Moxeza®

GoodRx

Moxifloxacin 0.5% · ophthalmic solution

Antibiotic

Approved uses

Bacterial conjunctivitis

Linked generic 0.5% label: 1 drop in the affected eye TID x 7 days. Branded xanthan gum formulation: 1 drop BID.

FDA label, Indications and Usage and Dosage and Administration (linked generic SPL, setid 4dee7a26); BID formulation trial: Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011;28(7):566-574.

OFF-LABELNot in the FDA label for this product

Endophthalmitis prophylaxis at cataract surgery, intracameral

0.03 mL (150 mcg) of undiluted 0.5% solution injected into the anterior chamber at the end of phacoemulsification.

RCT · n=3,640 · single-center

Prospective randomized partially masked single-center trial, 3,640 eyes: acute endophthalmitis within 6 weeks in 1 of 1,818 injected eyes (0.05%) vs 7 of 1,822 uninjected (0.38%), P = 0.035, with no difference in corrected distance acuity, endothelial cell density, IOP or central corneal thickness; both arms also received topical 0.5% moxifloxacin and 0.1% dexamethasone postoperatively. A retrospective before-and-after registry of 617,453 surgeries at 10 Aravind hospitals found 0.02% (64/314,638) with prophylaxis vs 0.07% (214/302,815) without (P < 0.001); that is a registry comparison, not a randomized one. Both studies injected an unpreserved 0.5% topical solution; the xanthan gum vehicle is not the product studied intracamerally.

Melega MV, Alves M, Cavalcanti Lira RP, et al. Safety and efficacy of intracameral moxifloxacin for prevention of post-cataract endophthalmitis: randomized controlled clinical trial. J Cataract Refract Surg. 2019;45(3):343-350. Registry: Haripriya A, Chang DF, Ravindran RD. Endophthalmitis reduction with intracameral moxifloxacin prophylaxis: analysis of 600 000 surgeries. Ophthalmology. 2017;124(6):768-775 (doi 10.1016/j.ophtha.2017.01.026). The companion sub-study from the same group names the injected product as Vigamox solution: Ferreira BG, Cardoso da Silva I, Melega MV, et al. J Cataract Refract Surg. 2021;47(1):40-45 (doi 10.1097/j.jcrs.0000000000000365).

Bacterial keratitis

Trial regimen: 0.5% solution instilled hourly for 48 hours, then tapered by clinical response, in ulcers 2 to 8 mm.

RCT · n=61 · underpowered

Randomized three-arm trial, 61 patients (20 on moxifloxacin 0.5%, 21 on gatifloxacin 0.3%, 20 on fortified cefazolin 5% plus tobramycin 1.3%): 93% healed overall, no significant difference in mean time to heal (P = 0.98), and treatment failure in 1 of 20 vs 2 of 20 on fortified antibiotics. The authors' stated conclusion is that the study failed to find a difference, which at 20 patients per arm and 62% culture positivity is not a demonstration of equivalence. The report does not name the formulation used.

Shah VM, Tandon R, Satpathy G, et al. Randomized clinical study for comparative evaluation of fourth-generation fluoroquinolones with the combination of fortified antibiotics in the treatment of bacterial corneal ulcers. Cornea. 2010;29(7):751-757.

Contraindications

History of hypersensitivity to moxifloxacin, to other quinolones, or to any component of the formulation.

Available Forms

3 mL bottle, 0.5% solution, 5 mg moxifloxacin base per mL

Mechanism of Action

Fluoroquinolone; antibacterial action follows inhibition of topoisomerase II (DNA gyrase), the enzyme required for replication, transcription and repair of bacterial DNA, and of topoisomerase IV, which partitions chromosomal DNA at cell division. That target set differs from macrolides, aminoglycosides and tetracyclines, so no cross-resistance with those classes exists, although cross-resistance between systemic moxifloxacin and some other quinolones has been observed.

Warnings & Precautions

Hypersensitivity reactions: Serious and occasionally fatal anaphylactic reactions have been reported with systemically administered quinolones, including moxifloxacin, some following the first dose, with cardiovascular collapse, angioedema, airway obstruction, dyspnea, urticaria and pruritus; discontinue if an allergic reaction occurs and treat serious reactions as an emergency.
Resistant organism overgrowth: Prolonged use may allow overgrowth of non-susceptible organisms including fungi; if superinfection occurs, discontinue and start alternative therapy, examining with slit lamp and fluorescein where appropriate.
Contact lens wear: Not appropriate in the presence of signs or symptoms of bacterial conjunctivitis.

Common Side Effects

Ocular, 1% to 6%: Conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, tearing.
Systemic, 1% to 4%: Fever, increased cough, infection, otitis media, pharyngitis, rash, rhinitis.

Pregnancy & Lactation

Pregnancy: No adequate and well-controlled studies in pregnant women. Oral dosing in rats and monkeys and IV dosing in rabbits through organogenesis produced no adverse maternal or fetal effects at clinically relevant doses; embryo-fetal findings (reduced fetal weight, delayed skeletal ossification, and in rabbits abortion and malformations) appeared only at systemic exposures hundreds to thousands of times the human AUC at the ophthalmic dose, several of them maternally toxic.

Lactation: No data on presence in human milk, effects on the breastfed infant, or effects on milk production. Transfer into milk occurs in lactating rats after oral dosing, and systemic levels after topical ocular use are low.

Pediatric Use

≥4 months