Moxifloxacin Hydrochloride 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 pneumoniae, Streptococcus viridans group.
• Aerobic Gram-negative microorganisms: Acinetobacter lwoffii, Haemophilus influenzae, Haemophilus parainfluenzae.
• Other microorganisms: Chlamydia trachomatis.

Intraocular injection: A highly effective intraocular antibiotic used for the prevention of postoperative bacterial endophthalmitis.

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

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

Eye Ointment: It should be applied thinly and evenly to the affected eye three times a day for the first two days and for the next five days apply two times a day or as advised by the registered physician.

Intraocular injection: Intraocular Moxifloxacin can be administered as 0.2–0.4 ml dose prior to ocular surgery via intraocular route. The final dose must be determined by the doctor.

Drug–drug interaction studies have not been performed with Moxifloxacin Hydrochloride ophthalmic solution. In vitro studies show that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that it is unlikely to affect the pharmacokinetics of drugs metabolized by these cytochrome P450 enzymes.

Moxifloxacin Hydrochloride ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, other quinolones, or any component of the formulation.

The most commonly reported ocular adverse effects include conjunctivitis, reduced visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular itching, subconjunctival hemorrhage, and tearing. These occur in approximately 1–6% of patients. Non-ocular adverse effects (1–4%) include fever, cough, infection, otitis media, pharyngitis, rash, and rhinitis.

There are no adequate and well-controlled studies in pregnant women; therefore, use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. It is not known whether Moxifloxacin is excreted in human milk, but it is presumed to be present. Caution should be exercised when administered to nursing mothers.

Prolonged use may lead to overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue treatment and start alternative therapy. Patients should be examined with appropriate magnification such as slit lamp when clinically necessary. Patients with bacterial conjunctivitis should avoid contact lenses.

Ophthalmic antibacterial drugs

Store below 25°C. Do not freeze. Keep in a cool, dry place protected from light. Keep out of reach of children. Do not touch dropper tip to any surface. Do not use after one month of opening.