Epzicom treats HIV infection. Do not skip any doses as this may make it more difficult to treat HIV.
Epzicom is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults. Epzicom belongs to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help decrease the amount of HIV in your blood.
This medication comes in tablet form and is taken once a day, with or without food.
Common side effects of Epzicom include trouble sleeping, depression, and headache.
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Uses of Epzicom
Epzicom is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
For more information on this medication choose from the list of selections below.
Epzicom Drug Class
Epzicom is part of the drug class:
Side Effects of Epzicom
Epzicom can cause the following serious side effects:
- Serious allergic reaction that can cause death.
- Lactic acidosis with liver enlargement (hepatomegaly) that can cause death.
- Worsening of HBV infection.
- Changes in immune system. When you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor.
- Changes in body fat. These changes have happened in patients taking antiretroviral medicines like Epzicom. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.
Some HIV medicines including Epzicom may increase your risk of heart attack. If you have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes, tell your doctor.
The most common side effects with Epzicom are:
- trouble sleeping
- stomach pain
- abnormal dreams
Most of these side effects did not cause people to stop taking Epzicom.
This list of side effects is not complete. Ask your doctor or pharmacist for more information.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take any of the following medicines:
- hepatitis medicines such as interferon or ribavirin
- HIVID (zalcitabine, ddC)
- Epivir or Epivir-HBV (lamivudine, 3TC), Atripla (efavirenz/emtricitabine/and tenofovir disoproxil fumarate), Ziagen (abacavir sulfate), Combivir (lamivudine and zidovudine), Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), Emtriva (emtricitabine), Truvada (emtricitabine/tenofovir disoproxil fumarate) or Trizivir (abacavir sulfate, lamivudine, and zidovudine)
This is not a complete list of Epzicom drug interactions. Ask your doctor or pharmacist for more information.
- Serious Allergic Reaction to abacavir. Patients taking Epzicom may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701 than if you do not. Your doctor can determine with a blood test if you have this gene variation.
- If you stop Epzicom because of an allergic reaction, NEVER take Epzicom or any other abacavir-containing medicine (Ziagen and Trizivir) again. If you take Epzicom or any other abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.
- If you stop Epzicom for any other reason, even for a few days, and you are not allergic to Epzicom, talk with your doctor before taking it again. Taking Epzicom can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If your doctor tells you that you can take Epzicom again, start taking it when you are around medical help or people who can call a doctor if you need one.
- Lactic Acidosis. Some human immunodeficiency virus (HIV) medicines, including Epzicom, can cause a rare but serious condition called lactic acidosis with liver enlargement (hepatomegaly). Nausea and tiredness that don't get better may be symptoms of lactic acidosis. In some cases this condition can cause death. Women, overweight people, and people who have taken HIV medicines like Epzicom for a long time have a higher chance of getting lactic acidosis and liver enlargement. Lactic acidosis is a medical emergency and must be treated in the hospital.
- Worsening of hepatitis B virus (HBV) infection. Patients with HBV infection, who take Epzicom and then stop it, may get “flare-ups” of their hepatitis. “Flare-up” is when the disease suddenly returns in a worse way than before. If you have HBV infection, your doctor should closely monitor your liver function for several months after stopping Epzicom. You may need to take anti-HBV medicines.
- Use with interferon- and ribavirin-based regimens. Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking Epzicom as well as interferon with or without ribavirin and you experience side effects, be sure to tell your doctor.
Epzicom can have other serious side effects.
Do not take Epzicom if you:
- have ever had a serious allergic reaction (a hypersensitivity reaction) to Epzicom or any other medicine that has abacavir as one of its ingredients (Trizivir and Ziagen).
- have a liver that does not function properly.
- are less than 18 years of age.
Epzicom Food Interactions
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Epzicom there are no specific foods that you must exclude from your diet when receiving Epzicom.
Before starting Epzicom tell your doctor about all of your medical conditions, including if you:
- have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
- are pregnant or planning to become pregnant. We do not know if Epzicom will harm your unborn child. You and your doctor will need to decide if Epzicom is right for you. If you use Epzicom while you are pregnant, talk to your doctor about how you can be on the Antiviral Pregnancy Registry for Epzicom.
- are breastfeeding. Some of the ingredients in Epzicom can be passed to your baby in your breast milk. It is not known if they could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to the baby in the breast milk.
- have liver problems including hepatitis B virus infection.
- have kidney problems.
- have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Epzicom and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Epzicom falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
If you take Epzicom while you are pregnant, talk to your healthcare provider about how you can take part in the Pregnancy Registry for Epzicom. The purpose of the pregnancy registry is to collect information about the health of you and your baby.
Epzicom and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers not breastfeed their infants to avoid risk of HIV-1 transmission. Both medicines in Epzicom may be excreted in human breast milk. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, your doctor advise you not to breastfeed while taking Epzicom.
- Take Epzicom by mouth exactly as your doctor prescribes it. The usual dose is 1 tablet once a day. Do not skip doses.
- You can take Epzicom with or without food.
- If you miss a dose of Epzicom, take the missed dose right away. Then, take the next dose at the usual time.
- Do not let your Epzicom run out.
- Starting Epzicom again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If you run out of Epzicom even for a few days, you must ask your doctor if you can start Epzicom again. If your doctor tells you that you can take Epzicom again, start taking it when you are around medical help or people who can call a doctor if you need one.
- If you stop your anti-HIV drugs, even for a short time, the amount of virus in your blood may increase and the virus may become harder to treat.
- If you take too much Epzicom, call your doctor or poison control center right away.
Take Epzicom exactly as your doctor prescribes it. Follow the directions on your prescription label carefully.
The recommended dose of Epzicom in adults is one tablet daily, along with other antiretroviral medicines.
If you take too much Epzicom seek emergency medical attention or call your local Poison Control Center right away.
If Epzicom is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
- Store Epzicom at room temperature between 59° to 86°F (15° to 30°C).
- Keep Epzicom and all medicines out of the reach of children.
Epzicom FDA Warning
WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of this medication (Epzicom ).
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups:(1) fever,
(3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain),
(4) constitutional (including generalized malaise, fatigue, or achiness), and
(5) respiratory (including dyspnea, cough, or pharyngitis).
- Discontinue this medication as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. HLA-B*5701-negative patients may develop a suspected hypersensitivity reaction to abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue this medication if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart this medication or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
Reintroduction of this medication or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours.
Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir, lamivudine, and other antiretrovirals
Exacerbations of Hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, which is one component of this medication. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue this medication and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.