OPTIMOX

Moxifloxacin 0.5%

Sterile Eye Drops

 

Description:

Optimox 0.5% is a sterile eye drops. It contains Moxifloxacin which is a synthetic broad-spectrum antibacterial agent of 4th generation fluoroquinolone.

Composition:

Optimox 0.5% Sterile Eye Drops: Each ml contains 5 mg Moxifloxacin equivalent to Moxifloxacin Hydrochloride.

Pharmacology:

Moxifloxacin shows antibacterial activity by inhibiting the bacterial enzyme topoisomerase II (DNA gyrase) and topoisomerase IV.

Indications:

Optimox 0.5% Eye Drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of following organisms: Aerobic gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group. Aerobic Gram-negative microorganisms: Acinetobacter iwoffii, Haemophilus influenzae, Haemophilus parainfluenzae.

Dosage & administration:

One drop in the affected eye 3 times per day for 7 days.

Contraindications:

Moxifloxacin Hydrochloride eye drops is contraindicated in patients with history of hypersensitivity to Moxifloxacin, to other quinolones or to any of components in the medication.

Side-effects:

The most frequently reported ocular side effects were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, sub-conjunctival hemorrhage and tearing. These events occurred in approximately 1-6% of patients.

Precautions:

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

Use in Pregnancy:

Moxifloxacin eye drops 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.

Use in Lactating Mother:

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 Hydrochloride eye drops is administered to a lactating mother.

Paediatric Use:

The safety and effectiveness of Moxifloxacin eye drops in infants below 1 year of age have not been established. But clinical study showed that Moxifloxacin eye drops can be used even younger than 1 month of age of children.

Geriatric use:

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

Drug Interaction: 

Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride eye drops. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isoenzymes.

No clinically significant drug interactions between theophylline, warfarin, digoxin, or glyburide have been observed with Moxifloxacin.

Storage:

Store at 2°-25°C. Keep out of the reach of children.

Packing:

Plastic dropper bottle containing 5 ml eye drops.