{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "ketorolac tromethamine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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 due to seasonal allergic conjunctivitis.",
        "source": "US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": true
      },
      {
        "text": "Use with Other Topical Ophthalmic Medications Ketorolac tromethamine ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, alpha-agonists, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.",
        "source": "US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and efficacy in pediatric patients below the age of 2 have not been established.",
        "source": "US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category C Pregnancy Category C: Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively.",
        "source": "US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": true
      },
      {
        "text": "These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/mL x 0.05 mL/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis.",
        "source": "US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": true
      },
      {
        "text": "Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality.",
        "source": "US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution is administered to a nursing woman.",
        "source": "US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": true
      },
      {
        "text": "Nonteratogenic Effects: Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ketorolac tromethamine ophthalmic solution during late pregnancy should be avoided. 8.3 Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution is administered to a nursing woman.",
        "source": "US FDA label for ketorolac tromethamine (Ketorolac Tromethamine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ketorolac-tromethamine.json",
        "verbatim": true
      }
    ]
  }
}