Neofloxin

Therapeutic indications

External infections of the eye such as blepharitis, infectious conjunctivitis, keratitis, corneal ulcers and other eye infections caused by susceptible microorganisms, both gram-positive and gram-negative and anaerobic.

Actions

Neofloxin contains Ofloxacin, a fluoroquinolone with broad-spectrum antimicrobial activity against most gram-positive and gram-negative aerobic bacteria, mycobacteria, mycoplasma, chlamydia, and some anaerobic species.

Ofloxacin exerts its bactericidal effect by inhibiting bacterial DNA gyrase, an essential bacterial enzyme in the duplication, transcription and repair processes of bacterial DNA. It has activity against gram-positive bacteria such as: S. aureus, S. epidermidis, S. pneumoniae; and gram-negative bacteria such as: E. cloacae, H. Influenzae, P. mirabilis, P. aeruginosa.


Pharmacokinetics and pharmacodynamics in humans

Following Neofloxin ocular instillation, Neofloxin is distributed systemically by absorption through the nasal mucosa, or local ocular distribution by transcomeal-transconjunctival absorption; it subsequently accumulates in the aqueous humor and is distributed to other intraocular structures, as well as potentially to the systemic circulation through the trabecular network.

Ofloxacin, unlike other fluoroquinolones, has a superior pharmacokinetic profile, with much faster absorption and several times higher serum concentrations, reaching high concentrations in most tissues and body fluids. Finally, the drug is excreted through the kidneys.

Contraindications

Neofloxin is contraindicated in patients with a history of hypersensitivity to ofloxacin or other quinolones, or to any of the other ingredients in the formula.

Side Effects

 

Burning, photophobia, tearing, dryness and eye congestion. Ofloxacin has a relatively minor number of adverse effects and the microbial resistance to its action does not arise quickly.


Composition

Each ml contains:

Ofloxacin 3mg

Excipients and purified water C.S.P. 1ml

Posology and administration 

 

Administration route: Ophthalmic.

Conjunctivitis, keratitis and infectious blepharitis:

instill one or two drops into the conjunctival sac every 2 to 4 hours for the first two days, and then four times a day for an additional 5 days.

Corneal ulcer:

instill two drops in the affected eye every 15 minutes for the first 6 hours and then two drops every 30 minutes in the affected eye for the rest of the first day. On the second day, instill two drops into the affected eye every hour; from the third to the fourteenth day, instill two drops in the affected eye every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Storage recommendations

Store at a temperature between 15 °C and 25 °C. Protect  from freezing.

 

Presentation

Dropper bottle with 5 ml of solution.

Drug and other interactions

Specific drug interaction studies have not been conducted with ofloxacin.

Precautions or restrictions on use during pregnancy and lactation

Neofloxin should not be administered during pregnancy and lactation.

Pediatric use: Safety and effectiveness in children under 12 years of age have not been established and there is no evidence that topical ophthalmic doses have an effect on the joints.

Laboratory test alterations

Its use prior to taking a sample for ocular secretion culture can cause false negative results.

Precautions and relationship with effects of carcinogenesis, mutagenesis and teratogenesis and on fertility

In in vitro mutagenesis, carcinogenesis, teratogenesis and fertility tests in rats and rabbits the results have been negative with ofloxacin.