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Indications

This ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms-

Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumonia, Streptococcus viridans group.

Aerobic Gram-negative microorganisms: Acinetobacter iwoffii, Haemophilus influenza, Haemophilus parainfluenzae.

Pharmacology

The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Dosage And Administration

One drop in the affected eye(s) 2 times daily for 7 days.

Interaction

Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride.

Side Effects

In 1-6% patients the most frequently reported ocular adverse events are eye irritation, pyrexia, conjunctivitis, decreased visual acuity, dry eye, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage and tearing.

Pregnancy And Lactation

Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus as there are no adequate and well-documented studies in pregnant women. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin is administered to a breast feeding mother.

Precautions And Warnings

Prolonged use may result in overgrowth of non-susceptible organisms, including fungi with other anti-infective.

Overdose Effects

There is practically no risk of adverse effects due to accidental ingestion, since a bottle of 5 ml eye drops solution contains only 25 mg Moxifloxacin that is much lower than recommended daily oral dose.

Therapeutic Class

Ophthalmic antibacterial drugs.

Use in special populations

Pediatric Use: The safety and effectiveness of Moxifloxacin in infants below four months of age was not proven. However, several clinical studies show that the drug may be used safely in children even younger than one month of age.

Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Storage Conditions

Store in a cool and dry place away from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. After one month of the first opening do not use the medicine of dropper.