Ropivacaine Hydrochloride

1 INDICATIONS AND USAGE 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 an amide local anesthetic indicated in adults 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.

6 ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to ropivacaine hydrochloride at concentrations up to 1% in clinical trials. Each patient was counted once for each type of adverse event.

8.1 Pregnancy 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) .

5 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) 5.1 General Warnings and Precautions Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an intravenous line inserted. All necessary precautions should be taken to avoid intravascular injection. 4 CONTRAINDICATIONS Ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. History of hypersensitivity to local anesthetics of the amide type. (4)