Moxeza alcon

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Vigamox Alcon, a Novartis Division. Tobrex Alcon, a Novartis Division. Ocuflox Allergan. Zymaxid Allergan. FDA Yes.

CE Mark Not specified. Active Ingredients Moxifloxacin hydrochloride. Application Topical. Status Prescription. Strength 0. From Your Peers. Company Information Contact the company for additional information, availability, or pricing: Alcon, a Novartis Division alcon.

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Ciloxan Alcon, a Novartis Division. Vigamox Alcon, a Novartis Division. Tobrex Alcon, a Novartis Division. Ocuflox Allergan. Zymaxid Allergan. FDA Yes. CE Mark Not specified. Active Ingredients Moxifloxacin hydrochloride. Application Topical. Status Prescription. Strength 0. From Your Peers. Company Information Contact the company for additional information, availability, or pricing: Alcon, a Novartis Division alcon. Compare Antibiotic » 10 products ». View All Antibiotic » 10 products ».

Ophthalmologists frequently administer moxifloxacin and other anti-infective agents either topically or intraocularly to reduce the incidence of postoperative endophthalmitis. Endophthalmitis occurs at a low incidence following cataract surgery estimated to be between 0.

Outsourcing facilities have compounded moxifloxacin drug products from bulk drug substances and repackaged the FDA-approved topical moxifloxacin drugs. Traditional and hospital pharmacies generally, those that operate under section A of the Federal Food, Drug, and Cosmetic Act , as well as individual ophthalmologists have used moxifloxacin ophthalmic solutions, approved for topical administration, as the starting material to prepare moxifloxacin drugs for use during intraocular procedures.

FDA searched the Adverse Event Reporting System FAERS database for all reports through December 19, , and identified 29 cases that described TASS associated with intraocular administration of drugs containing moxifloxacin 16 compounded drugs using moxifloxacin as a bulk drug substance, 10 repackaged Moxeza, 2 unspecified a Vigamox, and 1 unspecified a Moxeza. Of the 29 TASS cases, five reported use of 0. Most cases were reported by a health care professional and did not report the use of concomitant intraocular drugs or drugs containing multiple active ingredients.

According to one facility that reported 10 of these cases, TASS developed within one week after intraocular administration of a compounded drug containing moxifloxacin. The report indicated a positive drug-event association, as the TASS events ceased following the discontinuation of the use of moxifloxacin at the facility.

When the compounded moxifloxacin drug was reintroduced during subsequent surgical procedures, patients again presented with TASS. While it is not possible to determine if the TASS events were solely due to exposure to intraocular moxifloxacin, the occurrence of additional cases following re-introduction of compounded moxifloxacin use reduces the likelihood of other causes.

Moxifloxacin topical ophthalmic solutions are FDA approved and marketed under the proprietary names Moxeza and Vigamox.

Neither drug is approved for intraocular administration. FDA is aware of multiple literature reports that claim to support the use of intraocular moxifloxacin for the prophylaxis of endophthalmitis, and it is a common practice among ophthalmologists in association with cataract surgery.

There also are no adequate and well controlled studies that demonstrate that any anti-infective, topical or intraocular, is effective in reducing the incidence of endophthalmitis. Moxifloxacin is an anti-infective, which, in a dose dependent manner, kills specific microorganisms. Moxifloxacin, in sufficient concentrations, may also contribute to cellular injury in the human body.

In addition to selecting the proper concentration and volume, the safety of an intraocularly injected drug is also dependent on the content of the active and inactive ingredients in the formulation. There are two different topical moxifloxacin ophthalmic solutions approved for marketing, Vigamox moxifloxacin ophthalmic solution 0. Although these two drugs contain the same active ingredient with the same concentration, they contain different inactive ingredients. Moxeza contains xanthan gum, which has been linked to causing TASS.

Moxeza carries a specific warning that it is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Moxeza should not be used, diluted, repackaged or compounded for intraocular injection. FDA recommends that before health care professionals administer moxifloxacin intraocularly, they know its formulation.