Ribavirin Capsules
[Indications] For respiratory syncytial virus pneumonia and bronchitis, skin herpes virus infection.
[Name of drug]
Ribavirin Capsules
Chinese Name:利巴韦林胶囊
Commodity name: Weilake
Chinese Pinyin: Libaweilin jiaonang
[Ingredients] Ribavirin
Chemical name:1-, β -D-, furan ribose, -1H-1, 2, 4-, three, triazole, -3-, carboxy amide.
Chemical formula:
Molecular formula: C8H12N4O5
Molecular weight: 244.21
[Character] The content of this product is white or white like particles or powder.
[Indications] For respiratory syncytial virus caused by pneumonia and bronchitis, skin herpes virus infection.
[Specification] 0.15g/ granule
[Usage and Dosage] Oral 1. viral respiratory tract infection: adults once 0.15g (1 tablets), 3 times a day, for 7 days. 2. skin herpes virus infection: adults once 0.3g (2 tablets), 3 times a day, for 7 days. 3. children daily weight 10mg/kg, take 4 times, for 7 days.
[Adverse Effects] The common adverse reactions were anemia, fatigue, etc, which disappeared after withdrawal. The less common adverse events were fatigue, headache, insomnia, anorexia, nausea, vomiting, mild diarrhea, constipation, and red blood cells, white blood cells and hemoglobin.
[Contraindicated] Allergic to this product, pregnant women banned.
[Matters Needing Attention]
1. Have serious anemia, abnormal liver function, with caution.
2. The interference of diagnosis: after oral administration of this product caused by elevated blood bilirubin can be as high as 25%. A large dose can cause a decrease in hemoglobin levels.
3. Early medication. Respiratory syncytial virus pneumonia is generally effective in the first 3 days. This product is not suitable for patients without laboratory diagnosis of respiratory syncytial virus infection.
4. Long-term or large doses of liver function, blood picture adverse reactions.
[Medication for Pregnant Women and Lactating Women]
1. This product has strong teratogenic effects on rabbit, dose of 1mg/kg caused by embryo damage, so the ban for pregnant women and women who may become pregnant (the in vivo elimination is very slow, clear 4 weeks are not completely autologous after drug withdrawal).
2. A small amount of drugs excreted by the milk, and the mother and the two generations of animals are toxic, so breast-feeding women during the medication period to stop breast-feeding, milk should also be discarded. Due to the self limited nature of respiratory syncytial virus infection in lactating women, this product is not intended for use in this case.
[Child Medication] The oral dose of children under 6 years old is uncertain.
[Senile Medication] Older adults are not recommended for use.
[Drug Interactions] This product is antagonistic to Zidorf and has an antagonistic effect because the product inhibits the conversion of zidovudine to an active type of zidovudine.
[Overdose] High dose use can cause heart damage and can cause dyspnea, chest pain, etc. in patients with respiratory problems (COPD or asthma).
[Pharmacology and Toxicology]
1. Pharmacology
Broad-spectrum antiviral drug. In vitro, it can inhibit the growth of many viruses such as respiratory syncytial virus, influenza virus, hepatitis A virus, adenovirus and so on, but its mechanism is not clear. This product does not change virus adsorption, invasion or shelling, and does not induce interferon production. The drug into the infected cells after rapid phosphorylation, a competitive inhibitor of the product as the virus synthetase, inhibition of inosine monophosphate dehydrogenase, influenza virus RNA polymerase and guanosine mRNA transferase, which caused the decrease of intracellular guanosine phosphate three, virus damage RNA and protein synthesis, the inhibition of virus replication and transmission. Respiratory syncytial virus may also act as an immune agent and neutralizing antibodies.
2. Toxicology
Animal experiments have shown that this product can induce benign tumors in the breast, pancreas, pituitary and adrenal gland, but the carcinogenicity of the human body is not certain. Drugs such as hamsters can cause deformities of the skull, palate, eye, jaw, skeleton and gastrointestinal tract, but the offspring survived less. However, the effects of drugs on fetal litter have not been found in primate experiments. Mice, rats and monkeys oral dose of Ribavirin, were 30, 60 and 4 weeks (120mg/kg or equivalent dose given weight for 5kg children 4.8, 12.3 and 111.4mg/kg, or 2.5, 5.1 adult weight was 60kg and 40mg/kg), heart injury.
[Pharmacokinetics]
Rapid oral absorption, bioavailability of about 45%, a handful of aerosol inhalation. The peak concentration of serum was 1.5 hours after oral administration, and the peak concentration of blood drug (Cmax) was about 1 ~ 2mg/L. The children were exposed to the mask for 2.5 hours every day for 3 days, the average peak concentration of blood drug (Cmax) was 0.2mg/L; the daily dose of 20 hours was 5 days, the average peak concentration of blood drug (Cmax) was 1.7mg/L, and almost no combination with plasma protein. The concentrations of drugs in respiratory tract secretions were much higher than those in serum. Drugs can enter red blood cells and accumulate large quantities. After long-term medication, the concentration of cerebrospinal fluid can reach 67% of the serum concentration at the same time. This product can penetrate the placenta, but also into the milk. Intrahepatic metabolism. The blood elimination half-life (t1/2) is about 0.5 to 2 hours. This product is mainly excreted through the kidneys. The rate of urinary excretion was 30% to 55% hours in 72~80 hours. Fecal excretion rate of 72 hours, about 15%. Drugs can accumulate in red blood cells for several weeks.
[Storage] Sealed storage.
[Packing] Aluminum plastic packing, 10 grain / plate * 1 plate (or 2 plate) / box.
[Validity] 24 months.
[Implementation Criteria] Chinese Pharmacopoeia, 2010 edition, two parts
[Approval Number] SFDA approval number H10940157
[Production Enterprise]
Name of enterprise: Zhejiang Chengyi Pharmaceutical Co., Ltd
Production address: No. 118, Chemical Road, Dongtou District, Wenzhou city,Zhejiang province,China
Phone number: 86-577-6348-3979
Fax number: 86-577-6348-5135