Ofloxacin Ophthalmic Solution IP 0.3 % w/v
COMPOSITION
Each ml contains:
Ofloxacin IP 3 mg
Benzalkonium Chloride BP 0.01 % w/v
(as preservative)
Water for Injections BP q.s.
DESCRIPTION
A clear, pale to light yellow-greenish solution.
PHARMACODYNAMIC
Pharmacotherapeutic group: Ophthalmological, anti-infectives, fluoroquinolones.
ATC code: S01AE01
The primary mechanisms of action is through inhibition of bacterial DNA gyrase, the enzyme responsible for maintaining the structure of DNA. Ofloxacin is a synthetic fluorinated 4-quinolone antibacterial agent with activity against a broad spectrum of Gram negative and to a lesser degree Gram positive organism.
PHARMACOKINETICS
After ophthalmic instillation, ofloxacin is well maintained in the tear-film. In a healthy volunteer study, mean tear film concentrations of ofloxacin measured four hours after topical dosing (9.2 µg/g) were higher than the 2µ g/ml minimum concentration of ofloxacin necessary to inhibit 90% of most ocular bacterial strains (MIC90) in-vitro. Maximum serum ofloxacin concentrations after ten days of topical dosing were about 1000 times lower than those reported after standard oral doses of ofloxacin, and no systemic side-effects attributable to topical ofloxacin were observed.
THERAPEUTIC INDICATION
FLOWELL is indicated for the topical treatment of external ocular infections (such as conjunctivitis and keratoconjunctivitis) in adults and children caused by ofloxacin – sensitive organisms. Safety and efficacy in the treatment of ophthalmia neonatorum has not been established.
DOSAGE AND ADMINISTRATION
Topical ocular use.
For all ages: one to two drops in the affected eye(s) every two to four hours for the first two days and then four times daily. The length of treatment should not exceed ten days.
INSTRUCTION FOR USE
Apply FLOWELL Eye Drops in the following way:
- Wash your hands. Tilt your head back and look at the ceiling.
- Gently pull the lower eyelid down until there is a small pocket.
- Turn the bottle upside down and gently press the bottle to release drops into eyes that needs treatment.
- Let go of the lower lid, and close your eye for 30 seconds.
- To avoid contamination, do not let the tip of dropper touch your eye or anything else.
- Replace and tighten the cap straight after use.
OVERDOSE
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
CONTRAINDICATION
It is contra-indicated in individuals who have shown hypersensitivity to Ofloxacin, any of its excipients or any other quinolones.
WARNING AND PRECAUTIONS
- It is not for injection.
- Do not use the eye drop with contact lenses.
- Drug should be discontinued, if any allergic reaction occurs. Use this drug with caution in patient who have exhibited sensitivities to other quinolones antibacterial agents.
- Safety and effectiveness in infants below the age of one year have not been established.
- Sun or UV-exposition should be avoided during use of ofloxacin due to the potential for photosensitivity.
- Patients should be monitored in case of prolonged use.
PREGNANCY AND LACTATION
There have been no adequate and well-controlled studies performed in pregnant women. Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended that Ofloxacin not be used in pregnant women. Because Ofloxacin and other quinolones taken systemically are excreted in breast milk, and there is potential for harm to nursing infants, a decision should be made whether to temporarily discontinue nursing or not to administer the drug, taking into account the importance of the drug to the mother.
DRUG INTERACTION
No interaction studies have been performed.
It has been shown that the systemic administration of some quinolones inhibits the metabolic clearance of caffeine and theophylline. Drug interaction studies conducted with systemic ofloxacin have demonstrated that metabolic clearance of caffeine and theophylline are not significantly affected by ofloxacin.
Although there have been reports of an increased prevalence of CNS toxicity with systemic dosing of fluoroquinolones when used concomitantly with systemic nonsteroidal anti-inflammatory drugs (NSAIDs), this has not been reported with the concomitant systemic use of NSAIDs and ofloxacin.
Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
ADVERSE EFFECTS
Eye irritation; ocular discomfort; taste disturbance; keratitis; conjunctivitis.
PRESENTATION
FLOWELL Eye Drops are supplied in 5 ml sterilized opaque plastic container with nozzle and cap.
STORAGE AND OTHER INFORMATION
Store at temperature below 30 °C. Keep this medicine out of the sight and reach of children. Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate the solution. Use the solution within one month after opening the container.
