Ropivacaine Hydrochloride
Indications
Ropivacaine Hydrochloride Injection, USP 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.
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.
Pharmacology
Ropivacaine is a member of the amino amide class of local anesthetics and is supplied as the pure S‑(‑)‑enantiomer. Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.
Dosage & Administration
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.
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.
Contraindications
Ropivacaine Hydrochloride Injection, USP is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide-type.
Side Effects
Most common adverse reactions (incidence ≥5%) are hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.
Pregnancy & Lactation
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. One publication reported that ropivacaine is present in human milk at low levels following administration of ropivacaine in women undergoing cesarean section. No adverse reactions were reported in the infants. There is no available information on the drug’s effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ropivacaine and any potential adverse effects on the breastfed child from ropivacaine or from the underlying maternal condition.
Precautions & Warnings
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.
In performing ropivacaine hydrochloride blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardia arrest.
Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine hydrochloride is not approved for this use.
Signs of methemoglobinemia may occur.
In performing ropivacaine hydrochloride blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardia arrest.
Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine hydrochloride is not approved for this use.
Signs of methemoglobinemia may occur.
Use in Special Populations
Pediatric Use: The safety and efficacy of ropivacaine in pediatric patients have not been established.
Geriatric Use: Of the 2,978 subjects that were administered ropivacaine injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older which includes 127 patients (4%) 75 years of age and over. Ropivacaine injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age.
Hepatic Impairment: Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.
Renal Impairment: This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function.
Geriatric Use: Of the 2,978 subjects that were administered ropivacaine injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older which includes 127 patients (4%) 75 years of age and over. Ropivacaine injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age.
Hepatic Impairment: Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.
Renal Impairment: This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function.
Therapeutic Class
Local & Surface anesthesia
