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 Quinsair.
HEALTH CANADA ADVISORY
JANUARY 23, 2017
Health Canada has issued new restrictions concerning the use of levofloxacin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Abnormal heart rhythms: Quinsair can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, chlorpromazinepimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with levofloxacin. 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 Quinsair may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Quinsair, and whether any special monitoring is needed.
Allergy: People who have had an allergic reaction to other quinolones may also be allergic to levofloxacin. Before you use Quinsair, inform your doctor about any previous adverse reactions you have had to medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
Antibiotic-related diarrhea: As with other antibacterials, levofloxacin inhalation can cause a severe form of diarrhea associated with a condition known as pseudomembranous colitis. If you develop severe diarrhea while taking (or within a few weeks of taking) Quinsair, contact your doctor.
Behaviour and movement changes: Rarely, Quinsair can cause movement disorders or behaviour changes such as agitation, anxiety, confusion, depression, tremors, hallucinations, and other mood changes. If you experience any of these, or notice them in a family member who is taking Quinsair, stop taking Quinsair and contact your doctor immediately.
Breathing problems: Occasionally, inhaled medications may cause the airways to spasm and close up, making breathing even more difficult (bronchospasm). This can be life-threatening. If you experience increased difficulty breathing after using a dose of inhaled levofloxacin, seek immediate medical attention.
Diabetes: Levofloxacin may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Quinsair.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Quinsair may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Quinsair, and whether any special monitoring is needed.
Drowsiness/dizziness: Levofloxacin inhalation may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Quinsair affects you.
Kidney function: Kidney Disease or reduced kidney function may cause Quinsair to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Quinsair may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Quinsair, and whether any special monitoring is needed.
Liver function: Very rarely, levofloxacin may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Quinsair may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Quinsair, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Quinsair.
Myasthenia Gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Levofloxacin can cause increased muscle weakness for people with myasthenia gravis. If you have myasthenia gravis, discuss with your doctor how Quinsair may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Quinsair, and whether any special monitoring is needed.
Peripheral Neuropathy: Although rare, levofloxacin may affect the nerves of the skin and limbs. If you start to feel pain, burning, tingling, numbness, or weakness, stop taking Quinsair and contact your doctor immediately.
Resistance: There is a chance that bacteria can become resistant to Quinsair. If you are not getting better despite using Quinsair, contact your doctor.
Seizures: There have been occasional reports of seizures occurring with levofloxacin. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Quinsair may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Quinsair, and whether any special monitoring is needed.
Sensitivity to sun: An exaggerated sunburn reaction may occur for some people taking quinolone antibiotics, including levofloxacin. Avoid exposure to excessive sunlight, including sunlamps and tanning beds, and use sunblock with minimum SPF 15.
Tendinitis: Tendons are cords of fibrous tissue that attach muscle to bone. Quinolone antibiotics can cause inflammation and rarely, rupture of a tendon. If you experience unexpected or unusual pain in the shoulder, hand or heel, contact your doctor as soon as possible.
Pregnancy: Quinsair should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Quinsair, contact your doctor immediately.
Breast-feeding: It is not known if levofloxacin inhalation passes into breast milk. If you are a breast-feeding mother and are taking Quinsair, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Quinsair have not been established for children.
