Besivance

Generic Name: Besifloxacin Hydrochloride
Class: Antibacterials
VA Class: OP201
Chemical Name: (+) - 7 - [(3R) - 3 - aminohexahydro - 1H - azepin - 1 - yl] - 8 - chloro - 1 - cyclopropyl - 6 - fluoro - 4 - oxo - 1,4 - dihydroquinoline - 3 - carboxylic acid hydrochloride
Molecular Formula: C19H21ClFN3O3•HCl
CAS Number: 405165-61-9

Introduction

Fluoroquinolone anti-infective agent.1 2 3

Uses for Besivance

Bacterial Ophthalmic Infections

Treatment of conjunctivitis caused by susceptible strains of CDC coryneform group G, Corynebacterium pseudodiphtheriticum, C. striatum, Haemophilus influenzae, Moraxella lacunata, Staphylococcus aureus, S. epidermidis, S. hominis, S. lugdunensis, Streptococcus mitis group, S. oralis, S. pneumoniae, or S. salivarius.1

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Besivance Dosage and Administration

Administration

For topical use only.1 Not for injection.1 Not for subconjunctival injection or introduction directly into anterior chamber of the eye.1

Ophthalmic Administration

Apply topically to the eye as an ophthalmic suspension.1

Invert the closed bottle containing besifloxacin hydrochloride ophthalmic suspension and shake once prior to use.1

Remove contact lenses before administration.1

Dosage

Available as besifloxacin hydochloride; dosage expressed in terms of besifloxacin.1

Pediatric Patients

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

Children ≥1 year of age: 1 drop of a 0.6% suspension in the affected eye(s) 3 times daily (given 4–12 hours apart) for 7 days.1

Adults

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

1 drop of a 0.6% suspension in the affected eye(s) 3 times daily (given 4–12 hours apart) for 7 days.1

Cautions for Besivance

Contraindications

  • Manufacturer states none known.1

Warnings/Precautions

Warnings

Administration

For topical use only.1 Not for injection.1 Not for subconjunctival injection or introduction directly into the anterior chamber of the eye.1

Infectious Complications

Possible overgrowth of nonsusceptible organisms (e.g., fungi) with prolonged use; if superinfection occurs, discontinue drug and institute other appropriate therapy.1

Patient Monitoring

Careful monitoring, including slit-lamp biomicroscopy and fluorescein staining when appropriate, may be necessary in some patients.1

Contact Lenses

Patient should not wear contact lenses in the presence of signs and symptoms of bacterial conjunctivitis and while receiving besifloxacin ophthalmic suspension.1

Specific Populations

Pregnancy

Category C.1

Lactation

Caution advised.1

Pediatric Use

Safety and efficacy not established in children <1 year of age.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1

Common Adverse Effects

Conjunctival redness.1

Interactions for Besivance

No formal drug interaction studies to date.1

Besivance Pharmacokinetics

Absorption

Bioavailability

Maximum plasma concentration of besifloxacin after topical application of 0.6% ophthalmic suspension to each eye 3 times daily for 16 doses was <1.3 ng/mL.1

Distribution

Extent

Penetrates into conjunctiva and aqueous humor; maximum concentrations reported are 62.8 and 1.7 mcg/mL, respectively.2

Elimination

Half-life

7 hours.1

Stability

Storage

Ophthalmic

Suspension

15–25°C.1 Protect from light.1

Actions

  • Inhibits DNA synthesis in susceptible organisms via inhibition of DNA topoisomerases (DNA gyrase, topoisomerase IV).1 2

  • Spectrum of activity includes gram-positive aerobic bacteria and many gram-negative aerobic bacteria.1 2

  • Active against CDC coryneform group G, Corynebacterium pseudodiphtheriticum, C. striatum, Haemophilus influenzae, Moraxella lacunata, Staphylococcus aureus, S. epidermidis, S. hominis, S. lugdunensis, Streptococcus mitis group, S. oralis, S. pneumoniae, S. salivarius.1

Advice to Patients

  • Importance of discontinuing drug and informing clinician at first sign of rash or other sign of hypersensitivity.1

  • Importance of completing the entire prescribed course of treatment, even if feeling better after a few days.1

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with besifloxacin or other antibacterials in the future.1

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1

  • Importance of not wearing contact lenses in the presence of signs and symptoms of bacterial conjunctivitis and while receiving besifloxacin ophthalmic suspension.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Besifloxacin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.6% (of besifloxacin)

Besivance

Bausch & Lomb

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions February 1, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bausch & Lomb. Besivance (besifloxacin ophthalmic suspension) 0.6% prescribing information. Tampa, FL; 2009 Apr.

2. Karpecki P, DePaolis M, Hunter JA et al. Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: a multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study. Clin Ther. 2009; 31:514-26. [PubMed 19393842]

3. Tepedino ME, Heller WH, Usner DW et al. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009; 25:1159-69. [PubMed 19323612]

4. Sheikh A, Hurwitz B. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database of Systematic Reviews. 2006; 2CD001211.

5. McDonald MB, Protzko EE, Brunner LS et al. Efficacy and safety of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5% for treating bacterial conjunctivitis. Ophthalmology. 2009; 116:1615-23. [PubMed 19643483]

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