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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

Sun Pharmaceutical Industries, Inc.

SOLUTION/ DROPS

Strength 5 mg/mL

KETOROLAC TROMETHAMINE Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Ketorolac Tromethamine (Ketorolac Tromethamine) which is also known as Ketorolac Tromethamine and Manufactured by Sun Pharmaceutical Industries, Inc.. It is available in strength of 5 mg/mL per ml. Read more

Ketorolac Tromethamine (Ketorolac Tromethamine) 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
  • Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
  • Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for:u00a0
  • The treatment of inflammation following cataract surgery. ()u00a0
  • The temporary relief of ocular itching due to seasonal allergic conjunctivitis. ()
  • One drop of ketorolac tromethamine ophthalmic solution should be applied to the affected eye(s) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis. n For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ketorolac tromethamine ophthalmic solution should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. ()
  • Ketorolac tromethamine ophthalmic solution 0.5% is supplied sterile in white opaque LDPE dropper bottles with white opaque plug and sealed with gray pantone opaque pilfer-proof caps as follows:u00a0
  • Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. ()
  • 5 mL size bottle filled with 3 mL of solution
  • 5 mL size bottle filled with 5 mL of solution
  • 10 mL size bottle filled with 10 mL of solution
  • Ketorolac tromethamine ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
  • Hypersensitivity to any component of this product. ()
  • No data
  • Delayed healing ()u00a0
  • Cross-sensitivity or hypersensitivity ()u00a0
  • Increased bleeding time due to interference with thrombocyte aggregation ()u00a0
  • Corneal effects including keratitis ()
  • The most frequent adverse reactions reported by up to 40% of patients participating in clinical trials have been transient stinging and burning on instillation. () To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or .
  • No data
  • Keto ro lac t ro met ham ine op htha lm ic so lut i on 0.5% is a m ember of the pyrrolo-u00adpyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthal mic use. Its che mical na me is (u00b1)-5-Benzoyl-2, 3-dihydro-1H pyrrolizi ne-1-carboxylic acid co m pound with 2-a mino-2-(hydroxy methyl)-1,3-propanediol ( 1:1) and it has the following structure:
  • Each mL of ketorolac tromethamine ophthalmic solution contains: ketorolac tromethamine USP 0.5%. benzalkonium chloride solution (50%) NF 0.02%. edetate disodium USP 0.1%; octoxynol 40; water for injection USP; sodium chloride USP; hydrochloric acid NF and/or sodium hydroxide NF to adjust the pH.
  • No data
  • Ketorolac tr o metha mine was not ca rcinogenic in either rats given up to 5 mg/kg/day orally for 24 months or in mice given 2 mg /kg/day orally for 18 months. These doses are approximately 125 ti mes and 50 ti mes higher respectively than the maxi m um re com mended h u man topical ophthal mic daily dose given as QID for itching to affected eyes on a mg/kg basis.
  • Ketorolac tromethamine was not mutagenic in the Ames assay or in forward mutation assays. Si milarly, it did not result in an increase in unscheduled DNA synthesis or an i ncrea se in chro moso me breakage in mice. However, ketorolac trometha mine did result in an increased incide nce in chro mosomal ab err atio ns in Chinese ha mster ovary cells.
  • Ketorol ac t ro metha mine did not i mpair fe rtility when ad ministered orally to male and fe male rats at doses up to 9 mg/kg/day and 16 mg/kg/day, respectively. These doses are respectively 225 and 400 ti mes higher than the typical h u man topical ophthal mic daily dose.
  • Two controlled clinical studies sho wed that k etorolac tro metha mine ophthal mic solution was significa ntly more effective than its vehicle in relieving ocular itching caused by seasonal all ergic conjuncti vitis.
  • Two controlled clinical studies sho wed that pati ents t reated for two weeks with ket o rolac tro metha mi ne ophthal mic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its ve hicle.
  • Results from clinical studies indicate that k etorolac tro metha mine has no significant effect upon intraocular pressure; ho wever, chan ges in intraoc ular pressure may occur following cataract surgery.
  • Ketorolac tromethamine ophthalmic solution 0.5% is supplied sterile in white opaque LDPE dropper bottles with white opaque plug and sealed with gray pantone opaque pilfer-proof caps as follows:
  • 3 mL in 5 mL bottle u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 47335-219-90
  • 5 mL in 5 mL bottle u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 47335-220-90
  • 10 mL in 10 mL bottle u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 47335-221-90
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 and 30u00b0C (59u00b0 and 86u00b0F) [see USP Controlled Room Temperature]. Protect from light.
  • No data
  • NDC 47335-219-90 Ketorolac Tromethamine Ophthalmic Solution 0.5% Rx onlyu00a0 3 mL n
  • NDC 47335-219-90 Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR USE IN THE EYES ONLY Rx only 3 mL SUN PHARMAn n n
  • NDC 47335-220-90 Ketorolac Tromethamine Ophthalmic Solution 0.5% Rx onlyu00a0 5mLn n n
  • NDC 47335-220-90 Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR USE IN THE EYES ONLY Rx only 5 mL SUN PHARMAn n n
  • NDC 47335-221-90 Ketorolac Tromethamine Ophthalmic Solution 0.5% Rx only 10 mLn
  • NDC 47335-221-90 Ketorolac Tromethamine Ophthalmic Solution 0.5% FOR USE IN THE EYES ONLY Rx only 10 mL SUN PHARMAn n n

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Name Patient Supply

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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