Quinsair

The usual dose is the contents of one ampule (240 mg) inhaled twice a day for 28 days. The doses should be used as close to 12 hours apart as possible, and no less than 8 hours apart. Quinsair should be used in cycles of 28 days on treatment followed by 28 days off treatment.

Each dose should be given with the hand-held reusable nebulizer provided to you. Do not dilute or mix Quinsair with other medications in the nebulizer. If you are using other medications that require a nebulizer, use them first, then use Quinsair. The administration of a dose takes approximately 5 to 7 minutes.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Quinsair exactly as prescribed by your doctor.

If you miss a dose, and it is less than 4 hours since the missed dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Quinsair at room temperature, in its original packaging to protect it from light and moisture, and keep it out of the reach of children. The ampules are supplied in a foil sachet. Once the foil sachet is opened, the ampules should be used within 4 days. Once an ampule is opened, it should be used immediately.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each single-use, ready-to-use ampule of clear, pale yellow, sterile solution contains 240 mg of levofloxacin. Nonmedicinal ingredients: magnesium chloride hexahydrate and water for injection.

Each 28-day pack of levofloxacin inhalation contains 56 ampules (14 foil laminate sachets each containing 4 ampules) packaged in a box with a Consumer Information Leaflet plus one ZIRELA™ Nebulizer Handset packaged in its own box with the Manufacturer's Instruction for Use.

Do not take Quinsair if you:

• are allergic to levofloxacin or any ingredients of the medication
• have a history of Tendinitis or tendon rupture caused by using quinolone antibiotics

There may be an interaction between levofloxacin inhalation and any of the following:

• Alfuzosin
• amantadine
• Amiodarone
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apomorphine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• BCG vaccine
• Buprenorphine
• chloral hydrate
• chloroquine
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Rosiglitazone)
• Disopyramide
• Domperidone
• Dronedarone
• Famotidine
• Fingolimod
• Flecainide
• formoterol
• Galantamine
• hydroxychloroquine
• Indacaterol
• Indapamide
• lithium
• Loperamide
• lopinavir
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Maprotiline
• mefloquine
• Methadone
• mifepristone
• multivitamin supplements
• mycophenolate
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• Octreotide
• Pimozide
• Primaquine
• procainamide
• Propafenone
• protein kinase inhibitors (e.g., Bosutinib, Dasatinib, Nilotinib, sunatinib)
• Romidepsin
• Quinapril
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• ritonavir
• salmeterol
• saquinavir
• selective serotonin reuptake inhibitors (SSRIS; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• sevelamer
• sodium picosulfate
• Solifenacin
• sotalol
• sulfamethoxazole
• tacrolimus
• Tamoxifen
• Tetrabenazine
• Theophylline
• Tizanidine
• Trazodone
• Trimethoprim
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• typhoid vaccine
• Vardenafil
• Varenicline
• Venlafaxine
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Quinsair. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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.