Epivir (lamuvidine) 100mg. x60 Tablets

Epivir is a nucleoside analogue. It works by blocking the growth of HIV.

Generic Name: lamivudine
Dosage Form: tablets, film coated and oral solution
FULL PRESCRIBING INFORMATION

Indications and Usage for Epivir

Epivir is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.

Epivir Dosage and Administration

2.1 Adults and Adolescents >16 years of age

The recommended oral dose of Epivir in HIV-1-infected adults and adolescents >16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].

2.2 Pediatric Patients

 The recommended oral dose of Epivir Oral Solution in HIV-1-infected pediatric patients 3 months to 16 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day), administered in combination with other antiretroviral agents.

 Epivir is also available as a scored tablet for HIV-1-infected pediatric patients who weigh ≥14 kg and for whom a solid dosage form is appropriate. Before prescribing Epivir Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow Epivir Tablets, the oral solution formulation should be prescribed.

Epivir 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. It works by blocking the ability of the hepatitis B virus to multiply and infect new liver cells.

Important information about Epivir

Epivir should not be taken together with Combivir, a medication that contains a combination of lamivudine and zidovudine. Epivir 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. Epivir 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 this medication: 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 Epivir, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to Epivir 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 Epivir, 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.

Before taking Epivir

You should not take Epivir 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 this medication, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;
• liver disease (including hepatitis B);

• a history of pancreatitis; or

• if you have used a medicine similar to Epivir 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.

Epivir 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. Epivir 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 this medication: 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. Epivir 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 Epivir. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether Epivir had any effect on the baby.

You should not breast-feed while you are using this medication. 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 Epivir contain 3 to 4 grams of sucrose (sugar) per dose.

How should I take Epivir?

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.

Epivir can be taken with or without food.

You may need to break a Epivir 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 Epivir 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 Epivir. 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 Epivir overdose are not known.

What should I avoid while taking Epivir?

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

Taking Epivir 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 side effects

Stop using Epivir 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.

See also: Epivir side effects in more detail

What other drugs will affect Epivir?

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 Epivir. 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.

* A generic version of this drug is available, however only if permitted to import into your country by your country's health agency or ministry.