국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
bupivacaine hydrochloride (UNII: 7TQO7W3VT8) (bupivacaine - UNII:Y8335394RO), epinephrine bitartrate (UNII: 30Q7KI53AK) (epinephrine - UNII:YKH834O4BH)
Septodont Inc.
bupivacaine hydrochloride
bupivacaine hydrochloride 5 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults. Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) is not recommended for children. Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide type or to other components of Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) solutions.
Store at 25°C (77°F). May be stored for brief periods during shipment at temperatures not to exceed 30°C (86°F). Do not permit to freeze. Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) – Sterile isotonic solutions containing sodium chloride. Each 1 mL contains 5 mg bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 7 mg sodium chloride, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted with sodium hydroxide or hydrochloric acid. Solutions of bupivacaine that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its colour is pinkish or darker than slightly yellow or if it contains a precipitate. Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) (NDC 0362-9011-10) is available in cardboard boxes containing a blister of 10 X 1.8 mL dental cartridges.
Abbreviated New Drug Application
VIVACAINE- BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION SEPTODONT INC. ---------- VIVACAINE BUPIVACAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTION (AS BITARTRATE) (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP) RX ONLY THIS SOLUTION IS INTENDED FOR DENTAL USE. DESCRIPTION Bupivacaine hydrochloride is (±) -1-Butyl-2', 6'-pipecoloxylidide monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Molecular Weight - 342.90 C H N O • HCl • H O Epinephrine is (-)-3, 4-Dihydroxy-α-[(methylamino)-methyl] benzyl alcohol. It has the following structural formula: Molecular Weight - 183.20 C H NO Bupivacaine is available in a sterile isotonic solution with epinephrine 1:200,000. Solutions of bupivacaine containing epinephrine may not be autoclaved. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. CLINICAL PHARMACOLOGY Bupivacaine stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia. The onset of action following dental injections is usually 2 to 10 minutes and anesthesia may last two or three times longer than lidocaine and mepivacaine for dental use, in many patients up to 7 hours. The duration of anesthetic effect is prolonged by the addition of epinephrine 1:200,000. ™ 18 28 2 2 9 13 3 duration of anesthetic effect is prolonged by the addition of epinephrine 1:200,000. It has also been noted that there is a period of analgesia that persists after the return of sensation, during which time the need for strong analgesic 전체 문서 읽기