Acyclovir Glucose Injection

Pharmacological action: This product is a synthetic nucleoside antiviral drug, which has inhibitory effects on herpes simplex virus type Ⅰ (HSV-1), type Ⅱ (HSV-2) and varicella-zoster virus (VZV) in vivo and in vitro. Cell culture results show that this product has the strongest inhibitory effect on HSV-1 virus, followed by HSV-2 and VZV virus. Because this product has affinity for thymidine kinase (TK) encoded by HSV and VZV, it has a highly selective inhibitory effect. This type of viral enzyme converts acyclovir into acyclovir monophosphate, a nucleoside analog. The monophosphate is further converted into diphosphate by guanylate kinase in the cell, and then converted into triphosphate by multiple enzymes in the cell. In vitro, acyclovir triphosphate terminates herpes virus DNA replication in the following three ways: 1) competitive inhibition of viral DNA polymerase; 2) entry and termination of extended viral DNA chain; 3) inactivation of viral DNA polymerase. Compared with VZV, this product has stronger antiviral activity against HSV because of the stronger phosphorylation of the virus's thymidine kinase (TK). Toxicological studies Genotoxicity: 16 genetic toxicity tests were conducted, and no mutagenic effect was found in 4 microbial studies; the results of 2 in vitro cytogenetic tests conducted on mouse lymphoma cells and human lymphocytes showed that this product has a mutagenic effect. In 5 in vitro cytogenetic tests (3 on Chinese hamster ovary cells and 2 on mouse lymphoma cells), no mutagenic effect was found. In 2 in vitro cell transformation tests conducted after administration to immunocompromised, weaned, homologous young mice, one result was positive, and it was seen that the cells were morphologically transformed into tumor cells, while in the other test, the same result was not seen (probably due to lower sensitivity). When Chinese hamsters are given 380-760 times the human dose, chromosomal damage can be caused; when rats are given 62-125 times the dose, there is no significant change in chromosomal damage; the dominant lethal test in mice (at 36-73 times the human dose) is negative. Reproductive toxicity: The results of tests on mice (450 mg/kg/day, PO) and rabbits (25 mg/kg/day, SC) show that this product has no effect on their fertility and reproductive function. The plasma drug concentrations of mice and rats are 9-18 times and 8-15 times the human blood drug levels, respectively. When rats and rabbits are given higher doses (50 mg/kg/day, SC, 11-22 times and 16-31 times the human level, respectively), implantation can be reduced, but the size of the same litter is not affected. When rats take this product (50 mg/kg/day, SC) before and after delivery, the average corpus luteum, total implantation position and live fetuses between groups are statistically significantly reduced. Dogs were given this product for 1 month (50 mg/kg/day, IV, 21-41 times the human dose, blood concentration is 21-41 times that of humans) or for 1 year (60 mg/kg/day, PO, 6-12 times the human dose), and no testicular abnormalities were found. When higher doses were given to rats and dogs, testicular atrophy and sperm reduction were observed. When mice (450 mg/kg/day, PO), rabbits (50 mg/kg/day, SC or IV) and rats (50 mg/kg/day, SC) were exposed to doses that were 9-18, 16-106, and 11-22 times the human dose, respectively, no teratogenic effects were observed. There are no adequate and strictly controlled studies in pregnant women, but an epidemiological survey showed that the incidence of birth defects in infants was similar to that of the general population after tracking 756 pregnant women who were given systemic medication. However, these data are not sufficient to prove that it is safe for pregnant women and fetuses. This product can only be considered for use when its therapeutic effect on the fetus far outweighs its risks. For lactating women, the concentration of this product in breast milk is 0.6-4.1 times its blood concentration. When the dosage of lactating women reaches 0.3 mg/kg/day, this concentration may affect the infant, so lactating women should be cautious when using it and only use it when necessary. Carcinogenicity: During the life of rats and mice, 450 mg/kg of this product was given by tube feeding. The results showed that there was no statistically significant difference in the number of animals with tumors in the treatment group and the control group, and it did not shorten the incubation period of tumor occurrence. The maximum plasma concentrations of mice and rats are 3-6 times and 1-2 times the human level, respectively.

The main ingredient of this product is acyclovir, and its chemical name is: 2-amino-1,9-dihydro-9-[(2-hydroxyethoxymethyl)guanine. The chemical structure is as follows: Molecular formula: C8H11N5O3 Molecular weight: 225.21 The auxiliary material is glucose.

This product is a colorless or almost colorless clear liquid.

Used to treat viral sexual diseases: such as herpes simplex, herpes zoster, chickenpox, and genital warts and genital herpes caused by viral infections.

Intravenous drip 1. Adults (1) Initial treatment of severe genital herpes: 5 mg/kg per body weight every 8 hours for 5 days; (2) Skin and mucous membrane herpes simplex or severe herpes zoster in immunocompromised patients: 5-10 mg/kg per body weight every 8 hours, intravenous drip for more than 1 hour, for 7-10 days; (3) Herpes simplex encephalitis: 10 mg/kg per body weight every 8 hours for 10 days; (4) Adults with acute or chronic renal insufficiency should not use this product by intravenous drip, because too fast a drip rate may cause renal failure; (5) The maximum daily dose for adults is 30 mg/kg per body weight, or 1.5 g/m2 per body area. 2. Children (1) Initial treatment of severe genital herpes: infants and children under 12 years of age, 250 mg/m2 of body surface area every 8 hours for 5 days; (2) Mucocutaneous and mucosal herpes simplex in immunocompromised patients: infants and children under 12 years of age, 250 mg/m2 of body surface area every 8 hours for 7 days, and adults' dose for patients over 12 years of age; (3) Herpes simplex encephalitis: 10 mg/kg of body weight every 8 hours for 10 days; (4) Immunodeficiency combined with varicella: 10 mg/kg or 500 mg/m2 every 8 hours for 10 days; (5) The maximum dose for children is 500 mg/m2 of body surface area every 8 hours.

1. Allergic reactions: Sometimes rash, urticaria, and fever occur, which disappear after drug withdrawal. 2. Nervous system: Rarely, convulsions of the lower limbs, numbness of the tongue and hands and feet, tremors, and general fatigue occur. In this case, the dosage can be reduced or the drug administration can be stopped, and appropriate treatment can be given. 3. Kidneys: Sometimes, blood urea nitrogen and serum creatinine values increase, proteinuria, and red blood cells and mucus-like substances are found in urine sediment. In this case, the dosage can be reduced or the drug administration can be stopped. 4. Blood: Occasionally, red blood cells, white blood cells, hematocrit, and hemoglobin decrease. 5. Liver: Sometimes, abnormal liver function occurs. In this case, the drug administration can be stopped and symptomatic treatment can be given. 6. Digestive system: Sometimes, nausea, vomiting, and abdominal pain occur. 7. Others: Occasionally, serum protein decreases, cholesterol and triglycerides increase, and palpitations, dyspnea, and chest tightness occur. In this case, the drug administration can be stopped and appropriate symptomatic treatment can be given.

1. Patients with a history of allergy to this product are prohibited from using it. 2. There are no reports of contraindications for infants to use this product. 3. Patients with abnormal renal function, children and pregnant women should use it with caution.

Precautions for children: There are no reports of contraindications for infants. Precautions for pregnancy and lactation: Use with caution for pregnant women. Precautions for the elderly: The dosage and medication interval of this product should be adjusted for the elderly.

1. When used intravenously with interferon or methotrexate (intrathecal), it may cause mental abnormalities and should be used with caution. 2. When used intravenously with nephrotoxic drugs, it may aggravate nephrotoxicity, especially in patients with renal insufficiency. (3) When used in combination with zidovudine, it may cause nephrotoxicity, manifested as deep lethargy and fatigue.

Keep in a dark, airtight, cool place (no higher than 20℃).

100ml: Acyclovir 0.1g and glucose 5g

Tentative 24 months

Jinzhou Jiutai Pharmaceutical Co., Ltd.

• Founded in:

  1998-09-02

• Address:

  No. 41, Tai'anli, Taihe District, Jinzhou City, Liaoning Province

• Tax NO.:

  91210700242034190P

• Registered Funds:

  40.986462 million yuan

• Website:

  Log in to view

• Email:

  Log in to view