Rarely, telbivudine has caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, pale stools, dark urine, yellowing eyes/skin, unusual tiredness), or of lactic acidosis (such as stomach discomfort, nausea, vomiting, fast/difficult breathing, drowsiness, muscle pain, weakness, cold skin). These serious side effects may occur more often in women and obese patients.
You may have a serious worsening of hepatitis symptoms if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop telbivudine. Tell your doctor right away if you develop symptoms of worsening liver problems.
Telbivudine is used to treat long-term hepatitis B infection. Hepatitis B is an infection of the liver caused by the hepatitis B virus. Persistent infection can cause liver damage, rarely liver cancer, and liver failure. Telbivudine helps to decrease the amount of hepatitis B virus in your body. It is an antiviral that belongs to a class of drugs known as hepatitis B virus nucleoside reverse transcriptase inhibitors.
Telbivudine is not a cure for hepatitis B infection, and it does not prevent the spread of the virus to others through sexual contact or blood contamination (such as sharing used needles).
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking telbivudine and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually once daily or as directed by your doctor.
Dosage is based on your medical condition, kidney function, and response to treatment.
It is very important to continue taking this medication exactly as prescribed by your doctor. Do not skip any doses.
This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.
Tell your doctor if your condition does not improve or if it worsens.
See also Warning section.
Dizziness, tiredness, diarrhea, cough, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: unexplained muscle pain/tenderness/weakness.
Tell your doctor right away if any of these rare but serious side effects occur: numbness/tingling/burning or weakness/pain of arms/legs, difficulty walking, signs of infection (such as fever, persistent sore throat), easy bruising/bleeding.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking telbivudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, alcohol use.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
Avoid alcohol because it may worsen dizziness and liver problems.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
To decrease your risk of spreading hepatitis B to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.
During pregnancy, this medication should be used only when clearly needed. It is not known if this medication helps to prevent the hepatitis B virus from passing from the mother to the baby. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. The manufacturer states that breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Some products that may interact with this drug include: drugs that may affect the kidneys (including NSAIDs such as ibuprofen or naproxen).
The combination of telbivudine with interferon products (such as peginterferon) to treat hepatitis may increase the risk of numbness/tingling of the arms/legs. Consult your doctor for more details.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as liver tests, blood tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Keep all medical and laboratory appointments.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.
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