Edaravone Injection for Ischemic Stroke
China Edaravone Injection for Ischemic Stroke, Find details about China West Medicines, Medicine from Edaravone Injection for Ischemic Stroke
Basic Info.
Model NO.
5ml 20ml
Pharmaceutical Technology
Chemical Synthesis
Drug Reg./Approval No.
H20031342
Trademark
Bicun
Transport Package
Box Carton
Specification
5ml 20ml
Origin
China
HS Code
3004909000
Model NO.
5ml 20ml
Pharmaceutical Technology
Chemical Synthesis
Drug Reg./Approval No.
H20031342
Trademark
Bicun
Transport Package
Box Carton
Specification
5ml 20ml
Origin
China
HS Code
3004909000
Product Desciption
Edaravone Injection
Generic name: Edaravone Injection
Brand name: Bicun
Composition: 3-methyl-1-phenyl-2-pyrazolin-5-one
Chemical structure:
Molecular formula: C10H10N2O
Molecular weight: 174.20
Strength:(1)5ml:10mg (2)20ml:30mg
Discription:
This product is a kind of transparent liquid from colorless to pale yellow (or yellowish green)
Indications:Used to improve the neurologic symptoms, daily living ability and dysfunction caused by acute cerebral infarction.
Dosage and Administration:
30mg/dose, twice a day. Intravenous drip finished within 30 minutes after diluted with normal saline. The treatment course is within 14 days, and it is suggested that the drug is given within 24 hours as far as possible after the onset of the disease.
Precaution:
1.Patients with mild and moderate renal impairment must take it carefully, since it may aggravate renal failure.
2. Patients with liver function damage must be careful because of its possibility to aggravate the damage of liver function.
3. Patients with heart disease must be careful because of its possibility to aggravate the heart disease, or to cause renal insufficiency.
4. Elderly patients must be careful (there have been several death case reports)
As there are cases of exacerbation of acute renal insufficiency or deaths caused by renal failure, several renal function detections should be conducted during the product delivery process. Furthermore, it should also be observed after finishing the delivery process. If there are symptoms of renal function decrease or
oliguria, immediately stop the drug and conduct appropriate processing. Besides, special attention should be paid among elderly patient as there are many death case reports (most of them are above 80 years old).
Pharmacology and toxicology:
Pharmacological action
Edaravone is a kind of brain protective agent (free radical scavenger). Clinical research suggests that N-acetyl aspartate (NAA) is a marker of specific survival nerve cells, and it decreases sharply at the beginning of the onset of cerebral infarction. Used in patients with acute cerebral infarction, edaravone can inhibit the decrease of regional cerebral blood flow around the infarction, so that the NAA content in the brain is significantly higher than that in glycerol control group on the twenty-eighth day after onset. Preclinical studies suggest that edaravone which is administered intravenously in rats after ischemia / reperfusion, can prevent development of cerebral edema and cerebral infarction, alleviate the accompanying neurological symptoms and inhibit delayed neuronal death. Mechanism research suggesst that edaravone can scavenge free radicals
and inhibit lipid peroxidation, thereby inhibiting oxidative damage of brain cells, vascular endothelial cells and neurons.
Molecular weight: 174.20
Strength:(1)5ml:10mg (2)20ml:30mg
Discription:
This product is a kind of transparent liquid from colorless to pale yellow (or yellowish green)
Indications:Used to improve the neurologic symptoms, daily living ability and dysfunction caused by acute cerebral infarction.
Dosage and Administration:
30mg/dose, twice a day. Intravenous drip finished within 30 minutes after diluted with normal saline. The treatment course is within 14 days, and it is suggested that the drug is given within 24 hours as far as possible after the onset of the disease.
Precaution:
1.Patients with mild and moderate renal impairment must take it carefully, since it may aggravate renal failure.
2. Patients with liver function damage must be careful because of its possibility to aggravate the damage of liver function.
3. Patients with heart disease must be careful because of its possibility to aggravate the heart disease, or to cause renal insufficiency.
4. Elderly patients must be careful (there have been several death case reports)
As there are cases of exacerbation of acute renal insufficiency or deaths caused by renal failure, several renal function detections should be conducted during the product delivery process. Furthermore, it should also be observed after finishing the delivery process. If there are symptoms of renal function decrease or
oliguria, immediately stop the drug and conduct appropriate processing. Besides, special attention should be paid among elderly patient as there are many death case reports (most of them are above 80 years old).
Pharmacology and toxicology:
Pharmacological action
Edaravone is a kind of brain protective agent (free radical scavenger). Clinical research suggests that N-acetyl aspartate (NAA) is a marker of specific survival nerve cells, and it decreases sharply at the beginning of the onset of cerebral infarction. Used in patients with acute cerebral infarction, edaravone can inhibit the decrease of regional cerebral blood flow around the infarction, so that the NAA content in the brain is significantly higher than that in glycerol control group on the twenty-eighth day after onset. Preclinical studies suggest that edaravone which is administered intravenously in rats after ischemia / reperfusion, can prevent development of cerebral edema and cerebral infarction, alleviate the accompanying neurological symptoms and inhibit delayed neuronal death. Mechanism research suggesst that edaravone can scavenge free radicals
and inhibit lipid peroxidation, thereby inhibiting oxidative damage of brain cells, vascular endothelial cells and neurons.
Toxicology research
Genotoxicity: Results in edaravone's Ames test, CHL chromosome aberration test and micronucleus test in mice were all negative.
Reproductive toxicity: in general reproductive toxicity test in which rats were treated with edaravone 3, 20, 200mg/KG, animals in 20, 200mg/Kg groups had orange-brown urine color, lacrimation, salivation and decreased locomotor activity, body weight and food intake, while in the 200mg/Kg group the average sexual cycle of female rats extended, the fertility of female and male rats was reduced and the fetal thymus residual rate increased. In toxicity test during the teratogenic sensitive period, intravenous injections of edaravone 3,30, 300mg/Kg were conducted to pregnant rats. In the 300mg/Kg group the female rat's food intake decreased and their body weight increase slowed down. Male fetus weight in all groups and that of the female ones in 30mg/Kg group were lower than those of the control group. In all groups fetal visceral malformation rate increased and there was a delay tendency in auricle expansion, palpebral dehiscence, testicular drooping and vaginal opening.
Pharmacokinetics:
According to foreign literature:
Blood concentration
Healthy adult male subjects (5 cases) and healthy elderly subjects over 65 years old (5 cases), with0.5 mg/Kg dose, twice a day, intravenous infusion within 30 minutes each time. After 2 days of medication, the drug concentration changes in plasma and parameters obained from the begining of the administration are shown in the following figures:
In both healthy adult male subjects and healthy elderly subjects, the drug concentration in the plasma was almost equally disappearing, and no accumulation was found. Serum protein binding rate Vitro test results showed that the binding rates of human serum protein and human serum albumin in edaravone were 92% and 89 to 91%, respectively.
Metabolism
The metabolites of edaravone in plasma are the complex of sulphuric acid and the complex of glucuronic acid. The main metabolites in urine are glucuronic acid complex and sulphuric acid complex.
Excretion
Healthy adult male subjects and healthy elderly subjects received this product twice a day with 0.5 mg/Kg each time, intravenous drip whithin 30 minutes, for 2 consecutive days. The excretion of urine contained by the 12th hour after administration 0.7% to 0.9% raw drugs and 71% to 79.9% metabolites.
Storage:
Protect from light and keep in the shade (no more than 20ºC)
Packs:
(1) Medium borosilicate glass ampoule, 5ml/ampoule, 6 ampoules per box.
(2) Medium borosilicate glass ampoule, 20ml/ampoule, 6 ampoules per box; 4 ampoules per box.
Shelf-life:24 months
Genotoxicity: Results in edaravone's Ames test, CHL chromosome aberration test and micronucleus test in mice were all negative.
Reproductive toxicity: in general reproductive toxicity test in which rats were treated with edaravone 3, 20, 200mg/KG, animals in 20, 200mg/Kg groups had orange-brown urine color, lacrimation, salivation and decreased locomotor activity, body weight and food intake, while in the 200mg/Kg group the average sexual cycle of female rats extended, the fertility of female and male rats was reduced and the fetal thymus residual rate increased. In toxicity test during the teratogenic sensitive period, intravenous injections of edaravone 3,30, 300mg/Kg were conducted to pregnant rats. In the 300mg/Kg group the female rat's food intake decreased and their body weight increase slowed down. Male fetus weight in all groups and that of the female ones in 30mg/Kg group were lower than those of the control group. In all groups fetal visceral malformation rate increased and there was a delay tendency in auricle expansion, palpebral dehiscence, testicular drooping and vaginal opening.
Pharmacokinetics:
According to foreign literature:
Blood concentration
Healthy adult male subjects (5 cases) and healthy elderly subjects over 65 years old (5 cases), with0.5 mg/Kg dose, twice a day, intravenous infusion within 30 minutes each time. After 2 days of medication, the drug concentration changes in plasma and parameters obained from the begining of the administration are shown in the following figures:
In both healthy adult male subjects and healthy elderly subjects, the drug concentration in the plasma was almost equally disappearing, and no accumulation was found. Serum protein binding rate Vitro test results showed that the binding rates of human serum protein and human serum albumin in edaravone were 92% and 89 to 91%, respectively.
Metabolism
The metabolites of edaravone in plasma are the complex of sulphuric acid and the complex of glucuronic acid. The main metabolites in urine are glucuronic acid complex and sulphuric acid complex.
Excretion
Healthy adult male subjects and healthy elderly subjects received this product twice a day with 0.5 mg/Kg each time, intravenous drip whithin 30 minutes, for 2 consecutive days. The excretion of urine contained by the 12th hour after administration 0.7% to 0.9% raw drugs and 71% to 79.9% metabolites.
Storage:
Protect from light and keep in the shade (no more than 20ºC)
Packs:
(1) Medium borosilicate glass ampoule, 5ml/ampoule, 6 ampoules per box.
(2) Medium borosilicate glass ampoule, 20ml/ampoule, 6 ampoules per box; 4 ampoules per box.
Shelf-life:24 months
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