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Drug Information For:
VIREAD 300MG TABLETS
Ingredient Name:TENOFOVIR DISOPROXIL FUMARATE (te-NOE-fo-veer dye-soe-PROX-ill FYOU-mar-ate)
Drug Manufacturer:GILEAD SCIENCES, INC
Common Uses:This medicine is an antiviral reverse transcriptase inhibitor used for treating HIV infection in combination with other medicines. It is also used to treat chronic hepatitis B virus (HBV) infection. It may also be used for other conditions as determined by your doctor.
Before Using This Medicine:WARNING: Severe and sometimes fatal lactic acidosis (a buildup of lactic acid in the blood) and liver problems have occurred with this type of medicine. The risk may be greater in women, patients who are very overweight, or patients who have been taking nucleoside medicines (eg, emtricitabine, tenofovir) for a long time. TELL YOUR DOCTOR RIGHT AWAY if you develop symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or lightheadedness; fast or irregular heartbeat). TELL YOUR DOCTOR RIGHT AWAY if you develop symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, nausea, stomach pain). SOME PATIENTS WITH HEPATITIS B VIRUS (HBV) infection who took this medicine had severe worsening of HBV infection after they stopped it. Patients who have HBV infection need close medical follow-up to check for worsening liver problems for at least several months after they stop this medicine. Keep all doctor and lab appointments. Do not stop taking this medicine without checking with your doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking adefovir, other medicines that contain tenofovir, or medicines that may harm the kidney (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; cyclosporine; nonsteroidal anti-inflammatory drugs / NSAIDs, such as ibuprofen; tacrolimus; vancomycin). Ask your doctor if you are not sure if any of your medicines might harm your kidneys. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, didanosine, HIV protease inhibitors (eg, atazanavir, lopinavir/ritonavir). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of abnormal liver function tests, liver problems, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of kidney problems (including kidney problems caused by another medicine called adefovir), if you are on dialysis, if you are overweight, or if you are unable to swallow tablets. Tell your doctor if you have osteoporosis (weak bones), a family history of osteoporosis, other risk factors for osteoporosis (eg, smoking, poor nutrition), or a history of bone problems (eg, fracture). Tell your doctor if you have both HIV and HBV infections. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe liver problems (eg, an enlarged liver) or lactic acidosis.Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine:Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. TAKE THIS MEDICINE by mouth with or without food. DO NOT SUDDENLY STOP TAKING THIS MEDICINE without checking with your doctor. This may cause the virus to become less sensitive to this or other medicines. If you have hepatitis B, your condition could become worse if you suddenly stop taking this medicine. DO NOT take more than the recommended dose, change your dose, or stop taking this medicine or any of your medicines without checking with your doctor. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Do not use this medicine if the seal over the bottle opening is broken or missing. Keep this medicine in its original container and keep the container tightly closed. KEEP THIS MEDICINE out of the reach of children and away from pets. Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away, make sure that children or pets cannot find them. TAKING THIS MEDICINE at the same time each day will help you remember to take it. Continue to take this medicine even if you feel well. Do NOT miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, 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.
Cautions:DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. Lab and/or medical tests may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS while you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. THIS MEDICINE MAY CAUSE DIZZINESS. This effect may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. KEEP A LIST of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using this medicine. Be sure that each of your health care providers know all the medicines that you are taking. WHEN YOUR MEDICINE SUPPLY IS LOW, get more from your doctor or pharmacist as soon as you can. Do not stop taking this medicine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. THIS MEDICINE IS NOT A CURE FOR HIV OR HBV INFECTION. Patients infected with HIV may still get illnesses and infections associated with the disease. Remain under the care of your doctor. THIS MEDICINE DOES NOT STOP THE SPREAD OF HIV or HBV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV or HBV. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV or HBV to others. IF YOU HAVE HBV INFECTION, you will need close medical follow-up for several months after stopping treatment with this medicine. Follow-up includes medical exams and blood tests to check for HBV infection that could be getting worse. THIS MEDICINE MAY IMPROVE immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start this medicine. CHECK WITH YOUR DOCTOR to see if you should take a calcium and vitamin D supplement while you are taking this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. THE DOSE OF THIS MEDICINE IN CHILDREN is determined based on body weight; they will need to have regular weight checks while they take this medicine. FOR WOMEN: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. It is not known if this medicine is found in breast milk. MOTHERS INFECTED WITH HIV SHOULD NOT BREAST-FEED. There is a risk of passing the HIV infection or this medicine to the baby. Donot breast-feed while taking this medicine.
Possible Side Effects:SIDE EFFECTS that may occur while taking this medicine include back pain; diarrhea; dizziness; gas; headache; indigestion; loss of appetite; nausea; runny or stuffy nose; sweating; tiredness; trouble sleeping; vomiting; weakness; or weight loss. If they continue or are bothersome, check with your doctor. CHANGES IN BODY FAT (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking this medicine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience anxiety; bone pain; change in the amount of urine produced; chest pain; depression; fever, chills, or persistent sore throat; muscle pain, weakness, or cramping; numbness, burning, pain, or tingling in the hands or feet; severe or persistent nausea or vomiting; shortness of breath; symptoms of lactic acidosis (eg, unusual weakness or tiredness; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or lightheadedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite; stomach pain). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose:If overdose is suspected, contact your local poison control center or emergency room immediately.
Additional Information:If you have HIV infection, you should be tested for HBV infection before you start to take this medicine. If you have HBV infection, you should be tested for HIV infection before you start to take this medicine. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
Copyright 2014 Wolters Kluwer Health, Inc.