Country: United States
Language: English
Source: NLM (National Library of Medicine)
BUPIVACAINE HYDROCHLORIDE ANHYDROUS (UNII: AKA908P8J1) (BUPIVACAINE - UNII:Y8335394RO), epinephrine bitartrate (UNII: 30Q7KI53AK) (epinephrine - UNII:YKH834O4BH)
Carestream Health Inc.
BUPIVACAINE HYDROCHLORIDE ANHYDROUS
BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
Marcaine® 0.5% with epineprhine 1:200,000 is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults. Marcaine® 0.5% with epinephrine 1:200,000 is not recommended for children. Marcaine® 0.5% with epinephrine 1:200,000, 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 bupivacaine solutions.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. Do not permit to freeze. Marcaine® 0.5% with epinephrine 1:200,000 injection (as bitartrate) – 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. Marcaine® 0.5% with epinephrine 1:200,000 injection (NDC 31382-557-05) is available in cardboard boxes containing 5 blisters of 10 × 1.8 mL dental cartridges.
Abbreviated New Drug Application
MARCAINE - BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION CARESTREAM HEALTH INC. ---------- MARCAINE® 0.5% WITH 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 WEIG HT - 34 2.90 C H N O • HCL • H O Epinephrine is (-)-3, 4-Dihydroxy-α-[(methylamino)-methyl] benzyl alcohol. It has the following structural formula: MOLECULAR WEIG HT - 183.20 C H NO Bupivacaine is available in a sterile isotonic solution with epinephrine 1:200,000 (as bitartrate). 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. It has also been noted that there is a period of analgesia that persists after the return of sensation, during 18 28 2 2 9 13 3 which time the need for strong analgesic is reduced. After injection of bupivacaine for caudal, epidural or periph Read the complete document