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Gatifloxacin (Zymaxid)

Trade Name : ZYMAXID

Allergan, Inc.

SOLUTION/ DROPS

Strength 5 mg/mL

GATIFLOXACIN 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 Gatifloxacin (Zymaxid) which is also known as ZYMAXID and Manufactured by Allergan, Inc.. It is available in strength of 5 mg/mL per ml. Read more

Gatifloxacin (Zymaxid) 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
  • No data
  • ZYMAXID is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
  • u00a0u00a0
  • *Efficacy for these organisms were studied in fewer than 10 infectionsu00a0
  • ZYMAXIDn is au00a0quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
  • 1
  • Day 1: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1.
  • u00a0u00a0
  • Days 2 through 7: Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7. ()
  • u00a0
  • Ophthalmic solution: 0.5% gatifloxacin (5 mg/mL)
  • Ophthalmic solution: 0.5% gatifloxacin (5mg/mL) ()
  • ZYMAXIDu00a0is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medicationu00a0n n .
  • ZYMAXID is contraindicated inu00a0patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication. ()
  • No data
  • Hypersensitivity ()n
  • Growth of Resistant Organisms with Prolonged Use ()n
  • Corneal Endothelial Cell Injury ()
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions occurring in u2265 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain. ()
  • No data
  • ZYMAXID is a quinolone antimicrobial topical ophthalmic solutionu00a0for the treatment of bacterial conjunctivitis. u00a0Its chemical name is (u00b1)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, sesquihydrate. Its molecular formula is CHFNO u00b7 1u00bdu00a0HO and its molecular weight is 402.42. Its chemical structure is:
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • u00a0u00a0u00a0u00a0nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • ZYMAXID is a clear, pale yellow, sterile, preserved aqueous solution with an osmolality of 260-330 mOsm/kg and a pH of 5.1-5.7.
  • ZYMAXIDn contains the active ingredient gatifloxacin 0.5% (5 mg/mL) and the inactive ingredients benzalkonium chloride 0.005%, edetate disodium,u00a0sodium chloride and purified water. ZYMAXID may contain hydrochloric acid and/or sodium hydroxide to adjust pH.
  • No data
  • Carcinogenesis
  • A statistically significant increase in the incidence of large granular lymphocyte (LGL) leukemia was seen in male rats treated with 100 mg/kg/day (approximately 405-fold higher than the MRHOD, on a mg/m basis). Fischer 344 rats have a high spontaneous background rate of LGL leukemia and the incidence in high-dose males only slightly exceeded the historical control range established for this strain. There was no increase in neoplasms among Fischer 344 rats given gatifloxacin in the diet for 2 years at doses averaging 47 mg/kg/day in males and 139 mg/kg/day in females (approximately 190- and 560-fold higher than the MRHOD, respectively), on a mg/m basis.
  • Mutagenesis
  • in vitro
  • in vitro
  • in vivo
  • Impairment of Fertility
  • In two randomized, double-masked, multicenter clinical trials, where patients 1-89 years of age were dosed for 5 days, ZYMAXIDn was clinically superior to its vehicle on day 6 in patients with conjunctivitis and positive conjunctival cultures. u00a0Clinical outcomes for the trials demonstrated clinical success (resolution of conjunctival hyperemia and conjunctival discharge) in 58% (193/333) of patients for the gatifloxacin-treated groups versus 45% (148/325) for the vehicle-treated groups. u00a0Microbiological outcomes for the same clinical trials demonstrated a statistically superior eradication rate for causative pathogens of 90% (301/333) for gatifloxacin vs. 70% (228/325) for vehicle. u00a0Please note that microbiological eradication does not always correlate with clinical outcome in anti-infective trials.
  • ZYMAXIDn (gatifloxacinu00a0ophthalmic solution) 0.5%u00a0is supplied sterile in a white, low density polyethylene (LDPE) bottle with a controlled dropper tip, and a tan, high impact polystyrene (HIPS) cap in the following size:
  • 2.5 mL in 5 mL bottle: NDC 0023-3615-25
  • Storage:n- u00a0
  • Avoiding Contamination of the Product
  • Potential for Hypersensitivity Reactionsn- [see Warnings and Precautions n- (n- Arrayn- ) and Contraindication (n- Arrayn- )n- ]n- .
  • u00a9 2017u00a0Allergan. All rights reserved.
  • All trademarks are the property of their respective owners.nttu00a0u00a0u00a0u00a0u00a0nt
  • Patented. See www.allergan.com/patentsIrvine, CA 92612Made in the U.S.A.
  • 72366US14
  • PRINCIPAL DISPLAY PANELNDC 0023-3615-25n n n n u00a0Rx Only Sterile

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