Ganciclovir Injection

(1) Ganciclovir belongs to the guanine antiviral drugs. (2) This product is a homologue of acyclovir, but has a stronger effect, especially against cytomegalovirus in AIDS patients. After entering the cell, this product is rapidly phosphorylated to form a monophosphate compound, and then converted into a triphosphate compound by the action of cellular kinase. The phosphorylation process of this drug in cells infected with cytomegalovirus is faster than that in normal cells. The triphosphate of this drug can competitively inhibit DNA polymerase and be incorporated into the DNA of viruses and host cells, thereby inhibiting DNA synthesis. This drug has a stronger inhibitory effect on viral DNA polymerase than on host cell DNA polymerase.

Ganciclovir.

1. It is suitable for the induction and maintenance treatment of cytomegalovirus retinitis in immunodeficient patients (including AIDS patients). 2. It can also be used to prevent cytomegalovirus infection in patients receiving organ transplantation and to prevent cytomegalovirus disease in AIDS patients with positive cytomegalovirus serological test.

P>　　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 <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, for more than 1 hour. For patients with impaired renal function, the dosage should be adjusted according to the creatinine clearance: when the creatinine clearance is 50-69 ml/min, 2.5 mg/kg should be intravenously dripped every 24 hours; when the creatinine clearance is 25-49 ml/min, 1.25 mg/kg should be intravenously dripped every 24 hours; when the creatinine clearance is 10-24 ml/min, 0.625 mg/kg should be intravenously dripped every 24 hours; when the creatinine clearance is <10 ml/min, the drug should be 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 should be 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 intravenously infused, 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 100ml of sodium chloride injection, 5% glucose injection, compound sodium chloride injection or compound sodium lactate injection. The concentration of the infusion solution shall not be greater than 10mg/ml.

1. Common adverse reactions include bone marrow suppression. After taking the drug, the neutrophil count of about 40% of patients decreases to below 1000/mm3, and the platelet count of about 20% of patients decreases to below 50,000/mm3. In addition, anemia may occur. 2. Central nervous system symptoms such as mental abnormalities, tension, tremors, etc., occur in about 5% of patients, and coma and convulsions may occur occasionally. 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.

Patients who are allergic to this product or acyclovir are contraindicated.

Didanosine: When didanosine was taken 2 hours before or concurrently with oral ganciclovir, steady-state dianosine AUC0-12 increased by 111±114% (range 10% to 493%) (n=12 patients, 23 observations). When didanosine was taken 2 hours before oral ganciclovir, steady-state ganciclovir AUC decreased by 12±17% (-44% to 5%), but concomitant use of the two drugs was not affected by ganciclovir AUC (n=12). Renal clearance of either drug was not significantly altered. When a standard IV ganciclovir initial dose (5 mg/kg IV infusion for 1 hour every 12 hours) was coadministered with didanosine 200 mg orally every 12 hours, steady-state didanosine increased by 70±40% (range 3% to 121%, n= 11), Cmax increased by 49±42% (range: -28 to 125%). In another study, when standard intravenous maintenance doses of ganciclovir (5 mg/kg intravenous drip for 1 hour, once every 24 hours) were co-administered with didanosine 200 mg orally every 12 hours, the plasma concentration of didanosine (AUC12-24) remained unchanged during the first dose interval of didanosine. The pharmacokinetic parameters of ganciclovir were not affected by didanosine. There was no significant change in the renal clearance of the two drugs in each study. Azidothymidine: When the oral dose of ganciclovir was 1000 mg once every 8 hours and combined with azidothymidine 100 mg every 4 hours, the mean steady-state ganciclovir AUC0-8 decreased by -17±25% (range: -52% to 23%) (n=12). Azidothymidine was stable in the presence of ganciclovir. The mean steady-state AUC0-4 of ganciclovir decreased by 19±27% (range: -11% to 74%). Because both azidothymidine and ganciclovir may cause neutropenia and anemia, some patients may not be able to tolerate the full-dose combination of the two drugs. Propanecil: When the oral dose of ganciclovir is 1000 mg once every 8 hours, combined with Propanecil 500 mg once every 6 hours, the mean steady-state ganciclovir AUC0-8 decreased by 53±91% (range: -14% to 299%) (n=10). The renal clearance of ganciclovir was reduced by 22±20% (range: -54% to -4%), and this interaction is related to competition for renal tubular secretion. Imipenem-cilastatin: There have been reports of non-significant seizures in patients receiving ganciclovir and imipenem-cilastatin at the same time, so these drugs should not be used unless the potential benefits outweigh the risks. Can be used simultaneously. Other drugs: Drugs that inhibit the replication of rapidly dividing cell populations, such as bone marrow, spermatogonia, and skin germinal layer and gastrointestinal mucosal cells, 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, can only be used simultaneously with ganciclovir when the potential benefits outweigh the risks. There are no formal studies on the interaction of ganciclovir with commonly used drugs for organ transplant recipients. The simultaneous use of ganciclovir with drugs known to have potential nephrotoxicity, such as cyclosporine or amphotericin B, can increase serum inosine levels. In a retrospective analysis, 91 patients with heterotopic liver transplantation received ganciclovir (5 mg/kg intravenous drip for 1 hour, once every 12 hours) and oral cyclosporine (therapeutic dose), and no effect on the whole blood concentration of cyclosporine was observed.

Keep away from light and store in airtight container.

2ml: 50mg

Jiangsu Lianshui Pharmaceutical Co., Ltd.

• Founded in:

  1999-05-21

• Address:

  No. 18, Hongri Avenue, Lianshui Economic Development Zone

• Tax NO.:

  91320826139830519D

• Registered Funds:

  80 million yuan

• Email:

  Log in to view