Learn more about usage, cautions, and possible side effects .
Chemical Name: EMTRICITABINE (EM-trye-SYE-ta-been) and TENOFOVIR DISOPROXIL FUMARATE (ten-OH-foe-vir dye-soe-PROX-ill FYOU-mar-ate)
This medicine is an antiviral combination of 2 reverse transcriptase inhibitors used to treat HIV infection in combination with other medicines. This medicine is not a cure for HIV or AIDS. It may also be used for other conditions as determined by your doctor.
WARNING: LACTIC ACIDOSIS (buildup of an acid in the blood), a severe and sometimes fatal side effect, has been reported with this type of medicine. Tell your doctor right away if you experience extreme weakness or tiredness; unusual muscle pain; difficulty breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or lightheadedness; or fast or irregular heartbeat. SEVERE AND SOMETIMES FATAL LIVER PROBLEMS have been reported with this type of medicine. Tell your doctor right away if you experience yellowing of the skin or eyes; dark urine; light-colored bowel movements (stools); not feeling like eating for several days; nausea; or stomach pain. THIS MEDICINE HAS NOT BEEN APPROVED TO TREAT HEPATITIS B VIRUS (HBV) INFECTION. The safety and effectiveness of this medicine in patients who have both HBV and HIV infection have not been confirmed. Some patients with both HBV and HIV infection who took this medicine experienced severe worsening of HBV infection after they stopped it. Patients who have both HBV and HIV 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 taking another medicine that contains emtricitabine, tenofovir, adefovir, or lamivudine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking acyclovir; cidofovir; ganciclovir; valacyclovir; valganciclovir; HIV protease inhibitors (eg, atazanavir); lopinavir/ritonavir; didanosine; or medicines that may affect kidney function. Ask your doctor or pharmacist if you are not sure if any of your medicines may affect your kidneys. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including if you have bone problems; kidney problems; dialysis treatment; liver problems; HBV infection; allergies; pregnancy; or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of abnormal liver function tests, severe liver problems, severe kidney problems, or lactic acidosis. Use of this medicine in children under age 18 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
Follow the directions for taking this medicine provided by your doctor. TAKE THIS MEDICINE with or without food. STORE THIS MEDICINE at 77 degrees F (25 degrees C) away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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. 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. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. 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. Also, some conditions (eg, hepatitis B) could become worse if you suddenly stop taking this medicine. Taking this medicine at the same time each day will help you remember to take it. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. DO NOT take more than 1 dose in the same day.
DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. THIS MEDICINE MAY CAUSE DIZZINESS OR LIGHTHEADEDNESS. These effects 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 knows 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 INFECTION. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. THIS MEDICINE DOES NOT STOP THE SPREAD OF HIV TO OTHERS through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. THIS MEDICINE IS NOT FOR THE TREATMENT OF HBV. If you have HBV and HIV, 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. THE RISK OF SEVERE SIDE EFFECTS (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are very overweight (obese), and patients who have taken reverse transcriptase inhibitors (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from this medicine. 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. 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. ASK YOUR DOCTOR if you should take a calcium and vitamin D supplement while you are taking this medicine. Lab tests, including liver and kidney function tests and bone mineral density tests, may be performed to monitor your condition or check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS 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. 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. DO NOT BREAST-FEED while taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include abnormal skin sensations; back pain; changes in body fat (eg, increased fat in the upper back and stomach areas, decreased fat in the face, arms, and legs); cough; diarrhea; dizziness; gas; headache; indigestion; lightening of the skin color on the palms of hands or soles of feet; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); sleeplessness; strange dreams; sweating; vomiting; weakness; or weight loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bone pain; chest pain; chills; dark urine; decreased urination or difficulty urinating; dizziness; extreme weakness or tiredness; fast or irregular heartbeat; feeling cold, especially in the arms and legs; fever; increased thirst; increased urination; light-colored bowel movements (stools); lightheadedness; mental or mood changes (eg, depression); not feeling like eating for several days; numbness, burning, pain, or tingling in the hands or feet; shortness of breath; severe or persistent dizziness; sore throat; stomach pain with nausea and vomiting; unusual muscle pain; unusual tiredness; or yellowing of the skin or eyes. 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. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. 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.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately.
If you have any questions concerning how to prevent spreading HIV infection to other people, ask your doctor, nurse, or pharmacist. Always use a condom during sexual intercourse. 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 YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.
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