Emtriva

DRUG DESCRIPTION

EMTRIVA is the brand name of emtricitabine, a synthetic nucleoside analog with activity against human immunodeficiency virus type 1 (HIV-1) reverse transcriptase.

The chemical name of emtricitabine is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3oxathiolan-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:

EMTRIVA®  (emtricitabine) Structural Formula Illustration

Emtricitabine is a white to off-white powder with a solubility of approximately 112 mg/mL in water at 25 °C. The log P for emtricitabine is -0.43 and the pKa is 2.65.

EMTRIVA is available as capsules or as an oral solution.

EMTRIVA capsules are for oral administration. Each capsule contains 200 mg of emtricitabine and the inactive ingredients, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone.

EMTRIVA oral solution is for oral administration. One milliliter (1 mL) of EMTRIVA oral solution contains 10 mg of emtricitabine in an aqueous solution with the following inactive ingredients: cotton candy flavor, FD&C yellow No. 6, edetate disodium, methylparaben, and propylparaben (added as preservatives), sodium phosphate (monobasic), propylene glycol, water, and xylitol (added as a sweetener). Sodium hydroxide and hydrochloric acid may be used to adjust pH.

What are the possible side effects of emtricitabine (Emtriva)?

Stop using emtricitabine and 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.

Emtricitabine 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;
  • ...

Read All Potential Side Effects and See Pictures of Emtriva »

What are the precautions when taking emtricitabine (Emtriva)?

Before taking emtricitabine, tell your doctor or pharmacist if you are allergic to it; 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, cirrhosis), alcohol use.

Before having surgery, tell your doctors 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...

Read All Potential Precautions of Emtriva »


Emtriva Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, nausea, diarrhea, trouble sleeping, or darkening skin color on palms of hands and soles of feet may occur. If any of these effects persist or worsen, notify 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression).

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

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, 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 emtricitabine, tell your doctor or pharmacist if you are allergic to it; 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, cirrhosis), alcohol use.

Before having surgery, tell your doctors 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.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug.

During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Emtricitabine may be part of that treatment. Discuss the risks and benefits with your doctor.

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


Emtriva Patient Information Including Side Effects

Brand Names: Emtriva

Generic Name: emtricitabine (Pronunciation: em trye SYE ta been)

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

What is emtricitabine (Emtriva)?

Emtricitabine is an antiviral medication. It is in a category of HIV medicines called reverse transcriptase inhibitors. Emtricitabine works by preventing HIV cells from multiplying in the body.

Emtricitabine is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). Emtricitabine is not a cure for HIV or AIDS.

Emtricitabine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of emtricitabine (Emtriva)?

Stop using emtricitabine and 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.

Emtricitabine 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;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • slow or uneven heart rate.

Emtricitabine may also cause severe liver damage, which can be fatal. Call your doctor at once if you have any of these symptoms of liver problems:

  • nausea, stomach pain;
  • loss of appetite;
  • low fever;
  • dark urine;
  • clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Early in your treatment with emtricitabine, you may have a flare-up of other infections such as tuberculosis, pneumonia, or cytomegalovirus. Contact your doctor if you develop any possible symptoms of other infections, such as fever, chills, sore throat, cough, flu symptoms, or problems with breathing or vision.

Less serious side effects may include:

  • headache;
  • diarrhea, mild nausea or stomach pain;
  • darkened patches of skin on your palms and/or soles;
  • sleep problems (insomnia);
  • cough, runny nose;
  • skin rash; or
  • change in the shape or location of body fat (especially in the arms, legs, face, neck, breasts, and trunk).

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 emtricitabine (Emtriva)?

Some people have developed a life-threatening condition called lactic acidosis while taking entricitabine. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. 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, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Emtricitabine may also cause severe liver damage, which can be fatal. Call your doctor at once if you have any of these symptoms of liver problems: nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Treatment of HIV/AIDS almost always requires using many medicines together. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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