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Besifloxacin

Medically reviewed by Drugs.com. Last updated on Oct 6, 2020.

Pronunciation

(be si FLOX a sin)

Index Terms

  • Besifloxacin HCl
  • Besifloxacin Hydrochloride
  • BOL-303224-A
  • SS734

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 (edta) disodium dihydrate]

Brand Names: U.S.

  • Besivance

Pharmacologic Category

  • Antibiotic, Fluoroquinolone
  • Antibiotic, Ophthalmic

Pharmacology

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.

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.

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 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

What is this drug used for?

• It is used to treat eye infections.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Short-term pain

• Eye redness

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.