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Ketorolac Tromethamine (Acuvail)

Trade Name : ACUVAIL

Allergan, Inc.

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 (Acuvail) which is also known as ACUVAIL and Manufactured by Allergan, Inc.. It is available in strength of 4.5 mg/mL per ml. Read more

Ketorolac Tromethamine (Acuvail) 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
  • ACUVAIL
  • u00ae
  • ACUVAILu00a0ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for the treatment of pain and inflammation following cataract surgery. ()
  • One drop of ACUVAILu00a0should 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.u00a0()
  • 4.5 mg/mL ketorolac tromethamineu00a0solution (0.45%) in a single-use vial.
  • ACUVAILu00a0ophthalmic solution containing 4.5 mg/mL ketorolac tromethamine in a single-use vial. ()
  • ACUVAILu00a0solution 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 ()n
  • Cross-sensitivity or hypersensitivity () n
  • Increased bleeding time due to interference with thrombocyte aggregation ()n
  • Corneal effects including keratitis ()
  • 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.
  • Most common adverse reactions occurring in 1-6% of patients wereu00a0increased intraocular pressure, conjunctival hemorrhage, and vision blurred. ()
  • No data
  • ACUVAILu00a0(ketorolac tromethamine ophthalmic solution) 0.45%u00a0is 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:
  • ACUVAILn- u00a0
  • Each mL of ACUVAILu00a0ophthalmic solution contains:ketorolac tromethamine 0.45%.u00a0n carboxymethylcellulose sodium; sodium chloride; sodium citrate dihydrate; and purified water with sodium hydroxide and/or hydrochloric acid to adjust pH.u00a0
  • No data
  • Ketorolac tromethamine was not carcinogenic in either rats given up to 5 mg/kg/day orally for 24 monthsu00a0or 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.
  • Ketorolac tromethamine was not mutagenic in the Amesassay or in forward mutation assays. Similarly, it did not result in anu00a0u00a0increase in unscheduled DNA synthesis or anu00a0u00a0increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.
  • 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 1500 and 2700 times higher than the typical human topical ophthalmic daily dose.
  • Two multicenter, randomized, double-masked, parallel group comparison studies including approximately 500 patients were conducted to evaluate the effects of ACUVAILu00a0on 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 ACUVAILu00a0had a significantly higher incidence of clearing of anterior chamber inflammation 53% (167/318) versusu00a0patients receiving vehicle 26% (41/155)u00a0at day 14.
  • ACUVAILu00a0was also significantly superior to vehicle in resolving ocular pain. On Day 1 post cataract surgery, 72% (233/322) of patients in the ACUVAILu00a0group were pain free compared to 40% (62/156) of patients in the vehicle group.
  • 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.
  • ACUVAILu00a0(ketorolac tromethamine ophthalmic solution) 0.45% is available as a sterile solution supplied in clear, LDPE, single-use vials packaged in 3 foil pouches, 10 vials per pouch:
  • 30 Single-Use Vials 0.4 mL each: NDC 0023-3507-31
  • Storagen- :
  • No data
  • NDC 0023-3507-31ACUVAIL(ketorolac tromethamineophthalmic solution)0.45%Preservative-FreeFOR SINGLE-USE ONLYRx Onlysterile
  • NDC 0023-3507-30ACUVAIL(ketorolac tromethamineophthalmic solution)0.45%Preservative-FreeFOR SINGLE-USE ONLYRx Onlysterile
  • NDC 0023-3507-31ACUVAIL(ketorolac tromethamineophthalmic solution)0.45%Preservative-FreeFOR SINGLE-USE ONLYRx Onlysterile

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