Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Ophthalmic:
Besivance: 0.6% (5 mL) [contains benzalkonium chloride, edetate disodium dihydrate]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
Half-Life Elimination
~7 hours
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.
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to besifloxacin, any component of the formulation, or other quinolones.
Dosage and Administration
Dosing: Adult
Bacterial conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) 3 times daily (4 to 12 hours apart) for 7 days
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Instill 1 drop into affected eye(s) 3 times daily (4 to 12 hours apart) for 7 days
Administration
Ophthalmic: For topical ophthalmic use only. Wash hands before and after instillation. Invert bottle while closed and shake once prior to each administration. Avoid contaminating the applicator tip with affected eye(s), fingers, or other sources.
Storage
Store between 15°C to 25°C (59°F to 77°F). Protect from light.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Frequency not always defined.
1% to 2%:
Central nervous system: Headache
Ophthalmic: Conjunctival erythema (2%), blurred vision, eye irritation, eye pain, eye pruritus
Warnings/Precautions
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.
Special populations:
- 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
Pregnancy Considerations
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 punctal occlusion for 3 to 5 minutes after application to decrease potential exposure to the fetus (Samples 1988).
Patient Education
- 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 eye redness. Have patient report immediately to prescriber vision changes, eye pain, or severe 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 health care 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.
