NDC 0065-0006 Moxeza

Moxifloxacin Hydrochloride

NDC Product Code 0065-0006

NDC 0065-0006-03

Package Description: 3 mL in 1 BOTTLE

NDC Product Information

Moxeza with NDC 0065-0006 is a a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Moxeza is moxifloxacin hydrochloride. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Moxeza Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BORIC ACID (UNII: R57ZHV85D4)
  • SORBITOL (UNII: 506T60A25R)
  • TYLOXAPOL (UNII: Y27PUL9H56)
  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Quinolone Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Quinolones - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA022428 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-18-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Moxifloxacin Ophthalmic

Moxifloxacin Ophthalmic is pronounced as (mox ee flox' a sin)

Why is moxifloxacin ophthalmic medication prescribed?
Moxifloxacin ophthalmic solution is used to treat bacterial conjunctivitis (pink eye; infection of the membrane that covers the outside of the eyeballs and the inside of ...
[Read More]

* Please review the disclaimer below.

Moxeza Product Label Images

Moxeza Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

MOXEZA® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Aerococcus viridans*Corynebacterium macginleyi*Enterococcus faecalis*Micrococcus luteus*Staphylococcus arlettae*Staphylococcus aureusStaphylococcus capitisStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus saprophyticus*Staphylococcus warneri*Streptococcus mitis*Streptococcus pneumoniaeStreptococcus parasanguinis*Escherichia coli*Haemophilus influenzaKlebsiella pneumoniae*Propionibacterium acnesChlamydia trachomatis**Efficacy for this organism was studied in fewer than 10 infections.

2 Dosage And Administration

Instill 1 drop in the affected eye(s) 2 times daily for 7 days.

3 Dosage Forms And Strengths

4 mL bottle filled with 3 mL of sterile ophthalmic solution of moxifloxacin 0.5%.

4 Contraindications

None.

5.1 Topical Ophthalmic Use Only

NOT FOR INJECTION. MOXEZA® solution is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.

5.2 Hypersensitivity Reactions

In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

5.3 Growth Of Resistant Organisms With Prolonged Use

As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.

5.4 Avoidance Of Contact Lens Wear

Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

6 Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.The data described below reflect exposure to MOXEZA® solution in 1263 patients, between 4 months and 92 years of age, with signs and symptoms of bacterial conjunctivitis. The most frequently reported adverse reactions were eye irritation, pyrexia and conjunctivitis, reported in 1-2% of patients.

8.1 Pregnancy

Pregnancy Category C. Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 25,000 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 5,000 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day.Since there are no adequate and well-controlled studies in pregnant women, MOXEZA® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when MOXEZA® solution is administered to a nursing mother.

8.4 Pediatric Use

The safety and effectiveness of MOXEZA® solution in infants below 4 months of age have not been established.There is no evidence that the ophthalmic administration of moxifloxacin has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

8.5 Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

11 Description

MOXEZA® is a sterile solution for topical ophthalmic use.Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. C21H24FN3O4•HCl                   Mol Wt 437.9Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride.Each mL of MOXEZA® solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Inactives: Sodium chloride, xanthan gum, boric acid, sorbitol, tyloxapol, purified water, and hydrochloric acid and/or sodium hydroxide to adjust pH. MOXEZA® is a greenish-yellow, isotonic solution with an osmolality of 300-370 mOsm/kg and a pH of approximately 7.4. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder.

12.1 Mechanism Of Action

Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs [see Clinical Pharmacology (12.4)].

12.3 Pharmacokinetics

Moxifloxacin steady-state plasma pharmacokinetics were evaluated in healthy adult male and female subjects who were administered multiple, bilateral, topical ocular doses of MOXEZA® solution two times daily for four days with a final dose on day 5. The average steady-state AUC0-12 was 8.17 ± 5.31 ng*h/mL. Moxifloxacin Cmax following twice-daily bilateral ophthalmic administration of moxifloxacin 0.5% for 5 days is approximately 0.02% of that achieved with the oral formulation of moxifloxacin hydrochloride (Cmax following oral dosing of 400 mg AVELOX*, 4.5 ± 0.5 mcg/mL).

12.4 Microbiology

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 mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross-resistance has been observed between systemic moxifloxacin and some other quinolones.In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10-9 to < 1x10-11 for Gram-positive bacteria.Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:Aerococcus viridans*Corynebacterium macginleyi*Enterococcus faecalis*Micrococcus luteus*Staphylococcus arlettae*Staphylococcus aureusStaphylococcus capitisStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus saprophyticus*Staphylococcus warneri*Streptococcus mitis*Streptococcus pneumoniaeStreptococcus parasanguinis*Escherichia coli*Haemophilus influenzaKlebsiella pneumoniae*Propionibacterium acnesChlamydia trachomatis**Efficacy for this organism was studied in fewer than 10 infections.The following in vitro data are available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of MOXEZA® solution in treating ophthalmic infections due to these organisms have not been established in adequate and well-controlled trials.Moxifloxacin has been shown to be active in vitro against most strains of the microorganisms listed below. These organisms are considered susceptible when evaluated using systemic breakpoints; however, a correlation between the in vitro systemic breakpoint and ophthalmologic efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 mcg/mL or less (systemic susceptible breakpoint) against most (≥ 90%) strains of the following ocular pathogens.Aerobic Gram-positive microorganisms:Staphylococcus capraeStaphylococcus cohniiStaphylococcus lugdunensisStaphylococcus pasteuriStreptococcus agalactiaeStreptococcus milleri groupStreptococcus oralisStreptococcus pyogenesStreptococcus salivariusStreptococcus sanguisAerobic Gram-negative microorganisms:Acinetobacter baumanniiAcinetobacter calcoaceticusAcinetobacter juniiEnterobacter aerogenesEnterobacter cloacaeHaemophilus parainfluenzaeKlebsiella oxytocaMoraxella catarrhalisMoraxella osloensisMorganella morganiiNeisseria gonorrhoeaeNeisseria meningitidesPantoea agglomeransProteus vulgarisPseudomonas stutzeriSerratia liquefaciensSerratia marcescensStenotrophomonas maltophiliaAnaerobic microorganisms:Clostridium perfringensPeptostreptococcus anaerobiusPeptostreptococcus magnusPeptostreptococcus microsPeptostreptococcus prevotiiOther microorganisms:Mycobacterium tuberculosisMycobacterium aviumMycobacterium kansasiiMycobacterium marinum

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed.Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice.Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 25,000 times the highest recommended total daily human ophthalmic dose. At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.

14 Clinical Studies

In one randomized, double-masked, multicenter, vehicle-controlled clinical trial in which patients with bacterial conjunctivitis were dosed with MOXEZA® solution 2 times a day, MOXEZA® was superior to its vehicle for both clinical and microbiological outcomes. Clinical cure achieved on Day 4 was 63% (265/424) in MOXEZA® solution treated patients, versus 51% (214/423) in vehicle treated patients. Microbiologic success (eradication of baseline pathogens) was achieved on Day 4 in 75% (316/424) of MOXEZA® solution treated patients versus 56% (237/423) of vehicle treated patients. Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

16 How Supplied/Storage And Handling

MOXEZA® solution is supplied as a sterile ophthalmic solution in the Alcon DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.3 mL in a 4 mL bottle - NDC 0065-0006-03Storage: Store at 2°C - 25°C (36°F - 77°F).

17.1 Avoid Contamination Of The Product

Advise patients not to touch the dropper tip to any surface to avoid contaminating the contents.

17.2 Avoid Contact Lens Wear

Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

17.3 Hypersensitivity Reactions

Systemically administered quinolones, including moxifloxacin, have been associated with hypersensitivity reactions, even following a single dose. Patients should be told to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.Licensed to Alcon by Bayer Pharma AG.©2010, 2012, 2016 Novartis
*AVELOX is a registered trademark of Bayer AG.Alcon ®a Novartis companyDistributed by:ALCON LABORATORIES, INC.6201 South FreewayFort Worth, Texas 76134 USAalcon.medinfo@alcon.comT2017-23February 2017

* Please review the disclaimer below.