Moxifl-Dexame-Ketorol-Nacl(PF) (dexamethasone sod ph/moxifloxacin HCl/ketorolac/sod chlor/PF)
Ophthalmic Antibacterials Intraocular Vial (ML)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Moxifloxacin is a fluoroquinolone anti-infective agent.
Dexamethasone is a synthetic fluorinated 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: dexamethasone sod ph/moxifloxacin HCl/ketorolac/sod chlor/PF
Drug class: Ophthalmic Antibacterials
Therapeutic class: Ophthalmic Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Moxifl-Dexame-Ketorol-Nacl(PF)
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.
Dexamethasone or its sodium phosphate salt is applied topically to the eye or the ear. Potency of the sodium phosphate preparations is expressed in terms of dexamethasone phosphate. 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.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Corneal degeneration
- Corneal erosion
- Diabetes mellitus
- Dry eye
- Hemophilia
- Increased risk of bleeding due to coagulation disorder
- No disease contraindications
- 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.
More Frequent
- Conjunctivitis
- Keratitis
- Ocular itching
- Ocular pain
- Reduced visual acuity
- Subconjunctival hemorrhage
Less Frequent
- Conjunctival hyperemia
Rare or Very Rare
- Acute bacterial otitis media
- Fever
- Hypersensitivity drug reaction
- Infection
More Frequent
- Dry eye
- Eye tearing
Less Frequent
- Ocular discomfort
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.
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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