Besifloxacin is an active pharmaceutical ingredient in the Fluoroquinolones group (S01AE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised August 1, 2025[1]
6% w/v sterile ophthalmic suspension Contains poloxamer 407, polycarbophil, benzalkonium chloride. For a complete listing see Dosage Forms, Composition and Packaging section. 6% w/v is indicated for the treatment of patients one year of age and older with bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic, Gram-Positive CDC coryneform group G Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis Streptococcus oralis Streptococcus pneumoniae Aerobic, Gram-Negative Haemophilus influenzae To reduce the development of drug-resistant bacteria and maintain the effectiveness of BESIVANCE™ and other antibacterial drugs, BESIVANCE™ should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
Geriatrics (> 60 years of age):
No overall differences in safety and effectiveness have been observed between elderly and younger patients. 6% Page 4 of 27 Pediatrics (<1 years old): The safety and efficacy of BESIVANCETM in patients less than one year of age have not been established.
[1]Health Canada (DPD) · 02336847 · revised August 1, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
CONTRAINDICATIONS BESIVANCE™ is contraindicated in patients with known hypersensitivity to this drug, to other quinolones, or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
WARNINGS AND PRECAUTIONS General NOT FOR INJECTION INTO THE EYE. FOR TOPICAL OPHTHALMIC USE ONLY. BESIVANCE™ is a sterile suspension for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
There are no data to support use of BESIVANCE™ in patients with concomitant corneal injury/damage.
Contact Lenses:
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE™. Carcinogenesis and Mutagenesis Long-term studies in animals to determine the carcinogenic potential of besifloxacin have not been performed (see TOXICOLOGY).
Immune Anaphylaxis and Hypersensitivity:
Besifloxacin is only commercially available for topical ophthalmic administration. While anaphylaxis or other hypersensitivity reactions have not been observed with topical ophthalmic use of besifloxacin in humans, the potential for such reactions should be considered since patients with known hypersensitivity to fluoroquinolones were excluded from clinical trials.
In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching.
If any allergic reaction occurs, BESIVANCE™ should be discontinued and appropriate therapy should be administered as clinically indicated. 6% Page 5 of 27 Susceptibility/Resistance Development of Drug Resistant Bacteria: Prescribing BESIVANCE™ in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of resistant organisms.