HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ROPIVACAINE HYDROCHLORIDE safely and effectively. See full prescribing information for ROPIVACAINE HYDROCHLORIDE.
ROPIVACAINE HYDROCHLORIDE injection, for epidural, perineural, or infiltration use
Initial U.S. Approval: 1996
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 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)
History of hypersensitivity to local anesthetics of the amide-type. (4)
WARNINGS AND PRECAUTIONS
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 Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
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