Valgan 450 Dosage/Direction for Use

Posology: Caution - Strict adherence to dosage recommendations is essential to avoid overdose: Valganciclovir tablets cannot be substituted for ganciclovir tablets on a one-to-one basis.
Standard Dosage: Valganciclovir is administered orally, and should be taken with food (see Pharmacology: Pharmacokinetics: Special Populations and Absorption under Actions). After oral administration, Valganciclovir is rapidly and extensively converted into ganciclovir. The bioavailability of ganciclovir from Valganciclovir is up to 10-fold higher than from ganciclovir capsules. Therefore the dosage and administration of Valganciclovir tablets as described below should be closely followed (see Precautions and Overdosage).
For the treatment of CMV retinitis in patients with normal renal function: Adults: Induction: For patients with active CMV retinitis, the recommended dose is 900 mg valganciclovir (two Valganciclovir 450 mg tablets) twice a day for 21 days. Prolonged induction treatment may increase the risk of bone marrow toxicity (see Precautions).
Maintenance: Following induction treatment, or in patients with inactive CMV retinitis, the recommended dose is 900mg valganciclovir (two Valganciclovir 450 mg tablets) once daily with food. Patients whose retinitis worsens may repeat induction treatment (See Induction as previously mentioned).
The duration of maintenance treatment should be determined on an individual basis.
For Prevention of CMV disease in heart, kidney, and kidney-pancreas transplantation: For kidney transplant patients, the recommended dose is 900 mg (two Valganciclovir 450 mg tablets) once daily, with food starting within 10 days post-transplantation and continuing until 100 days post-transplantation. Prophylaxis may be continued until 200 days post-transplantation.
For patients who have received a heart, or kidney-pancreas transplant, the recommended dose is 900 mg (two Valganciclovir 450 mg tablets) once daily, with food starting within 10 days of post transplantation and continuing until 100 days post-transplantation.
Special dosage instructions: Geriatric Use: Safety and efficacy have not been established in this patient population. No studies have been conducted in adults older than 65 years of age. Since renal clearance decreases with age, Valganciclovir should be administered to elderly patients with special consideration of their renal status (see Table 3 and Pharmacology: Pharmacokinetics: Geriatric Population under Actions).
Patients with renal impairment: Serum creatinine levels or creatinine clearance should be monitored carefully. Dosage adjustment is required according to creatinine clearance, as shown in the table as follows. (See Table 3.)

Click on icon to see table/diagram/image

An estimated creatinine clearance (ml/min) can be related to serum creatinine by the following formulae: (See equation.)

Click on icon to see table/diagram/image

Patients undergoing haemodialysis: For patients on haemodialysis (CrCl < 10 ml/min) a dose recommendation cannot be given. Thus Valganciclovir should not be used in these patients (see Pharmacology: Pharmacokinetics under Actions and Precautions).
Patients with hepatic impairment: Safety and efficacy of Valganciclovir tablets have not been studied in patients with hepatic impairment. (See Pharmacology: Pharmacokinetics under Actions and Precautions.)
Children: Safety and efficacy have not been established in this patient population. The use of Valganciclovir in children is not recommended because the pharmacokinetic characteristics of Valganciclovir have not been established in this patient population (see Precautions).