Ganciclovir for injection

This product is an analog of 2'-deoxyguanine nucleotide, which can inhibit the replication of herpes virus. Its mechanism of action is: ganciclovir is first phosphorylated into monophosphate by the protein kinase homologue encoded by cytomegalovirus (CMV) (UL97 gene), and then further phosphorylated into diphosphate and triphosphate by cellular kinase. In CMV-infected cells, the amount of triphosphate is 100 times higher than that in non-infected cells, indicating that this product can be preferentially phosphorylated in infected cells. Once ganciclovir forms triphosphate, it can last for several days in CMV-infected cells. Ganciclovir triphosphate can inhibit viral DNA synthesis in the following ways: 1. Competitive inhibition of viral DNA polymerase: 2. Incorporation into the DNA of viruses and host cells, thereby terminating the extension of viral DNA. Ganciclovir has a stronger effect on viral DNA polymerase than on host polymerase. It has been clinically proven that this product is effective against infections caused by cytomegalovirus (CMV) and herpes simplex virus (HSV).

Ganciclovir.

This product is white powder or loose lumps.

1. To prevent cytomegalovirus disease that may occur in organ transplant recipients who are at risk for cytomegalovirus infection. 2. To treat cytomegalovirus retinitis in immunocompromised patients (including AIDS patients).

1. Induction period: intravenous drip of 5 mg/kg per body weight, once every 12 hours, each drip for more than 1 hour, the course of treatment is 14 to 21 days, and the dose should be reduced for patients with renal impairment. When the creatinine clearance rate is 50-69 ml/min, intravenous drip of 2.5 mg/kg every 12 hours; when the creatinine clearance rate is 25-49 ml/min, intravenous drip of 2.5 mg/kg every 24 hours; when the creatinine clearance rate is 10-24 ml/min, intravenous drip of 1.25 mg/kg every 24 hours; when the creatinine clearance rate is less than 10 ml/min, the drug is given 3 times a week, each time 1.25 mg/kg is given after hemodialysis. 2. Maintenance period: intravenous drip of 5 mg/kg per body weight, once a day, intravenous drip for more than 1 hour. For patients with renal impairment, the dose should be adjusted according to the creatinine clearance rate: when the creatinine clearance rate is 50-69 ml/min, intravenous drip of 2.5 mg/ every 24 hours kg; when the creatinine clearance rate is 25-49 ml/min, intravenous drip of 1.25 mg/kg every 24 hours; when the creatinine clearance rate is 10-24 ml/min, intravenous drip of 0.625 mg/kg every 24 hours; when the creatinine clearance rate is <10 ml/min, give 3 times a week, each time 0.625 mg/kg after hemodialysis. 3. Preventive medication: intravenous drip of 5 mg/kg per body weight, the drip time is at least 1 hour, once every 12 hours, for 7 consecutive days; followed by 5 mg/Kg, once a day, for a total of 7 days. When the product is intravenously dripped, the preparation method is as follows: first determine the dosage according to the patient's weight, dissolve it with an appropriate amount of water for injection or sodium chloride injection, and then inject it into 100 ml of sodium chloride injection, 5% glucose injection, compound sodium chloride injection or compound sodium lactate injection. The concentration of the drip solution shall not be greater than 10 mg/ml

1. Common adverse reactions include bone marrow suppression. After taking the drug, about 40% of patients have a neutrophil count reduced to less than 1000/mm3, and about 20% of patients have a platelet count reduced to less than 50,000/mm3. In addition, anemia may occur. 2. Central nervous system symptoms such as mental abnormalities, tension, tremors, etc., with an incidence of about 5%, and occasional coma, convulsions, etc. 3. Rash, itching, drug fever, headache, dizziness, dyspnea, nausea, vomiting, abdominal pain, loss of appetite, abnormal liver function, gastrointestinal bleeding, arrhythmia, increased or decreased blood pressure, hematuria, increased blood urea nitrogen, hair loss, decreased blood sugar, edema, general discomfort, increased creatinine, eosinophilia, local pain after injection, phlebitis, etc. may occur; AIDS patients with cytomegalovirus retinitis may experience retinal detachment.

It is contraindicated in patients who are allergic to ganciclovir or acyclovir.

Didanosine: When didanosine is taken 24 hours before or simultaneously with oral ganciclovir, the steady-state didanosine AUC0-12 increases by 11±114% (range: 10% to 493%) (n=12). When didanosine is taken 2 hours before oral ganciclovir, the steady-state AUC of ganciclovir decreases by 21±17% (range: -44% to 5%), but the AUC of ganciclovir is not affected when the two drugs are taken together (n=12). The renal clearance of both drugs is not significantly changed. When the standard initial intravenous dose of ganciclovir (5 mg/kg intravenous infusion for 1 hour, once every 12 hours) is co-administered with didanosine 200 mg orally, once every 12 hours, the steady-state didanosine AUC0-12 increases by 70±40% (range: 3% to 121%, n=11), and the Cmax increases by 49±48% (range -28% to 125%). In another study, when standard ganciclovir intravenous maintenance doses (5 mg/kg intravenous drip for 1 hour, once every 24 hours) were co-administered with didanosine 200 mg orally, once every 12 hours. During the first dose interval of didanosine, the AUC0-12 of didanosine increased by 50±26% (range: 22% to 110%, n=11). Cmax increased by 36±36% (range: -27% to 94%). During the dose interval when not co-administered with ganciclovir. Didanosine plasma concentrations (AUC12-24) were unchanged, and the pharmacokinetic parameters of ganciclovir were not affected by didanosine. The renal clearance of both drugs was not significantly changed in each study. Azidothymidine: When ganciclovir oral formulation 1000 mg once every 8 hours was combined with azidothymidine 100 mg once every 4 hours, the mean steady-state ganciclovir AUC0-8 decreased by 17±25% (range: -52% to 23%) (n=12), and the steady-state AUC0-4 of azidothymidine increased by 19±27% (range: -11% to 74%) in the presence of ganciclovir. Because both azidothymidine and ganciclovir may cause neutropenia and anemia, some patients may not be able to tolerate the combined use of the two drugs at full doses. Probenecid: When ganciclovir oral formulation 1000 mg once every 8 hours was combined with probenecid 500 mg once every 6 hours, the mean steady-state ganciclovir AUC0-8 increased by 53±91% (range: -14% to 299%) (n=10), and ganciclovir renal clearance decreased by 22±20% (range: -54% to -4%). This interaction is related to competition for renal tubular secretion. Imipenem-cilastatin: There have been reports of patients receiving ganciclovir and imipenem-cilastatin simultaneously, so these drugs should not be used simultaneously unless the potential benefits outweigh the risks. Other drugs: Drugs that inhibit the replication of rapidly dividing cell populations, such as bone marrow, spermatogonia, and cells of the germinal layer of the skin and gastrointestinal mucosa, can increase toxicity when used in combination with ganciclovir. Therefore, such drugs, such as dapsone, pentamidine, 5-fluorocytosine, vincristine, vinblastine, doxorubicin, amphotericin B, trimethoprim/sulfamethoxazole complex, or other nucleoside antagonists, should be used concomitantly with ganciclovir only if the potential benefit outweighs the risk. There are no formal studies of drug interactions between ganciclovir and commonly used drugs in organ transplant recipients. Concomitant use of ganciclovir with drugs known to be potentially nephrotoxic, such as cyclosporine or amphotericin B, may increase serum creatinine levels. In a retrospective analysis of 91 patients with heterotopic liver transplantation who received ganciclovir (5 mg/kg IV for 1 hour every 12 hours) and oral cyclosporine (therapeutic doses), no effect on cyclosporine whole blood concentrations was observed.

Keep tightly closed in a cool, dry place.

0.25g

Shanghai SPH New ASIA Pharmaceutical Co., Ltd.

• Founded in:

  1993-08-11

• Address:

  No. 978 Chuansha Road, Pudong New Area, Shanghai

• Tax NO.:

  91310115133738906M

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  1,052,429,132 yuan

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