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
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
ActionsActions
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Suspension | 0.6% (of besifloxacin) | Besivance | Bausch & Lomb |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 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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