telbivudine
 Telbivudine

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Tyzeka, |telbivudine Telbivudine

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telbivudine

Generic Name: telbivudine (tel BIV yoo deen)
Brand Names: Tyzeka

What is telbivudine?

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

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

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

What is the most important information I should know about telbivudine?

This medication may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis 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. Contact 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.

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

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled time to use the medication. Do not use extra medicine to make up the missed dose.

If you have hepatitis B you may develop liver symptoms after you stop taking telbivudine, 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 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, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

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

Do not use this medication if you are allergic to telbivudine.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

  • kidney disease;

  • 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.

If you have any of these conditions, you may not be able to use telbivudine, or you may need a dosage adjustment or special tests during treatment.

This medication may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis 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. Contact 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. 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.

If you are pregnant, your name may need to be listed on a telbivudine pregnancy registry when you start using this medication.

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.

How should I take telbivudine?

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.

Telbivudine may be taken with or without food.

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

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 telbivudine. Do not miss any scheduled visits.

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

While taking telbivudine, you should remain under the care of a doctor.

Store telbivudine at room temperature away from moisture and heat.

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 telbivudine overdose are not known.

What should I avoid while taking telbivudine?

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, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

Telbivudine 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. Call your doctor at once if you have any of these serious side effects:
  • muscle pain, tenderness, or weakness (may occur several weeks or months after you start taking telbivudine);

  • numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, fast or uneven heart rate, and feeling light-headed or fainting; or

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may be more likely to occur, such as:

  • runny or stuffy nose, cough, sore throat;

  • tired feeling;

  • mild fever;

  • dizziness;

  • stomach pain, nausea, vomiting, diarrhea;

  • joint pain; or

  • sleep problems (insomnia).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect telbivudine?

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

  • chloroquine (Aralen);

  • cyclosporine (Gengraf, Neoral, Sandimmune)

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

  • hydroxychloroquine (Plaquenil, Quineprox);

  • niacin (Niacor, Niaspan, Nicobid);

  • penicillamine (Cuprimine, Depen);

  • zidovudine (Retrovir);

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

  • cholesterol-lowering medicines such as atorvastatin (Lipitor), clofibrate (Atromid), fenofibrate (Antara, Lofibra, TriCor), gemfibrozil (Lopid), and simvastatin (Zocor); or

  • steroids (prednisone and others);

If you are using any of these drugs, you may not be able to use telbivudine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect telbivudine. 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.

Where can I get more information?

  • Your pharmacist has information about telbivudine written for health professionals that you may read.

What does my medication look like?

Telbivudine is available with a prescription under the brand name Tyzeka. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Tyzeka 600 mg--white, film-coated, oval shaped tablet

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ("Multum") is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum"s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum"s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.01. Revision Date: 11/9/06 3:45:59 PM.



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