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Moxifloxacin
0.5 %
Difluprednate
0.05%
Dosage Form & Strength
TID
Diflumox is indicated for the treatment of Post Ocular Surgery Conjunctivitis
Moxifloxacin The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. Difluprednate Ocular adverse reactions occurring in 5–15% of subjects in clinical studies with Difluprednate included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1–5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse events occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, scleral hyperemia, and uveitis.
Moxifloxacin:Drug-drug interaction studies have not been conducted with Moxifloxacin solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes
Difluprednate: Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Difluprednate is structurally similar to other corticosteroids. Moxifloxacin: Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl ring at the C7 position. The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
The half life of Moxifloxacin in Diflumox is 13 hours After repeated ocular instillation of 2 drops of Difluprednate (0.01% or 0.05%) four times per day for 7 days shows levels in blood were below the quantification limit (50 ng/mL), indicating the systemic absorption of difluprednate after ocular instillation is limited, so half life of Difluprednate in Diflumox is not applicable
Moxifloxacin: Pregnancy Because there are no adequate and well-controlled studies in pregnant women, Diflumox solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Diflumox has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Diflumox is administered to a nursing mother. Difluprednate: Pregnancy Teratogenic Effects – Pregnancy Category C Use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, Diflucor should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus. Lactation It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Diflucor is administered to a nursing woman
Moxifloxacin: Use in hepatic and renal impairment No dosage adjustment is necessary.
Moxifloxacin: Use in hepatic and renal impairment No dosage adjustment is necessary.
Pediatric Use The safety and effectiveness of Diflumox ophthalmic solution in children have not been established. Difluprednate: Pediatric Use Difluprednate was evaluated in a 3-month, multicenter, double-masked trial in 79 pediatric patients (39 Difluprednate; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing Difluprednate to prednisolone acetate ophthalmic suspension, 1%.
Moxifloxacin: Use in adults including the elderly (≥ 65 years) The dose is one drop in the affected eye(s) 3 times a day. The infection normally improves within 5 days and treatment should then be continued for a further 23 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. Difluprednate: Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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