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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

A-S Medication Solutions

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]

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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 Ketorolac Tromethamine (Ketorolac Tromethamine) which is also known as Ketorolac Tromethamine and Manufactured by A-S Medication Solutions. 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
  • n 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 tromethaminen ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for:
  • The treatment of inflammation following cataract surgery.
  • The temporary relief of ocular itching due to seasonal allergic conjunctivitis ().
  • One drop of ketorolac tromethamine should be applied to the affected eye(s) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis.
  • For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ketorolac tromethamine 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 plastic bottles with white opaque droppers with grey opaque ophthalmic HDPE plastic caps as follows
  • Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. ()
  • 11 mL size bottle filled with 5 mL or 10 mL ketorolac tromethamine ophthalmic solution, 0.5%.
  • Ketorolac tromethamine solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
  • Hypersensitivity to any component of this product. ()n
  • No data
  • Delayed healing ()n
  • Cross-sensitivity or hypersensitivity ()
  • Increased bleeding time due to interference with thrombocyte aggregation ()n
  • Corneal effects including keratitis ()n
  • 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 Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (u00b1)-5-benzoyl-2,3-dihydro-1-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure
  • Ketorolac Tromethamine Ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac Tromethamine Ophthalmic Solution is a racemic mixture of R-(+) and S-(-) - ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac Tromethamine Ophthalmic Solution is 290 mOsmol/kg.
  • Each mL of Ketorolac Tromethamine Ophthalmic Solution contains: Ketorolac tromethamine 0.5%. Benzalkonium chloride 0.01%. Edetate disodium dihydrate 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH; and water for injection.
  • No data
  • Ketorolac tromethamine was not carcinogenic 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 times and 50 times higher respectively than the maximum recommended human topical ophthalmic daily dose given as QID for itching to affected eyes on a mg/kg basis. n
  • Ketorolac tromethamine was not mutagenic in the Ames assay or in forward mutation assays. Similarly, it did not result in an increase in unscheduled DNA synthesis or an increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.n
  • Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 9 mg/kg/day and 16 mg/kg/day, respectively. These doses are respectively 225 and 400 times higher than the typical human topical ophthalmic daily dose.n
  • Two controlled clinical studies showed that ketorolac tromethamine ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis.n
  • Two controlled clinical studies showed that patients treated for two weeks with ketorolac tromethamine ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle.n
  • Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.n
  • Product: 50090-2762
  • NDC: 50090-2762-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
  • No data
  • No data

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