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QUINSAIR is a brand name for Levofloxacin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
QUINSAIR is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section.
QUINSAIR is also contraindicated in persons with a history of tendinitis or tendon rupture associated with the use of any member of the quinolone group of antimicrobial agents. WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Fluoroquinolones, including QUINSAIR, have been associated with disabling and potentially persistent adverse reactions which to date include, but are not limited to: tendinitis, tendon rupture, peripheral neuropathy and neuropsychiatric effects.
Levofloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients (see WARNINGS AND PRECAUTIONS, Cardiovascular). Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving quinolone therapy, including levofloxacin (see WARNINGS AND PRECAUTIONS, Immune).
Seizures may occur with quinolone therapy. QUINSAIR should be used with extreme caution in patients with known or suspected CNS disorders which may predispose to seizures or lower the seizure threshold (see WARNINGS AND PRECAUTIONS, Neurologic).
Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid QUINSAIR in patients with a known history of myasthenia gravis (see WARNINGS AND PRECAUTIONS, Musculoskeletal). Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages.
This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS AND PRECAUTIONS, Musculoskeletal). There are limited data on the use of levofloxacin in pregnant women and levofloxacin may be excreted in breast milk.
Non-clinical studies suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism. Consider alternate inhalation therapy to QUINSAIR during pregnancy (see WARNINGS AND PRECAUTIONS, Special Populations).
General QUINSAIR (Levofloxacin Inhalation Solution) produces systemic exposure to levofloxacin. Thus Warnings and Precautions associated with systemic (IV or oral) administration of levofloxacin or other fluoroquinolones may be relevant to patients receiving QUINSAIR.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Levofloxacin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
4 mL (100 mg/mL) Page 5 of 50 QUINSAIR should only be administered by the inhalation route and only be used with the ZIRELA® Nebulizer System manufactured by PARI Respiratory Equipment, Inc. Do not use other liquid formulations of levofloxacin in the ZIRELA® Nebulizer System as they have not been formulated for inhalation use.
QUINSAIR is not for ocular, oral, intravenous, subcutaneous, intramuscular or intrathecal administration and should not be used with any other device. Safety and efficacy of QUINSAIR have not yet been established beyond 3 consecutive cycles (6 months) of therapy (see DOSAGE AND ADMINISTRATION, Dosing Considerations and CLINICAL TRIALS).
Prescribing QUINSAIR in the absence of known Pseudomonas aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria. The administration of levofloxacin increased the incidence and severity of osteochondrosis in immature rats and dogs.
Other quinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species. Consequently, levofloxacin should not be used in pre-pubertal patients (see Part II: TOXICOLOGY).
Although levofloxacin is soluble, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been observed rarely in patients receiving other quinolones, when associated with high doses and an alkaline urine.
Although crystalluria was not observed in clinical trials with levofloxacin, patients are encouraged to remain adequately hydrated. As with any antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during levofloxacin therapy.
Use of levofloxacin with other drugs may lead to interactions. , warfarin), coagulation tests should be monitored when these drugs are given concomitantly (see DRUG INTERACTIONS, Drug-Drug Interactions). Cardiovascular QT Prolongation Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia.
During post-marketing surveillance, very rare cases of torsades de pointes have been reported in patients taking systemically administered levofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
, amiodarone, sotalol) antiarrhythmic agents, and cisapride. Elderly patients may be more susceptible to drug-associated effects on the QT interval. 4 mL (100 mg/mL) Page 6 of 50 hypokalemia, significant bradycardia, cardiomyopathy, patients with myocardial ischemia, and patients with congenital prolongation of the QT interval should be avoided (see DRUG […]