Prednisolone Ph-Moxiflox-Ketor (prednisolone sodium phosphate/moxifloxacin HCl/ketorolac)
Ophthalmic Antibacterials Ophthalmic (EYE) Drops
Last reviewed · Source: First Databank (FDB) drug data
Overview
Moxifloxacin is a fluoroquinolone anti-infective agent.
Prednisolone is a synthetic corticosteroid.
Ketorolac, a pyrrolizine carboxylic acid derivative, 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.
Generic name: prednisolone sodium phosphate/moxifloxacin HCl/ketorolac
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 Ph-Moxiflox-Ketor
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.
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.
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.
Ketorolac tromethamine is applied topically to the eye as an ophthalmic solution. To prevent contamination of the solution, patients should be instructed to avoid allowing the tip of the dispensing container to contact any surface, the eyelids, or surrounding structures. Contact lenses should be removed prior to administration of ketorolac tromethamine ophthalmic solution. The preservative-free solution is for single use only in one or both eyes; the preservative-free solution should be used immediately after opening and any unused portion should be discarded immediately after administration.
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.
The manufacturer states that ketorolac tromethamine ophthalmic solution has been used safely in conjunction with other ophthalmic agents, including antibiotics, beta-adrenergic blocking agents, carbonic anhydrase inhibitors, cycloplegics, and/or mydriatics. The ophthalmic solution also has been used in conjunction with injectable sedatives (e.g., diazepam, hydroxyzine, lorazepam, promethazine hydrochloride), hyaluronidase, and/or local anesthetics (bupivacaine hydrochloride, lidocaine hydrochloride, tetracaine hydrochloride).
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.
- Fungal infection of eye
- Herpes simplex dendritic keratitis
- Tuberculosis of the eye
- Vaccinia virus keratitis
- Amebic infection of the eye
- Ocular hypertension
- Corneal degeneration
- Corneal erosion
- Diabetes mellitus
- Dry eye
- Hemophilia
- Increased risk of bleeding due to coagulation disorder
- Krukenberg spindle
- No disease contraindications
- 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.
More Frequent
- Conjunctivitis
- Keratitis
- Ocular itching
- Ocular pain
- Reduced visual acuity
- Subconjunctival hemorrhage
Less Frequent
- Conjunctival hyperemia
- Keratitis
- Ocular hypertension
Rare or Very Rare
- Acute bacterial otitis media
- Adrenocortical insufficiency
- Asthma exacerbation
- Bronchospastic pulmonary disease
- Cataracts
- Central serous chorioretinopathy
- Corneal degeneration
- Corneal edema
- Corneal erosion
- Corneal erosion
- Corneal ulcer
- Corneal ulcer
- Fever
- Fungal infection of eye
- Glaucoma
- Globe perforation
- Hypercortisolism
- Hypersensitivity drug reaction
- Hypersensitivity drug reaction
- Impaired wound healing
- Infection
- Keratitis
- Ocular hemorrhage
- Optic nerve damage
- Perforation of cornea
- Punctate keratitis
- Reduced visual acuity
- Uveitis
- Visual changes
- Visual field defect
More Frequent
- Blurred vision
- Blurred vision
- Conjunctival hemorrhage
- Conjunctival hyperemia
- Dry eye
- Eye tearing
- Headache disorder
- Infiltrate of cornea
- Ocular hypertension
- Ocular pain
Less Frequent
- Contact dermatitis
- Headache disorder
- Iritis
- Ocular discomfort
- Ocular irritation
- Ocular itching
- Ocular pain
- Ocular redness
- Skin rash
Rare or Very Rare
- Accommodation disorder
- Allergic dermatitis
- Blepharoptosis
- Calcification of cornea
- Chemosis
- Conjunctival hyperemia
- Conjunctivitis
- Corneal dystrophy
- Corneal edema
- Cough
- Dizziness
- Dry eye
- Dysgeusia
- Eye tearing
- Eyelid edema
- Foreign body sensation of eye
- Impaired wound healing
- Iritis
- 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.
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.
Reproduction studies in rabbits and rats receiving oral ketorolac tromethamine dosages up to 109 and 303 times the maximum recommended human topical ophthalmic dosage of ketorolac tromethamine 0.5% (on a mg/kg basis), respectively, have not revealed evidence of harm to the fetus. However, oral dosages exceeding 45 times the maximum recommended human topical ophthalmic dosage of ketorolac tromethamine 0.5% (on a mg/kg basis) in rats produced dystocia and was associated with an increased neonatal death rate. There are no adequate and controlled studies to date using ophthalmic ketorolac tromethamine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Ketorolac tromethamine ophthalmic solution should not be used during late pregnancy, since inhibitors of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system (e.g., 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.
Because ketorolac is distributed into milk following systemic administration (see Pharmacokinetics: Distribution, in Ketorolac 28:08.04.92), the ophthalmic solution should be used with caution in nursing women.
No overall differences in safety and efficacy of moxifloxacin 0.5% ophthalmic solution have been observed between geriatric and 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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