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VALCYTE

It is important that you take valganciclovir tablets with food. This is to make sure the medicine is fully absorbed into the body and will work properly.

To get the best results, valganciclovir must be given for the full time of treatment. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, valganciclovir must be taken on a regular schedule.

Dosing

The dose of valganciclovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of valganciclovir. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For treatment of CMV in the eyes:
    • Adults To start, 900 milligrams (mg) two times a day with food. As you improve the dose may be changed to 900 mg once a day with food.
    • Children Use and dose must be determined by your doctor.

Storage

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For valganciclovir, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to valganciclovir or ganciclovir. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy Valganciclovir has not been studied in pregnant women. However, studies in animals have shown that valganciclovir causes birth defects and other problems. Use of valganciclovir during pregnancy should be avoided whenever possible. The use of birth control is recommended during valganciclovir therapy. Men should use a condom while taking valganciclovir, and for at least 90 days following treatment.

Breast-feeding It is not known whether valganciclovir passes into the breast milk. However, valganciclovir is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of valganciclovir in children with use in other age groups.

Older adults Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of valganciclovir in the elderly with use in other age groups.

Other medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking valganciclovir, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) Caution should be used if these medicines and valganciclovir are used together; receiving valganciclovir while you are using these medicines may make anemia and other blood problems worse

• Didanosine (e.g., Videx) or
• Mycophenolate (e.g., CellCept) or
• Probenecid (e.g., Benemid) Use of these medicines with valganciclovir may increase the chance of side effects

• Kidney disease Valganciclovir may build up in the blood in patients with kidney disease, increasing the chance of side effects

• Low platelet count or
• Low red blood cell count or
• Low white blood cell count Valganciclovir may make these blood diseases worse