"The US Food and Drug Administration (FDA) has approved Gilead Sciences' fixed-dose HIV combination pill Odefsey containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF; 25 mg), the company announced.
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.
LAMIVUDINE/ZIDOVUDINE - ORAL
COMMON BRAND NAME(S): Combivir
WARNING: Zidovudine, one of the medications in this product, can decrease bone marrow function, which may lead to low numbers of red and white blood cells. A low number of red blood cells can lead to anemia. A low number of white blood cells can decrease your body's ability to fight serious, life-threatening infections. These serious side effects occur more frequently in people with advanced HIV disease (AIDS). Seek immediate medical attention if you develop any signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat) or signs of infection (such as fever, chills, cough, persistent sore throat). Your doctor will check your blood cell counts while you are taking this medication to decrease the risk of these side effects.
Zidovudine may also cause muscle problems. Seek immediate medical attention if you develop signs of muscle problems (such as wasting or decrease in muscle size, weight loss, muscle weakness/pain/tenderness).
Rarely, lamivudine and zidovudine have 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 and HIV, you may have a serious worsening of hepatitis symptoms if you stop taking lamivudine. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop lamivudine. Tell your doctor immediately if you develop symptoms of worsening liver problems.
USES: This product contains 2 drugs: lamivudine and zidovudine. It is used 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. Both lamivudine and zidovudine belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).
Lamivudine/zidovudine 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 in combination with other HIV medications 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 lamivudine/zidovudine, and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually 2 times daily or as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.
Because this combination product has fixed doses of lamivudine and zidovudine, it should only be used if your doctor has determined that the doses of both medications in this product are right for you. This product is not to be used in children weighing less than 30 kilograms (66 pounds).
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 times each day.
Additional Combivir Information
Combivir - User Reviews
Combivir User Reviews
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