Here is the complete information for Valganciclovir Powder for Oral Solution 50 mg/mL:
💊 Valganciclovir Powder for Oral Solution 50 mg/mL
🧪 Generic Name:
Valganciclovir Hydrochloride
📦 Form & Strength:
- Powder for oral solution, when reconstituted provides:
50 mg/mL of valganciclovir
🦠 Uses / Indications:
Valganciclovir is a prodrug of ganciclovir, used for:
- Treatment of CMV retinitis in AIDS patients
- Prevention of CMV disease in solid organ transplant recipients
(especially kidney and heart transplants, including pediatric use)
⚖️ Dosage & Administration:
💡 Always administer with food to enhance absorption
💡 Use provided oral dispenser for accurate dosing
Pediatric Dosing (Prophylaxis after transplantation):
- Calculated using body surface area (BSA) and renal function
- Usual duration: up to 100–200 days post-transplant
Dosing Formula:
Dose (mg) = 7 × BSA × Creatinine Clearance (CrCl)
Max: 900 mg per dose
Adult Prophylaxis / Treatment (if using oral solution):
- Same total daily dose as tablets (e.g., 900 mg/day)
- Divide total daily dose by 50 mg/mL to get volume to administer
⚠️ Precautions:
- Myelosuppression: Risk of neutropenia, anemia, thrombocytopenia
- Renal dosing adjustment mandatory
- Avoid direct contact with powder or solution—wear gloves if needed
- Teratogenic & mutagenic — effective contraception is advised during and 90 days post-therapy
🚫 Contraindications:
- Hypersensitivity to valganciclovir/ganciclovir
- Severe blood cell disorders unless benefit outweighs risk
- Pregnancy (unless clearly indicated)
💥 Side Effects:
- Neutropenia, anemia, thrombocytopenia
- GI upset (nausea, vomiting, diarrhea)
- CNS: Headache, confusion
- Liver/kidney enzyme elevations
🧴 Reconstitution & Storage:
- Add exactly 91 mL of purified water to reconstitute
- Shake well until fully dissolved
- Store in refrigerator (2°C–8°C)
- Shelf life after reconstitution: 49 days
- Do not freeze
- Dispense with child-resistant cap and oral syringe