OVEL

Sterile Eye Drops

Description:

Ovel Sterile Eye Drops contains Levofloxacin, a fluoroquinolone antimicrobial, active against broad spectrum of gram-positive and gram-negative ocular pathogens.

Composition:

Each ml contains Levofloxacin Hemihydrate INN equivalent to Levofloxacin 5 mg.

Preservative: Benzalkonium Chloride Solution 0.005% v/v.

Indications:

Ovel Sterile Eye Drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms.

Aerobic gram-positive bacteria: Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Group C/F), Streptococcus (Group G), viridans group streptococci.

Aerobic gram-nagetive bacteria: Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens.

In some study it has been found that levofloxacin is indicated in post-operative ocular infections and endophthalmitis.

Dosage and administration:

Days 1 & 2: Instill 1-2 drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.

Days 3 to 7: Instill 1-2 drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.

Side-effects:

The most frequently reported adverse reactions are transient decreased vision, fever, foreign body sensation, headache, ocular pain or discomfort, and photophobia. These events occurred in approximately 1-3% of patients. Other reported reactions occurring in less than 1% of patients included allergic reactions, lid edema, ocular dryness, and ocular itching.

Precautions & Warning:

* Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy.

* Patients wearing contact lenses must not use the drops during the time the lenses are worn.

* Should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

Contraindication:

Hypersensitivity to Levofloxacin, to other quinolones or to any component of the product.

Drug Interaction:

Specific drug interaction studies have not been conducted with topical Levofloxacin. However, the systemic administration of some quinolones has become shown to elevate plasma concentration of theophylline interfere with the metabolism of caffeine and has been associated with transient elevation in serum creatinine level in patients receiving systemic cyclosporine concomitantly.

Pregnancy:

There are no adequate and well controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers:

Levofloxacin has not been measured in human milk. Based upon data from Ofloxacin it can be presumed that Levofloxacin is excreted in human milk. Caution should be exercised when Ovel is administered to a nursing mother.

Pediatric use:

Safety and efficacy in infants below the age of 1 year have not been established.

Geriatric use:

No overall differences in safety or efficacy have been observed between elderly and other adult patients.

Information for patients:

Avoid contaminating the dropper bottle tip with material from the eye, finger or other source.

Storage:

Store at 15-25º C. Keep out of the reach of children.

Packing:

Plastic dropper bottle containing 5 ml  eye Drops.