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Highly Regulated (List I)

BESIVANCE

0,6% (0,6 MG/ML)/Ophthalmic Suspension/BESIFLOXACINE
BAUSCH LOMB INCORPORATED
ManufacturerVerified lab

BAUSCH LOMB INCORPORATED

Public retail price
N/ADZD

Identification

Active ingredient (INN)
BESIFLOXACINE
Internal code
17 D 182
Country of Origin
United States
Pharmaceutical form
Ophthalmic Suspension
Prescription List
Highly Regulated (List I)
Packaging
b/01 flacon 5ml
BESIVANCE
Clinical View
Highly Regulated (List I)

DAWA Clinical Workbench v2.0

Information may not be accurate. Always consult a physician, pharmacist, or specialist before acting on any data shown here.

Description

Besifloxacin is a fourth generation fluoroquinolone-type opthalmic antibiotic for the treatment of bacterial conjunctivitis.

FDA approved on

May 28, 2009.

Indications

Treatment of bacterial conjunctivitis.

Bacterial isolates that are susceptible to besifloxacin include: CDC coryneform group G; Corynebacterium pseudodiphtheriticum; Corynebacterium striatum; Haemophilus influenzae; Moraxella lacunata; Staphylococcus aureus; Staphylococcus epidermidis; Staphylococcus hominis; Staphylococcus lugdunensis; Streptococcus mitis group; Streptococcus oralis; Streptococcus pneumoniae; Streptococcus salivarius*

Pharmacodynamics

Besifloxacin tear concentrations were higher than

MIC90 (minimum inhibitory concentration) values for common bacterial pathogens and sustained for 24 hours or longer.

Mean residence time in the conjunctiva was 4.7 hours.

Mechanism of Action

topoisomerase 4 subunit A (Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd)) Antagonist DNA topoisomerase 4 subunit A (Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4)) Antagonist DNA gyrase subunit A (Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd)) Antagonist + 1 more target.

Absorption

Although ocular surface concentrations are high, average systemic concentrtions after three-times daily dosing was less than 0.5 ng/mL.

This indicates that besifloxacin is not appreciably absorbed into the systemic and has a very low risk of systemic side effects.

Half-life

The average elimination half-life of besifloxacin in plasma following multiple dosing was estimated to be 7 hours.

Adverse Effects

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Toxicity

LD50, rat: >2000 mg/kg. The most common adverse reaction reported in 2% of patients treated with besifloxacin was conjunctival redness.

Alternatives