Each capsule contains: GANCICLOVIR 250 mg.

 

Ganciclovir is a synthetic guanine derivative active against cytomegalovirus ( CMV) and herpes simplex virus ( HSV ).

 

Mechanism of Action : Ganciclovir is an acyclic nucleoside analogue of

2- deoxyguanosine that inhibits replication of herpes viruses. Ganciclovir has been shown to be active against cytomegalovirus (CMV ) and herpes simplex virus ( HSV ) in human clinical studies .

Antiviral Activity : The median concentration of ganciclovir that inhibits CMV replication (IC50 ) in vitro ( laboratory strains or clinical isolates ) has ranged from 0.02 to 3.48 μg/mL. Ganciclovir inhibits mammalian cell proliferation ( CIC50  ) in vitro at higher concentrations ranging from 30 to 725 μg/mL. Bone marrow-derived colony-forming cells are more sensitive  ( CIC50 0.028 to 0.7 μg/mL ).

 

The absolute bioavailability of  Ganciclovir Capsules under fasting conditions was approximately 5% and following food was 6 % to 9 %.

Binding to plasma proteins was 1 % to 2 % over Ganciclovir concentrations of 0.5 and 51 μg/mL.

Following oral administration of a single 1000 mg dose of Ganciclovir 86 ± 3 % of the administered dose was recovered in the feces and 5 ± 1 % was recovered in the urine.

Renal excretion of unchanged drug by glomerular filtration and active tubular secretion is the major route of elimination of Ganciclovir.

 

-Treatment of diseases due to Cytomegalovirus and herpes simplex virus.

-Prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease.

-CMV retinitis in immunocompromised patients.

 

Ganciclovir  is contraindicated in patients with hypersensitivity to Ganciclovir.

 

-Hematologic : Ganciclovir should not be administered if the absolute neutrophil count is less than 500 cells/μl or the platelet count is less than 25.000 cells/μl.

-Pregnancy : Ganciclovir is contraindicated during pregnancy .

Women of child bearing potential should be advised to use effective contraception during treatment.

Men should be advised to practice barrier contraception, during and for at least 90 days following treatment.

 

Care should be taken if the following drugs are used concomitantly with Ganciclovir:

Didanosine, Zidovudine, Probenecid.

Imipenem – cilastatin :  should not be used concomitantly with Ganciclovir.

Other medications :  It is possible that drugs that inhibit replication of rapidly dividing cell populations such as bone marrow, spermatogonia and germinal layers of skin and gastrointestinal mucosa may have additive toxicity when administered concomitantly with Ganciclovir. Therefore, drugs such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfamethoxazole combinations or other nucleoside analogues, should be considered for concomitant use with Ganciclovir only if the potential benefits are judged to outweigh the risks.

 

It may rarely cause neutropenia, asthenia, edema, headache, malaise, constipation, dyspepsia, dyspnea.

 

The recommended dosage of GANVIR capsules is 1000 mg 3 times daily with food. Alternatively, the dosing regimen of 500 mg 6 times daily every 3 hours with food.

In patients with renal impairment, the dose  should be modified.

 

- A pack of 30 capsules.