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).
Atripla is not approved to treat hepatitis B virus (HBV) infection. Safety and effectiveness have not been confirmed in patients who have both HIV and HBV. Some patients with HBV who were treated with similar medicines have had severe worsening of liver problems after they stopped treatment. Patients with both HIV and HBV who take Atripla should have medical exams and liver function tests performed for at least several months after they stop taking Atripla.
Atripla is used for:
Treating HIV infection alone or along with other medicines.
Atripla is an antiviral combination of 3 reverse transcriptase inhibitors. It works by slowing the growth of HIV, the virus that causes AIDS. Atripla is not a cure for HIV or AIDS.
Do NOT use Atripla if:you are allergic to any ingredient in Atriplayou have developed red, swollen, blistered, or peeling skin after taking efavirenz, a component of Atriplayou have moderate to severe kidney problemsyou have abnormal liver function tests, moderate to severe liver problems (eg, enlarged or fatty liver), or lactic acidosisyou are taking adefovir, astemizole, atazanavir, bepridil, cisapride, an ergot derivative (eg, dihydroergotamine, ergotamine), midazolam, pimozide, St. John's wort, terfenadine, triazolam, or voriconazoleyou are taking a medicine that contains lamivudine, or another medicine that contains efavirenz, emtricitabine, or tenofoviryou take a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask your doctor if you are not sure if any of your medicines might harm your kidneys
Contact your doctor or health care provider right away if any of these apply to you.
Before using Atripla:
Some medical conditions may interact with Atripla. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:if you are pregnant, planning to become pregnant, or are breast-feedingif you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplementif you have allergies to medicines, foods, or other substancesif you have a history of bone problems (eg, fracture, osteoporosis), seizures, diabetes, high cholesterol, kidney problems (including dialysis treatment), lactic acidosis, or liver problems (eg, hepatitis, abnormal liver function tests)if you have a history of mental or mood problems (eg, depression), suicidal thoughts or actions, or alcohol or other substance abuse or dependenceif you are very overweight
Some MEDICINES MAY INTERACT with Atripla. Tell your health care provider if you are taking any other medicines, especially any of the following:Astemizole, bepridil, cisapride, ergot derivatives (eg, ergotamine), midazolam, pimozide, terfenadine, or triazolam because the risk of irregular heartbeat, severe drowsiness, or breathing problems may be increasedAcyclovir, adefovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, or other medicines that may harm the kidneys (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, NSAIDs [eg, ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Atripla's side effects. Ask your doctor or pharmacist if you are not sure if any of your medicines may harm the kidneysLamivudine or other medicines that contain efavirenz, emtricitabine, or tenofovir because they may increase the risk of Atripla's side effectsHIV protease inhibitors (eg, atazanavir , ritonavir) because they may decrease Atripla's effectiveness or increase the risk of Atripla's side effectsRifamycins (eg, rifampin) or St. John's wort because they may decrease Atripla's effectivenessDidanosine because the risk of its side effects may be increased by AtriplaWarfarin because its effectiveness may be decreased or the risk of its side effects may be increased by AtriplaAzole antifungals (eg, ketoconazole, posaconazole, voriconazole), calcium channel blockers (eg, diltiazem, verapamil), carbamazepine, cyclosporine, HMG-CoA reductase inhibitors (eg, atorvastatin), hormonal contraceptives (eg, birth control pills, etonogestrel), macrolide antibiotics (eg, clarithromycin), maraviroc, methadone, phenobarbital, phenytoin, rifabutin, sertraline, sirolimus, or tacrolimus because their effectiveness may be decreased by AtriplaMedicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if Atripla may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Atripla:
Use Atripla as directed by your doctor. Check the label on the medicine for exact dosing instructions.An extra patient leaflet is available with Atripla. Talk to your pharmacist if you have questions about this information.Take Atripla by mouth on an empty stomach at least 1 hour before or 2 hours after eating.Take Atripla with a full glass of water (8 oz/240 mL).Do not take Atripla if the seal over the bottle opening is broken or missing.Continue to take Atripla even if you feel well. Do not miss any doses.Take Atripla at the same time each day, preferably at bedtime, unless otherwise directed by your doctor.Do not suddenly stop taking Atripla 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 Atripla.If you miss a dose of Atripla, 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.
Ask your health care provider any questions you may have about how to use Atripla.
Important safety information:Atripla may cause drowsiness, dizziness, or trouble concentrating. These effects may be worse if you take it with alcohol or certain medicines. Use Atripla with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Atripla; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.Atripla may cause dizziness, drowsiness, trouble sleeping, trouble concentrating, or unusual dreams. These effects usually go away after you have taken Atripla for about 2 to 4 weeks. Taking it at bedtime may help to decrease these effects. Check with your doctor if they continue or are severe.Do NOT take more than the recommended dose, change your dose, or stop taking Atripla without checking with your doctor. Taking more than the recommended dose may not provide additional benefits and may increase the risk of side effects.You should be tested for HBV infection before you start to take Atripla.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 Atripla. Be sure that each of your health care providers knows all the medicines that you are taking.Atripla is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.Atripla 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.When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Atripla, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.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 Atripla. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.Atripla 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 Atripla.Check with your doctor to see if you should take a calcium and vitamin D supplement while you are taking Atripla.Diabetes patients - Atripla may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.Women who may become pregnant should have a negative pregnancy test before they start to take Atripla. Discuss any questions or concerns with your doctor.If you may become pregnant, you must use an effective form of birth control while you take Atripla and for 12 weeks after you stop taking it. Hormonal birth control (eg, birth control pills) may not work as well while you are using Atripla. You should always use a barrier form of birth control (eg, condoms), even if you already use a hormonal birth control method. If you have questions about effective birth control, talk with your doctor.Atripla may affect certain lab tests, including drug tests. Be sure your doctor and lab personnel know you are taking Atripla.Lab tests, including liver and kidney function, cholesterol and triglyceride levels, and bone density, may be performed while you use Atripla. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.Use Atripla with caution in the ELDERLY; they may be more sensitive to its effects.Atripla should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.PREGNANCY and BREAST-FEEDING: Atripla may cause harm to the fetus. Do not become pregnant while you take Atripla and for 12 weeks after you stop taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Atripla while you are pregnant. It is not known if Atripla is found in breast milk. Do not breast-feed while taking Atripla. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Atripla to the baby.
Possible side effects of Atripla:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; drowsiness; gas or indigestion; headache; loss of appetite; mild stomach pain; muscle or joint aches; nausea; skin discoloration (small spots or freckles); stomach upset; strange dreams; stuffy or runny nose; tiredness; trouble concentrating; trouble sleeping; vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; change in personality; chest pain; confusion; decreased coordination; delusions; fever, chills, or persistent sore throat; hallucinations; memory loss; mental, mood, or behavior changes (eg, abnormal thoughts, agitation, aggression, anxiety, depression, nervousness, paranoia); muscle pain or weakness; numbness, burning, pain, or tingling of the hands, feet, or skin; red, swollen, blistered, or peeling skin; seizures; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; suicidal thoughts or actions; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, dizziness or lightheadedness; fast or difficult breathing; fast or irregular heartbeat; feeling cold, especially in the arms and legs; stomach pain with nausea and vomiting; unusual muscle pain; unusual weakness or tiredness); symptoms of liver problems (eg, dark urine; pale stools; persistent loss of appetite; yellowing of the skin or eyes).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If Overdose is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include hallucinations; muscle twitching; severe dizziness, drowsiness, or coordination problems; trouble concentrating; trouble sleeping.Proper storage of Atripla:
Store Atripla at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Store only in original container and keep it tightly closed. Do not store in the bathroom. Do not use Atripla if it is past the expiration date on the bottle. Keep Atripla out of the reach of children and away from pets.
General information:If you have any questions about Atripla, please talk with your doctor, pharmacist, or other health care provider.Atripla is to be used only by the patient for whom it is prescribed. Do not share it with other people.If your symptoms do not improve or if they become worse, check with your doctor.Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Atripla. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.