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Valganciclovir
Valganciclovir

Valganciclovir(Valcyte)Valsydx

Valganciclovir is a deoxynucleoside analogue inhibitor of cytomegalovirus (CMV) DNA polymerase.

  • 450mg*60tablets

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Introduction of Valganciclovir

Valganciclovir, the active ingredient of Valcyte, is a prodrug of ganciclovir. After oral administration, it is rapidly converted to ganciclovir, which blocks CMV replication by inhibiting the activity of viral DNA polymerase.

Indications

Valganciclovir is mainly indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), and for the prevention of CMV infection in high-risk solid organ transplant recipients.

Overview

Generic Name
Valganciclovir,盐酸缬更昔洛韦片
Brand Name
Valcyte,万赛维,Valsydx
Drug Type
Rx Drug,Targeted Drug
Active Ingredient
Valganciclovir
Dosage Form
450mg*60tablets
Specification
Tablets
Description
Pink, film‑coated, oval tablets, debossed with “VGC” on one side and “450” on the other.
Expiry Date
24 months
Storage
It is recommended to store at room temperature (20 °C to 25 °C).

Dosage and Administration

1.Standard DoseThe usual dose is 900 mg, to be taken with food.

2.Induction Therapy for CMV RetinitisFor patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice daily for 21 days. Prolonged induction therapy may increase the risk of myelotoxicity.

3.Maintenance Therapy for CMV RetinitisFollowing induction therapy, or in patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once daily.Patients with worsening retinitis may repeat induction therapy.

4.Prevention of CMV Infection in Transplant Patients(1) Renal transplant patients: The recommended dose is 900 mg (two 450 mg tablets) once daily, starting within 10 days after transplantation and continuing until 200 days post-transplant.(2) Patients receiving solid organ transplants other than renal: The recommended dose is 900 mg (two 450 mg tablets) once daily, starting within 10 days after transplantation and continuing until 100 days post-transplant.

Use in Special Populations

Pregnancy and Lactation

Pregnant Women and Women of Childbearing Potential

Valganciclovir hydrochloride tablets should be avoided in pregnant women or women who may be pregnant, unless the benefit to the mother clearly outweighs the potential risk to the fetus.

Lactating Women

Breastfeeding is not recommended during treatment with valganciclovir. If use is clinically necessary, breastfeeding must be discontinued under medical supervision.

Geriatric Patients

The efficacy and safety of valganciclovir in geriatric patients have not been established. Geriatric patients commonly have age‑related decreases in hepatic and renal function. Valganciclovir should be used with caution and under close medical supervision if required.

Pediatric Patients

The safety and efficacy of valganciclovir hydrochloride tablets have not been established in pediatric patients in China. Therefore, the use of valganciclovir hydrochloride tablets is not recommended in children.

Side Effects

Valganciclovir is a prodrug of ganciclovir and is rapidly converted to ganciclovir after oral administration. Therefore, the known adverse reactions associated with ganciclovir are expected to occur with the use of valganciclovir hydrochloride tablets. The common adverse reactions observed in clinical studies are as follows:

Gastrointestinal System

Diarrhea, nausea, vomiting, abdominal pain, constipation, dyspepsia.

General Disorders

Fever, fatigue, edema of the lower extremities.

Blood and Lymphatic System

Neutropenia, anemia.

Infections

Oral candidiasis, pharyngitis, nasopharyngitis, upper respiratory tract infections.

Central and Peripheral Nervous System

Headache, insomnia, tremor, dizziness.

Skin and Appendages

Dermatitis, rash.

Respiratory, Thoracic and Mediastinal Disorders

Cough, dyspnea.

Hepatobiliary Disorders

Liver function abnormalities, hepatitis, jaundice.

Musculoskeletal System

Back pain, arthralgia.

Renal and Urinary System

Renal function abnormalities, hematuria, impotence, renal failure, increased frequency of urination, decreased renal creatinine clearance.

Metabolism and Nutrition Disorders

Anorexia, electrolyte disturbances, dehydration, increased blood alkaline phosphatase, increased blood creatine phosphokinase, decreased blood glucose, increased blood lactate dehydrogenase, diabetes mellitus, hypoproteinemia.

Special Senses

Retinal detachment, blurred vision.

Cardiovascular System

Arrhythmias (including ventricular arrhythmias), migraine, phlebitis, tachycardia, deep vein thrombophlebitis, vasodilation.

Surgical Complications

Postoperative complications, postoperative pain, postoperative incision infection, increased wound drainage, wound dehiscence. Potentially life-threatening bleeding associated with thrombocytopenia.

Other

Depression, blood pressure disorders, graft and transplant rejection, and other conditions may also occur.

Contraindications

1.Valganciclovir hydrochloride tablets are contraindicated in patients with known hypersensitivity to valganciclovir, ganciclovir, or any other ingredient in the product.

2.Due to the similar chemical structures of valganciclovir hydrochloride tablets, acyclovir, and valacyclovir, cross‑hypersensitivity may occur among these medicinal products.

Warnings and Precautions

1.Valganciclovir hydrochloride tablets must not be substituted for ganciclovir capsules on a 1:1 basis.

2.For patients with severe leukopenia, neutropenia, anemia, and/or thrombocytopenia, treatment with hematopoietic growth factors and/or dose interruption should be considered.

3.Dosage adjustment based on creatinine clearance is required in patients with renal impairment.

4.Convulsions, sedation, dizziness, ataxia, and/or confusion have been reported following the use of valganciclovir hydrochloride tablets and/or ganciclovir.

5.Tablets must not be broken or crushed.

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Contact Information

If any issues arise, please contact us immediately.

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Questions

What should I avoid while taking Valcyte +

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Avoid activities that may increase your risk of bleeding or injury.

Avoid driving or hazardous activity until you know how Valcyte will affect you. Your reactions could be impaired.

Using this medicine will not prevent your disease from spreading. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

What other drugs will affect Valcyte +

Valcyte can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may affect Valcyte, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What happens if I miss a dose +

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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