Moxifloxacin Ophthalmic Solution
Moxifloxacin Ophthalmic Solution is an FDA drug label for the active ingredient MOXIFLOXACIN OPHTHALMIC manufactured by Fosun Pharma USA Inc. administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231217.
- Generic name
- MOXIFLOXACIN OPHTHALMIC
- Manufacturer
- Fosun Pharma USA Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC
- Dosage form
- N/A
- NDC
- 72266-158
- Application
- ANDA208778
- Label effective
- 20231217
Indications & Usage
1 INDICATIONS AND USAGE Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species * Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. Moxifloxacin ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species* Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group , Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis. *Efficacy for this organism was studied in fewer than 10 infections. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instill one drop in the affected eye 3 times a day for 7 days. Moxifloxacin ophthalmic solution is for topical ophthalmic use. Instill one drop in the affected eye 3 times a day for 7 days. ( 2 )
Contraindications
4 CONTRAINDICATIONS Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. ( 4 )
Warnings
Not available.
Adverse Reactions
6 ADVERSE REACTIONS 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 most frequently reported ocular adverse events 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% to 6 % of patients. Nonocular adverse events reported at a rate of 1% to 4 % were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. The most frequently reported ocular adverse events 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% to 6% of patients. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .