(az ith roe mye' sin)
[Posted 5/17/2012]ISSUE:FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17, 2012 ( Web Site) reporting a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. FDA is reviewing the results from this study and will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review.
BACKGROUND:Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP. The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the WARNINGS section. FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.
RECOMMENDATION:Patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional. Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides. For more information visit the FDA website at: Web Siteand Web Site.
WHY is this medicine prescribed?
Azithromycin is used to treat certain infections caused by bacteria, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, skin, and throat. Azithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics will not work for colds, flu, or other viral infections.
HOW should this medicine be used?
Azithromycin comes as a tablet and oral suspension (liquid) to take by mouth. It is usually taken with or without food once a day for 1 to 5 days. To help you remember to take azithromycin, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take azithromycin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Shake the liquid well before each use to mix the medication evenly. Use only the syringe provided to measure the correct amount of medication. Rinse the syringe with water after taking the full dose of medication.
The tablets should be taken with a full glass of water.
Take azithromycin until you finish the prescription, even if you feel better. Stopping azithromycin too soon may cause bacteria to become resistant to antibiotics.
Are there OTHER USES for this medicine?
Azithromycin is also used sometimes to treatH. pyloriinfection, early Lyme disease, and other infections. It is also used sometimes to prevent heart infection in patients having dental or other procedures and to prevent STD in victims of sexual assault. Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking azithromycin,
- tell your doctor and pharmacist if you are allergic to azithromycin, clarithromycin (Biaxin), dirithromycin (Dynabac), erythromycin (E.E.S., E-Mycin, Erythrocin), or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); cyclosporine (Neoral, Sandimmune); digoxin (Lanoxin); dihydroergotamine (D.H.E. 45, Migranal); ergotamine (Ergomar); medications that suppress the immune system; nelfinavir (Viracept); phenytoin (Dilantin); and terfenadine (Seldane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you take antacids (Mylanta, Maalox), take them 2 hours before or 4 hours after azithromycin.
- tell your doctor if you have or have ever had cystic fibrosis, human immunodeficiency virus (HIV), irregular heartbeat, or kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking azithromycin, call your doctor.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
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?
Azithromycin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- stomach pain
- mild skin rash
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- severe skin rash
- difficulty breathing or swallowing
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- yellowing of the skin or eyes
- rapid, pounding, or irregular heartbeat
Azithromycin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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 the tablets 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. Keep liquid medicine tightly closed at room temperature or in the refrigerator, and throw away any unused medication after 10 days. Do not freeze. 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?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to azithromycin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the azithromycin, call your doctor.
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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