Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ROPIVACAINE HYDROCHLORIDE (UNII: V910P86109) (ROPIVACAINE - UNII:7IO5LYA57N)
Hikma Pharmaceuticals USA Inc.
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 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 doses
Ropivacaine Hydrochloride Injection, USP is a sterile, clear, colorless solution, essentially free from visible particles and is supplied as follows: 2 mg/mL (40 mg/20 mL) single dose vial, Cartons of 10 vials (NDC 0143-9263-10) 5 mg/mL (150 mg/30 mL) single dose vial, Cartons of 10 vials (NDC 0143-9264-10) 7.5 mg/mL (150 mg/20 mL) single dose vial, Cartons of 10 vials (NDC 0143-9265-10) 10 mg/mL (200 mg/20 mL) single dose vial, Cartons of 10 vials (NDC 0143-9266-10) Storage Solutions should be stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. The 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 HIKMA PHARMACEUTICALS USA 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 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/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) or 10 mg/mL (1%) in single-dose vials. (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 HIKMA PHARMACEUTICALS USA INC. AT 1- 877-845-068 Lire le document complet