Florobex Ophthalmic Suspension 0.6%

Uses

This drug is used for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

CDC coryneform group G, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Haemophilus influenza, Moraxella lacunata, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus lugdunensis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia, Streptococcus salivarius.

Florobex Ophthalmic Suspension 0.6% is also used to associated treatment for these conditions: Bacterial Conjunctivitis

How Florobex Ophthalmic Suspension 0.6% works

Florobex Ophthalmic Suspension 0.6% is a bactericidal fluroquinolone-type antibiotic that inhibits bacterial enzymes, DNA gyrase and topoisomerase IV. By inhibiting DNA gyrase, DNA replication, transcription, and repair is impaired. By inhibiting topoisomerase IV, decatenation during cell devision is impaired. Inhibiting these two targets also slows down development of resistance.

Dosage

Florobex Ophthalmic Suspension 0.6% dosage

Adults and children (1 year of age and older): Instill one drop in the affected eye(s) 3 times a day for 7 days.

Pediatric Use: The safety and effectiveness of Florobex Ophthalmic Suspension 0.6% in infants below one year of age have not been established.

The safety and effectiveness of Florobex Ophthalmic Suspension 0.6% in infants below one year of age have not been established.

Side Effects

The most frequently reported ocular adverse event was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache.

Toxicity

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

Precaution

This drug is for topical ophthalmic use only and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. As with other anti -infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. To prevent contamination do not touch the tip of the dropper to eye, eyelid or any surface of the affected eye. Patients should not wear contact lenses during the course of therapy with this drug.Shake well before use.

Interaction

No such information found. Topical ophthalmic use only

Food Interaction

Volume of Distribution

Not absorbed into the systemic

Elimination Route

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.

Clearance

N/A

Elimination Route

N/A

Pregnancy & Breastfeeding use

Pregnancy Category C. No adequate and women. This drug should be used during potential risk to the fetus. well-controlled studies are established in pregnant pregnancy only if the potential benefit justifies the It is not known whether Florobex Ophthalmic Suspension 0.6% is secreted in human milk or not. Caution should be exercised when Florobex Ophthalmic Suspension 0.6% is administered to a nursing mother.

Contraindication

Hypersensitivity to the active ingredient or any component of this formulation.

Acute Overdose

No information is available.

Interaction with other Medicine

No information is available.

Storage Condition

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.

Innovators Monograph

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