"On January 7, 2010, FDA approved an updated Atripla label including new efficacy, safety and resistance data in treatment experienced patients from a trial (Study 073: A Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy "...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
EFAVIRENZ/EMTRICITABINE/TENOFOVIR - ORAL
COMMON BRAND NAME(S): Atripla
WARNING: Rarely, this medication has caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). Tell your doctor immediately if you develop symptoms of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, pale stools, dark urine, yellowing eyes/skin, unusual tiredness), or of lactic acidosis (such as stomach discomfort, nausea, vomiting, fast/difficult breathing, drowsiness, muscle pain, weakness, cold skin). These serious side effects may occur more often in women and obese patients.
If you have hepatitis B infection, your hepatitis symptoms may get worse or become very serious if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop efavirenz/emtricitabine/tenofovir. Tell your doctor immediately if you develop symptoms of worsening liver problems.
USES: This product contains 3 different medications: efavirenz, emtricitabine, and tenofovir. It is used alone or with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Efavirenz belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Emtricitabine and tenofovir belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).
Efavirenz/emtricitabine/tenofovir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This product may also be used to reduce the risk of getting HIV infection after contact with the virus. Consult your doctor for more details.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking efavirenz/emtricitabine/tenofovir and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth on an empty stomach, without food, usually once daily at bedtime or as directed by your doctor. Taking this medication at bedtime helps to decrease some of the side effects. See Side Effects section.
Because this combination product has fixed doses of efavirenz, emtricitabine, and tenofovir, you should only use it if your doctor has determined that the doses of all 3 medications in this product are right for you.
It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.
This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.
Additional Atripla Information
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