Lamivudine and tenofovir

Lamivudine and tenofovir are antiviral medicines that stop the human immunodeficiency virus (HIV) from multiplying in your body.

Lamivudine and tenofovir is a combination medicine used to treat HIV, the virus that can lead to acquired immunodeficiency syndrome (AIDS). Lamivudine and tenofovir is not a cure for HIV or AIDS.

Lamivudine and tenofovir is used in adults and children who weigh at least 77 pounds.

Lamivudine and tenofovir may also be used for reasons not mentioned in this medication guide.

Your doctor will do blood tests to ensure you do not have conditions that would make it unsafe for you to use lamivudine and tenofovir.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You can take lamivudine and tenofovir with or without food.

You will need regular medical tests. Your kidney and liver function may also need to be monitored.

Doses of lamivudine and tenofovir for children are based on weight. Your child's dose may need to change if they gain or lose weight.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's guidance. Every person with HIV should stay under a doctor's care.

Store in the original container at room temperature, away from moisture and heat.

If you have ever had hepatitis B, this virus may become active or worsen in the months after you stop using lamivudine and tenofovir. You may need regular liver function tests while using this medicine and for several months after your last dose.

lamivudine and tenofovir can cause serious side effects. Call your doctor right away if you have symptoms like upper stomach pain, loss of appetite, dark urine, yellowing of your skin or eyes, bone pain, or muscle weakness.

You may develop lactic acidosis, which is a dangerous build-up of lactic acid in your blood. Call your doctor or seek emergency medical help if you experience unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

If you have ever had hepatitis B, it may become active or worsen after you stop using lamivudine and tenofovir. You may need to have liver function tests done frequently for several months.

You should not use this medicine if you are allergic to lamivudine or tenofovir.

Tell your doctor if you have ever had:

• liver disease, including cirrhosis or hepatitis B or C (especially if you also use ribavirin or interferon alfa);
• kidney disease (or if you are on dialysis);
• a pancreas disorder; or
• bone problems, including osteoporosis or a broken bone.

You may develop lactic acidosis, which is a serious build-up of lactic acid in your blood. The risk may be higher if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Tell your doctor if you are pregnant, and use your medications correctly to manage your infection. HIV can be transmitted to your baby if the virus is not under control during pregnancy. Your name may be included on a registry to monitor any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be transmitted to the baby through your breast milk.

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

Lamivudine and tenofovir may cause serious side effects. Call your doctor right away if you have:

• new or worsening bone pain;
• muscle weakness;
• pain in your arms, hands, legs, or feet;
• swelling around your midsection;
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Lamivudine and tenofovir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, balance or eye movement problems, weakness or tingling; or
• swelling in your neck or throat (enlarged thyroid), changes in your menstrual cycle, impotence.

Common side effects of lamivudine and tenofovir may include:

• headache;
• pain;
• diarrhea;
• rash;
• depression; 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.

Usual Adult Dose for HIV Infection:

1 tablet orally once a dayUse: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection:

At least 35 kg: 1 tablet orally once a dayUse: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking other medications that contain an ingredient called sorbitol, which is often used as a sweetener in liquid medicines. Ask your pharmacist if you are unsure whether a medicine contains this ingredient.

Using lamivudine and tenofovir will not stop your disease from spreading. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Lamivudine and tenofovir can be harmful to your kidneys, particularly if you are also taking certain medications for infections, cancer, osteoporosis, preventing organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Inform your doctor about all your other medications, especially any other antivirals used to treat HIV or hepatitis C.

Other medications may influence lamivudine and tenofovir, including both prescription and over-the-counter drugs, vitamins, and herbal products. Make sure to tell your doctor about all the medications you are currently taking and any that you begin or stop using.

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