Product Description

VALGAN 450MG (VALGANCICLOVIR)

WHAT IS VALGAN (VALGANCICLOVIR)?

WHAT THE USES VALGAN 450 MG (VALGANCICLOVIR) ?

HOW VALGAN 450 MG  (VALGANCICLOVIR) WORKS?

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT VALGAN 450 MG (VALGANCICLOVIR)?

Valganciclovir has caused birth defects in animal studies. Do not use valganciclovir without telling your doctor if you are pregnant. Use birth control to prevent pregnancy, whether you are a man or a woman. Valganciclovir use by either parent may cause birth defects. A man taking valganciclovir should use a condom during treatment, and for at least 90 days after treatment ends. Serious infections may occur during treatment with valganciclovir. Stop using this medicine and call your doctor right away if you have signs of infection such as fever, chills, sore throat, weakness, cold or flu symptoms, painful mouth sores, pale skin, easy bruising or bleeding, dry cough, weight loss, or trouble breathing. Valganciclovir (Valgan) and ganciclovir (Cytovene) must never be taken together.

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING VALGAN 450 MG (VALGANCICLOVIR)?

You should not use this medicine if you are allergic to valganciclovir or ganciclovir (Cytovene). Valganciclovir (Valgan) and ganciclovir (Cytovene) must never be taken together. Your doctor may have switched you from ganciclovir (Cytovene) to valganciclovir (Valgan). The strength of these two medications is different. A valganciclovir tablet contains more medicine than a ganciclovir capsule. You may not need to use as many valganciclovir tablets as you did ganciclovir capsules. Take only the number of valganciclovir tablets your doctor has prescribed.

To make sure valganciclovir is safe for you, tell your doctor if you have:

1.  kidney disease (or if you are on dialysis);
2. a blood cell disorder (such as anemia or low levels of platelets in your blood); or
3. if you are receiving radiation treatment or drugs that weaken your immune system (such as cancer medicine or steroids).

Valganciclovir can cause birth defects. Do not use it if you are pregnant, and tell your doctor right away if you become pregnant. You may need to have a negative pregnancy test before taking valganciclovir. Use effective birth control while you are taking valganciclovir and for at least 30 days after your treatment ends. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Valganciclovir will not prevent congenital (inherited) CMV in a newborn baby. If a man fathers a child while using valganciclovir, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir. This medication can affect fertility (your ability to have children), whether you are a man or a woman. You should not breastfeed while you are taking valganciclovir. Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

HOW SHOULD I TAKE VALGAN  450 MG (VALGANCICLOVIR)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Valganciclovir tablets are for adults or children, but valganciclovir liquid is only for children. Adults should not use the oral solution or the dose may not be correct. Take valganciclovir with food. Drink plenty of liquids while you are taking valganciclovir. Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. Do not crush or break a valganciclovir tablet. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.

While using valganciclovir, you may need frequent blood tests. You should have your eyes checked at least every 4 to 6 weeks while you are using valganciclovir. Your doctor may want you to have eye exams more often. Use valganciclovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Store valganciclovir tablets at room temperature away from moisture and heat. Store valganciclovir liquid in the refrigerator. Do not freeze. Throw away any unused after 49 days.

WHAT HAPPENS IF I MISS A DOSE FOR VALGAN  450 MG (VALGANCICLOVIR)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.

WHAT HAPPENS IF I OVERDOSE FOR VALGAN  450 MG (VALGANCICLOVIR)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include urinating less than usual or not at all, swelling, weight gain, stomach pain, nausea, vomiting, signs of infection (fever, chills, sore throat, flu symptoms), or jaundice (yellowing of the skin or eyes).

WHAT SHOULD I AVOID WHILE TAKING VALGAN450 MG (VALGANCICLOVIR)?

Valganciclovir may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drugs or medicine needles is never safe, even for a healthy person. Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Avoid activities that may increase your risk of bleeding or injury.

WHAT OTHER DRUGS WILL AFFECT VALGAN 450 MG (VALGANCICLOVIR)?

Valganciclovir can harm your kidneys. This effect is increased when you also use certain other medicines, including antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, an injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve). Other drugs may interact with valganciclovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all the medicines you use now and any medicine you start or stop using.

WHERE CAN I GET MORE INFORMATION FOR VALGAN  450 MG (VALGANCICLOVIR)?

Your pharmacist can remember, keep this and all other medicines out of the reach of children, never share your medicines with others and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time-sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to and provide more information about valganciclovir.

A substitute for, the expertise, skill, knowledge, and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective, or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

WHAT IS SIDE EFFECTS FOR VALGAN 450 MG (VALGANCICLOVIR)?

Night sweats, Pain, Abdominal pain, Abnormal thoughts, Anxiety, Back pain, Blood infection, Bone pain, Stiffness, Chest pain, Chills, Confusion, Constipation, Convulsion, Cough, Decrease in body weight, Depression, Disorientation (alteration of mental status), Dizziness, Altered taste, Difficulty in swallowing, Ear pain, Decreased red blood cell count, Eye pain, Fatigue, Fever, Fungal infection of the mouth, Headache, Increased creatinine level in the blood, Indigestion, Insomnia, Liver enzyme increased, Loss of appetite, Feeling of discomfort, Muscle cramp, Muscle pain, Nausea, Renal impairment, Retinal detachment, Skin inflammation, Itching, Skin redness, Swelling, Urinary tract infection, Vitreous humor (part of the eye) floaters, Vomiting, Weakness, Abnormal sensation in the skin

WHAT IS EXPERT ADVICE FOR VALGAN 450 MG (VALGANCICLOVIR)?

1. Special care should be taken in patients who have hematological cytopenia (deficiency in cellular elements in circulating blood) or a history of drug-related hematological cytopenia and in patients receiving radiotherapy or hemodialysis.
2. Seek medical advice from your doctor while taking valganciclovir as it has the potential to cause birth defects, cancers, temporary or permanent failure of sperm production.
3. Valganciclovir may reduce the blood cell count. Do not start the treatment until the neutrophil count is >500 cells/?l, platelet count >25000/?l, or hemoglobin level >8 g/dl.
4. Females of childbearing potential should use effective contraception while on valganciclovir therapy.
5. Males should practice barrier contraception during treatment for? 9 0 days and thereafter unless it is sure that the female partner is not at risk of pregnancy.
6. Tell your doctor if you are taking imipenem-cilastatin, as it may cause fits if taken concomitantly.
7. Do not take didanosine, zidovudine, mycophenolate mofetil, mycophenolic acid, or probenecid while taking valganciclovir as it may worsen the side effects.
8. You may be monitored with complete blood counts and platelet counts tests at regular intervals during valganciclovir treatment.
9. Do not drive or operate machinery as valganciclovir may make you drowsy, dizzy, unsteady, confused, less alert, or cause seizures.

FREQUENTLY ASKED QUESTIONS FOR VALGAN 450 MG (VALGANCICLOVIR)