Moxeza - Product Information
|Condition:||Conjunctivitis, Bacterial, Conjunctivitis, Eye Infection, Bacterial (Conjunctivitis, Bacterial)|
|Form:||Liquid solution, Eye drops (ophthalmic)|
|Ingredients:||Moxifloxacin hydrochloride, Sodium chloride, Xanthan gum, Boric acid, Sorbitol, Tyloxapol, Purified water, and Hydrochloric acid and/or Sodium hydroxide.|
Indications and Usage
Moxeza solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
*Efficacy for this organism was studied in fewer than 10 infections.
Dosage and Administration
Instill 1 drop in the affected eye(s) 2 times daily for 7 days.
Dosage Forms and Strengths
4 mL bottle filled with 3 mL of sterile ophthalmic solution of moxifloxacin hydrochloride, 0.5% as base.
Warnings and Precautions
Topical Ophthalmic Use Only
NOT FOR INJECTION. Moxeza solution is for topical ophthalmic use only and should not be injected subconjunctivally or 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.
Growth of Resistant Organisms with Prolonged Use
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 examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.
Avoidance of Contact Lens Wear
Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Moxeza solution in 1263 patients, between 4 months and 92 years of age, with signs and symptoms of bacterial conjunctivitis. The most frequently reported adverse reactions were eye irritation, pyrexia and conjunctivitis, reported in 1-2% of patients.
Use in Specific Populations
Pregnancy Category C. Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 25,000 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 5,000 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day.
Since there are no adequate and well-controlled studies in pregnant women, Moxeza solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxeza solution is administered to a nursing mother.
The safety and effectiveness of Moxeza solution in infants below 4 months of age have not been established.
There is no evidence that the ophthalmic administration of moxifloxacin has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
How Supplied/Storage and Handling
Moxeza solution is supplied as a sterile ophthalmic solution in the Alcon DROP-TAINER dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
3 mL in a 4 mL bottle - NDC 0065-0006-03
Storage: Store at 2°C- 25°C (36°F - 77°F).
Patient Counseling Information
Avoid Contamination of the Product
Patients should be advised not to touch the dropper tip to any surface to avoid contaminating the contents.
Avoid Contact Lens Wear
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Systemically administered quinolones, including moxifloxacin, have been associated with hypersensitivity reactions, even following a single dose. Patients should be told to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.
Licensed to Alcon by Bayer Pharma AG.
U.S. PAT. NO. 5,607,942; 6,716,830; 7,671,070