Vigamox®

GoodRx

Moxifloxacin 0.5% · ophthalmic solution

Antibiotic

Approved uses

Bacterial conjunctivitis

1 drop in the affected eye TID for 7 days.

FDA label, Indications and Usage (1) and Dosage and Administration (2). Trial: Granet DB, Dorfman M, Stroman D, Cockrum P. A multicenter comparison of polymyxin B sulfate/trimethoprim ophthalmic solution and moxifloxacin in the speed of clinical efficacy for the treatment of bacterial conjunctivitis. J Pediatr Ophthalmol Strabismus. 2008;45(6):340-349. Program review: Keating GM. Moxifloxacin 0.5% ophthalmic solution: in bacterial conjunctivitis. Drugs. 2011;71(1):89-99 (doi 10.2165/11205840-000000000-00000).

OFF-LABELNot in the FDA label for this product

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 (perforation or nonhealing ulcer) in 1 of 20 versus 2 of 20 on fortified antibiotics, with 62% culture positivity. The authors state the study failed to find a difference, which at 20 patients per arm is not a demonstration of equivalence. The report does not name the commercial product 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.

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 eyes

Prospective randomized partially masked single-site trial, 3,640 eyes: acute endophthalmitis within 6 weeks in 1 of 1,818 injected eyes (0.05%) versus 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 postoperative topical 0.5% moxifloxacin and 0.1% dexamethasone, so what was tested is the added injection. A retrospective before-and-after clinical registry of 617,453 cataract surgeries at 10 Aravind hospitals found 0.02% (64 of 314,638) with prophylaxis versus 0.07% (214 of 302,815) without (P < 0.001); that is a registry comparison, not a randomized one. A companion randomized substudy of 93 patients from the same group names the injected product as Vigamox solution and found no change in macular or choroidal thickness at day 30 or 60.

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). Substudy naming the injected product: Ferreira BG, Cardoso da Silva I, Melega MV, et al. Macular and choroidal thickness after intracameral moxifloxacin for prevention of postcataract endophthalmitis. J Cataract Refract Surg. 2021;47(1):40-45 (doi 10.1097/j.jcrs.0000000000000365).

Contraindications

History of hypersensitivity to moxifloxacin, to other quinolones, or to any component of this product.

Available Forms

3 mL in a 4 mL bottle, 0.5% solution, 5 mg moxifloxacin base per mL

Mechanism of Action

8-methoxy fluoroquinolone with a diazabicyclononyl ring at C7; kills by inhibiting topoisomerase II (DNA gyrase), the enzyme that replicates, transcribes and repairs bacterial DNA, and topoisomerase IV, which partitions chromosomal DNA at cell division. That target set is unlike those of macrolides, aminoglycosides and tetracyclines, so no cross-resistance with those classes exists, although cross-resistance with some other quinolones has been observed.

Warnings & Precautions

Hypersensitivity reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients receiving systemically administered quinolones, some after the first dose, with cardiovascular collapse, loss of consciousness, angioedema, airway obstruction, dyspnea, urticaria and itching; discontinue at once 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.
Lens wear: Contact lenses are not appropriate while signs or symptoms of bacterial conjunctivitis are present.

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.
Nonocular, 1% to 4%: Fever, increased cough, infection, otitis media, pharyngitis, rash, rhinitis.

Pregnancy & Lactation

Pregnancy: No adequate and well-controlled studies in pregnant women to inform drug-associated risk. Oral dosing in rats and monkeys and IV dosing in rabbits through organogenesis produced no adverse maternal or fetal effects at clinically relevant doses; reduced fetal weight and delayed skeletal development in rats, and abortion, malformations and delayed ossification in rabbits, appeared only at systemic exposures hundreds to thousands of times the human AUC at the ophthalmic dose, several of them maternally toxic. A pre- and postnatal rat study showed reduced pup birth weight and decreased prenatal and neonatal survival only at 500 mg/kg/day, about 277 times the human AUC and a maternally lethal dose.

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

Safety and effectiveness established in all ages, including neonates.