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|Cytovene Capsules

Cytovene Capsules

Cytovene Capsules is used for:

Preventing CMV infection in patients with HIV infection or certain organ transplant patients. It is used as an alternative to the injectable form of Cytovene Capsules for treating CMV eye infection in patients with a weakened immune system. It may also be used for other conditions as determined by your doctor.

Cytovene Capsules is an antiviral agent. It works by blocking reproduction of the CMV virus.

Do NOT use Cytovene Capsules if:

• you are allergic to any ingredient in Cytovene Capsules or to acyclovir
• you have very low white blood cell or platelet levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cytovene Capsules:

Some medical conditions may interact with Cytovene Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of blood disorders, kidney problems, other eye problems, HIV infection, or bone marrow problems
• if you are on dialysis or do not have a weakened immune system
• if you have low white blood cell or platelet levels, or if you have a history of low white blood cell or platelet levels caused by medicine, chemotherapy, or radiation

Some MEDICINES MAY INTERACT with Cytovene Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney
• Imipenem/cilastin because seizures may occur
• Probenecid because it may increase the risk of Cytovene Capsules"s side effects
• Zidovudine because the risk of blood disorders may be increased
• Adriamycin, amphotericin B, dapsone, didanosine, flucytosine, pentamidine, trimethoprim/sulfamethoxazole, vinblastine, or vincristine because the risk of their side effects may be increased by Cytovene Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cytovene Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cytovene Capsules:

Use Cytovene Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cytovene Capsules by mouth with food.
• Swallow Cytovene Capsules whole. Do not break, crush, or chew before swallowing.
• Drinking extra fluids while you are taking Cytovene Capsules is recommended. Check with your doctor for instructions.
• Continue to use Cytovene Capsules even if you feel well. Do not miss any doses.
• Use caution when handling the capsules. Avoid contact with your skin, eyes, mouth, or nose if a capsule is broken or crushed. If such contact occurs, wash thoroughly with soap and water or rinse your eyes with plain water.
• If you miss a dose of Cytovene Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cytovene Capsules.

Important safety information:

• Cytovene Capsules may cause dizziness and drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Cytovene Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Cytovene Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Cytovene Capsules may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Cytovene Capsules is not a cure for CMV infection and you may continue to experience effects of the infection during or after treatment.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Tell your doctor or dentist that you take Cytovene Capsules before you receive any medical or dental care, emergency care, or surgery.
• Cytovene Capsules has been shown to cause cancer in animals, and may cause cancer in humans. Discuss any questions or concerns with your doctor.
• If you may become pregnant, you must use an effective form of birth control while you take Cytovene Capsules. If you have questions about effective birth control, talk with your doctor.
• Cytovene Capsules may lower sperm production and make you unable to have children. Discuss any questions or concerns with your doctor.
• Men who take Cytovene Capsules should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Cytovene Capsules and for at least 90 days after you stop taking it.
• Lab tests, including kidney function tests, eye examinations, and complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Cytovene Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
• Cytovene Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Cytovene Capsules may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cytovene Capsules while you are pregnant. It is not known if Cytovene Capsules is found in breast milk. Do not breast-feed while using Cytovene Capsules.

Possible side effects of Cytovene Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; loss of appetite; sweating; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; confusion; fever, chills, or sore throat; numbness or tingling of hands or feet; pain, swelling, or redness at the injection site; severe or persistent stomach pain; unusual bleeding or bruising; unusual tiredness or weakness; vision changes (eg, blurred vision, flashes of light); vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased urination; severe diarrhea or vomiting.

Store Cytovene Capsules between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cytovene Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Cytovene Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Cytovene Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cytovene Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.