Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Moxifloxacin ophthalmic solution USP, 0.5% is supplied as a sterile ophthalmic solution in a sterile 5 mL natural low density polyethylene bottle fitted with a natural low density polyethylene nozzle and sealed with a tan coloured high density polyethylene cap as follows: 3 mL in a 5 mL bottle (NDC 68180-421-01) Storage: Store at 2°C to 25°C (36°F to 77°F).; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Moxifloxacin Ophthalmic Solution USP, 0.5% NDC 68180-421-01 container carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Moxifloxacin ophthalmic solution USP, 0.5% is supplied as a sterile ophthalmic solution in a sterile 5 mL natural low density polyethylene bottle fitted with a natural low density polyethylene nozzle and sealed with a tan coloured high density polyethylene cap as follows: 3 mL in a 5 mL bottle (NDC 68180-421-01) Storage: Store at 2°C to 25°C (36°F to 77°F).
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Moxifloxacin Ophthalmic Solution USP, 0.5% NDC 68180-421-01 container carton
Overview
Moxifloxacin ophthalmic solution USP is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8- methoxy-7- [(4aS,7aS)-octahydro- 6H- pyrrolol [3,4-b] pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. Each mL of moxifloxacin ophthalmic solution USP, 0.5 % contains 5.45 mg moxifloxacin hydrochloride USP, equivalent to 5 mg moxifloxacin base. Inactives: boric acid, sodium chloride, sorbitol, tyloxapol, xanthan gum, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection. Moxifloxacin ophthalmic solution USP, 0.5% is a greenish-yellow, isotonic solution with an osmolality of 300 to 370 mOsm/kg and a pH of approximately 7.4. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. USP pH and Osmolality tests are pending. figure 1
Indications & Usage
Moxifloxacin Ophthalmic Solution USP is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans*, Corynebacterium macginleyi*, Enterococcus faecalis*, Micrococcus luteus*, Staphylococcus arlettae*, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus*, Staphylococcus warneri*, Streptococcus mitis*, Streptococcus pneumoniae, Streptococcus parasanguinis*, Escherichia coli*, Haemophilus influenzae, Klebsiella pneumoniae*, Propionibacterium acnes, Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections. ( 1 ) Moxifloxacin ophthalmic solution USP is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans* Corynebacterium macginleyi* Enterococcus faecalis* Micrococcus luteus* Staphylococcus arlettae* Staphylococcus aureus Staphylococcus capitis Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus* Staphylococcus warneri* Streptococcus mitis* Streptococcus pneumoniae Streptococcus parasanguinis* Escherichia coli* Haemophilus influenza Klebsiella pneumoniae* Propionibacterium acnes Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections.
Dosage & Administration
Instill 1 drop in the affected eye(s) 2 times daily for 7 days. ( 2 ) Instill 1 drop in the affected eye(s) 2 times daily for 7 days.
Warnings & Precautions
Corneal Endothelial Damage and Toxic Anterior Segment Syndrome : Intracameral injections will cause harm to endothelium. ( 5.1 ) Hypersensitivity Reactions : Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. ( 5.2 ) Prolonged Use : May result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. ( 5.3 ) Avoid Contact Lens Wear : Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.4 ) 5.1 Corneal Endothelial Damage and Toxic Anterior Segment Syndrome NOT FOR INTRACAMERAL USE OR INJECTION. Moxifloxacin ophthalmic solution will cause damage to the corneal endothelium if introduced directly into the anterior chamber of the eye. Toxic Anterior Segment Syndrome (TASS) has been reported following intraocular administration of moxifloxacin. TASS is typically characterized by anterior chamber inflammatory reactions, such as fibrin, cell or flare and corneal edema, but other events, such as hypopyon, keratic precipitates or vitreous opacities may also occur. 5.2 Hypersensitivity Reactions 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. 5.3 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. 5.4 Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
Contraindications
None. ( 4 ) None.
Adverse Reactions
The most common adverse reactions reported in 1% to 2% of patients were eye irritation, pyrexia, and conjunctivitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 moxifloxacin ophthalmic 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% to 2% of patients.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.