Ribavirin and Glucose Injection 100ml:200mg
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Ribavirin and Glucose Injection
Ribavirin and Glucose Injection is a sterile solution of Ribavirin and Glucose in water for injection.
Molecular formula: C8H12N4O5
Molecular weight: 244.21
The product is a colorless and clear liquid.
Pharmacology and toxicity:
Ribavirin is synthetical nucleoside antiviral drug. In vitro cell culture test shows that the product has the selective inhibitive effect to R. S. virus. The mechanism of action is not clear, but the results that its in vitro antiviral activity can be reversed by guanosine and xanthosine indicate that product can take effect as metabolic analogue of these cells.
Repeating administrating toxicity: Mouse, rat and monkey are orally administered respectively by dosage of 30, 36 and 120 mg/kg, it may cause heart injury if administrative time is 4 weeks or longer.
Inherent toxicity: The concentration of the product is 0.015 or 0.03-5.0mg/ml, in the absence of metabolic activator, it may increase the chance of cell transformation and mutation in Balb/c3T3(fibroblast) and L5178Y(leucoma) of mouse. When the concentration scope is between 3.75~10.0mg/ml and in the present of metabolic activator, the mutation rate of L5178Y(leucoma) cell may increase as 3~4 times. Micronucleus test on mouse shows that it has clastogenic effect when the administrative dosage is between 20~200mg/kg by drip phleboclysis. In the dominant lethal test, it is absent of mutational symptom when rat is intraperitoneally injected by dosage of 50~200mg/kg for successive 5 days.
Genetic toxicity: When the male mouse is administered by dosage of 35~150mg/kg, it can cause sperm tube atrophy clearly, sperm concentration decreases and paramorph sperm increases. After stopping administrating, the function of producing sperm is partially recovered. The other toxicity test also shows that when the dosage for adult rat is as low as 16mg/kg through oral administration, it appear injury of testis; there is no study on more lower dosage. There is absence of genetic toxicity of female animals. Studies on different races have proved that the product has potential toxicity of teratogenic or embryo-killed symptoms. When the hamster is administered by dosage no less than 2.5mg/kg for one time and the dosage for rabbit and rat are respectively 0.3mg/kg and 1.0mg/kg, the results of these tests all prove that the product has teratogenic effect. The teratogenic parts mainly happen in cranium, palate, eyes, four limbs, jaw bones, skeleton and gastrointestinal tract, the incidence rate and state of illness will become worse when increase the dosage. Survival rates fetus and filial generation decrease. The dosage that causes embryos of rabbit and rat deathly is 1mg/kg, the dosages that dont cause teratogenic effect are respectively 0.1mg/kg and 0.3mg/kg. (Calculate according to area of body surface, equivalent doses for human use are respectively 0.015mg/kg and 0.04mg/kg)
Carcinogenecity: The long term study results on rat which is administered by dosage of 16~200mg/kg show that the product may induce innocent mastoncus, pancreatic duct bump, pituitary tumor and suprarenoma. The preliminary tests on mouse and rat for 18~24 months is not the end-result, but these tests prove that when the mouse and rat are administered by the dosage of 20~75mg/kg and 10~40mg/kg respectively the injury of blood vessel and retinal reducctase are related with long term use of the product.
Administrate Ribavirin 800mg by drip phleboclysis for 30 minutes, after 5 minutes the plasma concetration is 17.815.55g/mg, after 30 minutes the plasma concetration is 42.3110.45g/mg. Ribavirin is dispersed all over the body quickly after administration, the concentration in discharge of respiratory tract is usually higher than blood drug level. And it can go through blood-brain barrier, in long tern of administration the concentration in hindbrain spinal fluid and reach to 67% of the homeochronous blood drug level. The product can stay in akaryocyte for several weeks, it can permeate placenta and go into milk. It almost doesnt combine with hemoglobin. The metabolin in liver is discharged out of body through kidney. By drip phleboclysis, in interval of 0~48 hours, 16.7110.3% of the product is discharged out of body through urine as the original drug form, 6.211.7% of the product is out of body as metabolin form. It is slow to remove the product out of body, it still cant be discharged out of body wholly after stopping administration for 4 weeks.
It is an antiviral drug. It is indicated for viral pneumonia and viral bronchitis caused by chimpanzee coryza agent.
Dosage and administration:
By drip phleboclysis and slowly.
For adult, 500~1000mg/day, 2 times/day, 3~7 days is a course of treatment. Or administered according to doctor's orders. The administrative time should be above 20 minutes.
The overriding toxicity of ribavirin is hemolytic anemia. In the first 1~2 weeks after oral administration it appears decrease of hemoglobin, erythrocyte and leucocyte; 10% of the patients may accompany the side effect about heart and lung. In, during and after administration hemoglobin should be monitored frequently, patients with thalassemia and sickle-cell are suggested not using the product. Patients with pancreatitis symptom and have already suffered pancreatitis are forbidden to use the product. There has been reports that it causes fatal or nonfatal cardiac damage for patients with anaemic after administration, so patients with heart disease history and conspicuous heart disease symptom should not use the product. Stop administrating immediately if any of heart disease symptoms appears and give appropriate treatments.
In the clinical trial of ribavirin (including oral preparation) , the side effects observed in the whole body are as follows: languor, angina, debility, calefy, ague, flu and etc. Nervous system symptom: circumgyration. Alimentary system symptom: Decreased food appetite, Stomach discomfort, nausea and vomiting, diarrhea, constipation, cacochylia and etc. Muscular skeletal system symptom: courbature, arthralgia and etc. Spiritual system symptom: insomnia, emotional, irritability, depression, attention disturbance, nervousness and etc. Respiratory system symptom: anhelation, rhinitis and etc. Skin and accompaniment system symptom: alopecie, efflorescence, itching and etc. Others symptom: gustatory sensation is abnormal; acoustic sensibility is abnormal.
In the general dosage it seldom appears side effects, including reciprocity anaemia that can be recovered after stopping administration. Some patients appear thirsty, diarrhoea, stomachache, agrypnia, restlessness and etc. In large dosage, it can inhibit formulation of hemoglobin, with symptom of haematolysis, reticulocytosis, aerothorax, asphyxia, hypotension and etc. It seldom appears Decreased food appetite, low-grade gastrointestinal tract reaction, circumgyration, headache, efflorescence and etc.
Patient with the following symptoms,
Sensitive to any ingredient of product.
Gravida is forbidden to use.
Check complete blood count (including hemoglobin level, lencocyte count, blood platelets count) and blood biochemical (including liver function, TSH) periodically, especially for hemoglobin check (before administrating, the 2, 4 week after administration) . Gravidity test should be carry on for women who may gestate.
Use cautiously for patients with serious anemia. Patients with thalassemia and sickle-cell are suggested not using the product. Patients with pancreatitis symptom and have already suffered pancreatitis are forbidden to use the product. Patients with heart disease history and conspicuous heart disease symptom should not use the product. Stop administrating immediately if any of heart disease symptoms appears and give appropriate treatments.
Use cautiously for patients whose function of liver is abnormal. If creatinine clearance rate <50ml/min, it is suggested not using ribavirin.
The product has interference with diagnosis. It can cause increase of hemobilirubin(25%) , in large dosage it can lead to decrease of hemoglobin.
Patients with viral pneumonia caused by chimpanzee coryza agent should be administered in the first 3 days. The product is not suitable to patients who are diagnosed not suffering from chimpanzee coryza agent.
Pregnancy and Lactation:
There is enough animal tests prove that rivavirin has mutagenesis and fetal toxicity, the product can cause fetus congenital deformity or died. Before and during administrating, in the 6 months after stopping administrating, people who be administered the product should avoid gestation. Person who may gestate should adopt 2 method to avoid gestation effectively, inform doctors if gestation. Gravida is forbidden to use the product. A small quality of product is excreted through milk, it exists potential risk for nursing infant, so it is suggested not using the product for women in lactation.
It is lack of safety documents for pediatric use.
There is no clinical study documents on people with age above 65. After administering the product, the rate of suffering anemia of the old is higher than the young, it may appear the decrease of function of kidney, it is easy to accumulate. It is suggested not using the product for old people.
It has antagonism effect when used together with Zidovudine.
Large dosage can lead to heart damage. For patients with respiratory passage disease (such as chronic obstructive pulmonary disease, asthma and so on ) , it can cause dyspnea, stethalgia and etc.
Specification: 100ml:0.2g Ribavirin and 5.0g Glucose
Storage: Store in closed container; protect from light.
Packing: Glass bottle
Expiry date: Two years