Ribavirin and Glucose Injection

1. Pharmacological action Ribavirin is a synthetic nucleoside antiviral drug. In vitro cell culture experiments have shown that this product has a selective inhibitory effect on respiratory syncytial virus (RSV). The mechanism of action of this product is still unclear, but the results that its in vitro antiviral activity can be reversed by guanosine and xanthine nucleosides suggest that this product may act as a metabolic analog of these cells. 2. Toxicological studies (1) Repeated dose toxicity: Oral administration of this product at doses of 30, 36 and 120 mg/kg for 4 weeks or longer can cause cardiac damage in mice, rats and monkeys. (2) Genotoxicity: This product can increase cell transformation and mutation of mouse Balb/c3T3 (fibroblasts) L5178Y (lymphoma) at concentrations of 0.015 and 0.03-5.0 mg/ml in the absence of metabolic activators. The concentration range is 3.75-10.0 mg/ml. When metabolic activators are added, the mutation rate of L5178Y cells is increased to a certain extent (3-4 times). The results of the mouse micronucleus test indicate that the intravenous injection of this product in the dose range of 20-200 mg/kg has a clastogenic effect. In the dominant lethal test, rats were intraperitoneally injected with this product in the dose range of 50-200 mg/kg for 5 consecutive days, and no mutagenic effect was observed. (3) Reproductive toxicity: When male mice were given a dose range of 35-150 mg/kg, it could cause obvious atrophy of the seminiferous tubules, decreased sperm concentration and increased number of sperm with abnormal morphology. Spermatogenesis was partially restored 3-6 months after discontinuation of the drug. Several other toxicity tests also indicate that when adult rats were given this product orally at a dose lower than 16 mg/kg, it could cause testicular damage (atrophy of the seminiferous tubules), and no studies on lower doses were conducted. The reproductive capacity of male animals has not yet been studied. Animal studies of different species have confirmed that this product has significant teratogenic and/or embryocidal toxicity. Hamsters were given a single dose of 2.5 mg/kg or more, and rabbits and rats were given doses of 0.3 and 1.0 mg/kg, respectively. The results have confirmed 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 the fetus and offspring is reduced. The dose of this product that causes embryonic lethality in rabbits and rats is 1 mg/kg, and the dose without teratogenic effect is 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). (4) Carcinogenicity: Long-term studies on rats given this product at a dose of 16-200 mg/kg by feeding suggest that this product may induce benign breast, pancreatic duct, pituitary and adrenal tumors. The 18-24 month preliminary carcinogenicity studies on mice and rats are not final results, but these studies confirmed that the vascular damage and retinal reductase denaturation in mice and rats at doses of 20-75 and 10-40 mg/kg, respectively, were related to long-term administration of this product.

The main ingredients of this product are ribavirin and glucose. The chemical name of ribavirin is: 1-β-D-furanosyl-1H-1,2,4-triazole-3-carboxamide. Its structural formula is: molecular formula: C8H12N4O5, molecular weight: 244.21. The auxiliary material is water for injection.

This product is a colorless clear liquid.

Antiviral drug. Used for viral upper respiratory tract infections.

Slow intravenous drip. Adults take 500~1000mg (2.5~5 bottles) per day, divided into two doses, for 3~7 days, or as directed by a doctor. Each drip should last for more than 20 minutes.

The main toxicity of ribavirin is hemolytic anemia, which causes a decrease in hemoglobin, red blood cells, and white blood cells within the first 1 to 2 weeks after oral treatment. About 10% of patients may have side effects in the heart and lungs. Hemoglobin should be frequently monitored before, during, and after treatment. This product is not recommended for patients with thalassemia or sickle cell anemia. This product should not be used in patients with symptoms of pancreatitis or clear pancreatitis. It has been reported that patients with anemia taking this product 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 during the use of this product, the drug should be discontinued immediately and appropriate treatment should be given. General systemic adverse reactions observed in clinical trials using ribavirin (including oral preparations) include fatigue, headache, weakness, fatigue, chest pain, fever, chills, flu symptoms, etc. Nervous system symptoms: dizziness; digestive system symptoms include loss of appetite, stomach discomfort, nausea and vomiting, mild diarrhea, constipation, indigestion, etc.; musculoskeletal system symptoms include muscle pain and joint pain; mental system symptoms include insomnia, emotionality, irritability, depression, attention disorder, neurosis, etc.; respiratory system symptoms include dyspnea, rhinitis, etc.; hair loss, rash, itching, etc. occur in the skin appendage system; abnormal taste and hearing are also observed. At normal doses, side effects of this product are rare, mainly reversible anemia, which can be slowly restored after discontinuation of the drug; a few patients experience thirst, loose stools, stomach pain, insomnia, irritability, etc.; large doses can inhibit hemoglobin synthesis, hemolysis, reticulocytosis, pneumothorax, asphyxia, hypotension, etc. Occasionally, there is loss of appetite, mild gastrointestinal reactions, dizziness, headache and rash.

1. Those who are allergic to this product are prohibited from using it; 2. Pregnant and lactating women are prohibited from using it.

Precautions for children: There is currently a lack of detailed research data. Precautions for pregnancy and lactation: Pregnant and lactating women are prohibited. Precautions for the elderly: No adequate clinical studies have been conducted on elderly patients over 65 years old. The possibility of anemia in elderly patients using this product is greater than that in young patients. The renal function of the elderly is often reduced, which can easily lead to accumulation. This product is not recommended for elderly patients.

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

Keep in a dark, airtight container in a cool place (not exceeding 20°C).

100ml: Ribavirin 0.2g and glucose 5g

24 months

Henan Shuanghe Huali Pharmaceutical Co., Ltd.

• Founded in:

  2011-09-30

• Address:

  No. 369 Qinggong Road, Pingdingshan City

• Tax NO.:

  91410400582895296J

• Registered Funds:

  118 million yuan

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