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This medicine contains important and useful components, as it consists of
Ganciclovir is available in the market in concentration.
Ganciclovir
Before initiating Ganciclovir, it is crucial for patients to consult their healthcare provider, especially considering the following precautions:
- Bone Marrow Suppression: Ganciclovir can cause bone marrow suppression, leading to conditions such as leukopenia, neutropenia, anemia, and thrombocytopenia. This can increase the risk of infections and bleeding. Routine blood tests to monitor blood counts are recommended during treatment, especially for long-term use.
- Pregnancy and Breastfeeding: Ganciclovir is classified as Pregnancy Category C, meaning it can potentially harm the fetus. It should only be used during pregnancy if the benefits outweigh the risks. Ganciclovir is also excreted in breast milk, and breastfeeding should be avoided during treatment. Women of childbearing potential should use effective contraception during and for at least 30 days after treatment.
- Renal Function: The drug is primarily eliminated by the kidneys, so it should be used with caution in patients with renal impairment. Dose adjustment may be required in patients with reduced kidney function.
- Reproductive Health: Ganciclovir can affect male fertility and sperm count, which may be reversible upon discontinuation of the drug. Men should be advised to use contraception during and for at least 90 days after treatment.
- CNS Effects: Central nervous system (CNS) toxicity, such as headache, dizziness, and confusion, can occur during Ganciclovir therapy, especially in high doses. Caution is advised for patients with existing CNS conditions.
Ganciclovir is primarily prescribed for the treatment of viral infections caused by the cytomegalovirus (CMV) and other related viruses. The key indications for Ganciclovir include:
- Cytomegalovirus (CMV) Retinitis: Ganciclovir is used to treat CMV retinitis, a sight-threatening infection that occurs most commonly in immunocompromised patients, such as those with HIV/AIDS.
- CMV Prophylaxis in Organ Transplant Recipients: It is also used to prevent CMV infections in patients who have undergone solid organ transplants (e.g., kidney, heart, or liver transplants) to reduce the risk of developing CMV disease.
- CMV Colitis and Esophagitis: Used in the treatment of CMV infections of the gastrointestinal tract, including colitis and esophagitis in immunocompromised individuals.
- Herpes Simplex Virus (HSV) and Varicella Zoster Virus (VZV) Infections: Ganciclovir may be used to treat infections caused by HSV and VZV in immunocompromised patients when alternative treatments are not appropriate.
Ganciclovir should not be used in the following conditions:
- Hypersensitivity to Ganciclovir or Related Compounds: Patients who have a known hypersensitivity or allergic reaction to Ganciclovir or any components of the formulation should avoid its use.
- Severe Renal Impairment: Ganciclovir is contraindicated in patients with severe renal impairment, especially those with creatinine clearance less than 10 mL/min. In these patients, the risk of toxicity is high, as the drug is cleared by the kidneys.
- Pregnancy: Ganciclovir should be avoided during pregnancy unless absolutely necessary, as it can potentially harm the fetus.
- Breastfeeding: Since Ganciclovir is excreted in breast milk, its use in breastfeeding mothers is contraindicated.
Common and serious side effects of Ganciclovir include:
- Common Side Effects:
- Bone Marrow Suppression: A significant risk, leading to neutropenia, thrombocytopenia, and anemia. Regular blood counts should be monitored.
- Nausea and Vomiting: Gastrointestinal symptoms like nausea and vomiting are common and may affect patient compliance.
- Fever: Fever and chills may occur as part of an immune response to the drug.
- Headache: Some patients report headaches during treatment.
- Serious Side Effects:
- Neutropenia: A significant decrease in white blood cells, leading to a weakened immune system and an increased risk of infections.
- Renal Toxicity: Renal failure, particularly in patients with pre-existing kidney disease, can occur.
- Seizures: In rare cases, Ganciclovir may cause seizures, particularly in those with renal impairment.
- Hematologic Toxicity: Severe suppression of bone marrow function may lead to critical conditions like aplastic anemia, granulocytopenia, and severe thrombocytopenia.
- Hypersensitivity Reactions: These may include rash, itching, and more severe responses such as anaphylaxis.
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Ganciclovir is an antiviral agent that works by inhibiting the replication of certain DNA viruses, primarily cytomegalovirus (CMV), and to a lesser extent, herpes simplex virus (HSV) and varicella zoster virus (VZV). The mechanism of action involves:
- Inhibition of Viral DNA Synthesis: Once administered, Ganciclovir is phosphorylated by viral and cellular kinases to form Ganciclovir triphosphate, an active metabolite. This metabolite inhibits the viral DNA polymerase enzyme, which is essential for the replication of viral DNA.
- Selective Action: It selectively targets viral DNA polymerase, leading to the inhibition of viral DNA replication, without significantly affecting host DNA. This helps reduce viral load and prevent the spread of the infection.
Ganciclovir can interact with a variety of drugs, affecting its efficacy or increasing the risk of adverse effects:
- Myelosuppressive Drugs: Co-administration with other drugs that suppress bone marrow (e.g., chemotherapy agents, antiretroviral drugs) can increase the risk of bone marrow suppression. Close monitoring of blood counts is recommended.
- Probenecid: This drug may increase the levels of Ganciclovir in the blood by decreasing renal clearance. If used together, a dose reduction of Ganciclovir may be necessary.
- Other Antiviral Drugs: Ganciclovir should be used cautiously with other antiviral drugs, as the combination can increase the risk of nephrotoxicity.
- Cyclosporine and Tacrolimus: The use of Ganciclovir with immunosuppressants like cyclosporine or tacrolimus (commonly used after organ transplants) may increase the risk of kidney damage.
- Zidovudine: Co-administration with zidovudine (an HIV medication) may increase the risk of hematologic toxicity, including anemia.
The adult dosage of Ganciclovir varies based on the condition being treated:
- CMV Retinitis (in immunocompromised patients): 5 mg/kg every 12 hours by intravenous infusion for the first 14 to 21 days. Maintenance therapy after this period may be reduced to 5 mg/kg once daily.
- CMV Prophylaxis in Organ Transplant Patients: 1.5 mg/kg once daily, initiated within 10 days of transplantation and continued for 100 days.
- CMV Colitis/Esophagitis: Initial treatment may involve 5 mg/kg every 12 hours, followed by a maintenance dose.
- Herpes Simplex Virus: Ganciclovir may be used at doses similar to those used for CMV but adjusted based on the severity of the condition.
For pediatric patients, the dose of Ganciclovir is based on weight and the condition being treated:
- CMV Retinitis: The recommended dose is 6 mg/kg every 12 hours intravenously, although it may vary depending on the severity of the infection and the child's specific needs.
- CMV Prophylaxis: For prophylaxis in pediatric organ transplant recipients, the dose is typically 3-6 mg/kg/day, adjusted for renal function.
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In patients with renal impairment, the dosage of Ganciclovir must be reduced to account for the decreased clearance of the drug. The following adjustments are generally recommended:
- CrCl > 70 mL/min: Standard dosing is typically maintained.
- CrCl 50-70 mL/min: Reduce the dose by approximately 25%.
- CrCl 25-49 mL/min: Reduce the dose by approximately 50%.
- CrCl < 25 mL/min: Consider further dose reductions, or use a longer dosing interval to minimize the risk of toxicity.
Not available in a medicine form yet