Lomecin Ophthalmic Ointment

Lomecin is indicated for bacterial infections, including bacterial conjunctivitis, blepharitis, and blepharo-conjunctivitis which are due to Lomecin susceptible germs. It is also indicated for the treatment of keratitis and corneal ulcer.

Each ml eye drops contains:

• Active Substance: Lomefloxacin Hydrochloride INN equivalent to Lomefloxacin 3 mg
• Preservative: Benzalkonium Chloride 0.02 mg

Lomefloxacin is a difluorinated quinolone. It is bactericidal with a broad spectrum of antibacterial activity. Lomefloxacin interferes with bacterial DNA related processes like initiation, elongation, and termination phases of replication, transcription, DNA repair, recombination, transposition, supercoiling and relaxation of DNA. The target molecule for quinolones is the subunit of bacterial enzyme gyrase (topoisomerase II). The forming of a stable complex between the quinolone and the whole gyrase tetramer A2B2 leads to impaired enzyme functions, resulting in a rapid killing of sensitive bacteria. Plasmid mediated transfer of resistance has not been observed so far. Cross-resistance has only been reported with other quinolones, but not with any other group of antibiotics.

Adults and children (above 1 year of age): Instill one drop 2 times daily into the lower conjunctival sac. At the beginning of treatment, application should be more frequent, apply 5 drops within 20 minutes or 1 drop every hour during 6 -10 hours.

In order to avoid reduction of efficacy, no ophthalmic preparations containing heavy metals, such as zinc, should be used during 15 minutes preceding and following application of the eye drops

Lomefloxacin is contraindicated in persons with a known hypersensitivity to any component of this product.

Slight and transient burning immediately after instillation of the eye drops has been reported in 4.7% of users. Although phototoxicity has not been reported after ophthalmic use, photosensitization is possible. Since the following allergic reactions have been reported after systemic use of Lomecin, they can not be excluded after topical ophthalmic use: allergic reactions, asthma, dyspnoea, urticaria, erythema, pruritus, and hypersensitization.

Animal studies have revealed that after systemic use, Lomefloxacin passes the placental barrier and is also excreted in maternal milk. Clinical studies on the use of Lomefloxacin eye drops during human pregnancy or lactation are not available. The drug therefore, should only be used when the potential benefit to the pregnant/lactating woman outweighs the potential risk to the fetus or the infant.

Lomecin eye drops contains Benzalkonium Chloride as a preservative, which can permeate into soft hydrophilic contact lenses. For this reason soft hydrophilic contact lenses should be taken out before applying Lomecin eye drops, and be replaced after 15 minutes.

4-Quinolone preparations, Ophthalmic antibacterial drugs

Store at below 30°C in a dry place protected from light. It is desirable that the contents should not be used more than one month after first opening of the bottle.