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Drug overview for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium):
Generic name: PREDNISOLONE ACETATE/MOXIFLOXACIN HCL/BROMFENAC SODIUM
Drug class: Ophthalmic Antibacterials
Therapeutic class: Ophthalmic Agents
Bromfenac sodium is a prototypical nonsteroidal anti-inflammatory agent Moxifloxacin is a fluoroquinolone anti-infective agent. Prednisolone is a synthetic corticosteroid. (NSAIA).
No enhanced Uses information available for this drug.
Generic name: PREDNISOLONE ACETATE/MOXIFLOXACIN HCL/BROMFENAC SODIUM
Drug class: Ophthalmic Antibacterials
Therapeutic class: Ophthalmic Agents
Bromfenac sodium is a prototypical nonsteroidal anti-inflammatory agent Moxifloxacin is a fluoroquinolone anti-infective agent. Prednisolone is a synthetic corticosteroid. (NSAIA).
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium):
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.
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.
Moxifloxacin is commercially available for topical ophthalmic administration as moxifloxacin hydrochloride; dosage is expressed in terms of moxifloxacin.
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.
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.
Moxifloxacin is commercially available for topical ophthalmic administration as moxifloxacin hydrochloride; dosage is expressed in terms of moxifloxacin.
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. 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.
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 available.
No generic dosing information available.
The following drug interaction information is available for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium):
Drug contraindication overview.
Known hypersensitivity to bromfenac sodium or any ingredient in the formulation. 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. Moxifloxacin 0.5% ophthalmic solution is contraindicated in patients with known hypersensitivity to moxifloxacin, other quinolones, or any component in the formulation.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Fungal infection of eye |
| Herpes simplex dendritic keratitis |
| Tuberculosis of the eye |
| Vaccinia virus keratitis |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Amebic infection of the eye |
| Ocular hypertension |
There are 8 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Diabetes mellitus |
| Epithelial keratopathy |
| Krukenberg spindle |
| No disease contraindications |
| Ocular redness |
| Open angle glaucoma |
| Rheumatoid arthritis |
| Severe myopia |
The following adverse reaction information is available for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium):
Adverse reaction overview.
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. 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. 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.
There are 34 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Conjunctivitis Keratitis Ocular itching Ocular pain Reduced visual acuity Subconjunctival hemorrhage |
Conjunctival hyperemia Impaired wound healing Ocular hypertension |
| Rare/Very Rare |
|---|
|
Acute bacterial otitis media Adrenocortical insufficiency Cataracts Central serous chorioretinopathy Corneal degeneration Corneal edema Corneal erosion Corneal ulcer Epithelial keratopathy Fever Fungal infection of eye Glaucoma Globe perforation Hypercortisolism Hypersensitivity drug reaction Hyphema Infection Iritis Keratitis Optic nerve damage Punctate keratitis Reduced visual acuity Uveitis Visual changes Visual field defect |
There are 38 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Blurred vision Dry eye Eye tearing |
Blurred vision Conjunctival hyperemia Foreign body sensation of eye Headache disorder Iritis Ocular discomfort Ocular hemorrhage Ocular irritation Ocular itching Ocular pain Ocular redness Photophobia |
| Rare/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 |
The following precautions are available for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium):
Safety and efficacy not established in children younger than 18 years of age. 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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
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.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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). 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.
(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.
Not known whether bromfenac is distributed into milk following topical application to the eye. Caution if used in nursing women. 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.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Bromfenac (ophth) | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Systemic absorption likely minimal; unlikely to cause adv effects in infant |
| Moxifloxacin (ophth) | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Amount of systemic absorption unknown, caution advised. |
| Prednisolone (ophth) | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Amt of systemic absorption unknown, caution advised. |
No substantial differences in safety and efficacy relative to younger adults. No overall differences in safety and efficacy of moxifloxacin 0.5% ophthalmic solution have been observed between geriatric and younger adults.
Precaution Exists
Geriatric management or monitoring precaution exists.
Precaution Exists
Geriatric management or monitoring precaution exists.
| Drug Name | Narrative | REN | HEP | CARDIO | NEURO | PULM | ENDO |
|---|---|---|---|---|---|---|---|
| Prednisolone (ophth) | Increased risk of diabetes, cataracts, or glaucoma. Frequent ophthalmic exams recommended. | N | N | N | N | N | Y |
The following prioritized warning is available for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for PREDNISOLONE AC-MOXIFLOX-BROMF (prednisolone acetate/moxifloxacin hcl/bromfenac sodium)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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