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 Act Levofloxacin.
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: Act Levofloxacin can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, mesylate, 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 Act Levofloxacin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Act Levofloxacin, and whether any special monitoring is needed.
Allergic reactions: In rare cases, some people may develop an allergic reaction to Act Levofloxacin. Signs of an allergic reaction include a severe rash, swollen face, or difficulty breathing. If these occur, contact your doctor immediately.
Blood sugar levels: Levofloxacin may cause a loss of control of blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Act Levofloxacin. People without diabetes have also been known to experience high or low blood sugars while taking levofloxacin.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Act Levofloxacin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Act Levofloxacin, and whether any special monitoring is needed.
If you experience signs of high blood sugar (fruity breath odour, weight loss, increased thirst, or increased need to urinate) or low blood sugar (cold sweat, cool pale skin, headache, or weakness) contact your doctor.
Drowsiness/reduced alertness: Levofloxacin may cause dizziness or lightheadedness, which can affect the mental abilities needed to drive or operate machinery. Avoid driving or performing other potentially hazardous tasks until you have determined how Act Levofloxacin affects you.
Kidney function: The safety of levofloxacin for people with decreased kidney function has not been studied. Because levofloxacin is removed by the body mostly by the kidneys, it is possible that Kidney Disease or reduced kidney function may cause Act Levofloxacin to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Act Levofloxacin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Act Levofloxacin, 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 Act Levofloxacin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Act Levofloxacin, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Act Levofloxacin.
Myasthenia Gravis: Myasthenia gravis is an autoimmune disorder that causes specific muscle weakness. Levofloxacin may make muscle weakness worse. If you have myasthenia gravis, discuss with your doctor how Act Levofloxacin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Act Levofloxacin, and whether any special monitoring is needed.
Nervous system disorders: Rare cases of disorders that affect the nervous system have been reported by people taking Act Levofloxacin. If you are experiencing seizures, tremors, confusion, hallucinations, depression, agitation, anxiety, paranoia, or disturbing thoughts, contact your doctor immediately.
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 Act Levofloxacin and contact your doctor immediately.
Seizures: There have been occasional reports of seizures occurring with quinolone antibiotics. Seizures are more likely to occur when higher doses of Act Levofloxacin are taken. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Act Levofloxacin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Act Levofloxacin, and whether any special monitoring is needed.
Stomach problems (especially colitis): In rare cases, levofloxacin may cause a condition called pseudomembranous colitis (serious antibiotic-induced diarrhea). Therefore, if diarrhea occurs after starting the medication, contact your doctor.
Sun sensitivity: People who take levofloxacin are more likely to experience Sunburn. While taking levofloxacin, be careful if you spend time in the sun. Avoid exposure to excessive sunlight, including sunlamps and tanning beds, and use sunblock with minimum SPF 15. Stop taking levofloxacin if severe sun sensitivity occurs.
Tendinitis: Levofloxacin, like other antibiotics in this group, may increase the chance of tendon injury. In some cases, this effect may be long-lasting. Injuries occur more commonly for seniors, people taking corticosteroid medications, and people who have had a kidney, heart, or lung transplant. If you feel any new pain in the tendons, stop taking levofloxacin, avoid physical exercise, and consult your doctor.
Pregnancy: Act Levofloxacin should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Act Levofloxacin, contact your doctor immediately.
Breast-feeding: Act Levofloxacin may pass into breast milk. If you are a breast-feeding mother and are taking levofloxacin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children and adolescents: The safety and effectiveness of levofloxacin for children and adolescents younger than 18 years of age have not been established. Children who have not reached puberty should not take levofloxacin, since it may affect the normal growth of bones.
Seniors: People over the age of 65 are more likely to experience serious side effects of levofloxacin, such as tendinitis, liver toxicity, or heart problems.
