentsply Pharmaceutical
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
SUBMUCOSAL
PRESCRIPTION DRUG
2% Xylocaine DENTAL 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. 2% Xylocaine DENTAL 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.
- 2% Xylocaine DENTAL with Epinephrine 1:50,000 (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 66312-181-16). - 2% Xylocaine DENTAL with Epinephrine 1:100,000 (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 66312-176-16). 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
XYLOCAINE- LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION DENTSPLY PHARMACEUTICAL ---------- 2% XYLOCAINE DENTAL WITH EPINEPHRINE 1:50,000 (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP) LIDOCAINE HCL 2% (34 MG/1.7 ML) (20 MG/ML) AND EPINEPHRINE 1:50,000 INJECTION 2% XYLOCAINE DENTAL WITH EPINEPHRINE 1:100,000 (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP) 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 2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 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). 2% Xylocaine DENTAL 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 • HCI • H O 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 The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. COMPOSITION OF THE 2% XYLOCAINE DENTAL 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) 2% Xylocaine Dental with Epinephrine 1:50,000 2 1:50,000 6.5 1.2 0.25 2% Xylocaine Dental with Epinephrine 1:100,000 2 1:100,000 6.5 1.2 0.25 The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Lidocaine stabilizes the neuronal membrane by inhibiting the ionic Læs hele dokumentet