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Valcyte

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Valcyte

Valcyte
(valganciclovir hydrochloride) Tablets, Oral Solution

WARNING

HEMATOLOGIC TOXICITY, CARCINOGENICITY, TERATOGENICITY, AND IMPAIRMENT OF FERTILITY

  • Clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia [see WARNINGS AND PRECAUTIONS].
  • In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Valcyte contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV.

Valcyte is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink®.

Valcyte is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of Valcyte for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring.

Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5•HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2- [(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6.

The chemical structure of valganciclovir HCl is:

Valcyte (valganciclovir hydrochloride) Structural Formula Illustration

All doses in this insert are specified in terms of valganciclovir.

What are the possible side effects of valganciclovir (Valcyte)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using valganciclovir and call your doctor at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • urinating...

Read All Potential Side Effects and See Pictures of Valcyte »

What are the precautions when taking valganciclovir hcl (Valcyte)?

Before taking valganciclovir, tell your doctor or pharmacist if you are allergic to it; or to ganciclovir or acyclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems (such as kidney dialysis), a low number of blood cells (red or white blood cells, platelets), radiation treatment.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Wash your hands well to prevent the spread of...

Read All Potential Precautions of Valcyte »

Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.

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Valcyte - User Reviews

Valcyte User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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