Valcyte (Valganciclovir Hcl) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Valcyte

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The history of the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) dates back to 1981, when homosexual men with symptoms of a disease that now are considered typical of AIDS were first described in Los Angeles and New York. The men had an unusual type of lung infection (pneumonia) called Pneumocystis carinii (now known as Pneumocystis jiroveci) pneumonia (PCP) and rare skin tumors called Kaposi's sarcomas. The patients were noted to have a severe reduction in a type of cell in the blood (CD4 cells) that is an important part of the immune system. These cells, often referred to as T cells, help the body fight infections. Shortly thereafter, this disease was recognized throughout the United States, Western Europe, and Africa. In 1983, researchers in the United States and France described the virus that causes AIDS, now known as HIV, belonging to t...

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Valcyte

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Valcyte
(valganciclovir hydrochloride) Tablets

Valcyte
(valganciclovir hydrochloride) for Oral Solution

WARNING

HEMATOLOGIC TOXICITY, CARCINOGENICITY, TERATOGENICITY, AND IMPAIRMENT OF FERTILITY

Clinical toxicity of Valcyte (valganciclovir hcl) , 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 (valganciclovir hcl) 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 (valganciclovir hcl) 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 (valganciclovir hcl) 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)?

Stop taking valganciclovir and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
easy bruising, unusual bleeding;
numbness or tingling in a part of the body;
signs of infection (fever, chills, body aches, flu symptoms); or
seizure (convulsions).

Other, less serious side...

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: 9/8/2010
This monograph has been modified to include the generic and brand name in many instances.