VALCYTE for ORAL SOLUTION

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Generic Name for VALCYTE for ORAL SOLUTION

Valganciclovir (as HCl) (prodrug of ganciclovir) 50mg/mL; pwd for reconstitution; tutti-frutti flavor.

Legal Classification:

Rx

Pharmacological Class for VALCYTE for ORAL SOLUTION

Nucleoside analogue.

Manufacturer of VALCYTE for ORAL SOLUTION

Roche Laboratories

Indications for VALCYTE for ORAL SOLUTION

Prevention of CMV disease in kidney and heart transplant pediatric patients (4 months to 16 years old) at high risk.

Adult dose for VALCYTE for ORAL SOLUTION

Use tablet form.

Children's dosing for VALCYTE for ORAL SOLUTION

<4months: not recommended. Take with food. ≥4months: Dose (mg)= 7 x BSA x Creatinine Clearance (see literature). Round calculated dose to the nearest 25mg increment; max 900mg.

Also:

Contraindications for VALCYTE for ORAL SOLUTION

Acyclovir or ganciclovir allergy.

Warnings/Precautions for VALCYTE for ORAL SOLUTION

Do not substitute on a mg-per-mg basis for ganciclovir. Avoid handling broken tabs. Withhold dose if absolute neutrophil count <500 cells/microliter, platelet count <25,000/microliter, or hemoglobin <8 g/dL. Reduce dose or discontinue if blood dyscrasias occur. Renal impairment. Cytopenia or cytopenic reactions to drugs, chemicals, irradiation. Monitor CBCs, platelets, ophthalmic, and renal function. Maintain adequate hydration. Use effective contraception during (men and women) and for at least 90 days after treatment (men). Elderly. Pregnancy (Cat.C: teratogenic, embryotoxic, carcinogenic, aspermatogenesis in animals), nursing mothers: see literature.

Interactions for VALCYTE for ORAL SOLUTION

Zidovudine increases anemia/neutropenia risk. Caution with nephrotoxic drugs (eg, cyclosporine, amphotericin B, mycophenolate). Monitor for toxicity with didanosine. Probenecid increases levels. Caution with drugs that inhibit replication of rapidly-dividing cells (eg, dapsone, pentamidine, antineoplastics). Avoid imipenem-cilastatin (seizures).

Adverse Reactions for VALCYTE for ORAL SOLUTION

GI upset, fever, bone marrow depression, headache, insomnia, retinal detachment, peripheral neuropathy, paresthesia, aplastic anemia, bleeding, CNS effects, elevated serum creatinine, infections, tremor, hypertension.

How is VALCYTE for ORAL SOLUTION supplied?

Tabs—60
Soln—100mL (after constitution); available soon

Related Disease:

Cytomegalovirus

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