Lamivudine & Zidovudine

Lamivudine/zidovudine is a prescription medication used to treat human immunodeficiency virus (HIV) infection. It is a single tablet containing 2 medications, lamivudine and zidovudine. They belong to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs) which stop the virus from replicating.

This medication comes in tablet form and is usually taken twice daily, with or without food.

Common side effects include nausea, vomiting, headaches, and tiredness.

Lamivudine/zidovudine is a prescription medicine used to treat HIV infection. HIV (human immunodeficiency virus) is the virus that causes AIDS (acquired immune deficiency syndrome).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

For adults and adolescents weighing ≥30 kilograms, the recommended dose is one tablet (equal to 150 mg lamivudine, 300 mg zidovudine) twice daily.

For children, the recommended dose should be based on body weight not to exceed adult doses.

WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS, EXACERBATIONS OF HEPATITIS B

Zidovudine, one of the 2 active ingredients in this medication, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease.

Prolonged use of zidovudine has been associated with symptomatic myopathy.

Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine, zidovudine, and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and 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.

Do not use lamivudine/zidovudine:

• If you previously had an allergic reaction to lamivudine/zidovudine or to any of the ingredients in the product.
• If you have a very low red blood cell count (anemia) or very low white blood cell count (neutropenia).

Lamivudine/zidovudine should not be taken with drugs containing lamivudine, zidovudine, or emtricitabine, including EPIVIR (lamivudine), EPIVIR-HBV (lamivudine), RETROVIR (zidovudine), EPZICOM (abacavir sulfate and lamivudine), TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine), ATRIPLA (efavirenz, emtricitabine, and tenofovir), EMTRIVA (emtricitabine), or TRUVADA (emtricitabine and tenofovir)

Lamivudine/zidovudine may cause a decrease in certain types of blood counts (including red blood cells, white blood cells and platelets) and an increase in certain liver enzymes.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat in the upper back and neck ("buffalo hump"), breasts, and around the trunk. 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 at this time.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Grave's disease (which affects the thyroid gland), Guillain-Barre syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor right away.

The class of medicines to which lamivudine/zidovudine belongs (NRTIs) can cause a condition called lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver. Symptoms of lactic acidosis include feeling of weakness, loss of appetite, sudden unexplained weight loss, upset stomach and difficulty breathing. This rare but serious side effect occurs more often in women. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with lamivudine/zidovudine your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

Consult your doctor at your next visit if any of the following undesirable events occur:

• signs of an allergic reaction such as rash, hives, itching, swelling, and difficulty breathing or swallowing
• signs of lactic acidosis such as muscle or stomach pain, extreme weakness or tiredness, feeling cold, enlarged or tender liver, and weight loss
• and frequent infections

Commonly reported side effects include:

• nausea and vomiting
• headaches
• fatigue
• diarrhea
• a general feeling of being unwell

Tell your healthcare provider about any side effect that is bothersome or does not go away.

This is not a complete list of this medication's side effects. Ask your doctor or pharmacist for more information.

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

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• phenytoin (Dilantin, Phenytek)
• valproic acid (Depakene, Depakote, Stavzor)
• oxazepam (Serax)
• lorazepam (Ativan)
• codeine
• morphine
• methadone (Dolophine, Methadose)
• rifampin (Rifadin)
• rifapentine (Priftin)
• indomethacin
• ketoprofen
• naproxen
• cimetidine (Tagamet)
• probenecid (Benuryl) 
• co-trimoxazole
• atovaquone (Mepron)
• amphotericin
• interferon medications
• vincristine
• vinblastine
• doxorubicin (Adriamycin, Doxil)
• clarithromycin
• ribavirin (Copegus, Rebetol, Ribasphere, Virazole)
• zalcitabine (Hivid)
• stavudine (Zerit)
• ganciclovir (Cytovene)
• fluconazole (Diflucan)
• nelfinavir (Viracept)
• ritonavir (Norvir)

Lamivudine/zidovudine should not be taken with drugs containing lamivudine, zidovudine, or emtricitabine, including EPIVIR (lamivudine), EPIVIR-HBV (lamivudine), RETROVIR (zidovudine), EPZICOM (abacavir sulfate and lamivudine), TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine), ATRIPLA (efavirenz, emtricitabine, and tenofovir), EMTRIVA (emtricitabine), or TRUVADA (emtricitabine and tenofovir).

This is not a complete list of lamivudine/zidovudine drug interactions. Ask your healthcare provider or pharmacist for more information.

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.

This medication 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.

There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry (the registry number is 1-800-258-4263).

Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

It is recommended that HIV-infected women do not breastfeed their infants in order to avoid transmission of HIV. The active substances in lamivudine/zidovudine are found in human breast milk. Mothers taking lamivudine/zidovudine should not breastfeed their infants.

When your lamivudine/zidovudine supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of this medication. The amount of virus in your blood may increase if the medicine is stopped for even a short time.

Lamivudine/zidovudine is not a cure for HIV-1 infection. Avoid doing things that can spread infection to others:

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection.
• Do not breastfeed.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat in the upper back and neck ("buffalo hump"), breasts, and around the trunk.