국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
ropivacaine hydrochloride (UNII: V910P86109) (ropivacaine - UNII:7IO5LYA57N)
Sagent Pharmaceuticals
EPIDURAL
PRESCRIPTION DRUG
Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration Ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. Risk Summary There are no available human data on use of ropivacaine hydrochloride in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see Clinical Considerations) . No teratogenicity was observed at dos
Ropivacaine Hydrochloride Injection, USP is a clear, colorless solution supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container and container closure are not made with natural rubber latex.
Abbreviated New Drug Application
ROPIVACAINE HYDROCHLORIDE- ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION SAGENT PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ROPIVACAINE HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROPIVACAINE HYDROCHLORIDE INJECTION. ROPIVACAINE HYDROCHLORIDE INJECTION, FOR EPIDURAL, PERINEURAL, OR INFILTRATION USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Ropivacaine Hydrochloride Injection is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. (1) Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration (1) Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration (1) DOSAGE AND ADMINISTRATION See Table 1 for Dosage Recommendations (2.2) DOSAGE FORMS AND STRENGTHS Injection: 2 mg per mL (0.2%) in single-dose, ready-to-use, polypropylene flexible bags (3) CONTRAINDICATIONS History of hypersensitivity to local anesthetics of the amide type. (4) WARNINGS AND PRECAUTIONS Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. (5.1) In performing ropivacaine hydrochloride blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardia arrest. (5.2) Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine hydrochloride is not approved for this use. (5.3). Signs of methemoglobinemia may occur. (5.4) ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 5%) are hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SAGENT PHARMACEUTICALS, INC. AT 1-866- 625-1618 OR FDA AT 전체 문서 읽기