Label: KETOROLAC TROMETHAMINE solution/ drops

  • NDC Code(s): 60505-1003-1, 60505-1003-2
  • Packager: Apotex Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 26, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE.  KETOROLAC TROMETHAMINE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosing - Patient Dosing - The recommended dose of ketorolac tromethamine ophthalmic solution is one drop four times a day to the affected eye(s) for relief of ocular itching ...
  • 3 DOSAGE FORMS AND STRENGTHS
    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 - 11 ...
  • 4 CONTRAINDICATIONS
    Ketorolac tromethamine solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Delayed Healing - Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Studies Experience - Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects. Pregnancy Category C - Pregnancy Category C: Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral ...
  • 11 DESCRIPTION
    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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - 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 ...
  • 14 CLINICAL STUDIES
    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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    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 ...
  • 17 PATIENT COUNSELING INFORMATION
    17.1 Slow or Delayed Healing - Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs). 17.2 Avoiding ...
  • PRINCIPAL DISPLAY PANEL
    Representative sample of labeling (see the HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 0.5% BOTTLE LABEL - APOTEX CORP. NDC 60505-1003-1 - KETOROLAC TROMETHAMINE ...
  • INGREDIENTS AND APPEARANCE
    Product Information