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Gatifloxacin (Gatifloxacin)

Trade Name : Gatifloxacin

Mylan Pharmaceuticals 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 (Gatifloxacin) which is also known as Gatifloxacin and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 5 mg/mL per ml. Read more

Gatifloxacin (Gatifloxacin) 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
  • Contraindications, Hypersensitivity ()u00a0u00a0u00a0u00a0u00a009/2016
  • Warnings and Precautions, Hypersensitivity ()u00a0u00a0u00a0u00a0u00a009/2016
  • Gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
  • Gatifloxacin ophthalmic solution is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: group, ()
  • Day 1: Instill one drop every two hours in the affected eye(s) while awake, up to eight times on Day 1.
  • Days 2 through 7: Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7. ()
  • Ophthalmic solution: 0.5% gatifloxacin (5 mg/mL)
  • Ophthalmic solution, 0.5% gatifloxacin (5 mg/mL) ()
  • Gatifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication. ()
  • No data
  • 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. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or n
  • No data
  • Gatifloxacin is a quinolone antimicrobial ophthalmic solution for the treatment of bacterial conjunctivitis. Its chemical name is (u00b1)-1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl)-1-piperazinyl-4-oxo-1,4-dihydroquinoline-3-carboxylic acid, hemihydrate. Its molecular formula is CHFNOu2022u00bd HO, and its molecular weight is 384. Its chemical structure is:
  • Gatifloxacin ophthalmic solution is a clear, pale yellow, sterile, preserved aqueous solution with an osmolality of 260 to 330 mOsm/kg and a pH of 5.1 to 5.7.
  • Gatifloxacin ophthalmic solution contains the active ingredient gatifloxacin 0.5% (5 mg/mL) and the inactive ingredients benzalkonium chloride 0.005%, edetate disodium, sodium chloride and water for injection. Gatifloxacin ophthalmic solution may contain hydrochloric acid and/or sodium hydroxide to adjust pH.
  • No data
  • No data
  • In two randomized, double-masked, multicenter clinical trials, where patients 1 to 89 years of age were dosed for five days, gatifloxacin ophthalmic solution was clinically superior to its vehicle on day 6 in patients with conjunctivitis and positive conjunctival cultures. Clinical 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 vs. 45% (148/325) for the vehicle-treated groups. Microbiological 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. Please note that microbiological eradication does not always correlate with clinical outcome in anti-infective trials.
  • Gatifloxacin Ophthalmic Solution is a sterile, clear, pale yellow solution practically free from particles of 0.5% gatifloxacin. Each mL of Gatifloxacin Ophthalmic Solution, 0.5% contains 5.120 mg gatifloxacin hemihydrate equivalent to 5 mg (0.5%) gatifloxacin.
  • Gatifloxacin Ophthalmic Solution, 0.5% is supplied as a 2.5 mL solution in a 5 mL three piece container consisting of a white low density polyethylene bottle, a white low density polyethylene open nozzle and a tan high density polyethylene cap.
  • 2.5 mL fillNDC 0378-5431-35carton of one bottle
  • Storage: Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F). Protect from freezing.
  • Avoiding Contamination of the Product:u00a0
  • Potential for Hypersensitivity Reactions:n- [see and ]
  • gatifloxacin
  • ophthalmic solution 0.5% for topical ophthalmic use
  • Read this Instructions for Use before you start using gatifloxacin ophthalmic solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • Important information about gatifloxacin ophthalmic solution:
  • Before you use gatifloxacin ophthalmic solution for the first time:
  • How should I store gatifloxacin ophthalmic solution?
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:
  • Manufactured by:
  • Micro Labs Limited
  • Bangalore u2013 560 099, INDIA
  • M.L. No.: KTK/28/357/2006
  • Revised: 8/2017
  • MCR:GATIOP:R3
  • NDC 0378-5431-35
  • Gatifloxacinn- Ophthalmicn- Solutionn- 0.5%
  • For Use in then- Eyes Only
  • Rx only 2.5 mL
  • Sterile
  • Each mL contains:n- Active:
  • Preservative:
  • Inactives:
  • Usual Dosage:
  • Days 2 through 7: Instill onedrop two to four times dailyin the affected eye(s) whileawake.
  • See accompanyingprescribing information.
  • Keep this and all medicationn- out of the reach of children.
  • Storage: Store at 15u00b0 ton- 25u00b0C (59u00b0 to 77u00b0F). Protectn- from freezing.
  • Bottle filled to u00bd capacity.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • MCR:5431:1C:R2
  • Mylan.com
  • M.L. No.: KTK/28/357/2006

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