Moxifloxacin-Bromfenac (moxifloxacin HCl/bromfenac sodium)
Ophthalmic Antibacterials Ophthalmic (Eye) Drops
Last reviewed · Source: First Databank (FDB) drug data
Overview
Moxifloxacin is a fluoroquinolone anti-infective agent.
Bromfenac sodium is a prototypical nonsteroidal anti-inflammatory agent (NSAIA).
Moxifloxacin is a fluoroquinolone anti-infective agent. Like other commercially available fluoroquinolones, moxifloxacin contains a fluorine at the C-6 position of the quinolone nucleus. Moxifloxacin, like gatifloxacin, contains an 8-methoxy group and has been termed an 8-methoxy fluoroquinolone.
Like other fluoroquinolones, moxifloxacin inhibits DNA synthesis in susceptible organisms via inhibition of type II DNA topoisomerases (DNA gyrase, topoisomerase IV).
Moxifloxacin is active in vitro and in vivo in conjunctival infections against some gram-positive bacteria, including Staphylococcus (S. aureus, S. arlettae, S. capitis, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. warneri ), Streptococcus (S. mitis, S. parasanguinis, S. pneumoniae, viridans streptococci ), Enterococcus faecalis, Aerococcus viridans, Corynebacterium (C. macginleyi), Micrococcus luteus, and Propionibacterium acnes.
Moxifloxacin also is active in vitro and in vivo in conjunctival infections against some gram-negative bacteria, including Acinetobacter lwoffii, Escherichia coli, Haemophilus influenzae, H. parainfluenzae, and Klebsiella pneumoniae. The drug also is active against Chlamydia trachomatis.
Cross-resistance can occur between moxifloxacin and other fluoroquinolones.
For the topical treatment of conjunctivitis caused by susceptible bacteria, moxifloxacin hydrochloride is commercially available as aqueous ophthalmic solutions containing 5 mg of moxifloxacin per mL. Moxifloxacin 0.5% ophthalmic solution (Moxeza(R)) is isotonic (osmolality of 300-370 mOsm/kg) and has a pH of approximately 7.4. Moxifloxacin 0.5% ophthalmic solution (Vigamox(R)) is isotonic (osmolality of 290 mOsm/kg) and has a pH of approximately 6.8.
Following topical application of moxifloxacin 0.5% ophthalmic solution to the eye, the drug is absorbed systemically and low moxifloxacin concentrations are attained in plasma. In a study in healthy adults using moxifloxacin 0.5% ophthalmic solution (Moxeza(R)), multiple, bilateral, topical ocular doses of the ophthalmic solution were applied twice daily for 4 days and resulted in peak plasma concentrations of moxifloxacin that were approximately 0.02% of those reported with usual dosages of oral moxifloxacin. In a study in healthy adults using moxifloxacin 0.5% ophthalmic solution (Vigamox(R)), bilateral topical doses of the ophthalmic solution were applied 3 times daily for 5 days and resulted in mean steady-state peak plasma concentrations and estimated daily exposure (determined by area under the plasma concentration-time curve (AUC)) 1600 and 1000 times lower, respectively, than values reported with usual dosages of oral moxifloxacin.
The half-life of systemically absorbed moxifloxacin is approximately 13 hours.
Bromfenac sodium is a prototypical NSAIA. The drug inhibits the synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase (COX), including both COX-1 and COX-2 isoenzymes. The mechanism(s) of the ocular effects of NSAIAs appears to be associated principally with the inhibition of ocular prostaglandin synthesis.
By reducing ocular production of prostaglandins, NSAIAs can inhibit ocular inflammation and other reactions mediated primarily or secondarily by prostaglandins.
Generic name: moxifloxacin HCl/bromfenac sodium
Drug class: Ophthalmic Antibacterials
Therapeutic class: Ophthalmic Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Moxifloxacin-Bromfenac
Indications
No indications are available for this drug.
Dosing
Moxifloxacin is commercially available for topical ophthalmic administration as moxifloxacin hydrochloride; dosage is expressed in terms of moxifloxacin.
Dosage of bromfenac sodium, which is commercially available as the sesquihydrate, is expressed in terms of bromfenac.
The recommended adult dosage of bromfenac for the management of postoperative ocular inflammation and pain in patients who have undergone cataract extraction is 1 drop of a 0.09% solution in the affected eye(s) twice daily, beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.
Bromfenac sodium is applied topically to the eye as an ophthalmic solution. Care should be taken to avoid contamination of the solution container.
Bromfenac sodium ophthalmic solution should not be administered while wearing contact lenses.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been performed using moxifloxacin 0.5% ophthalmic solution.
In vitro studies indicate that moxifloxacin does not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2C9, C19, 2D6, or 3A4; moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these CYP isoenzymes.
No formal drug interaction studies have been performed to date.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Moxifloxacin 0.5% ophthalmic solution is contraindicated in patients with known hypersensitivity to moxifloxacin, other quinolones, or any component in the formulation.
Known hypersensitivity to bromfenac sodium or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Diabetes mellitus
- Epithelial keratopathy
- No disease contraindications
- Ocular redness
- Rheumatoid arthritis
Adverse reactions
Moxifloxacin 0.5% ophthalmic solution (Moxeza(R)): Adverse effects reported in 1-2% of patients include eye irritation, pyrexia, and conjunctivitis.
Moxifloxacin 0.5% ophthalmic solution (Vigamox(R)): Adverse effects reported in approximately 1-6% of patients include conjunctivitis, decreased visual acuity, ocular dryness, keratitis, ocular discomfort/pain/pruritus, ocular hyperemia, subconjunctival hemorrhage, and tearing. Adverse systemic effects reported in approximately 1-4% of patients include fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
Adverse effects reported in 2% or more of patients receiving bromfenac sodium ophthalmic solution include abnormal ocular sensation, conjunctival hyperemia, ocular redness or irritation (e.g., pruritus, burning, stinging, pain), headache, and iritis.
More Frequent
- Conjunctivitis
- Keratitis
- Ocular itching
- Ocular pain
- Reduced visual acuity
- Subconjunctival hemorrhage
Less Frequent
- Conjunctival hyperemia
- Impaired wound healing
Rare or Very Rare
- Acute bacterial otitis media
- Corneal degeneration
- Corneal erosion
- Epithelial keratopathy
- Fever
- Hypersensitivity drug reaction
- Hyphema
- Infection
- Iritis
- Keratitis
More Frequent
- Dry eye
- Eye tearing
Less Frequent
- Blurred vision
- Conjunctival hyperemia
- Foreign body sensation of eye
- Headache disorder
- Ocular discomfort
- Ocular hemorrhage
- Ocular irritation
- Ocular itching
- Ocular pain
- Ocular redness
- Photophobia
Rare or Very Rare
- Cough
- Pharyngitis
- Rhinitis
- Skin rash
Precautions
No enhanced messaging available.
Moxifloxacin 0.5% ophthalmic solution (Moxeza(R)): Safety and efficacy have not been established in infants younger than 4 months of age.
Moxifloxacin 0.5% ophthalmic solution (Vigamox(R)): Safety and efficacy have not been not established in infants younger than 1 year of age.
Although systemic quinolones have been associated with arthropathy in immature animals, there is no evidence that administration of moxifloxacin ophthalmic solution has any effect on weight bearing joints.
Safety and efficacy not established in children younger than 18 years of age.
Category C. (See Users Guide.)
Data are not available regarding use of moxifloxacin 0.5% ophthalmic solution in pregnant women, and the drug should be used during pregnancy only if potential benefits to the woman justify potential risks to the fetus.
In animal studies using oral moxifloxacin, reduced fetal weight and delayed fetal skeletal development were reported.
Category C. (See Users Guide.) Avoid use in late pregnancy (i.e., third trimester) because of known effects on fetal cardiovascular system (possible premature closure of the ductus arteriosus).
Although distribution of moxifloxacin into milk following ophthalmic administration has not been studied, it is presumed that the drug is distributed into human milk.
Caution is advised if moxifloxacin ophthalmic solution is used in nursing women.
Not known whether bromfenac is distributed into milk following topical application to the eye. Caution if used in nursing women.
No overall differences in safety and efficacy of moxifloxacin 0.5% ophthalmic solution have been observed between geriatric and younger adults.
No substantial differences in safety and efficacy relative to younger adults.
ICD codes
No ICD codes are available for this drug.
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.