MOXEZA® (moxifloxacin ophthalmic solution) 0.5%

MOXEZA® (moxifloxacin ophthalmic solution) 0.5%

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MOXEZA® (moxifloxacin ophthalmic solution) 0.5%

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 Molecular Weight 437.9 g/mol

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: boric acid, hydrochloric acid and/or sodium hydroxide to adjust pH, purified water, sodium chloride, sorbitol, tyloxapol, and xanthan gum.

Indications and usage

  • MOXEZA 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 aureus
  • Staphylococcus capitis
  • Staphylococcus epidermidis
  • Staphylococcus haemolyticus
  • Staphylococcus hominis
  • Staphylococcus saprophyticus*
  • Staphylococcus warneri*
  • Streptococcus mitis*
  • Streptococcus pneumoniae
  • Streptococcus parasanguinis*
  • Escherichia coli*
  • Haemophilus influenza
  • Klebsiella pneumoniae*
  • Propionibacterium acnes
  • Chlamydia trachomatis*

*Efficacy for this organism was studied in fewer than 10 infections.

Mechanism of action

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.

Dosage and administration

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

Warnings and precautions

Corneal Endothelial Damage and Toxic Anterior Segment Syndrome: NOT FOR INTRACAMERAL USE OR INJECTION. MOXEZA will cause damage to the corneal endothelium if introduced directly into the anterior chamber of the eye.

Toxic Anterior Segment Syndrome (TASS) has been reported following intraocular administration of moxifloxacin. TASS is typically characterized by anterior chamber inflammatory reactions, such as fibrin, cell or flare and corneal edema, but other events, such as hypopyon, keratic precipitates or vitreous opacities may also occur.

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.

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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.

Avoidance of Contact Lens Wear: Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

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 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% to 2% of patients.

Use in specific populations

Pregnancy: There are no adequate and well-controlled studies with MOXEZA in pregnant women to inform any drug-associated risks

Lactation: There are no data regarding the presence of MOXEZA in human milk, the effects on the breastfed infants, or the effects on milk production/excretion to inform risk of MOXEZA to an infant during lactation. A study in lactating rats has shown transfer of moxifloxacin into milk following oral administration. Systemic levels of moxifloxacin following topical ocular administration are low, and it is not known whether measurable levels of moxifloxacin would be present in maternal milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MOXEZA and any potential adverse effects on the breastfed child from MOXEZA.

Pediatric Use: The safety and effectiveness of MOXEZA 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.

Storage

Store at 2°C to 25°C (36°F to 77°F).

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