Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Mylan Azithromycin.
HEALTH CANADA ADVISORY
August 13, 2018
Health Canada has issued information concerning the use of azithromycin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, droperidol, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, probucol, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with azithromycin. You are more at risk for this type of abnormal heart rhythm and its complications if you:
- are female
- are older than 65 years of age
- have a family history of sudden cardiac death
- have a history of heart disease or abnormal heart rhythms
- have a slow heart rate
- have congenital prolongation of the QT interval
- have Diabetes
- have had a Stroke
- have low potassium, magnesium, or calcium levels
- have nutritional deficiencies
If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Mylan Azithromycin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Azithromycin, and whether any special monitoring is needed.
Antibiotic-associated colitis: Mylan Azithromycin, like other antibiotics, may cause a potentially dangerous condition called antibiotic-associated colitis or pseudomembranous colitis. Symptoms include severe, watery diarrhea that may be bloody. If you notice these symptoms, stop taking azithromycin and contact your doctor as soon as possible.
Bacterial resistance: Misuse of an antibiotic such as azithromycin may lead to the growth of resistant bacteria that will not be killed by the antibiotic. If this happens, azithromycin may not work for you in the future. Although you may begin to feel better early in your course of treatment with azithromycin, you need to take the full course exactly as directed to finish ridding your body of the infection and to prevent resistant bacteria from taking hold. Do not take azithromycin or other antibiotics to treat a viral infection such as The Common Cold; antibiotics do not kill viruses, and using them to treat viral infections can lead to the growth of resistant bacteria.
Kidney Disease: If you have kidney disease or reduced kidney function, discuss with your doctor how Mylan Azithromycin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Azithromycin, and whether any special monitoring is needed.
Liver disease: The liver is responsible for removing most of the azithromycin from the body. If it is not working properly, there is an increased risk of side effects of the medication. If you have liver disease or reduced liver function, discuss with your doctor how Mylan Azithromycin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Azithromycin, and whether any special monitoring is needed.
Mylan Azithromycin may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Myasthenia gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Azithromycin may cause the symptoms of myasthenia gravis to flare up. If you have myasthenia gravis, discuss with your doctor how Mylan Azithromycin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Azithromycin, and whether any special monitoring is needed.
Overgrowth of organisms: Prolonged or repeated use of azithromycin may result in an overgrowth of bacteria or fungi and organisms that are not killed by the medication. This can cause other infections, such as yeast infections, to develop.
Pregnancy: The safety of azithromycin for use by pregnant women has not been established. Mylan Azithromycin should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Mylan Azithromycin, contact your doctor immediately.
Breast-feeding: Mylan Azithromycin passes into breast milk. If you are a breast-feeding mother and are taking azithromycin it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and efficacy of azithromycin tablets or suspension have not been established for treating children younger than 6 months of age who have acute otitis media or community-acquired pneumonia.
The safety and efficacy of azithromycin tablets or suspension have not been established for treating children younger than 2 years of age who have throat infections or Tonsillitis.
The safety and efficacy of azithromycin injection have not been established for children less than 16 years of age.
