Archive for the ‘nucleoside reverse transcriptase inhibitors (NRTIs)’ Category

Videx EC

Videx EC Delayed-Release Enteric-Coated Capsules

Videx EC Delayed-Release Enteric-Coated Capsules may cause serious and sometimes fatal inflammation of the pancreas (pancreatitis). This has occurred in patients who have just started taking Videx EC Delayed-Release Enteric-Coated Capsules and in patients who have already been taking it. Contact your doctor immediately if you experience sudden stomach or back pain, swelling of the stomach, fever or chills, nausea or vomiting, or fast heartbeat.

Videx EC Delayed-Release Enteric-Coated Capsules may cause severe and sometimes fatal lactic acidosis and liver problems. Fatal lactic acidosis has also occurred in pregnant women who have used Videx EC Delayed-Release Enteric-Coated Capsules along with certain other medicines for HIV (eg, stavudine). Tell your doctor if you are taking stavudine and you are pregnant or planning to become pregnant.

Videx EC Delayed-Release Enteric-Coated Capsules are used for:

Treating HIV infection when used in combination with other medicines.

Videx EC Delayed-Release Enteric-Coated Capsules are a nucleoside analogue reverse transcriptase inhibitor that stops the growth of HIV-1, the virus that causes AIDS.

Do NOT use Videx EC Delayed-Release Enteric-Coated Capsules if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Videx EC Delayed-Release Enteric-Coated Capsules:

Some medical conditions may interact with Videx EC Delayed-Release Enteric-Coated Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Videx EC Delayed-Release Enteric-Coated Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Videx EC Delayed-Release Enteric-Coated Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Videx EC Delayed-Release Enteric-Coated Capsules:

Use Videx EC Delayed-Release Enteric-Coated Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Videx EC Delayed-Release Enteric-Coated Capsules.

Important safety information:

Possible side effects of Videx EC Delayed-Release Enteric-Coated Capsules:

All medicines may cause side effects, but many people have no, or minor side effects.

Breast enlargement; changes in body fat; darkened complexion with purple markings; diarrhea; dry mouth; headache; itching; muscle pain; skin and facial wasting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain or discomfort, numbness of an arm or leg, or shortness of breath; confusion; dark urine; dizziness; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever or chills; lightheadedness; low body temperature; nausea or vomiting; numbness, tingling, or pain in hands or feet; seizures; severe muscle pain or cramping; stomach pain; tiredness; weakness; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Videx EC Delayed-Release Enteric-Coated Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Brief storage up to 86 degrees F (30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Videx EC Delayed-Release Enteric-Coated Capsules out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Videx EC Delayed-Release Enteric-Coated Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

More Videx EC Delayed-Release Enteric-Coated Capsules resources

Videx

Videx Chewable/

Videx Chewable/Dispersible Buffered Tablets may cause serious and sometimes fatal inflammation of the pancreas (pancreatitis). This has occurred in patients who have just started taking Videx Chewable/Dispersible Buffered Tablets and in patients who have already been taking it. Contact your doctor immediately if you experience sudden stomach or back pain, swelling of the stomach, fever or chills, nausea or vomiting, or fast heartbeat.

Videx Chewable/Dispersible Buffered Tablets may cause severe and sometimes fatal lactic acidosis and liver problems. Fatal lactic acidosis has also occurred in pregnant women who have used Videx Chewable/Dispersible Buffered Tablets along with certain other medicines for HIV (eg, stavudine). Tell your doctor if you are taking stavudine and you are pregnant or plan to become pregnant.

Videx Chewable/Dispersible Buffered Tablets are used for:

Treating HIV infection when used in combination with other medicines.

Videx Chewable/Dispersible Buffered Tablets are a nucleoside analogue reverse transcriptase inhibitor that stops the growth of HIV-1, the virus that causes AIDS.

Do NOT use Videx Chewable/Dispersible Buffered Tablets if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Videx Chewable/Dispersible Buffered Tablets:

Some medical conditions may interact with Videx Chewable/Dispersible Buffered Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Videx Chewable/Dispersible Buffered Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Videx Chewable/Dispersible Buffered Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Videx Chewable/Dispersible Buffered Tablets:

Use Videx Chewable/Dispersible Buffered Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Videx Chewable/Dispersible Buffered Tablets.

Important safety information:

Possible side effects of Videx Chewable/Dispersible Buffered Tablets:

All medicines may cause side effects, but many people have no, or minor side effects.

Breast enlargement; changes in body fat; darkened complexion with purple markings; diarrhea; dry mouth; headache; itching; muscle pain; skin and facial wasting; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain or discomfort, numbness of an arm or leg, or shortness or breath; confusion; dark urine; dizziness; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever or chills; lightheadedness; low body temperature; nausea and vomiting; numbness, tingling, or pain in hands or feet; seizures; severe muscle pain or cramping; stomach pain; tiredness; weakness; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Videx Chewable/Dispersible Buffered Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store the tablets in a damp place, such as the bathroom, medicine cabinet, or near the kitchen sink. If the tablets are dispersed in water, the dose may be held for up to 1 hour at room temperature. Keep Videx Chewable/Dispersible Buffered Tablets out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Videx Chewable/Dispersible Buffered Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

More Videx Chewable/Dispersible Buffered Tablets resources

Compare Videx Chewable/Dispersible Buffered Tablets with other medications for the treatment of:

Tyzeka

Tyzeka

Generic Name: telbivudine (tel BIV yoo deen)

What is Tyzeka?

Tyzeka is an antiviral medication. It works by preventing viral cells from multiplying in the body and infecting new liver cells.

Tyzeka is used to treat chronic hepatitis B in adults. This medicine will not cure hepatitis.

Tyzeka may also be used for purposes other than those listed in this medication guide.

Important information about Tyzeka

Some people have developed a life-threatening condition called lactic acidosis while taking Tyzeka. Get emergency medical help if you have any of these symptoms of lactic acidosis: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking Tyzeka, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

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

What should I discuss with my health care provider before taking Tyzeka?

You should not use Tyzeka if you are allergic to telbivudine.

If you have certain conditions, you may need a dosage adjustment or special tests to safely use this medication. Before you take Tyzeka, tell your doctor if you have:

HIV or AIDS;

if you have received a liver transplant; or

if any hepatitis B medications you received in the past did not work well in treating your condition.

Tyzeka may cause lactic acidosis (the build up of lactic acid in the body, which can be fatal). You may be more likely to develop lactic acidosis if you are overweight, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.

It is not known whether this medication is safe to use while you are pregnant. Tyzeka may not keep you from passing hepatitis B to your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Tyzeka.

Your name may need to be listed on a pregnancy registry if you become pregnant while you are taking Tyzeka. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether the medication had any effect on the baby.

It is not known whether telbivudine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give Tyzeka to a child younger than 16 years old without the advice of a doctor.

How should I take Tyzeka?

Take Tyzeka exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Tyzeka may be taken with or without food. Take the medicine at the same time each day.

It is important to use Tyzeka regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Do not stop taking this medication without talking to your doctor.

While taking Tyzeka, you should remain under the care of a doctor. Your blood will need to be checked on a regular basis.

Your liver symptoms may become severe after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop taking this medicine. Do not miss any scheduled visits.

If your condition worsens after you stop taking Tyzeka, your doctor may recommend that you restart this medication or another treatment for hepatitis B.

Store Tyzeka at room temperature away from moisture and heat.

Throw away any unused or expired Tyzeka tablets in a closed container or sealed bag. You may also ask your pharmacist where to locate a community pharmaceutical take-back disposal program.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a Tyzeka overdose are not known.

What should I avoid while taking Tyzeka?

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

Tyzeka side effects

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

fast or uneven heart rate.

Call your doctor at once if you have any of these serious side effects:

muscle tenderness, or weakness (may occur several weeks or months after you start taking Tyzeka);

fever or flu symptoms and dark colored urine;

burning, pain or tingly feeling in your arms or legs; or

liver symptoms – pain in your upper stomach with low fever, loss of appetite, dark urine, clay-colored stools, and/or jaundice (yellowing of the skin or eyes).

Less serious Tyzeka side effects may include:

cough, sore throat;

headache, tired feeling;

dizziness;

muscle aches;

low fever;

bloating, mild nausea, vomiting, diarrhea;

itching or mild skin rash;

joint pain, back pain; or

sleep problems (insomnia).

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 other drugs will affect Tyzeka?

Tell your doctor about all other medications you use, especially:

cyclosporine (Gengraf, Neoral, Sandimmune)

erythromycin (E.E.S., Ery-Tab, E-Mycin);

penicillamine (Cuprimine, Depen);

zidovudine (Retrovir);

an antifungal antibiotic such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend);

anti-malaria drugs such as chloroquine (Aralen), hydroxychloroquine (Plaquenil, Quineprox);

cholesterol-lowering medicines such as atorvastatin (Lipitor), clofibrate (Atromid), fenofibrate (Antara, Lofibra, TriCor), gemfibrozil (Lopid), niacin (Advicor, Niacor, Niaspan, Nicobid), simvastatin (Zocor), and others;

an interferon such as Actimmune, Alferon N, Avonex, Betaseron, Infergen, Intron A, Rebetron, Rebif, Roferon-A, or peginterferon alfa-2a (Pegasys); or

steroids (prednisone and others).

This list is not complete and there may be other drugs that can interact with Tyzeka. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Hivid

Hivid

Hivid may infrequently cause severe side effects, which could be fatal. Hivid can cause severe nerve problems (peripheral neuropathy), and should be used with extreme caution in those who already suffer from this disorder. It may rarely cause swelling of the pancreas (pancreatitis). Tell your doctor immediately if vomiting, stomach/abdominal pain, or persistent nausea occur, as Hivid may need to be stopped until you can be checked. Severe and sometimes fatal lactic acidosis or severe liver disease may also occur. Rarely, fatal liver failure has occurred in those with hepatitis B infection while using Hivid . Hivid should be used with caution if you have a hepatitis B infection. Tell your doctor immediately if tingling/numbness of the hands and feet, dark urine, yellowing of eyes/skin, rapid breathing, muscle aches, or unusual drowsiness occurs.

Hivid is used for:

Treating HIV infection. It is used in combination with other medicines.

Hivid in a nucleoside reverse transcriptase inhibitor. It works by blocking the growth of HIV.

Do NOT use Hivid if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hivid :

Some medical conditions may interact with Hivid . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Hivid . Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hivid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hivid :

Use Hivid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Hivid .

Important safety information:

Possible side effects of Hivid :

All medicines may cause side effects, but many people have no, or minor, side effects.

Constipation; diarrhea; fatigue; headache; itching; loss of appetite; nausea; shift in body fat to stomach and upper back; tiredness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions; fast, shallow breathing; feeling cold; heart problems; lactic acid imbalance (slow or irregular heartbeat; dizziness; lightheadedness); liver inflammation (liver tenderness; weakness; fatigue); numbness, tingling, burning, or sharp shooting pains in arms, hands, legs, and feet; pain on swallowing; persistent or severe nausea; severe muscle pain or cramping; sores in mouth or throat; stomach pain; swelling of the hands or feet; vomiting; weakness or exhaustion.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store tablets at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tightly-closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hivid out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Hivid . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

More Hivid resources

Compare Hivid with other medications for the treatment of:

Hepsera

Hepsera

Some patients have developed severe and sometimes fatal worsening of hepatitis after they stop taking Hepsera . If you stop taking Hepsera , your doctor will need to perform liver function tests and check you closely for signs of worsening liver problems for at least several months. Be sure to keep all doctor and lab appointments.

Hepsera may cause serious kidney problems, especially if you already have or are at risk for kidney problems. Tell your doctor if you have a history of kidney problems. They may need to perform kidney function tests or adjust your dose of Hepsera . Contact your doctor right away if you develop a change in the amount of urine that you produce.

Use of Hepsera for hepatitis B infection in patients with untreated or unknown HIV infection may result in strains of the HIV virus that are resistent to treatment. Tell your doctor if you have HIV infection or may be at risk for HIV infection.

High levels of lactic acid in the blood and severe liver problems have infrequently been reported with the use of Hepsera either alone or with other medicines. These effects have been fatal in some cases. The risk of developing these problems may be greater if you are very overweight or have been using a nucleoside analog (eg, didanosine, lamivudine) for a long time. Notify your doctor immediately if you develop unusual weakness or fatigue, dark urine, yellowing of the skin or eyes, light-colored stools, loss of appetite, abdominal or stomach pain with or without nausea or vomiting, drowsiness, muscle aches or weakness, dizziness, lightheadedness, coldness (especially in the arms or legs), trouble breathing, or fast or irregular heartbeat.

Hepsera is used for:

Treating chronic hepatitis B virus (HBV) infection.

Hepsera is a nucleotide analog. It works by slowing the growth of the virus. It is not a cure for hepatitis B.

Do NOT use Hepsera if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hepsera :

Some medical conditions may interact with Hepsera . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Hepsera . Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hepsera may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hepsera :

Use Hepsera as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Hepsera .

Important safety information:

Possible side effects of Hepsera :

All medicines may cause side effects, but many people have no, or minor, side effects.

Diarrhea; fever; gas; headache; increased cough; indigestion; nausea; sore throat; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine you produce; cold arms and legs; dark urine; dizziness; fast or irregular heartbeat; light-colored bowel movements; loss of appetite; muscle pain; severe or persistent stomach pain, nausea, or vomiting; unusual drowsiness; unusual weakness or fatigue; or yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Hepsera at 77 degrees F (25 degrees C) in the original container. Store away from heat, moisture, and light. Do not use if the seal over the bottle opening is broken or missing. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Hepsera out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Hepsera . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

More Hepsera resources

Compare Hepsera with other medications for the treatment of:

Epivir-HBV

Epivir-HBV

High levels of lactic acid in the blood and severe, life-threatening liver problems have been reported with the use of Epivir-HBV alone or with other medicines. HIV counseling and testing should be offered to all patients before treatment for hepatitis B virus is started with Epivir-HBV and periodically during treatment. Epivir-HBV has a lower dose of the same active ingredient (lamivudine) than in Epivir, a medicine used to treat HIV infection. These formulations are not interchangeable. If Epivir-HBV is prescribed for a patient with hepatitis B virus and undiagnosed or untreated HIV infection, the HIV infection will be less treatable with Epivir-HBV and other medicines. Worsening of hepatitis B virus infection has been reported in patients who stop taking Epivir-HBV . Patients should have their liver function monitored closely for at least several months after stopping use of Epivir-HBV .

Epivir-HBV is used for:

Treating certain types of chronic hepatitis B virus infection.

Epivir-HBV is a nucleoside analogue. It works by reducing the amount of hepatitis B virus in the body by blocking the ability of the virus to multiply and infect new liver cells.

Do NOT use Epivir-HBV if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Epivir-HBV :

Some medical conditions may interact with Epivir-HBV . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Epivir-HBV . Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epivir-HBV may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Epivir-HBV :

Use Epivir-HBV as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Epivir-HBV .

Important safety information:

Possible side effects of Epivir-HBV :

All medicines may cause side effects, but many people have no, or minor, side effects.

Changes in body fat; chills; coughing; decreased appetite; diarrhea; difficulty sleeping; dizziness; ear, nose, and throat infection; general body discomfort; headache; indigestion; joint pain; muscle pain; nausea; sinus drainage; sore throat; stomach discomfort; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression (mental or mood changes); enlarged stomach; increased heart rate; numbness or tingling in the arms or legs; persistent sore throat, chills, or fever; severe muscle or joint pain; stomach tenderness or pain; unusual bleeding or bruising; unusual weakness or exhaustion; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (

Store Epivir-HBV at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Epivir-HBV out of the reach of children and away from pets.

General information:

This information is a summary only. It does not contain all information about Epivir-HBV . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

More Epivir-HBV resources

Epivir HBV

Epivir HBV

Generic Name: lamivudine (la MIV yoo deen)

What is Epivir HBV (lamivudine)?

Lamivudine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

The Epivir brand of lamivudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Lamivudine is not a cure for HIV or AIDS. The Epivir-HBV brand of lamivudine is used to treat chronic hepatitis B. Epivir-HBV should not be used in people who are infected with both hepatitis B and HIV.

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

What is the most important information I should know about Epivir HBV (lamivudine)?

Lamivudine should not be taken together with Combivir, a medication that contains a combination of lamivudine and zidovudine. Lamivudine may cause lactic acidosis (the build up of lactic acid in the body). Symptoms can start slowly and gradually get worse: unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Call your doctor at once if you have any of these symptoms, even if they are only mild. Lamivudine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking lamivudine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Before taking lamivudine, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to lamivudine in the past, such as abacavir (Ziagen), didanosine (Videx), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

If you have hepatitis B you may develop liver symptoms after you stop taking lamivudine, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

Epivir tablets and liquid contain a higher dose of lamivudine than Epivir-HBV. Epivir is for treating HIV and Epivir-HBV is for treating hepatitis B. Each time you get a refill of this medication, be sure you have received the correct brand to treat your condition.

What should I discuss with my healthcare provider before taking Epivir HBV (lamivudine)?

You should not take lamivudine if you are also taking Combivir (lamivudine/zidovudine), or if you have ever had an allergic reaction to a medicine containing lamivudine, including Combivir, Epzicom, or Trizivir. Before taking lamivudine, tell your doctor if you are allergic to any drugs, or if you have:

a history of pancreatitis; or

if you have used a medicine similar to lamivudine in the past, such as abacavir (Ziagen), didanosine (Videx), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

If you have any of the conditions listed above, you may need a dose adjustment or special tests to safely take this medication.

Lamivudine may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis symptoms can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Call your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Lamivudine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking lamivudine: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Lamivudine may also be more likely to cause pancreatitis in a pregnant woman. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using lamivudine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether lamivudine had any effect on the baby.

You should not breast-feed while you are using lamivudine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

If you have diabetes, you should know that the liquid forms of lamivudine contain 3 to 4 grams of sucrose (sugar) per dose.

How should I take Epivir HBV (lamivudine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Lamivudine can be taken with or without food.

You may need to break a lamivudine tablet in half when giving this medication to a child. Call your doctor if the child has any trouble swallowing the tablet.

Measure the liquid form of lamivudine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Epivir tablets and liquid contain a higher dose of lamivudine than Epivir-HBV. Epivir is for treating HIV and Epivir-HBV is for treating hepatitis B. Each time you get a refill of this medication, be sure you have received the correct brand to treat your condition.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using lamivudine. Do not miss any scheduled visits.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. 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.

Store this medication at room temperature away from moisture and heat. You may keep the oral solution (liquid) in the refrigerator but do not let it freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a lamivudine overdose are not known.

What should I avoid while taking Epivir HBV (lamivudine)?

Avoid drinking alcohol while taking lamivudine. Alcohol may increase the risk of damage to the pancreas and/or liver.

Taking lamivudine will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

Epivir HBV (lamivudine) side effects

Stop using lamivudine 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.

Call your doctor at once if you have any of these other serious side effects:

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

lactic acidosis – muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, and fast or uneven heart rate;

pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

peripheral neuropathy – numbness, tingling, or pain in your hands or feet;

easy bruising or bleeding, unusual weakness, pale skin;

white patches or sores inside your mouth or on your lips;

fever, chills, body aches, flu symptoms; or

any other signs of new infection.

Less serious side effects may include:

cough;

sleep problems (insomnia), strange dreams;

nausea, vomiting, diarrhea;

joint or muscle pain;

dizziness, headache, tired feeling; or

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Epivir HBV (lamivudine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

interferon-alfa (Roferon, Intron, Rebetron);

trimethoprim (Bactrim, Proloprim, Septra, Trimpex); or

ribavirin (Rebetol, Ribasphere, Copegus Virazole).

This list is not complete and there may be other drugs that can interact with lamivudine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Emtriva

Emtriva

Generic Name: emtricitabine (em trye SYE ta been)

What is Emtriva?

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

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

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

Important information about Emtriva

Some people have developed a life-threatening condition called lactic acidosis while taking Emtriva. 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.

Emtriva 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 Emtriva 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.

Before taking Emtriva

Do not use Emtriva if you are allergic to emtricitabine, or if you are also using:

efavirenz, emtricitabine, and tenofovir (Atripla); or

any medication containing lamivudine (Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir).

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Emtriva:

hepatitis B (HBV) infection;

pneumonia; or

cytomegalovirus.

Some people have developed a life-threatening condition called lactic acidosis while taking emtricitabine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on an antiviral pregnancy registry when you start using Emtriva.

You should not breast-feed while you are using Emtriva. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

How should I take Emtriva?

Take Emtriva exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Emtriva with a full glass of water.

Emtriva can be taken with or without food. Take the medicine at the same time each day to get the most benefit.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you have hepatitis B you may develop liver symptoms after you stop taking Emtriva, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using Emtriva. Do not miss any scheduled appointments.

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.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store Emtriva capsules at room temperature away from moisture, heat, and direct light. Store Emtriva liquid in the refrigerator. Do not freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an Emtriva overdose are not known.

What should I avoid while taking Emtriva?

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking Emtriva 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.

Emtriva side effects

Stop using Emtriva 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.

Emtriva 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.

Emtriva 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 Emtriva, 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 Emtriva 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Emtriva?

There may be other drugs that can affect Emtriva, making it less effective or making side effects more likely to occur. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Baraclude

Baraclude

Generic Name: entecavir (en TE ka veer)

What is Baraclude?

Baraclude (entecavir) is an antiviral medication. It prevents certain virus cells from multiplying in your body and reduces the amount of hepatitis B virus in the blood.

Baraclude is used to treat chronic hepatitis B. It also helps prevent the hepatitis B virus from multiplying and infecting new liver cells.

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

Important information about Baraclude

You should not take Baraclude if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated.

Some people have developed a life-threatening condition called lactic acidosis while taking Baraclude. 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.

Baraclude may also cause severe liver symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.

Some people with hepatitis B develop liver symptoms after they stop taking Baraclude, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

What should I discuss with my healthcare provider before taking Baraclude?

You should not take Baraclude if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated. If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take Baraclude, tell your doctor if you are allergic to any drugs, or if you have:

HIV or AIDS;

kidney disease;

liver disease; or

if you have had a liver transplant.

Some people have developed a life-threatening condition called lactic acidosis while taking Baraclude. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

FDA pregnancy category C. It is not known whether Baraclude is harmful to an unborn baby. Before you take Baraclude, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

It is not known whether entecavir passes into breast milk or if it could harm a nursing baby. Do not use Baraclude without telling your doctor if you are breast-feeding a baby.

How should I take Baraclude?

Take Baraclude exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

You may be required to be tested for HIV before you start taking Baraclude. Follow your doctor’s instructions.

Take Baraclude with a full glass of water. Take this medicine on an empty stomach, at least 2 hours before or 2 hours after eating.

Measure the liquid form (oral solution) of Baraclude with the dosing spoon provided with this medication. Hold the dosing spoon in an upright position and fill it slowly until the liquid reaches the mark of your correct dose. Rinse the dosing spoon with water after each use. If you do not receive a dosing spoon with your medication, ask your pharmacist for one.

Some people with hepatitis B develop liver symptoms after they stop taking Baraclude, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

Store Baraclude at room temperature away from moisture and heat.

Keep the tablets in a tightly-closed container.

Keep the bottle of oral liquid in its original carton to help protect the medicine from light. Throw away any unused Baraclude oral liquid after the expiration date on the label has passed.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an Baraclude overdose are not known.

What should I avoid while taking Baraclude?

Taking Baraclude will not prevent you from passing hepatitis B to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing hepatitis transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

Baraclude side effects

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.

Baraclude 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.

Baraclude may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

low fever;

nausea, stomach pain, loss of appetite;

dark urine, clay-colored stools; or

jaundice (yellowing of the skin or eyes).

Less serious Baraclude side effects may include:

mild nausea, vomiting, diarrhea, upset stomach;

temporary hair loss;

headache;

skin rash; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Baraclude?

Before taking Baraclude, tell your doctor if you are using any of the following drugs:

drugs that weaken your immune system (such as cancer medicine or steroids);

amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);

cyclosporine (Neoral, Sandimmune, Gengraf);

pentamidine (Nebupent, Pentam);

sirolimus (Rapamune), tacrolimus (Prograf);

antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled); or

any other antiviral medicines.

This list is not complete and there may be other drugs that can interact with Baraclude. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Zerit

Zerit

Generic Name: stavudine (STA vue deen)

What is Zerit?

Zerit is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body. HIV attacks the immune system, slowly destroying the body’s ability to fight off infection.

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

Zerit may also be used for other purposes not listed.

Important information about Zerit

Zerit can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking Zerit: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before taking Zerit, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to stavudine in the past, such as abacavir (Ziagen), didanosine (Videx), lamivudine (Epivir), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).

Some people have developed a life-threatening condition called lactic acidosis while taking Zerit. 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, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Before taking Zerit

Do not use Zerit if you are allergic to stavudine.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking Zerit, tell your doctor if you are allergic to any drugs, or if you have:

diabetes; or

a history of pancreatitis.

Some people have developed a life-threatening condition called lactic acidosis while taking Zerit. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

Zerit can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking Zerit: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

FDA pregnancy category C. It is not known whether Zerit is harmful to an unborn baby. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Zerit may also be more likely to cause lactic acidosis in a pregnant woman. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using Zerit. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether Zerit had any effect on the baby.

You should not breast-feed while you are using Zerit. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

If you have diabetes, you should know that the liquid form of this medication contains 50 milligrams (mg) of sucrose (sugar) per milliliter (mL). This is equal to 250 milligrams of sugar per teaspoon (5 mL) of Zerit liquid.

How should I take Zerit?

Take Zerit exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Zerit comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take Zerit with a full glass of water.

Zerit can be taken with or without food.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

It is important to use Zerit regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. 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.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any visits to your doctor.

Store Zerit at room temperature away from moisture and heat. Keep the bottle tightly closed. Keep the oral liquid in the refrigerator but do not let it freeze. Throw away any leftover medication after 30 days. Throw away any unused or expired Zerit in a closed container or sealed bag. You may also ask your pharmacist where to locate a community pharmaceutical take-back disposal program.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include numbness, burning, pain, or tingly feeling, nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

What should I avoid while taking Zerit?

Avoid drinking alcohol while taking Zerit. Alcohol may increase the risk of damage to the pancreas and/or liver.

Taking Zerit will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. 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.

Zerit side effects

Stop using Zerit 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.

Call your doctor at once if you have any of these other serious side effects:

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

lactic acidosis – muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired;

pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

peripheral neuropathy – numbness, tingling, or pain in your hands or feet;

high blood sugar – increased thirst, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting; or

any signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), mouth sores, or unusual weakness.

Less serious Zerit side effects may include:

diarrhea;

muscle pain;

headache;

mild skin rash; or

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zerit?

Before taking Zerit, tell your doctor if you are using any of the following drugs:

didanosine (Videx);

doxorubicin (Adriamycin);

hydroxyurea (Droxia, Hydrea);

interferon-alfa (Roferon, Intron, Rebetron);

ribavirin (Rebetol, Ribasphere, Copegus Virazole); or

zidovudine (Retrovir).

This list is not complete and there may be other drugs that can interact with Zerit. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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