Edaravone Injection

[Pharmacological Action] Edaravone is a brain protective agent (free radical scavenger). Clinical studies have shown that N-acetylaspartate (NAA) is a specific marker of surviving neurons, and its content decreases sharply in the early stage of cerebral infarction. When patients with acute cerebral infarction are given edaravone, the decrease in local cerebral blood flow around the infarction is inhibited, and the NAA content in the brain on the 28th day after onset is significantly higher than that in the glycerol control group. Preclinical studies have shown that intravenous administration of edaravone to rats after ischemia/ischemia-reperfusion can prevent the progression of cerebral edema and cerebral infarction, relieve the accompanying neurological symptoms, and inhibit delayed neuronal death. Mechanism studies have shown that edaravone can scavenge free radicals and inhibit lipid peroxidation, thereby inhibiting oxidative damage to brain cells, vascular endothelial cells, and neurons. [Toxicological Studies] Genetic toxicity: The results of the Ames test, CHL chromosome aberration test, and mouse micronucleus test for edaravone were all negative. Reproductive toxicity: In the general reproductive toxicity test, rats were given edaravone at 3, 20, and 200 mg/kg. The animals in the 20 and 200 mg/kg groups showed orange-brown urine, tearing, salivation, and decreased spontaneous activity, and slightly decreased body weight and food intake. The average sexual cycle of female rats in the 200 mg/kg group was prolonged, the fertility of female and male rats was reduced, and the fetal thymus residual rate was increased. In the teratogenic sensitive period toxicity test, pregnant rats were given edaravone at 3, 30, and 300 mg/kg by intravenous injection. The food intake of female rats in the 300 mg/kg group decreased, the weight gain slowed down, and they showed lying down, unstable gait, decreased spontaneous movement, and tearing after administration. The weight of male fetuses in each dose group and the weight of female fetuses in the 30 mg/kg group were lower than those in the control group. The rate of fetal visceral malformation in each dose group increased, and the ear auricle of young rats expanded, eyelid fissures, testicular ptosis, and vaginal opening tended to be delayed. Pregnant New Zealand white rabbits were given edaravone at 3, 20, and 100 mg/kg by intravenous injection. The animals in the 100 mg/kg group showed orange-brown urine, gait disorders, tearing, pupil constriction, abnormal breathing, hind limb paralysis, congestion, edema, necrosis and inflammation at the administration site; the placenta weight of the animals in the 3 and 100 mg/kg groups increased significantly. In the perinatal toxicity test, pregnant Wistar rats were given edaravone at 3, 20, and 200 mg/kg by intravenous injection. The food intake and weight gain of the animals in the 200 mg/kg group decreased during the administration period, and the animals showed symptoms such as shaking their heads, blinking, tearing, and decreased spontaneous movement. The results of the open field test on the 28th day after birth of the pups showed that the number of movements of the pups in the 20 and 200 mg/kg groups increased.

Edaravone. Excipients are propylene glycol and sodium metabisulfite.

This product is a colorless clear liquid.

Used to improve neurological symptoms, daily living activities and functional disorders caused by acute cerebral infarction.

30 mg once, twice a day, diluted in an appropriate amount of normal saline and then intravenously dripped, dripped within 30 minutes, a course of treatment is within 14 days. Start the medication within 24 hours after the onset of the disease if possible.

According to the observation of 569 clinical cases in Japan, 26 cases (4.57%) had adverse reactions. The main manifestations were abnormal liver function in 16 cases (2.81%) and rash in 4 cases (0.70%). Among the 569 cases, 122 cases (21.4%) had abnormal changes in clinical test values, mainly abnormal liver function test values such as AST increased by 7.71% (43/558) and ALT increased by 8.23% (46/559). Serious adverse reactions include: 1. Acute renal failure (extent unknown) During medication, multiple renal function tests should be performed and close observation should be made. When symptoms such as renal dysfunction or oliguria occur, the medication should be stopped and handled correctly. 2. Abnormal liver function, jaundice (all unknown extent) Accompanied by abnormal liver function and jaundice such as increased AST, ALT, ALP, gamma-GT, and LDH. Liver function needs to be tested and closely observed during medication. If abnormal conditions occur, the medication should be stopped and handled correctly. 3. Thrombocytopenia (extent unknown): If there is thrombocytopenia, close observation is required during medication. If abnormal conditions occur, stop medication and handle them properly. 4. Disseminated intravascular coagulation (DIC) (extent unknown): Symptoms of disseminated intravascular coagulation may occur, and regular testing is required during medication. When laboratory manifestations and clinical symptoms suspected of disseminated intravascular coagulation occur, stop medication and handle them properly. Other adverse reactions (incidence) and main manifestations are: 1. Allergies (0.1%~5%): Mainly manifested as rash, flushing, swelling, herpes, and itching. 2. Blood cell system (0.1%~5%): Mainly manifested as erythropenia, leukocytosis, leukocytosis, decreased hematocrit, decreased hemoglobin, thrombocytosis, and thrombocytopenia. 3. Injection site (0.1%~5%): Mainly manifested as rash and redness and swelling at the injection site. 4. Liver (incidence 5%): Main manifestations include increased AST, increased ALT, increased LDH, increased ALP, and increased gamma-GT. (Incidence 0.1%~5%): increased total bilirubin, positive urobilinogen, and bilirubinuria. 5. Kidney (0.1%~5%): Main manifestations include increased BUN, increased serum uric acid, decreased serum uric acid, increased proteinuria, hematuria, and increased creatinine (to unknown extent) 6. Digestive system (0.1%~5%): belching. 7. Others (0.1%~5%): fever, feeling of heat, increased blood pressure, increased serum cholesterol, decreased serum cholesterol, increased triglycerides, decreased serum total protein, increased CK (CPK), decreased CK (CPK), decreased serum potassium, and decreased serum calcium.

1. Patients with severe renal failure (may aggravate renal failure) 2. Patients with a history of allergy to this product.

Precautions for children: Children should not use this product (because there is no experience with its use, the safety of its use in children cannot be determined). Precautions for pregnancy and lactation: 1. Pregnant women or women who may become pregnant are prohibited from using this product (the safety of its use during pregnancy cannot be determined). 2. Women who are lactating are prohibited from using this product. If it must be used, breastfeeding should be stopped during the administration of this drug (there are reports of its distribution in breast milk in animal experiments). Precautions for the elderly: Due to the low physiological function of the elderly, the drug should be stopped and properly handled when adverse reactions occur. In general, elderly patients (over 80 years old) should use this product with caution.

1. When used in combination with antibiotics such as oxazolidinone sodium, piperacillin sodium hydrochloride, and cefotiam sodium, renal failure may be aggravated. Therefore, multiple renal function tests and other observations are required when using these drugs in combination. 2. In principle, this product must be diluted with normal saline (when mixed with various infusions containing sugar, the concentration of edaravone can be reduced). 3. It cannot be mixed with high-energy infusions or amino acid preparations or dripped through the same channel (mixing may reduce the concentration of edaravone). 4. Do not mix with anti-epileptic drugs (diazepam, phenytoin sodium, etc.) (causing turbidity). 5. Do not mix with potassium canrenoate (causing turbidity).

Protect from light and store in a cool place (not exceeding 20℃).

20ml:30mg

18 months

Kunming Jida Pharmaceutical Co., Ltd.

• Founded in:

  1993-08-14

• Address:

  No. 389, Kexin Road, High-tech Development Zone, Kunming, Yunnan Province

• Tax NO.:

  91530000622600182R

• Registered Funds:

  370 million yuan

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