Atripla

DRUG DESCRIPTION

ATRIPLA is a fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate (tenofovir DF). SUSTIVA is the brand name for efavirenz, a non-nucleoside reverse transcriptase inhibitor. EMTRIVA is the brand name for emtricitabine, a synthetic nucleoside analog of cytidine. VIREAD is the brand name for tenofovir DF, which is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. VIREAD and EMTRIVA are the components of TRUVADA.

ATRIPLA tablets are for oral administration. Each tablet contains 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir DF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablets are film-coated with a coating material containing black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.

Efavirenz: Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is:

Efavirenz Structural Formula Illustration

Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (less than 10 ?g/mL).

Emtricitabine: The chemical name of emtricitabine is 5-fluoro-1-(2R,5S)-[2(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position.

It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula:

Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25C.

Tenofovir Disoproxil Fumarate: Tenofovir DF is a fumaric acid salt of the bisisopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir disoproxil fumarate is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula:

Tenofovir DF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 C.

What are the possible side effects of efavirenz, emtricitabine, and tenofovir (Atripla)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Efavirenz, emtricitabine, and tenofovir may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing,...

Read All Potential Side Effects and See Pictures of Atripla

What are the precautions when taking efavirenz, emtricitabine, and tenofovir disoproxil fumarate (Atripla)?

Before taking efavirenz/emtricitabine/tenofovir, tell your doctor or pharmacist if you are allergic to any of the ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), mental/mood conditions (such as depression, thoughts of suicide, psychosis), drug/substance/alcohol abuse, seizures, high cholesterol/triglyceride levels, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), disease of the pancreas (pancreatitis).

This drug may make you dizzy or...

Read All Potential Precautions of Atripla


Atripla Consumer (continued)

SIDE EFFECTS: See also Warning and How to Use sections.

Dizziness, trouble sleeping, drowsiness, unusual dreams, and trouble concentrating may frequently occur. These side effects may begin 1-2 days after starting this medication and usually go away in 2-4 weeks. They are also reduced by taking this medication on an empty stomach at bedtime.

Tiredness, headache, nausea, vomiting, diarrhea, and skin discoloration (such as small spots/freckles, darkening of the palms of the hands/soles of the feet) may also occur.

If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, serious psychiatric symptoms may occur during efavirenz/emtricitabine/tenofovir treatment. These effects may be seen especially in people who have mental/mood conditions. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, rare thoughts of suicide, strange thoughts, anxiety, angry behavior, hallucinations, confusion).

Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of the hands/feet.

Tell your doctor immediately if any of these rare but serious side effects occur: signs of kidney problems (such as a change in the amount of urine), unusual thirst, muscle cramps/weakness, bone pain, easily broken bones, signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever).

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Efavirenz/emtricitabine/tenofovir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, blisters, peeling skin, fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking efavirenz/emtricitabine/tenofovir, tell your doctor or pharmacist if you are allergic to any of the ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), mental/mood conditions (such as depression, thoughts of suicide, psychosis), drug/substance/alcohol abuse, seizures, high cholesterol/triglyceride levels, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), disease of the pancreas (pancreatitis).

This drug may make you dizzy or drowsy or cause trouble concentrating. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Avoid alcohol and street drugs because they may worsen the side effects of this medication (such as liver problems, pancreatitis, dizziness, drowsiness, mental/mood symptoms).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

This medication is not recommended for use during pregnancy. It may harm an unborn baby, especially if taken during the first 3 months of pregnancy. Women of childbearing age should have a pregnancy test before starting efavirenz/emtricitabine/tenofovir. It is important to prevent pregnancy while taking this medication and for 3 months after treatment. Consult your doctor about using at least 2 reliable forms of birth control (such as condoms with birth control pills) during treatment and for 3 months after the end of treatment. This medication decreases the effectiveness of hormonal birth control products, so you must always use a barrier protection with these products. If you become pregnant or think you may be pregnant, tell your doctor immediately. Discuss the risks and benefits and other HIV treatment options during pregnancy to decrease the risk of HIV transmission to the baby.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Atripla Patient Information Including Side Effects

Brand Names: Atripla

Generic Name: efavirenz, emtricitabine, and tenofovir (Pronunciation: ef AV ir enz, em trye SYE ta been, and ten OF oh vir)

  • What is efavirenz, emtricitabine, and tenofovir (Atripla)?
  • What are the possible side effects of efavirenz, emtricitabine, and tenofovir (Atripla)?
  • What is the most important information I should know about efavirenz, emtricitabine, and tenofovir (Atripla)?
  • What should I discuss with my healthcare provider before taking efavirenz, emtricitabine, and tenofovir (Atripla)?
  • How should I take efavirenz, emtricitabine, and tenofovir (Atripla)?
  • What happens if I miss a dose (Atripla)?
  • What happens if I overdose (Atripla)?
  • What should I avoid while taking efavirenz, emtricitabine, and tenofovir (Atripla)?
  • What other drugs will affect efavirenz, emtricitabine, and tenofovir (Atripla)?
  • Where can I get more information?

What is efavirenz, emtricitabine, and tenofovir (Atripla)?

Efavirenz, emtricitabine, and tenofovir is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

Efavirenz, emtricitabine, and tenofovir treats HIV, which causes acquired immunodeficiency syndrome (AIDS). Efavirenz, emtricitabine, and tenofovir is not a cure for HIV or AIDS.

Efavirenz, emtricitabine, and tenofovir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of efavirenz, emtricitabine, and tenofovir (Atripla)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Efavirenz, emtricitabine, and tenofovir may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have any of these other serious side effects:

  • signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • fever, chills, body aches, flu symptoms;
  • unusual thoughts or behavior, severe depression, extreme fear, thoughts of hurting yourself or others, hallucinations;
  • severe blistering, peeling, and red skin rash; or
  • seizure (convulsions).

Less serious side effects may include:

  • dizziness, drowsiness, anxiety, depressed mood;
  • headache, tired feeling, ringing in your ears, vision problems;
  • sleep problems (insomnia), confusion, strange dreams, forgetfulness;
  • mild nausea, vomiting, diarrhea, loss of appetite, upset stomach;
  • darkened skin on the palms of your hands or the soles of your feet;
  • joint pain, back pain;
  • numbness or tingly feeling;
  • runny or stuffy nose, cough; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about efavirenz, emtricitabine, and tenofovir (Atripla)?

Do not use this medication while you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment.

Do not take this medication if you are also taking cisapride (Propulsid), midazolam (Versed), triazolam (Halcion), St. John's wort, voriconazole (Vfend), or an ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine). Do not take this medication with other medicines that also contain efavirenz, emtricitabine, tenofovir (Sustiva, Emtriva, Truvada, or Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

There are many other medicines that can cause interactions or serious medical problems if you take them together with efavirenz, emtricitabine, and tenofovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Some people have developed a life-threatening condition called lactic acidosis while taking this medication. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Efavirenz, emtricitabine, and tenofovir can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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