The bactericidal action of Moxifloxacin results from inhibition of enzymes DNA gyrase and topoisomerase IV required for bacterial DNA replication, transcription, repair and recombination.

Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described below.

Aerobic Gram-positive microorganisms: Corynebacterium species

micrococcus luteus, Staphylococcus aureur, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Staphylococcus pneumoniae, Staphylococcus viridans group.

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

Other microorganisms: Chlamydia trachomatis

Efficacy for this organism was studied in fewer than 10 infections.

INDICATIONS: Vigoquin Gel is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains and post-operative prophylaxis from susceptible strains.

DOSAE AND ADMINISTRATION: Instil one drop in the affected eye 3 times a day for 7 days or as directed by the ophthalmologist. Vigoquin Gel being a viscous liquid is retained on the ocular surface for a longer time, therefore the dosage may be determined by the ophthalmologist, after assessing the therapeutic response and condition of the patient.

CONTRAINDICATIONS: Vigoquin Gel is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.

WARNING AND PRECAUTIONS: NOT FOR INJECTION. For external use only.

In patients receining 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.

DRUGS INTERACTIONS: Drug interaction studies not been conducted with moxifloxacin solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9,CYP2C19 or CYP1A2 indicating that moxifloxacin is unlikely to alter the pharmacokinetic of drugs metabolized by these cytochrome P450 isoenzymes.

PREGNANCY

Pregnancy Category C: Since there are no adequate and well-controlled studies in pregnant women, moxifloxacin solution be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

LACTATION: 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 solution is administered to nursing mothers.

PAEDIATRIC USE: The safety and effectiveness if Vigoquin Gel solution in infants below 1 year of age have not been established. There is no evidence that the ophthalmic administration of Vigoquin Gel has any effect on weight bearing joints.

GERIATRIC USE: No overall difference in safety and effectiveness have been observed between elderly and younger patients.

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, subconjunctival hemorrhage and tearing. These events occurred in approximately 1-6% of patients.

Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash and rhinitis.

OVERDOSAGE: A topical overdose may be flushed from the eyes with warm tap water

PACKING: Vigoquin Gel solution is available in 5ml in lyondellbasel purell low density polyethylene dispensing system consisting of plastic bottle with good flexibility. Tamper evidence ring around the closure and neck area of the bottle.

STORAGE INSTRUCTIONS: Store at a temperature between 4°C to 25°C. Protect from light & moisture.

Do not freeze. Keep out of reach of children.

Use the solution within one month after opening the container.

For external use only.