(be si FLOX a sin)
- Besifloxacin Hydrochloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Besivance: 0.6% (5 mL) [contains benzalkonium chloride, edetate disodium dihydrate]
Brand Names: U.S.
- Antibiotic, Fluoroquinolone
- Antibiotic, Ophthalmic
Inhibits both DNA gyrase and topoisomerase IV. DNA gyrase is an essential bacterial enzyme required for DNA replication, transcription, and repair. Topoisomerase IV is an essential bacterial enzyme required for decatenation during cell division. Inhibition effect is bactericidal.
Use: Labeled Indications
Bacterial conjunctivitis: Treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans, CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Moraxella lacunata, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus hominis, Staphylococcus lugdunensis, Staphylococcus warneri, Streptococcus salivarius.
There are no contraindications listed in the manufacturer's labeling.
Bacterial conjunctivitis: Children ≥1 year, Adolescents, and Adults: Ophthalmic: Instill 1 drop into affected eye(s) 3 times daily (4 to 12 hours apart) for 7 days
Dosage adjustment for renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosage adjustment for hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
Ophthalmic: For topical ophthalmic use only. Wash hands before and after instillation. Shake bottle once prior to each administration. Avoid contaminating the applicator tip with affected eye(s), fingers, or other sources.
Store between 15°C to 25°C (59°F to 77°F). Protect from light.
There are no known significant interactions.
1% to 2%:
Central nervous system: Headache
Ocular: Conjunctival redness (2%), blurred vision, irritation, pain, pruritus
Concerns related to adverse effects:
• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with systemic quinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection. Discontinue use and initiate alternative therapy if superinfection occurs.
• Contact lens wearers: Contact lenses should not be worn during treatment of ophthalmic infections.
Dosage form specific issues:
• Ophthalmic solution: For topical ophthalmic use only. Do not inject ophthalmic solution subconjunctivally or introduce directly into the anterior chamber of the eye.
Pregnancy Risk Factor
Adverse events were observed in some animal reproduction studies. Systemic concentrations of besifloxacin following ophthalmic administration are low. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctual occlusion for 3 to 5 minutes after application to decrease potential exposure to the fetus (Samples 1988).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience short-term pain or subconjunctival hemorrhage. Have patient report immediately to prescriber vision changes, ophthalmalgia, or eye irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about besifloxacin ophthalmic
- Other brands: Besivance