Mosi Special Precautions

General: As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systematically administered quinolones have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.
Carcinogenesis, Mutagenesis , Impairment of Fertility: Moxifloxacin was not mutagenic in four bacterial in four bacterial strains used in the Ames Salmonell reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when V79 cells were used. Moxifloxacin was clastogenic in the V79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence in vivo in a micronucleus test or a dominant lethal test in mice.
Exacerbation of myasthenia gravis: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in person with myasthenia gravis. Post marketing serious adverse events, including deaths and requirement for ventilator support have been associated with flouroquinolones use in persons with myasthenia gravis. Avoid flouroquinolones in patients with known history of myasthenia gravis.
Use in Children: Safety and effectiveness in pediatric patients below the age of 1 year have not been established. There is no evidence that the ophthalmic administration of MOSI has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.
Use in Elderly: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.