VALCYTE 60'S IMP

Valganciclovir is a prodrug that is rapidly converted to its active form, ganciclovir, in the body. Ganciclovir's primary mechanism of action is the inhibition of viral DNA synthesis. It achieves this by selectively targeting and inhibiting a viral enzyme called DNA polymerase, which is crucial for the replication of certain viruses, particularly cytomegalovirus (CMV). Valganciclovir is efficiently phosphorylated by viral kinases, leading to the formation of ganciclovir triphosphate, which acts as a competitive substrate for viral DNA polymerase. This results in the incorporation of ganciclovir into the growing viral DNA chain, causing chain termination and inhibiting the replication of the virus. This mechanism effectively disrupts viral DNA synthesis, preventing the virus from replicating and spreading within the body.

Antiviral (nucleoside analogue)

Tablet

The following are the uses of Valganciclovir Tablet:

• Used for treating cytomegalovirus (CMV) retinitis, an eye infection that can cause vision loss in people with weak immune systems, such as those with AIDS.
• Used for preventing CMV disease in organ transplant patients, as it can reduce the risk of the virus causing health complications.
• Used for managing CMV infections in patients with HIV, helping to control the virus and prevent further damage.
• Used for treating severe CMV infections in newborns, ensuring prompt and effective treatment.
• Used for suppressing CMV in patients with kidney transplants, to maintain the health of the transplanted organ.
• Used for managing CMV-related neurological symptoms, such as encephalitis, by reducing viral activity.
• Used for improving survival rates in patients with CMV-related complications, offering a crucial treatment option.

In the case of an overdose of Valganciclovir Tablets, it is important to seek medical assistance promptly. Symptoms may include gastrointestinal issues, such as nausea and vomiting, as well as potential central nervous system effects like dizziness or headaches. The severity of these symptoms can vary based on the amount ingested and individual factors. Quick action and medical intervention are necessary to ensure appropriate treatment and minimize any potential harm caused by the overdose.

In the case of a missed dose of Valganciclovir Tablet, it is important to take the medication as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one, as this may increase the risk of side effects. If you miss multiple doses, consult your healthcare provider for guidance on how to safely resume your medication and adjust your dosing schedule if necessary.

To take Valganciclovir tablets, swallow the prescribed number of tablets whole with water, preferably with food, as directed by your healthcare professional, typically once or twice daily, following the dosage instructions provided.

Following are the conditions/situations when Valganciclovir Tablet should not be taken:

• Should not be used in individuals with a known allergy to Valganciclovir or its active ingredient, ganciclovir.
• Contraindicated in patients with severe kidney disease or those on dialysis.
• Not recommended for individuals with low blood cell counts, such as low white blood cells or platelets.
• Should not be used during pregnancy as it may harm the unborn baby.
• Breastfeeding mothers should not take Valganciclovir as it can pass into breast milk and potentially harm the nursing infant.
• Avoid in patients with a history of blood disorders or bone marrow suppression.
• Not suitable for individuals with a known sensitivity to any of the tablet's inactive ingredients.

The side effects of Valganciclovir Tablet may include:

• Nausea and vomiting
• Diarrhea
• Abdominal pain
• Headache
• Fatigue and weakness
• Tremors or shaking
• Skin rashes or itching
• Changes in blood cell counts

Following are the precautions and warnings for Valganciclovir Tablet:

• Not recommended for individuals with a known hypersensitivity or allergy to Valganciclovir or any of its components.
• Requires close monitoring of kidney function during treatment, especially in patients with pre-existing kidney problems.
• Patients with a history of bone marrow suppression or blood disorders should use with caution, as it may exacerbate these conditions.
• Not suitable for individuals with severe liver impairment, and dosage adjustments may be necessary for those with mild to moderate liver issues.
• Should be used with caution in elderly patients, as they may be more susceptible to certain side effects.
• Pregnant women should only use Valganciclovir if the potential benefits outweigh the risks, and it should be avoided during breastfeeding to prevent potential harm to the infant.
• Patients should maintain adequate hydration and seek medical attention if signs of dehydration occur while taking this medication.

Following are the drug interactions for Valganciclovir Tablet:

• Concomitant use with other myelosuppressive drugs, such as zidovudine or chemotherapy agents, may increase the risk of bone marrow suppression, leading to anemia, neutropenia, or thrombocytopenia.
• Use with nephrotoxic drugs, such as cyclosporine or amphotericin B, may increase the risk of kidney toxicity.
• Combining with probenecid may reduce renal clearance of valganciclovir, leading to increased drug levels and a higher risk of side effects.
• Concomitant use with didanosine may elevate didanosine levels, increasing the risk of toxicity, including pancreatitis and neuropathy.
• Immunosuppressants, such as tacrolimus or mycophenolate, when used with valganciclovir, may further suppress immune function, increasing the risk of infections.
• Use with aminoglycoside antibiotics, such as gentamicin, may increase the risk of nephrotoxicity.
• Concomitant use with other antivirals, such as acyclovir or foscarnet, may increase the risk of renal toxicity and bone marrow suppression.

Following are the food interactions for Valganciclovir Tablet:

• Valganciclovir may interact with high-fat meals, leading to increased absorption and potentially higher drug levels in the body. It is advisable to take the medication on an empty stomach, at least one hour before or two hours after a meal.
• Avoid grapefruit and grapefruit juice as they can affect the metabolism of Valganciclovir, potentially increasing its concentration in the blood and the risk of side effects.
• Limit alcohol consumption as it may increase the risk of liver problems and worsen side effects such as dizziness and fatigue.
• Avoid dairy products if you have a history of lactose intolerance or milk protein allergy, as some Valganciclovir formulations may contain lactose or milk proteins.
• Avoid foods fortified with arginine, an amino acid, as it may interact with Valganciclovir and potentially reduce its effectiveness.
• Ensure adequate hydration and consider increasing fluid intake to reduce the risk of kidney problems, especially if you have pre-existing kidney issues.
• Avoid vitamin C supplements or foods rich in vitamin C during treatment, as high doses of vitamin C may reduce the effectiveness of Valganciclovir.
• Follow a balanced diet to support overall health, as Valganciclovir treatment may impact appetite and nutrient absorption.

Valganciclovir Tablets should be stored in a secure and dry location, preferably in a medicine cabinet or designated storage area, at room temperature. Maintain a consistent temperature between 68°F and 77°F (20°C and 25°C) to ensure the medication's effectiveness. Keep the tablets in their original container, tightly sealed, to protect them from moisture and light. It is crucial not to store them in the bathroom or kitchen, as these areas may have varying temperatures and humidity levels that can degrade the medication. When disposing of unused or expired Valganciclovir Tablets, do not flush them down the toilet or throw them into the trash. Instead, utilize medicine take-back programs or consult your pharmacist for guidance on safe disposal methods to protect the environment and prevent unauthorized access. Keep the medication out of children's reach to prevent accidental ingestion.

Following are the quick tips for Valganciclovir Tablet:

• Take the tablet as directed by your doctor, typically with food.
• Swallow the tablet whole; do not crush or chew it.
• Maintain adequate hydration and drink plenty of fluids while on this medication.
• Complete the full course of treatment, even if you feel better early on.
• Inform your doctor if you have kidney problems for proper dosage adjustment.
• Regularly monitor your blood cell counts and kidney function while on this medication.
• Store the tablets at room temperature, away from moisture and light.