"Today the U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxiso"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
TELBIVUDINE - ORAL
COMMON BRAND NAME(S): Tyzeka
WARNING: Rarely, telbivudine has caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). Tell your doctor immediately 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 immediately if you develop symptoms of worsening liver problems.
USES: 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).
HOW TO USE: 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.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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