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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

Akorn

SOLUTION/ DROPS

Strength 4.5 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 Akorn. It is available in strength of 4.5 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 treatment of pain and inflammation following cataract surgery.n
  • Ketorolac Tromethamine Ophthalmic Solution is a nonsteroidal, anti-inflammatory indicated for the treatment of pain and inflammation following cataract surgery. ()n
  • One drop of Ketorolac Tromethamine Ophthalmic Solution should be applied by the patient to the affected eye twice daily beginning 1 day prior to cataract surgery, and continued through the first 2 weeks of the postoperative period. ()n
  • 4.5 mg/mL ketorolac tromethamine solution (0.45%) in a single-dose vial.n
  • Ketorolac Tromethamine Ophthalmic Solution containing 4.5 mg/mL ketorolac tromethamine in a single-dose vial. ()n
  • Ketorolac Tromethamine Ophthalmic Solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.n
  • Hypersensitivity to any component of this product. ()n
  • No data
  • Delayed healing ()n
  • Cross-sensitivity or hypersensitivity ()n
  • Increased bleeding time due to interference with thrombocyte aggregation ()n
  • Corneal effects including keratitis ()n
  • Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.n
  • Most common adverse reactions occurring in 1% to 6% of patients were increased intraocular pressure, conjunctival hemorrhage, and vision blurred. ()n
  • No data
  • Ketorolac Tromethamine Ophthalmic Solution 0.45% 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 its molecular weight is 376.40. Its molecular formula is CHNO. Its chemical structure is:n
  • Ketorolac Tromethamine Ophthalmic Solution is supplied as a sterile isotonic aqueous 0.45% preservative-free solution, with a pH of approximately 6.8. Ketorolac Tromethamine Ophthalmic Solution contains 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 osmolality of Ketorolac Tromethamine Ophthalmic Solution is approximately 285 mOsml/kg.n
  • Each mL of Ketorolac Tromethamine Ophthalmic Solution contains: ketorolac tromethamine 0.45%. carboxymethylcellulose sodium; sodium chloride; sodium citrate dihydrate; and water for injection with sodium hydroxide and/or hydrochloric acid to adjust pH.n
  • 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 900 times and 300 times higher respectively than the typical human topical ophthalmic daily dose given as twice daily to an affected eye 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 1,500 and 2,700 times higher than the typical human topical ophthalmic daily dose.n
  • Two multicenter, randomized, double-masked, parallel group comparison studies including approximately 500 patients were conducted to evaluate the effects of Ketorolac Tromethamine Ophthalmic Solution on anterior chamber cell and flare, and ocular pain relief following cataract extraction with posterior chamber intraocular lens (IOL) implantation. Results of these studies indicated that patients receiving Ketorolac Tromethamine Ophthalmic Solution had a significantly higher incidence of clearing of anterior chamber inflammation 53% (167/318) vs. patients receiving vehicle 26% (41/155) at day 14.n
  • Ketorolac Tromethamine Ophthalmic Solution was also significantly superior to vehicle in resolving ocular pain. On Day 1 post cataract surgery, 72% (233/322) of patients in the Ketorolac Tromethamine Ophthalmic Solution group were pain free compared to 40% (62/156) of patients in the vehicle group.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
  • Ketorolac Tromethamine Ophthalmic Solution 0.45% is available as a sterile solution supplied in clear, LDPE, single-dose vials packaged in 6 foil pouches, 5 vials per pouch:n
  • 30 Single-dose Vials, 0.4 mL each: NDC 17478-207-14n
  • Storage:
  • No data
  • Principal Display Panel Text for Container Label:n
  • Ketorolac Tromethaminen
  • Ophthalmic Solution 0.45%n
  • Principal Display Panel Text for Pouch Label:n
  • NDC 17478-207-14n
  • Ketorolac Tromethaminen
  • Ophthalmic Solutionn
  • 0.45%n
  • Preservative Freen
  • For Single Use Onlyn
  • Sterilen
  • 5 Single use Vials (0.4 mL each)n
  • FOR USE IN THE EYES ONLYn
  • Rx only Akorn Logon
  • Principal Display Panel Text for Carton Label:n
  • NDC 17478-207-14n
  • Ketorolac Tromethaminen
  • Ophthalmic Solutionn
  • 0.45%n
  • Preservative Freen
  • For Single Use Onlyn
  • Sterilen
  • 30 Single-use Vials (0.4 mL each)n
  • Rx only Akorn Logon

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Validated Cold Chain Shipment

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