AUDIENCE: Patient, Health Professional, Oncology
ISSUE: The antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. We are reviewing additional data and will communicate our conclusions and recommendations when our review is complete.
BACKGROUND: The serious lung condition for which long-term azithromycin was being studied called bronchiolitis obliterans syndrome is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Cancer patients who undergo stem cell transplants from donors are at risk for bronchiolitis obliterans syndrome. The manufacturer of brand name azithromycin is providing a Dear Healthcare Provider letter on this safety issue to health care professionals who care for patients undergoing donor stem cell transplants.
Azithromycin is not approved for preventing bronchiolitis obliterans syndrome. It is an FDA-approved antibiotic used to treat many types of infections affecting the lungs, sinuses, skin, and other parts of the body. The drug has been used for more than 26 years. It is sold under the brand names Zithromax and Zmax and as generics by many different drug companies. It works by stopping the growth of bacteria that can cause infections.
RECOMMENDATION: Health care professionals should not prescribe long-term azithromycin for prophylaxis of bronchiolitis obliterans syndrome to patients who undergo donor stem cell transplants because of the increased potential for cancer relapse and death.
Patients who have had a stem cell transplant should not stop taking azithromycin without first consulting with your health care professional. Doing so could be harmful without your health care professional's direct supervision. Talk with them if you have any questions or concerns about taking this medicine.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs. Azithromycin also is used to treat or prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that often affects people with human immunodeficiency virus (HIV)]. Azithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria.
Antibiotics such as azithromycin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
How should this medicine be used?
Azithromycin comes as a tablet, an extended-release (long-acting) suspension (liquid), and a suspension (liquid) to take by mouth. The tablets and suspension (Zithromax) are usually taken with or without food once a day for 1–5 days. When used for the prevention of disseminated MAC infection, azithromycin tablets are usually taken with or without food once weekly. The extended-release suspension (Zmax) is usually taken on an empty stomach (at least 1 hour before or 2 hours after a meal) as a one-time dose. 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 a dosing spoon, oral syringe, or measuring cup to measure the correct amount of medication. Rinse the measuring device with water after taking the full dose of medication.
If you receive azithromycin powder for suspension (Zithromax) in the single-dose, 1-gram packet, you must first mix it with water before you take the medication. Mix the contents of the 1-gram packet with 1/4 cup (60 mL) of water in a glass and consume the entire contents immediately. Add an additional 1/4 cup (60 mL) of water to the same glass, mix, and consume the entire contents to ensure that you receive the entire dose.
If you receive azithromycin extended-release suspension (Zmax) as a dry powder, you must first add water to the bottle before you take the medication. Open the bottle by pressing down on the cap and twisting. Measure 1/4 cup (60 mL) of water, and add to the bottle. Close the bottle tightly, and shake well to mix. Use the azithromycin extended-release suspension within 12 hours of receiving it from the pharmacy or after adding water to the powder.
If you vomit within an hour after taking azithromycin, call your doctor right away. Your doctor will tell you if you need to take another dose. Do not take another dose unless your doctor tells you to do so.
You should begin to feel better during the first few days of treatment with azithromycin. If your symptoms do not improve, or get worse, call your doctor.
Take azithromycin until you finish the prescription, even if you feel better. Do not stop taking azithromycin unless you experience the severe side effects described in the SIDE EFFECTS section. If you stop taking azithromycin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
Azithromycin is also used sometimes to treat H. pylori infection, travelers' diarrhea, and other gastrointestinal infections; Legionnaires' disease (a type of lung infection); pertussis (whooping cough; a serious infection that can cause severe coughing); and babesiosis (an infectious disease carried by ticks). It is also used to prevent heart infection in people 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, in Prevpac), dirithromycin (not available in the U.S.), erythromycin (E.E.S., ERYC, Erythrocin), telithromycin (Ketek; not available in the U.S.), any other medications, or any of the ingredients in azithromycin tablets or suspension (liquid). Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); cyclosporine (Neoral, Sandimmune); digoxin (Lanoxin); dihydroergotamine (D.H.E. 45, Migranal); ergotamine (Ergomar); medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), procainamide (Procanbid), quinidine, and sotalol (Betapace, Sorine); nelfinavir (Viracept); phenytoin (Dilantin); and terfenadine (not available in the U.S.). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking antacids containing aluminum hydroxide or magnesium hydroxide (Maalox, Mylanta, Tums, others), you will need to allow some time to pass between when you take a dose of these antacids and when you take a dose of azithromycin tablets or liquid. Ask your doctor or pharmacist how many hours before or after you take azithromycin you may take these medications. The extended-release suspension may be taken at any time with antacids.
- tell your doctor if you have ever had jaundice (yellowing of the skin or eyes) or other liver problems while taking azithromycin. Your doctor will probably tell you not to take azithromycin.
- tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or a fast, slow, or irregular heartbeat, and if you have low levels of magnesium or potassium in your blood; if you have a blood infection; heart failure; cystic fibrosis; myasthenia gravis (a condition of muscles and the nerves that control them); or if you have kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. 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 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 medication cause?
Azithromycin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
Some side effects can be serious. If you experience any of these symptoms, stop taking azithromycin and call your doctor immediately or get emergency medical treatment:
- fast, pounding, or irregular heartbeat
- rash with or without a fever
- blisters or peeling
- fever and pus-filled, blister-like sores, redness, and swelling of the skin
- wheezing or difficulty breathing or swallowing
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- vomiting or irritability while feeding (in infants less than 6 weeks old)
- severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
- yellowing of the skin or eyes
- extreme tiredness
- unusual bleeding or bruising
- lack of energy
- loss of appetite
- pain in the upper right part of the stomach
- flu-like symptoms
- dark-colored urine
- unusual muscle weakness or difficulty with muscle control
- pink and swollen eyes
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 (http://www.fda.gov/Safety/MedWatch) 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 azithromycin tablets, suspension, and extended-release suspension at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate or freeze the extended-release suspension. Discard any azithromycin suspension that is left over after 10 days or no longer needed. Discard any unused extended-release azithromycin suspension after dosing is complete or 12 hours after preparation.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 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.
- Zithromax® Single Dose Packets
- Zithromax® Tri-Paks®
- Zithromax® Z-Paks®