Prednisolone-Moxiflox-Bromfen (prednisolone acetate/moxifloxacin HCl/bromfenac sodium)
Ophthalmic Antibacterials Ophthalmic (EYE) Suspension, Drops(FINAL DOSAGE FORM)(ML)
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).
Prednisolone is a synthetic corticosteroid.
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: prednisolone acetate/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 Prednisolone-Moxiflox-Bromfen
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.
Potency of some sodium phosphate preparations is expressed in terms of prednisolone phosphate.
For use in the eye, 1 or 2 drops of prednisolone acetate ophthalmic suspension or prednisolone sodium phosphate ophthalmic solution may be instilled into the conjunctival sac every hour during the day and every 2 hours during the night for initial therapy in severe cases. In mild or moderate inflammation or when a favorable response is attained in severe cases, dosage may be reduced to 1 or 2 drops every 3-12 hours.
Alternatively, prednisolone sodium phosphate ophthalmic ointment may be instilled into the conjunctival sac 3 or 4 times daily initially, and once or twice daily thereafter. The ointment also may be used at night in conjunction with daytime use of a suspension or solution to reduce the frequent applications required with the liquid dosage forms.
The lowest effective concentration should be used and, if improvement does not occur within several days, the drug should be discontinued and other therapy begun. The duration of treatment depends on the type and severity of the disease and may range from a few days to several weeks; long-term therapy should be avoided. When the drug is discontinued, dosage should be gradually tapered to avoid exacerbation of the disease.
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.
Prednisolone acetate or sodium phosphate is applied topically to the eye. Care should be taken to avoid contamination of the tip of the ointment tube or dropper when the drug is used ophthalmically.
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.
- Fungal infection of eye
- Herpes simplex dendritic keratitis
- Tuberculosis of the eye
- Vaccinia virus keratitis
- Amebic infection of the eye
- Ocular hypertension
- Corneal erosion
- Diabetes mellitus
- Epithelial keratopathy
- Krukenberg spindle
- No disease contraindications
- Ocular redness
- Open angle glaucoma
- Rheumatoid arthritis
- Severe myopia
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
- Ocular hypertension
Rare or Very Rare
- Acute bacterial otitis media
- Adrenocortical insufficiency
- Cataracts
- Central serous chorioretinopathy
- Corneal degeneration
- Corneal degeneration
- Corneal edema
- Corneal erosion
- Corneal erosion
- Corneal ulcer
- Epithelial keratopathy
- Fever
- Fungal infection of eye
- Glaucoma
- Globe perforation
- Hypercortisolism
- Hypersensitivity drug reaction
- Hypersensitivity drug reaction
- Hyphema
- Infection
- Iritis
- Keratitis
- Keratitis
- Optic nerve damage
- Punctate keratitis
- Reduced visual acuity
- Uveitis
- Visual changes
- Visual field defect
More Frequent
- Blurred vision
- Dry eye
- Eye tearing
Less Frequent
- Blurred vision
- Conjunctival hyperemia
- Foreign body sensation of eye
- Headache disorder
- Headache disorder
- Iritis
- Ocular discomfort
- Ocular hemorrhage
- Ocular irritation
- Ocular itching
- Ocular pain
- Ocular pain
- Ocular redness
- Photophobia
Rare or Very Rare
- Accommodation disorder
- Allergic dermatitis
- Blepharoptosis
- Calcification of cornea
- Chemosis
- Conjunctival hyperemia
- Conjunctivitis
- Cough
- Dizziness
- Dysgeusia
- Eye tearing
- Foreign body sensation of eye
- Impaired wound healing
- Mydriasis
- Ocular infection
- Ocular irritation
- Ocular itching
- Ocular redness
- Pharyngitis
- Photophobia
- Rhinitis
- Skin rash
- Urticaria
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
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Last reviewed · Source: First Databank (FDB) drug data
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