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ribavirin injection

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ribavirin injection
ribavirin injection
ribavirin injection
ribavirin injection
Detail

【Ingredients】

Chemical name: 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-hydroxyamide.

Molecular formula: C8H12N4O5

Molecular weight: 244.21

Excipient name: water for injection.

【Properties】

This product is a colorless and clear liquid.

【Indications】

 Antiviral drugs. Used for viral pneumonia and bronchitis caused by respiratory syncytial virus.

【Dosage】  

Intravenous drip. Dilute with 5% dextrose injection or 0.9% sodium chloride injection to a solution containing 1mg per 1ml and then slowly instill it into the vein. 500~1000mg per day for adults and 10~15mg/kg per day for children, divided into two doses. Each intravenous infusion is more than 20 minutes, and the course of treatment is 3 to 7 days.

【Adverse reactions】    

The most important toxicity of ribavirin is hemolytic anemia. Hemoglobin, red blood cells, and white blood cells decrease in the first 1-2 weeks after oral treatment. About 10% of patients may have cardiopulmonary adverse reactions. Hemoglobin should be monitored frequently before and after treatment and during treatment. This product is not recommended for patients with thalassemia and sickle cell anemia. Patients with pancreatitis symptoms or clear pancreatitis should not use this product. It has been reported that taking this product for patients with anemia can cause fatal or non-fatal myocardial damage, so patients with a history of heart disease or obvious symptoms of heart disease should not use this product. If any symptoms of worsening heart disease occur with this product, the drug should be stopped immediately and corresponding treatment should be given.

General systemic adverse reactions observed in clinical trials of ribavirin (including oral preparations): fatigue, headache, weakness, fatigue, chest pain, fever, chills, flu, etc.; nervous system: dizziness; digestion: loss of appetite, stomach Facial discomfort, nausea and vomiting, mild diarrhea, constipation, indigestion, etc.; musculoskeletal: muscle pain, joint pain; mental: insomnia, emotional, irritability, depression, attention disorder, nervousness, etc.; breathing: difficulty breathing, Rhinitis, etc.; skin accessories: hair loss, rash, itching, etc.; abnormal taste and hearing abnormalities were also observed.

In general doses of this product, adverse reactions are rare, mainly reversible anemia, which can be recovered slowly after stopping the drug; a few patients experience thirst, loose stools, stomach pain, insomnia, irritability, etc.; high doses can inhibit hemoglobin synthesis and hemolysis , Increased reticulocytes, pneumothorax, asphyxia, hypotension, etc. Occasionally, loss of appetite, mild gastrointestinal reactions, dizziness, headache and skin rash.

【Taboo】

1. Those who are allergic to any of the ingredients in this product are prohibited.

2. Prohibited for pregnant women.

3. It is contraindicated in patients with autoimmune hepatitis.

4. Active tuberculosis should not be used.

【Precautions】

1. Regular blood routine (hemoglobin level, white blood cell count, platelet count), blood biochemical (liver function, TSH) check, especially blood drug protein check (including before the start, the second week, the fourth week of treatment). Monthly pregnancy tests are performed on women who may become pregnant.

2. Patients with severe anemia should use it with caution. Patients with thalassemia and sickle cell anemia are not recommended to use this product. Patients with pancreatitis symptoms or clear pancreatitis should not use this product. Patients with a history of heart disease or obvious symptoms of heart disease should not use this. If any symptoms of worsening heart disease occur with this product, the drug should be stopped immediately and corresponding treatment should be given.

3. Use with caution in patients with abnormal liver function. Ribavirin is not recommended for patients whose creatinine clearance rate is less than 50ml/min.

4. This product interferes with the diagnosis to a certain extent, can cause blood bilirubin to increase (up to 25%), and large doses can cause hemoglobin to decrease.

5. Take the medicine as soon as possible and administer it within the first 3 days of respiratory syncytial virus pneumonia. This product should not be used in patients who have not been confirmed to have respiratory syncytial virus infection without experiments.

[Medicine for pregnant and lactating women]

Sufficient animal studies have confirmed that ribavirin has obvious mutagenicity and embryotoxicity (appears when it is less than 1/20 of the human dosage). This product can cause congenital malformations or death of the fetus. Before treatment begins, treatment During the period and at least 6 months after stopping the drug, both men and women taking this product should avoid pregnancy. Those who may become pregnant should use at least two or more contraceptive methods for effective contraception. Once pregnant, they should immediately inform their doctor. This product is forbidden for pregnant women. A small amount of the drug is excreted through breast milk, because of the potential danger to the baby, it is not recommended for breastfeeding women to take this product.

【Children's Medication】

There is still a lack of detailed research data.

【Geriatric Medication】

There have not been sufficient clinical studies in elderly patients over 65 years of age. The possibility of using this product in elderly patients to develop anemia is greater than that in young patients. The renal function of the elderly tends to decline, which is likely to cause accumulation. It is not recommended for elderly patients to use this product.

【medicine interactions】

This product has an antagonistic effect when used together with zidovudine, because it can inhibit the transformation of zidovudine into active zidovudine phosphate.

【Overdose】

Large-dose application can cause heart damage, and for patients with respiratory diseases (chronic obstructive pulmonary disease or asthma patients) can cause breathing difficulties, chest pain, etc.

【Pharmacology and Toxicology】

Pharmacological action broad-spectrum antiviral drugs. It can inhibit the growth of multiple viruses such as respiratory syncytial virus, influenza virus, hepatitis A virus and adenovirus in vitro, and the mechanism is not fully understood. This product does not change virus adsorption, invasion and uncoating, nor does it induce interferon production. After the drug enters the virus-infected cell, it is rapidly phosphorylated. Its product acts as a competitive inhibitor of virus synthase, inhibiting inosine monophosphate dehydrogenase, influenza virus RNA polymerase and mRNA guanosine transferase, thereby causing intracellular guanosine The reduction of triphosphate damages the synthesis of viral RNA and protein, and inhibits the replication and spread of the virus. It may also have immune effects and neutralizing antibody effects on respiratory syncytial virus.

Toxicological studies Repeated administration toxicity: Mice, rats and monkeys can cause heart damage when the dosage of this product is 30, 36 and 120mg/kg administered orally for 4 weeks or longer.

Genotoxicity: The concentration of this product is 0.015 and 0.03-5.0mg/ml respectively. Under the condition of no metabolic activator, it can increase the cell transformation and mutation of mouse Balb/c3T3 (fibroblast) L5178Y (lymphoma). The concentration range is 3.75-10.0mg/ml. Under the condition of adding metabolic activator, the mutation rate of L5178Y cells has a certain increase (3-4 times). The results of the micronucleus test in mice suggest that this product has a cleavage-inducing effect when the dose range of intravenous injection is 20-200mg/kg. In the dominant lethal test, the dose range of this product was 50-200mg/kg by intraperitoneal injection of rats for 5 consecutive days, and no mutagenic effect was seen.

Reproductive toxicity: male mice given a dose range of 35-150mg/kg can cause significant atrophy of the seminiferous tube, a decrease in sperm concentration and an increase in the number of abnormal sperm. 3-6 months after the drug was stopped, the spermatogenic ability was partially restored.

Several other toxicity tests also indicate that oral administration of this product to adult rats at a dose as low as 16 mg/kg can cause testicular damage (atrophy of the seminiferous ducts), and a lower dose study has not been conducted. The reproductive ability of male animals has not been studied. Animal studies of different species have confirmed that this product has obvious teratogenic and/or embryo-killing potential toxicity. A single oral dose of this product for hamsters is 2.5 mg/kg or greater, and the doses for rabbits and rats are 0.3 and 1.0 mg/kg, respectively. The results have been confirmed to have teratogenic effects. Malformations mainly occur in the skull, palate, eyes, limbs, jaws, bones and gastrointestinal tract, and their incidence and severity increase with increasing doses. The survival rate of fetuses and offspring is reduced. The lethal dose of this product for rabbit and rat embryos is 1 mg/kg, and its non-teratogenic doses are 0.1 and 0.3 mg/kg respectively (calculated based on body surface area, equivalent to human equivalent doses of 0.015 and 0.04 mg/kg, respectively ).

Carcinogenicity: The results of long-term studies of rats given this product at a dose of 16-200mg/kg by admixture suggest that this product may induce benign breast, pancreatic duct, pituitary and adrenal tumors. The 12-18 months preliminary carcinogenicity tests in mice and rats were not the final results, but these tests confirmed that the doses of this product were 20-75 and 10-40 mg/kg, respectively, and vascular damage occurred in mice and rats. The denaturation of retinal reductase is related to the long-term administration of this product.

【Pharmacokinetics】

Ribavirin 800 mg intravenously within 30 minutes, the plasma concentration (μg/ml) after 5 minutes is 17.8 ± 5.5, and the plasma concentration after 30 minutes is 42.3 ± 10.4. Ribavirin enters the body and quickly distributes to all parts of the body. The concentration in respiratory secretions is mostly higher than the plasma concentration. It can pass through the blood-brain barrier, and the drug concentration in the cerebrospinal fluid can reach 67% of the blood drug concentration in the same period after long-term medication. This product can accumulate in red blood cells for several weeks, and can pass through the placenta and enter breast milk. It hardly binds to plasma proteins. Metabolized in the liver, mainly excreted by the kidneys. In the 0-48 hour interval, 16.7%±10.3% of the drug was excreted in urine as the original drug, and 6.2%±1.7% was excreted as metabolites. Elimination is slow in the body, and it cannot be completely eliminated from the body after stopping the drug for 4 weeks.




Personnel department: 0859-3338239

Email: tdyy@gztiandi.com

Address: Qianxinan Buyi and Miao Autonomous Prefecture, Guizhou Province No.6, Baokang Road, Yilong Hongxing Pharmaceutical Industrial Park

@copyright 2017 Guizhou Tiandi Pharmaceutical Co., Ltd.

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