Ropivacaine Mesylate Injection

Pharmacological action Ropivacaine is an amide local anesthetic that may block the generation and conduction of nerve impulses by increasing the threshold of nerve action potentials, delaying the spread of nerve impulses, and reducing the rate of action potential increase. The generation of anesthetic effects is related to the axial diameter, myelination and conduction velocity of nerve fibers. Toxicological studies Genetic toxicity: In vitro mouse lymphoma tests showed that ropivacaine has a weak mutagenic effect. However, the results of other genetic toxicity tests were negative, indicating that the results of in vitro mouse lymphoma tests may not appear in vivo. Reproductive toxicity: Male rats were subcutaneously given ropivacaine from 9 weeks before mating, and female rats were given ropivacaine from 2 weeks before mating until the 42nd day after mating. The dose was 23 mg/kg/day. The fertility and general reproductive behavior of rats were not significantly affected, but due to the toxicity of ropivacaine to pregnant rats, the number of deaths of pups increased within 3 days after delivery. Rats and rabbits were subcutaneously injected with ropivacaine during the teratogenic sensitive period, with the highest dose reaching 26 mg/kg/day and 13 mg/kg/day respectively (about 1/3 of the maximum human dose based on body surface area), and no teratogenic effect of ropivacaine was observed. Rats were subcutaneously given ropivacaine during the perinatal period, with a dose of up to 26 mg/kg/day, and no significant effects were observed on the later development, delivery, lactation, and survival and growth of the fetuses. Based on the ratio of milk/plasma drug concentrations in rat experiments, the daily intake of ropivacaine by young mice was 4% of the dose of the mother mice.

The main component of this product is ropivacaine mesylate, chemical name is (S)-N-(2,6-dimethylphenyl)-1-propyl-2-piperidinamide methanesulfonate Molecular formula: C17H26N2O.CH3SO3H Molecular weight: 370.51

This product is a colorless clear liquid.

1. Anesthesia for surgical operations: epidural anesthesia (including epidural anesthesia for cesarean section); local infiltration anesthesia. 2. Acute pain control: used for postoperative or labor analgesia, continuous epidural infusion or intermittent medication; local infiltration anesthesia.

Ropivacaine mesylate is only for use by clinicians with anesthesia experience or under their guidance. The reference doses of commonly used anesthesia are shown in the table below, or follow the doctor's advice. In general, surgical anesthesia (such as epidural medication) requires a higher concentration dose. For analgesics (such as epidural medication) to control acute pain, lower concentrations and doses are recommended. The recommended dose of ropivacaine mesylate injection is shown in the table below. (Based on the results of animal tests of this product, the concentration of this product should not exceed 8.94 mg/ml) Concentration (mg/ml) Volume (ml) Dose (mg) Onset time (min) Duration (hr) Surgical anesthesia Lumbar epidural block anesthesia (surgical operation) 5.96 15-30 8 9.4-17 8.8 15-302-4 8.94 15-25 1 3 4.1-22 3.5 10-203-5 1 1.92 15-201 7 8.8-23 8.410-204-6 Lumbar epidural block anesthesia (cesarean section) 5.9620-30119.2-178.815-252-48.9415-20134.1-178.810-203-5 Thoracic epidural block anesthesia (surgery) 5.965-1529.8-89.410-208.945-1544.7-134.110-20 Nerve trunk block (such as brachial anesthesia) 5.9635-5020 8.6-29815-305-88.9410-4089.4-357.610-256-10Infiltration anesthesia (micro-nerve block or local infiltration anesthesia)5.961-405.96-238.41-152-6Labor analgesiaLumber epidural block anesthesiaInitial dose2.3910-2023.9-47.810-150.5-1.5Maintenance dose2.396-14mL/h14.34-33.46mg/h Additional dose 2.3910-15mL/h23.9-35.85mg/hPostoperative analgesia Lumbar epidural block anesthesia continuous infusion 2.396-14mL/h14.34-33.46mg/hThorac epidural block anesthesia continuous infusion 2.394-8mL/h9.56-19.12mg/hInfiltration anesthesia 2.391-1002.39-2391-52-65.961-405.96-238.41-52-6

The adverse reactions of ropivacaine are similar to those of other long-acting amide local anesthetics. Except for accidental injection into a blood vessel or overdose, the side effects of local anesthesia are almost rare. They should be distinguished from the physiological reactions caused by the blockade of the nerve itself, such as the decrease in blood pressure and bradycardia during epidural anesthesia. Overdose and accidental injection into a blood vessel may cause serious systemic reactions. Allergic reactions: They are rare for amide local anesthetics (the most serious allergic reaction is anaphylactic shock). Neurological complications: Diseases of the nervous system and spinal dysfunction (such as anterior spinal vascular syndrome, arachnoiditis cauda equina syndrome) are related to regional anesthesia and are almost unrelated to local anesthetics. Acute systemic toxicity: Ropivacaine will only cause acute toxic reactions when the plasma concentration of the drug rises suddenly due to high doses or accidental injection of the drug into the blood vessel, or when the drug is overdosed. A patient had convulsions after accidentally injecting 200 mg of the drug into the blood vessel during brachial plexus block. Most of the adverse reactions related to anesthesia are related to the effects of nerve blockade and clinical conditions, and are rarely related to drug reactions. In clinical research, the incidence of hypotension in patients was 39%, and the incidence of nausea was 25%. Common adverse reactions reported in clinical practice (>1%) are hypotension, nausea, bradycardia, anxiety, and decreased sensation.

1. Patients who are allergic to amide local anesthetics are prohibited from using this product. 2. Patients with severe liver disease should use this product with caution. 3. Patients with hypotension and bradycardia should use this product with caution. 4. Patients with chronic renal insufficiency accompanied by acidosis and low plasma protein should use this product with caution. 5. For elderly patients or patients with other serious diseases who need regional anesthesia, efforts should be made to improve the patient's condition before anesthesia is administered, and the dosage should be adjusted appropriately.

Precautions for children: There is currently no research data on this product. Precautions for pregnancy and lactation: There are no clinical trials on the effects of ropivacaine on fetal growth in pregnant women, so caution is recommended. There are sufficient experimental reports on the use of ropivacaine as an obstetric anesthesia or analgesia during delivery, and no side effects have been observed. Lactation The secretion of ropivacaine or its metabolites in human milk has not been studied. Based on the ratio of milk/plasma concentrations in rat experiments, it is estimated that the daily intake of young rats is 4% of the dose of their mothers. Assuming that the ratio of human milk/plasma concentrations is the same as that of rats, the amount of ropivacaine ingested by breast-fed infants is much lower than the dose received in the uterus during pregnancy.

Patients receiving other local anesthetics or drugs related to the amide structure should also be treated with caution when ropivacaine injection is used concomitantly because toxic effects can be additive.

Sealed, store in a cool place

10ml:89.4mg

Tentative 18 months

STAR Pharmaceutical Pte.ltd

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