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Valcyte

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Vansevir (valganciclovir hydrochloride tablets) is an antiviral drug that is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor.

1. Drug name and main ingredients

1. Common name : Valganciclovirhydrochloride

2. Trade name :Valcyt e®

3. Dosage form :Film-coated tablets

4. Main ingredients :Each tablet contains valganciclovir hydrochloride 496.3mg (equivalent to valganciclovir 450mg), and excipients include microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. Film coat contains OpadryPink®.

2. Indications

Cytomegalovirus (CMV) retinitis : Used to treat CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

3. Specifications and properties of

1. Specifications of : 450mg/tablet (calculated as valganciclovir).

2. Characteristics : Film-coated tablets.

IV. Usage and Dosage

1. Induction therapy : 900mg (2 tablets) twice a day, taken with meals for 21 days.

2. Maintenance treatment : 900mg once a day, take with food.

3. Treatment of missed doses : If you miss a dose and it is >4 hours before the next dose, you can take it again, otherwise skip it. No need to take additional doses after vomiting.

5. Dose adjustment

Renal insufficiency : Adjust the dose according to creatinine clearance (CrCl): when CrCl is 40-59mL/min, the induction dose is reduced to 450mg twice a day, and the maintenance dose is 450mg once a day; CrC When CrCl is 25-39 mL/min, the induction dose is 450 mg once a day, and the maintenance dose is 450 mg once every 2 days; when CrCl is 10-24 mL/min, the induction dose is 450 mg once every 2 days, and the maintenance dose is 450 mg twice a week; it is contraindicated in patients with CrCl < 10 mL/min or hemodialysis patients.

6. Medication Precautions

1. Influence of diet : Must be taken with food to increase bioavailability.

2. Blood monitoring : Regular blood routine (neutrophils, platelets, hemoglobin) and renal function need to be tested regularly.

3. Neurotoxicity : May cause dizziness or confusion. Avoid driving or operating machinery.

7. Medication for special groups

1. Pregnant women: : Disabled (animal experiments show teratogenicity).

2. Lactation : Breastfeeding is prohibited during treatment and for at least 1 week after the last dose.

3. Children : Safety has not been established.

4. Elderly : The dosage needs to be adjusted according to renal function.

8. Adverse reactions

1. Common (≥20%) : Diarrhea (41%), nausea (30%), fever (31%), neutropenia (27%), anemia (26%).

2. Severe reactions : Bone marrow suppression (19% neutrophils <500/μL), retinal detachment (15%), acute kidney injury (3%).

9. Contraindications

1. Those allergic to valganciclovir or cyclovir.

2. Absolute neutrophil count <500/μL or platelet count <25,000/μL.

10. Drug interactions

1. Zidovudine : Increases the risk of anemia and neutropenia.

2. Didanosine : When used in combination, it can increase the AUC of didanosine by 111%.

3. Probenecid : can increase the plasma concentration of ganciclovir by 53%.

11. Storage method

1. Store in original packaging, away from light and moisture.

2. Storage temperature: 25°C (short-term fluctuation of 15-30°C is allowed).

Note : CMV viral load and fundus examination need to be monitored regularly during treatment. Avoid taking it with aluminum/magnesium-containing antacids (need to be separated by 2 hours).