Description

Valcyte 450mg 60’ct tablet is used to treat and prevent cytomegalovirus (CMV) infections, particularly in patients with weakened immune systems such as those with acquired immunodeficiency syndrome (AIDS) or those who have received organ transplants. It is used to treat CMV retinitis, which can cause vision problems and even blindness, and to prevent CMV infections in transplant recipients.             

Product Information

• Brand Name: Valcyte
• Generic Name: Valganciclovir
• Strength: 450mg
• Packaging: 60 tablets

Indications

• Treatment: Cytomegalovirus (CMV) retinitis in AIDS patients
• Prevention: CMV infections in transplant recipients

Dosage

• Treatment: 900 mg (two 450 mg tablets) twice a day for 21 days, followed by maintenance treatment of 900 mg once daily
• Prevention: 900 mg once daily for up to 100 days

Warnings

• Allergy: Not recommended for patients with a known allergy to valganciclovir or ganciclovir
• Caution: Use with caution in patients with low blood cell counts, kidney problems, or those undergoing radiotherapy or hemodialysis

Side Effects

• Common: Nausea, vomiting, diarrhea, headache
• Serious: Bone marrow suppression, kidney problems, liver damage

Availability

• Price Range: $54.83 to $312.25
• Online Pharmacies: Available in various online pharmacies and medical stores

Packaging and Storage

• Packaging: Pink, convex oval film-coated tablets marked with “VGC” on one side and “450” on the other side
• Storage: No special storage conditions required; keep out of reach of children and do not dispose of via wastewater or household waste
  

  Key Benefits:

  • Treats and prevents cytomegalovirus (CMV) infections, particularly in patients with weakened immune systems such as those with AIDS or organ transplant recipients 
  • Treats CMV retinitis, which can cause vision problems and blindness, in AIDS patients 
  • Prevents CMV infections in solid organ transplant recipients 

  Key Ingredients:

  • The active ingredient is valganciclovir, which is converted into the active drug ganciclovir in the body 
  • Each Valcyte 450mg tablet contains 450mg of valganciclovir 
  

  Valganciclovir

  Antiviral Medication for Cytomegalovirus (CMV) Infection

  More

  Trade names

  Valcyte, Valcip, others

  Pregnancy category

  AU: D

  Routes of administration

  By mouth

  Valcyte 450mg tablet, also known as valganciclovir, works by converting into ganciclovir, which is the active form of the drug. Here is a detailed explanation of its mechanism of action:

  Mechanism of Action

  1. Conversion to Ganciclovir:
     • Valganciclovir is a prodrug that is converted into ganciclovir in the body. This conversion occurs through the action of liver enzymes and esterases in the intestines and liver.
  2. Phosphorylation:
     • Ganciclovir is phosphorylated by a viral protein kinase (HCMV UL97) and cellular kinases. This phosphorylation process converts ganciclovir into ganciclovir triphosphate.
  3. Inhibition of Viral DNA Synthesis:
     • Ganciclovir triphosphate is a competitive inhibitor of deoxyguanosine triphosphate (dGTP). It is incorporated into viral DNA and preferentially inhibits viral DNA polymerases more than cellular DNA polymerases. This inhibition leads to chain termination and prevents the growth of the cytomegalovirus (CMV) virus.

  Pharmacokinetics

  • Oral Bioavailability: Valganciclovir has an oral bioavailability of approximately 60%.
  • Peak Concentration: The maximum concentration in the serum is reached within about 2 hours after administration.
  • Elimination: Valganciclovir is eliminated as ganciclovir in the urine, with a half-life of about 4 hours in people with normal kidney function.

  Clinical Use

  • Treatment of CMV Retinitis: Valcyte is used to treat CMV retinitis in AIDS patients. The recommended dose is 900 mg (two 450 mg tablets) twice a day for 21 days, followed by maintenance treatment of 900 mg once daily.
  • Prevention of CMV Infections: It is used to prevent CMV infections in transplant recipients. The recommended dose is 900 mg once daily for up to 100 days.

  Safety Considerations

  • Allergies: Valcyte should not be taken by patients with a known allergy to valganciclovir, ganciclovir, or its other ingredients.
  • Kidney Function: Patients with kidney problems may require a dosage adjustment, and regular blood tests may be necessary to monitor blood cell counts.
  

  Pregnancy

  • Contraindicated: Valcyte should not be used during pregnancy unless the therapeutic benefit for the mother outweighs the potential risk of teratogenic (birth defect-causing) damage to the fetus.
  • Contraception: Women of childbearing age should have a pregnancy test before starting Valcyte and use effective contraception during treatment and for at least 30 days after stopping.

  Breastfeeding

  • Contraindicated: Valcyte is contraindicated during breastfeeding. It is unknown if Valcyte/ganciclovir is excreted in human breast milk, but it may cause serious adverse reactions in the nursing infant.

  Lungs

  • Unknown Safety: It is unknown whether Valcyte 450mg tablet is safe to administer in patients with lung problems. Inform your physician if you have any lung disease before starting the treatment.

  Liver

  • Unknown Safety: It is unknown whether Valcyte 450mg tablet is safe to administer in patients with liver problems. Inform your physician if you have any liver disease before starting the treatment.

  Alcohol

  • Unknown Safety: It is unknown whether consuming alcohol while taking Valcyte 450mg tablet is safe. Drinking alcohol while consuming the medicine is generally not recommended as it may increase the risk of certain side effects, such as dizziness or drowsiness.

  Driving

  • Unsafe: While taking Valcyte 450mg tablet, it is unsafe to drive or use machines because it may cause dizziness, shaky, changes in vision, etc. Talk to your doctor for more information.

  Kidney Function

  • Dose Adjustments: Valcyte 450mg tablet should be used cautiously in individuals with impaired kidney function. Dose adjustments may be necessary, and close monitoring of kidney function is important.

  Blood Cell Counts

  • Monitoring: Patients with severe leukopenia, neutropenia, anaemia, thrombocytopenia, and pancytopenia should be closely monitored for blood cell count deterioration during therapy. Treatment with haematopoietic growth factors and/or dose interruption may be necessary.

  Handling

  • Precautions: The tablets should not be broken or crushed. Since Valcyte is considered a potential teratogen and carcinogen in humans, caution should be observed in handling broken tablets. Avoid direct contact of broken or crushed tablets with skin or mucous membranes.

  Cross-Hypersensitivity

  • Caution: Due to the similarity of the chemical structure of ganciclovir and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible. Caution should therefore be used when prescribing Valcyte to patients with known hypersensitivity to aciclovir or penciclovir.

  Administration

  • Method: Valcyte is administered orally, and whenever possible, should be taken with food.

  Storage

  • Conditions: The tablets should be stored at room temperature between 15°C to 30°C. Do not freeze. Keep out of sight and reach of pets and children.

  Side Effects

  • Management: Contact the healthcare professional instantly if you experience any side effects while taking Valcyte 450mg tablet. They may prescribe some over-the-counter or prescription medications to manage the side effects or reduce the tablet dosage.

  Dosage and Duration

  • Adherence: Strict adherence to dosage recommendations is essential to avoid overdose. The duration of treatment should be determined on an individual basis based on the specific condition being treated and the patient’s response.

  Paediatric Use

  • Special Considerations: For paediatric patients who are unable to swallow Valcyte film-coated tablets, Valcyte powder for oral solution can be administered. The safety and efficacy of Valcyte tablets have not been established in patients with hepatic impairment.

  Contraindications

  • Hypersensitivity: Valcyte is contraindicated in patients with hypersensitivity to valganciclovir, ganciclovir, or any of the excipients listed in section 6.1.

  Cross-Hypersensitivity

  • Caution: Due to the similarity of the chemical structure of ganciclovir and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible. Caution should therefore be used when prescribing Valcyte to patients with known hypersensitivity to aciclovir or penciclovir.

  Storage

  • Store the tablets at room temperature away from light and moisture. Do not store in the bathroom.
  • Keep Valcyte in a cool dry place where the temperature stays below 30°C.
  • This medicine does not require any special storage conditions.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use.
  • Keep out of sight and reach of pets and children.

  Reviews

  There are no direct reviews of Valcyte 450mg tablets in the provided search results. However, some general information about the medicine can be gathered:

  • Valcyte 450mg tablet belongs to a class of drugs called antivirals used to treat cytomegalovirus (CMV) infection of the retina of the eye in adult AIDS patients.
  • It is used to prevent disease caused by CMV in people who have received organ transplants. CMV disease can lead to serious infections in the body, including an infection in the eye called CMV retinitis that can cause blindness.
  • Valcyte works by slowing the growth of the CMV virus. It is changed in the body to the active form of the drug called ganciclovir.
  • Common side effects include diarrhea, upset stomach, dizziness, loss of balance or coordination, drowsiness, and unsteadiness.