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- Trizivir®(as a combination product containing Abacavir, Lamivudine, Zidovudine)
[Posted 03/01/2011]ISSUE:FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir (Ziagen) treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.
FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.
BACKGROUND:Abacavir is an antiviral medication used in combination with other antiretroviral drugs [abacavir and lamivudine (Epzicom); abacavir, lamivudine, and zidovudine (Trizivir)] for the treatment of HIV-1 infection.
RECOMMENDATION:Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional. For more information visit the FDA website at: Web Siteand Web Site.
Zidovudine may decrease the number of a certain type of white blood cell in the blood and cause anemia and muscle disorders. When used alone or in combination with other antiviral medications, zidovudine can also cause serious damage to the liver and a blood condition called lactic acidosis.
Call your doctor immediately if you experience any of the following symptoms: upset stomach, loss of appetite, dark yellow or brown urine, unusual bleeding or bruising, flu-like symptoms, yellowing of the skin or eyes, and pain in the upper right part of your stomach, muscle weakness, lack of strength, muscle pain, shortness of breath, unusual tiredness or weakness, and pale skin.
It is extremely important to keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to zidovudine.
WHY is this medicine prescribed?
Zidovudine is used alone or with other medications to treat human immunodeficiency virus (HIV) infection in patients with or without acquired immunodeficiency syndrome (AIDS). It will slow the spread of HIV infection in the body. Zidovudine is not a cure and may not decrease the number of HIV-related illnesses. Zidovudine does not prevent the spread of HIV to other people except when given to HIV-positive pregnant women. Zidovudine is given to HIV-positive pregnant women to prevent the infection from going to the baby. However, HIV infection may still occur in the infant despite this treatment.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
HOW should this medicine be used?
Zidovudine comes as a capsule, tablet, and syrup to take by mouth. It is usually taken three to four times a day. In some cases it may be taken five times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take zidovudine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take zidovudine even if you feel well. Do not stop taking zidovudine without talking to your doctor.
Are there OTHER USES for this medicine?
Zidovudine is also used sometimes to treat health care workers and other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the possible risks of using this drug for your condition.
What SPECIAL PRECAUTIONS should I follow?
Before taking zidovudine,
- tell your doctor and pharmacist if you are allergic to zidovudine or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetaminophen, acyclovir (Zovirax), aspirin, cimetidine (Tagamet), fluconazole (Diflucan), foscarnet (Foscavir), ganciclovir (Cytovene), indomethacin (Indocin), interferon, lorazepam (Ativan), oxazepam (Serax), probenecid (Benemid), valproic acid (Depakene, Depakote), and vitamins.
- tell your doctor if you have or have ever had liver or kidney disease, any disease or swelling of the muscle, anemia, a history of alcohol abuse, or bleeding or other blood problems.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking zidovudine, call your doctor.
- tell your doctor if you drink alcohol.
What SPECIAL DIETARY instructions should I follow?
Zidovudine should be taken at least 30 minutes before or 1 hour after a meal. You should take it sitting up with plenty of water.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Zidovudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- diarrhea or loose stools
- difficulty sleeping
If you experience the following symptom, or any of those listed in the IMPORTANT WARNING section, call your doctor immediately:
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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