Indication:
Proprietary Name- Besivance
Established Name - Besifloxacin
Applicant- Bausch and lomb Inc
Indication-
It is a quinolone antimicrobial agent
Treatment of Bacterial Conjuntivitis
Approved by FDA on 28-5-2009 (Ref- FDA approved List- 2009)
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Besifloxacin ophthalmic suspn 31-05-2011
0.6% w/v
For the treatment of bacterial conjuntivitis
Adverse Reaction:
The most common adverse event reported in 2% of patients treated with Besivance was conjunctival
redness
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Topical Ophthalmic Use Only.
Growth of Resistant Organisms with Prolonged Use.
Avoidance of Contact Lenses. Patients should not wear contact lenses if they have signs
or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
Besivance (besifloxacin ophthalmic suspension) 0.6%, is a quinolone antimicrobial
indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates
of certain bacteria:
DOSAGE AND ADMINISTRATION
Instill one drop in the affected eye(s) 3 times a day,four to twelve hours apart for 7 days.
DOSAGE FORMS AND STRENGTHS
7.5 mL size bottle filled with 5 mL of besifloxacin ophthalmic suspension, 0.6%
Patient Information:
1.Patients should be advised to avoid contaminatingthe applicator tip with material
from the eye, fingers or other source.
2.Although Besivance is not intended to be administered systemically, quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose.
3.Patients should be advised to discontinue use immediately and contact their physician
at the first sign of a rash or allergic reaction.
4.Patients should be told that although it is common to feel better early in the course
of the therapy, the medication should be taken exactly as directed.
5.Skipping doses or not completing the full course of therapy may
(1) decrease the effectiveness of the immediate treatment and
(2) increase the likelihoodthat bacteria will develop resistance and will not be
treatable by Besivance™ or other antibacterial drugs in the future.
6.Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance
7.Patients should be advised to thoroughly wash hands prior to using Besivance
8.Patients should be instructed to invert closed bottle (upside down) and shake
once before each use.
9.Remove cap with bottle still in the inverted position. Tilt head back, and with bottle inverted,gently squeeze bottle to instill one drop into the affected eye(s).
Pharmacology/ Pharmacokinetics:
Mechanism of Action
Besifloxacin is a fluoroquinolone antibacterial
Pharmacokinetics
Plasma concentrations of besifloxacin were measured in adult patients with suspected bacterial onjunctivitis who received Besivance™ bilaterally three times a day (16 doses total).
Pregnancy and lactation:
Pregnancy
Pregnancy Category C. Oral doses of besifloxacinup to 1000 mg/kg/day were not associated with visceral or skeletal malformations in rat pups in a study of embryo-fetal development.
Nursing Mothers
Besifloxacin has not been measured in human milk,although it can be presumed to be excreted in human milk. Caution should be exercised whenBesivance is administered to a nursing mother.
Pediatric Use
The safety and effectiveness of Besivance in infants below one year of age have not been
established. The efficacy of Besivance in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials .
Geriatric Use
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
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