Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ROPIVACAINE HYDROCHLORIDE (UNII: V910P86109) (ROPIVACAINE - UNII:7IO5LYA57N)
Civica, Inc.
EPIDURAL
PRESCRIPTION DRUG
Ropivacaine Hydrochloride 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 Injection 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, and preservative-free solution, available in single-dose containers in 5 mg/mL (0.5%) concentrations. Storage Solutions should be stored at 20 ºC to 25°C (68 ºF to 77 °F); [see USP Controlled Room Temperature]. Ropivacaine Hydrochloride container closure is not made with natural rubber latex. For single-dose vials: Discard unused portion.
Abbreviated New Drug Application
ROPIVACAINE HYDROCHLORIDE - ROPIVACAINE HYDROCHLORIDE INJECTION CIVICA, INC. ---------- 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 RX ONLY INDICATIONS AND USAGE Ropivacaine Hydrochloride 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 caesarean 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: 5 mg/mL (0.5%) in single-dose vial (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 CAPLIN STERILES LIMITED AT 1-866-978- 6111 OR FDA AT 1-800-FDA-1088 OR _www.fda.gov/medwatch_. DRUG INTERACTIONS Agents Les hele dokumentet