{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "fluorometholone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ).",
        "source": "US FDA label for fluorometholone (FLUOROMETHOLONE), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in infants below the age of two years have not been established.",
        "source": "US FDA label for fluorometholone (FLUOROMETHOLONE), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.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 fluorometholone (FLUOROMETHOLONE), retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.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 fluorometholone (FLUOROMETHOLONE), retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Teratogenic effects Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose.",
        "source": "US FDA label for fluorometholone (FLUOROMETHOLONE), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.json",
        "verbatim": true
      },
      {
        "text": "Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed.",
        "source": "US FDA label for fluorometholone (FLUOROMETHOLONE), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman.",
        "source": "US FDA label for fluorometholone (FLUOROMETHOLONE), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.",
        "source": "US FDA label for fluorometholone (FLUOROMETHOLONE), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.json",
        "verbatim": true
      },
      {
        "text": "Systemically-administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.",
        "source": "US FDA label for fluorometholone (FLUOROMETHOLONE), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.",
        "source": "US FDA label for fluorometholone (FLUOROMETHOLONE), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/fluorometholone.json",
        "verbatim": true
      }
    ]
  }
}