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, resulting in the termination of viral DNA extension. 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 phase: 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 is 50-69 ml/min, intravenous drip of 2.5 mg/kg every 12 hours; when the creatinine clearance is 25-49 ml/min, intravenous drip of 2.5 mg/kg every 24 hours; when the creatinine clearance is 10-24 ml/min, intravenous drip of 1.25 mg/kg every 24 hours; when the creatinine clearance is <10 ml/min, the drug is given 3 times a week, each time 1.25 mg/kg is given after hemodialysis. 2 Maintenance phase: intravenous drip of 5 mg/kg per body weight, once a day, for more than 1 hour. For patients with impaired renal function, the dosage is adjusted according to the creatinine clearance: when the creatinine clearance is 50-69 ml/min, 2.5 mg/kg is intravenously dripped every 24 hours; when the creatinine clearance is 25-49 ml/min, 1.25 mg/kg is intravenously dripped every 24 hours; when the creatinine clearance is 10-24 ml/min, 0.625 mg/kg is intravenously dripped every 24 hours; when the creatinine clearance is <10 ml/min, the drug is administered 3 times a week, 0.625 mg/kg each time 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 to 14 consecutive days; followed by 5 mg/kg, once a day, for a total of 7 days. When this product is administered by intravenous drip, the preparation method is as follows: first determine the dosage based on the patient's weight, dissolve it with an appropriate amount of water for injection or sodium chloride injection to a concentration of 50 mg/ml, 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 must 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 will increase by 11plusmn;114% (range: 10% to 493%) (n=12). When didanosine is taken 2 hours before oral ganciclovir, the steady-state AUC of ganciclovir will decrease by 21plusmn;17% (range: -44% to 5%). However, the AUC of ganciclovir is not affected when the two drugs are used simultaneously (n=12). The renal clearance of both drugs did not change significantly. When the standard ganciclovir IV initial dose (5 mg/kg IV infusion for 1 hour every 12 hours) was co-administered with didanosine 200 mg orally every 12 hours, the steady-state didanosine AUC0-12 increased by 70 plus mn; 40% (range: 3% to 121%, n=11) and Cmax increased by 49 plus mn; 48% (range -28% to 125%). In another study, when the standard ganciclovir IV maintenance dose (5 mg/kg IV infusion for 1 hour every 24 hours) was co-administered with didanosine 200 mg orally every 12 hours. During the first dose interval of didanosine, the AUC0-12 of didanosine increased by 50 plus mn; 26% (range: 22% to 110%, n=11). Cmax increased by 36 plus mn; 36% (range: -27% to 94%). dose interval when not co-administered with ganciclovir. Plasma concentrations of didanosine (AUC12-24) were unchanged, and the pharmacokinetic parameters of ganciclovir were not affected by didanosine. Renal clearance of both drugs was not significantly changed in any of the studies. Zidovudine: When ganciclovir was given orally at a dose of 1000 mg every 8 hours and combined with 100 mg of azidothymidine every 4 hours, the mean steady-state ganciclovir AUC0-8 decreased by 17 plus mn; 25% (range: -52% to 23%) (n = 12), and the steady-state AUC0-4 of azidothymidine increased by 19 plus mn; 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 plus mn; 91% (range: -14% to 299%) (n = 10), and ganciclovir renal clearance decreased by 22 plus mn; 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 (calculated as C9H13N5O4)

Wuhan Hiteck Biological Pharma Co., Ltd.

• Founded in:

  1992-04-08

• Address:

  Wuhan Economic and Technological Development Zone Haite Technology Park

• Tax NO.:

  91420100724667038L

• Registered Funds:

  130.894391 yuan

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