"Aug. 11, 2011 -- The FDA has approved Gilead's Complera, the second complete HIV treatment in a single, once-daily pill.
Complera is a combination of Truvada (which combines the nucleoside reverse transcriptase inhibitors Emtriva and "...
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 medications to help control your HIV infection, thereby improving your quality of life. It helps to decrease the amount of HIV in your body so your immune system can work better. It also lowers your risk of getting HIV disease complications (such as new infections, cancer). 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 and it does not prevent the spread of HIV to others through sexual contact or blood contamination (such as sharing used needles).
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 medication may also be used to prevent HIV infection after contact with the virus.
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
Atripla - User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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