Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.
Emtricitabine is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of emtricitabine have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV and HBV and discontinue emtricitabine. If appropriate, initiation of anti-hepatitis B therapy may be warranted .
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Emtricitabine is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine; monitor hepatic function upon discontinuation of therapy .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiretroviral Agent
Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor
Emtricitabine is used together with other medicines to treat human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
HIV infection destroys CD4 (T) cells, which are important to the immune system in your body. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI). It blocks HIV reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV to multiply. emtricitabine may lower the amount of HIV in your blood (viral load). It may also help to increase the number of T cells, also called CD4 cells. Lowering the amount of HIV in your blood lowers the chance of having problems when your immune system is weak.
Emtricitabine will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system.
Emtricitabine will not keep you or your child from spreading HIV to other people. People who receive emtricitabine may continue to have the problems usually related to AIDS or HIV disease.
emtricitabine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For emtricitabine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to emtricitabine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of emtricitabine in children.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emtricitabine in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems which may require an adjustment of dose in patients receiving emtricitabine.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of emtricitabine. Make sure you tell your doctor if you have any other medical problems, especially:
Take emtricitabine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking emtricitabine without checking with your doctor first.
It is important to take emtricitabine together in combination with other HIV medicines. Take all other medicines your doctor prescribed at the right time of the day. This will make your medicines work better.
When your emtricitabine supply runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to emtricitabine and be harder to treat.
emtricitabine can be taken with or without food.
Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
emtricitabine comes with patient instructions. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. You should talk to your doctor if you have any questions.
The dose of emtricitabine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of emtricitabine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of emtricitabine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the capsules in a closed container at room temperature, away from heat, moisture, and direct light.
Store the oral solution in the refrigerator if possible. Do not freeze. If the solution must be stored at room temperature, throw away any unused medicine after 3 months.
It is very important that your doctor check your progress at regular visits to make sure that emtricitabine is working properly. Blood tests may be needed to check for unwanted effects. Also, you or your child should remain under the care of a doctor while taking emtricitabine.
You or your child should not use emtricitabine if you are also taking lamivudine, Atripla™, Combivir®, Epivir®, Epivir-HBV®, Epzicom®, Trizivir®, or Truvada®. Tell your doctor right away if you are using any of these medicines. Do not start using emtricitabine until your doctor tells you to.
Two rare but serious reactions to emtricitabine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: abdominal discomfort or cramping; dark urine; decreased appetite; diarrhea; general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.
emtricitabine may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.
When you or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (e.g., pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.
You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
Emtricitabine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles with anyone or use dirty needles. If you have any questions about this, check with your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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