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Moxifloxacin Hydrochloride (Vigamox)

Trade Name : VIGAMOX

Alcon Laboratories, Inc.

SOLUTION/ DROPS

Strength 5 mg/mL

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

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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 (Vigamox) which is also known as VIGAMOX and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 5 mg/mL per ml. Read more

Moxifloxacin Hydrochloride (Vigamox) 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

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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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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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  • VIGAMOXu00ae solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
  • Corynebacterium n- Micrococcus luteus*n n- Staphylococcus aureusn n- Staphylococcus epidermidisn n- Staphylococcus haemolyticusn n- Staphylococcus hominisn n- Staphylococcus warneri*n n- Streptococcus pneumoniaen n- Streptococcus viridans n- Acinetobacter lwoffii*n n- Haemophilus influenzan n- Haemophilus parainfluenzae*n n- Chlamydia trachomatis
  • *Efficacy for this organism was studied in fewer than 10 infections.
  • VIGAMOXu00ae solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
  • *Efficacy for this organism was studied in fewer than 10 infections. ()
  • Instill one drop in the affected eye 3 times a day for 7 days.
  • Instill one drop in the affected eye 3 times a day for 7 days ()
  • 4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin 0.5%
  • 4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin 0.5% ()
  • VIGAMOXu00ae solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
  • VIGAMOXu00ae solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. ()
  • No data
  • 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 most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients.
  • Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
  • The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. ()n n n n n
  • Drug-drug interaction studies have not been conducted with VIGAMOXu00ae solution. studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.
  • No data
  • VIGAMOXu00ae (moxifloxacin ophthalmic solution) 0.5% 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.
  • Chemical Name:1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo-3-quinoline carboxylic acid, monohydrochloride. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of VIGAMOXu00ae solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base.
  • Contains: Active: n- Inactives:
  • VIGAMOXu00ae solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg.
  • No data
  • Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis).
  • 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 21,700 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 two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, VIGAMOXu00ae solution produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of baseline pathogens ranged from 84% to 94%.
  • In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis between birth and 31 days of age, patients were dosed with VIGAMOXu00ae or another anti-infective agent. Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 92% at Day 9.
  • Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.
  • VIGAMOXu00ae solution is supplied as a sterile ophthalmic solution in Alconu2019s 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 0065-4013-03
  • Storage: Store at 2u00b0C-25u00b0C (36u00b0F-77u00b0F).
  • Risk of Contamination
  • Concomitant Use of Contact Lenses
  • Potential for Hypersensitivity Reactionsn- [see Warnings and Precautions (5.2)]
  • Distributed by Alcon Laboratories, Inc. Fort Worth, TX 76134 USA
  • Licensed to Alcon by Bayer Pharma AG.
  • u00a9 2003-2011, 2016 Novartis
  • T2017-39March 2017
  • No data
  • No data

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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