Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Bupivacaine Hydrochloride (UNII: 7TQO7W3VT8) (Bupivacaine - UNII:Y8335394RO)
General Injectables & Vaccines, Inc
Bupivacaine Hydrochloride
Bupivacaine Hydrochloride 5 mg in 1 mL
EPIDURAL
PRESCRIPTION DRUG
MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see DOSAGE AND ADMINISTRATION (2.2)]. Limitations of Use Not all blocks are indicated for use with MARCAINE / MARCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see DOSAGE AND ADMINISTRATION (2.2), CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1, 5.4, 5.5, 5.7, 5.9)]. MARCAINE / MARCAINE WITH EPINEPHRINE is contraindicated in: - obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. - intravenous regional anesthesia (Bier Block) [see WARNINGS AND PRECAUTIONS (5.7)]. - patients with a known hyper
Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). [See USP Controlled Room Temperature.] MARCAINE—Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121 °C (250 °F) for 15 minutes. Protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. For single-dose vials: Discard unused portion. MARCAINE with epinephrine 1:200,000 (as bitartrate)—Do not autoclave solutions of MARCAINE that contain epinephrine and protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. For single-dose vials: Discard unused portion.
New Drug Application
MARCAINE- BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION GENERAL INJECTABLES & VACCINES, INC REFERENCE LABEL SET ID: 8DB7C501-993A-444D-A819-D1F9DF1D7B62 ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MARCAINE™ AND MARCAINE™ WITH EPINEPHRINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MARCAINE™ AND MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (BUPIVACAINE HYDROCHLORIDE) INJECTION, FOR INFILTRATION, PERINEURAL, CAUDAL, EPIDURAL, OR RETROBULBAR USE MARCAINE™ WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, FOR INFILTRATION, PERINEURAL, CAUDAL, OR EPIDURAL USE INITIAL U.S. APPROVAL: 1972 INDICATIONS AND USAGE MARCAINE contains bupivacaine, an amide local anesthetic, and MARCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2) (2) Limitations of Use (2) Not all blocks are indicated for use with MARCAINE / MARCAINE WITH EPINEPHRINE given clinically significant risks associated with use. (1, 2.2, 4, 5.1, 5.4, 5.5, 5.7, 5.9) (2) DOSAGE AND ADMINISTRATION Not for intrathecal use. (2.1) Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. (2.1, 5.4) Three mL of MARCAINE WITH EPINEPHRINE without antimicrobial preservative (0.5% bupivacaine with 1:200,000 epinephrine ) is recommended for use as a test dose prior to caudal and lumbar epidural blocks when clinical conditions permit. (2.4) See full prescribing information for: – Reco Přečtěte si celý dokument