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Moxifloxacin Hydrochloride (Moxeza)

Trade Name : MOXEZA

Alcon Laboratories, Inc.

SOLUTION

Strength 5 mg/mL

MOXIFLOXACIN HYDROCHLORIDE Quinolone Antimicrobial [EPC],Quinolones [CS]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Moxifloxacin Hydrochloride (Moxeza) which is also known as MOXEZA and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 5 mg/mL per ml. Read more

Moxifloxacin Hydrochloride (Moxeza) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • MOXEZA solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
  • Aerococcus viridans*n n- Corynebacterium macginleyi*n n- Enterococcus faecalis*n n- Micrococcus luteus*n n- Staphylococcus arlettae*n n- Staphylococcus aureusn n- Staphylococcus capitisn n- Staphylococcus epidermidisn n- Staphylococcus haemolyticusn n- Staphylococcus hominisn n- Staphylococcus saprophyticus*n n- Staphylococcus warneri*n n- Streptococcus mitis*n n- Streptococcus pneumoniaen n- Streptococcus parasanguinis*n n- Escherichia coli*n n- Haemophilus influenzan n- Klebsiella pneumoniae*n n- Propionibacterium acnesn n- Chlamydia trachomatis*n n- Array
  • MOXEZA solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:n n n *Efficacy for this organism was studied in fewer than 10 infections. n
  • Instill 1 drop in the affected eye(s) 2 times daily for 7 days.
  • Instill 1 drop in the affected eye(s) 2 times daily for 7 days. n
  • 4 mL bottle filled with 3 mL of sterile ophthalmic solution of moxifloxacin 0.5%.
  • 4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin 0.5%. n
  • None.
  • None. n
  • No data
  • Topical ophthalmic use only n
  • Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin n
  • Prolonged use may result in overgrowth of non-susceptible organisms, including fungi n
  • Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. n
  • 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 4u00a0months 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.
  • The most common adverse reactions reported in 1-2% of patients were eye irritation, pyrexia, and conjunctivitis. n
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • No data
  • 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.
  • CHFNOu2022HClu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Mol Wt 437.9
  • Chemical 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 5.45u00a0mg moxifloxacin hydrochloride, equivalent to 5u00a0mg 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.
  • No data
  • 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 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 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.
  • 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.
  • MOXEZA solution is supplied as a sterile ophthalmic solution in the Alcon DROP-TAINERu00ae 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 0065-0006-03
  • Storage: Store at 2u00b0C - 25u00b0C (36u00b0F - 77u00b0F).
  • No data
  • No data

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