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|Atripla

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 Atripla
• you have moderate to severe kidney problems
• you have a history of abnormal liver function tests, severe liver problems (eg, enlarged or fatty liver), or lactic acidosis
• you are taking carbamazepine, cisapride, an ergot derivative (eg, ergotamine), an H₁ antagonist (eg, astemizole, terfenadine), midazolam, St. John"s wort, triazolam, or voriconazole
• you are taking a medicine that contains lamivudine, or another medicine that contains efavirenz, emtricitabine, or tenofovir

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-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of bone problems (eg, osteoporosis, fracture), seizures, diabetes, kidney problems (including dialysis treatment), or liver problems (eg, hepatis B infection)
• if you have a history of mental or mood problems, suicidal thoughts or actions, or alcohol or other substance abuse or dependence
• if 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, cisapride, ergot derivatives (eg, ergotamine), midazolam, terfenadine, or triazolam because the risk of irregular heartbeat, severe drowsiness, or breathing problems may be increased
• Acyclovir, adefovir, cidofovir, ganciclovir, other medicines that may harm the kidney, valacyclovir, or valganciclovir 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 kidney
• Lamivudine or medicines that contain efavirenz, emtricitabine, or tenofovir because they may increase the risk of Atripla "s side effects
• HIV protease inhibitors (eg, atazanavir, lopinavir, ritonavir) because they may decrease Atripla "s effectiveness or increase the risk of Atripla "s side effects
• Rifabutin, rifampin, or St. John"s wort because they may decrease Atripla "s effectiveness
• Didanosine because the risk of its side effects may be increased by Atripla
• Warfarin because its effectiveness may be decreased or the risk of its side effects may be increased by Atripla
• Azole antifungals (eg, ketoconazole), carbamazepine, clarithromycin, HMG-CoA reductase inhibitors (eg, atorvastatin), methadone, phenobarbital, phenytoin, sertraline, or voriconazole because their effectiveness may be decreased by Atripla

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.
• Taking Atripla at the same time each day will help you remember to take it.
• 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.
• Do not 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.
• Dizziness, drowsiness, trouble sleeping, trouble concentrating, and strange dreams are common side effects during the first few weeks of therapy with Atripla . If any of these occur, check with your doctor about whether you should take your medicine at bedtime. This may help make these effects more tolerable.
• 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 effective birth control while you take Atripla . It is unknown how Atripla effects birth control (eg, birth control pills). 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, 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.
• 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 are using 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 this medicine. 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; headache; loss of appetite; muscle or joint aches; nausea; skin discoloration (small spots or freckles); stomach upset; strange dreams; stuffy nose; tiredness; trouble concentrating; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; decreased urination; delusions; fever, chills, or sore throat; hallucinations; lactic acidosis (eg, cold feeling, especially in the arms and legs; severe or persistent dizziness or lightheadedness; extreme weakness or tiredness; fast or irregular heartbeat; stomach pain with nausea or vomiting; trouble breathing; unusual muscle pain); liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); memory loss; mental, mood, or behavior changes (eg, depression); numbness, burning, pain, or tingling of the hands, feet, or skin; red, swollen, blistered, or peeling skin; seizures; stomach pain; suicidal thoughts or actions.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include muscle twitching or severe dizziness, drowsiness, or coordination problems.

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. Do not store in the bathroom. Do not use Atripla if 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.

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.