Ropivacaine

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. ( 1 ) Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. …

• See Table 1 for Dosage Recommendations
• Important Administration Instructions There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures
• Ropivacaine Hydrochloride Injection is not approved for this use [see Warnings and Precautions ]
• The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used
• The smallest dose and concentration required to produce the desired result should be administered
• The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient
• Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients
• To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly
• Use an adequate test dose (3 to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block. …

Ropivacaine Hydrochloride Injection, USP is a clear, colorless, preservative-free solution available as: Ropivacaine Hydrochloride Injection, USP Single Dose Vials • 0.2%, 20 mg per 10 mL (2 mg/mL), in 10 mL single-dose vial • 0.2%, 40 mg per 20 mL (2 mg/mL), in 20 mL single-dose vial • 0.5%, 100 mg per 20 mL (5 mg/mL), 20 mL single-dose vial • 0.5%, 150 mg per 30 mL (5 mg/mL), 30 mL single-dose v …

• Information for Patients and Caregivers When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity in the anesthetized part of the body following proper administration of lumbar epidural anesthesia
• Also, when appropriate, the physician should discuss other information including adverse reactions in the Ropivacaine Hydrochloride Injection package insert
• Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. …

• 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

Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics [see Warnings and Precautions ( 5.4 )]: Examples of Drugs Associated with Methemoglobinemia Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaq …

• Delay in proper management of dose-related toxicity, under ventilation, 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 cardiac 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. …

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. …

IN SPECIFIC POPULATIONS 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. …

Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution [see Adverse Reactions ( 6 ) and Warnings and Precautions ( 5.1 , 5.2 , 5.6 )]. 10.1 Treatment Therapy with Ropivacaine Hydrochloride should be discontinued at the first sign of toxicity. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.