Valcyte Tablet 450mg (Valganciclovir hydrochloride)

Adult dosage

Treatment of CMV retinitis in patients with AIDS Induction therapy: For patients with active CMV retinitis, take 900mg per dose twice daily with food for 21 days. Maintenance therapy: After induction therapy, or for patients with inactive CMV retinitis, take 900mg once daily with food. If retinitis worsens, repeat induction therapy. Prevention of CMV disease in organ transplant recipients Kidney transplant recipients should start taking this medicine within 10 days after transplantation and take 900mg once daily through day 200. Recipients of solid organ transplants other than kidney transplants should start taking this medicine within 10 days after transplantation and take 900mg once daily through day 100. Adult patients with renal impairment CrCl (ml/min) ≥60: Induction dose 900mg per dose twice daily; maintenance/prevention dose 900mg per dose once daily CrCl (ml/min) 40-59: Induction dose 450mg per dose twice daily; maintenance/prevention dose 450mg per dose once daily CrCl (ml/min) 25-39: Induction dose 450mg per dose once daily; maintenance/prevention dose 450mg per dose every other day CrCl (ml/min) 10-24: Induction dose 450mg per dose every other day; maintenance/prevention dose 450mg per dose twice weekly This medicine cannot be used in patients on dialysis (ClCR<10ml/min). Use of intravenous ganciclovir is recommended, and the dose should be adjusted according to the current prescribing information for intravenous ganciclovir. Creatinine clearance for women = 0.85 x creatinine clearance for men

Children's dosage

k=0.45 (younger than 2 years) k=0.55 (boys: 2 years to younger than 13 years, girls: 2 years to younger than 16 years) k=0.7 (boys: 13-16 years) For patients older than 16 years, refer to the adult dose. The recommended daily dose of this medicine for pediatric solid organ transplant recipients aged 4 months or older who are at risk of developing CMV disease is calculated using the following formula, based on body surface area (BSA) and creatinine clearance (Clcr) calculated using the Schwartz formula (ClcrS). Pediatric dose (mg)= 7×BSA×ClcrS If the calculated Schwartz creatinine clearance exceeds 150mL/min/1.73m2, use 150mL/min/1.73m2 in the formula. Pediatric kidney transplant recipients should start taking this medicine within 10 days after transplantation and take the recommended dose (7×BSA×ClcrS) once daily through day 200. Pediatric recipients of solid organ transplants other than kidney transplants should start taking this medicine within 10 days after transplantation and take the recommended dose (7×BSA×ClcrS) once daily through day 100. Round all calculated doses to the nearest multiple of 25mg, taking into account the dose that can actually be administered. If the calculated dose exceeds 900mg, administer the maximum dose of this medicine, 900mg. If the calculated dose is within 10% of a 450mg tablet (405mg-495mg) and the patient can swallow tablets, a 450mg tablet may be taken.

This medication is converted rapidly in the body to ganciclovir. It has been confirmed in animal studies that this drug has the potential to cause genetic mutation, teratogenic effects, and cancer. Thus, women of childbearing potential must use effective contraception for at least 30 days during and after treatment, while men should do so for at least 90 days during and after treatment. This drug should not be used in patients with very low blood cell counts or weakened bone marrow function, and frequent blood tests must be carried out during treatment to closely monitor blood counts. Since this drug can affect kidney function, dosage adjustments are needed for patients with impaired kidney function, and kidney function should be examined regularly. During therapy, neurological side effects such as seizures, dizziness, and confusion may occur, therefore it is advisable to avoid activities that require attention, such as driving or operating machinery. Pregnant and nursing women are recommended not to take this medication, and women planning pregnancy should consult a healthcare professional before use. This drug may interact with various other medications, so if you are taking other medications, it is essential to inform your doctor or pharmacist. Children, elderly patients, newborns, and infants require extra caution when taking this medication, and regular blood tests as well as kidney and liver function tests should be conducted. In case of overdose, severe bone marrow suppression and kidney damage may occur, so strict adherence to the dosage is necessary, and in case of overdose, immediate medical attention should be sought. This medication should not be divided or made into powder, and in case of direct contact with the medication, skin or eyes should be washed thoroughly. Keep this medicine out of the reach of children, and dispose of expired medications appropriately.

• Diarrhea
• fever
• fatigue
• nausea
• tremor
• neutropenia
• anemia
• leukopenia
• thrombocytopenia
• headache

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the effectiveness and safety of the drug for a long time.

Appearance

Pink oval film-coated tablet

Package unit

60 tablets/bottle