Ropivacaine Hydrochloride Injection, USP is indicated for producing local or regional anesthesia during surgical procedures and for the management of acute pain.

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 pain); local infiltration.

Ropivacaine is an amino amide type local anesthetic and is supplied as the pure S-(-)-enantiomer. Local anesthetics act by blocking the initiation and conduction of nerve impulses. This effect is achieved by increasing the threshold for electrical stimulation, slowing the propagation of nerve impulses, and reducing the rate of rise of the action potential. The degree and progression of anesthesia depend on the diameter, myelination, and conduction velocity of the affected nerve fibers. Clinically, the order of loss of nerve function is: (1) Pain → (2) Temperature → (3) Touch → (4) Proprioception → (5) Skeletal muscle tone.

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 is not approved for this use.

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. This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter. Allow adequate time for onset of anesthesia following administration of each test dose.

These products are intended for single-dose and are free from preservatives. Any solution remaining from an opened container should be discarded promptly.

Dosage Recommendations: Please see the attachment (Innovator Product Monograph) for details dosage guideline.

Ropivacaine Hydrochloride Injection, USP is contraindicated in patients with known hypersensitivity to ropivacaine or any amide-type local anesthetic.

Ropivacaine Hydrochloride Injection, USP is contraindicated in patients with known hypersensitivity to ropivacaine or any amide-type local anesthetic.

There are no adequate human data regarding the use of ropivacaine in pregnant women to assess risks such as birth defects or miscarriage. Ropivacaine has been detected in low concentrations in human breast milk following administration, particularly after cesarean section. No harmful effects have been observed in infants. The benefits of breastfeeding should be weighed against the mother’s need for the drug and any potential risks to the infant.

Delay in the appropriate management of dose-related toxicity, inadequate ventilation, and/or altered patient sensitivity may result in the development of acidosis, cardiac arrest, and potentially death.

During administration of ropivacaine hydrochloride blocks, accidental intravenous injection may occur and can lead to cardiac arrhythmias or cardiac arrest.

Continuous intra-articular infusion of local anaesthetics has been associated with chondrolysis. Ropivacaine hydrochloride is not approved for this indication.

Symptoms of methemoglobinemia may occur.

Pediatric Use: Safety and effectiveness in children have not been established.

Geriatric Use: Elderly patients may show increased sensitivity. Clinical studies indicate that analgesic level, blood pressure changes, and motor block intensity may vary with age.

Hepatic Impairment: Since ropivacaine is metabolized in the liver, caution is required in patients with liver disease. Severe hepatic impairment increases the risk of toxic drug levels.

Renal Impairment: The drug and its metabolites are excreted via the kidneys. Patients with impaired renal function may have a higher risk of toxicity, so dose adjustment and monitoring are necessary.

Local and surface anesthetic