CUBIMOX

MOXIFLOXACIN HYDROCHLORIDE

The 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: Acinetobacterlwoffii, Haemophilusinfluenzae, Haemophilusparainfluenzae Other microorganisms: Chlamydia trachomatis.

Ophthalmic antibacterial drugs

Moxifloxacin is a synthetic broad spectrum, flouroquinolone derivative antibacterial agent. Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative microorganisms. The bactericidal action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair and recombination.

For 0.5% Eye Drops: One drop in the affected eye 3 times per day for 7 days. For 0.5% 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.

The solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage and tearing. Nonocular adverse effects are fever, increased cough, infection, otitis media, pharyngitis, rash and rhinitis. Contraindications: It is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.

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 the solution is administered to a nursing mother.

As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Store in a cool and dry place, away from light. Keep out of reach of children.