Mifloksan Special Precautions

For ocular use only. Not for injection.
MIFLOKSAN ophthalmic 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, 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.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organism, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
Whenever clinical judgement dictates, the patients 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 symptoms of bacterial keratitis.
Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in older patients and those treated concurrently with corticosteroids. Therefore, treatment with MIFLOKSAN should be discontinued at the first sign of tendon inflammation.
Patient information: Avoid contaminating the applicator tip with the material from the eye, fingers or other source. Systemically administered quinolones have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact a physician at first sign of a rash or allergic reaction.
Effects on ability to drive and use machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patients should wait until their vision clears before driving or using machinery.
Carcinogenesis, mutagenesis, impairment of fertility: Studies have not been performed to evaluate the effect of ocular administration of MIFLOKSAN on fertility.
Use in Children: The safety and effectiveness of MIFLOKSAN ophthalmic solution in pediatric have not been established. There is no evidence that the administration of MIFLOKSAN ophthalmic solution 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 the Elderly: No differences in safety and effectiveness between adult patients and elderly.