{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "scopolamine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Application and Removal ( 2.1 ): • Each TRANSDERM SCŌP transdermal system delivers 1 mg of scopolamine over 3 days. • Only wear one transdermal system at a time. • Do not cut the transdermal system. • Wash hands thoroughly with soap and water after application. • Avoid touching or applying pressure to the transdermal system once applied.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Important Application and Removal Instructions • Each TRANSDERM SCŌP transdermal system is formulated to deliver in vivo approximately 1 mg of scopolamine over 3 days. • Only wear one transdermal system at any time. • Do not cut the transdermal system. • Apply the transdermal system to the skin in the postauricular area (hairless area behind one ear).",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of TRANSDERM SCŌP have not been established in pediatric patients. Pediatric patients are particularly susceptible to the anticholinergic adverse reactions of scopolamine, including neurologic and psychiatric adverse reactions and drug withdrawal syndrome.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "Application and Removal ( 2.1 ): • Each TRANSDERM SCŌP transdermal system delivers 1 mg of scopolamine over 3 days. • Only wear one transdermal system at a time. • Do not cut the transdermal system. • Wash hands thoroughly with soap and water after application. • Avoid touching or applying pressure to the transdermal system once applied.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Important Application and Removal Instructions • Each TRANSDERM SCŌP transdermal system is formulated to deliver in vivo approximately 1 mg of scopolamine over 3 days. • Only wear one transdermal system at any time. • Do not cut the transdermal system. • Apply the transdermal system to the skin in the postauricular area (hairless area behind one ear).",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.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 scopolamine (Transderm Scop), retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "( 5.2 , 8.5 ) • Renal or Hepatic Impairment : Consider more frequent monitoring during treatment due to increased risk of CNS adverse reactions.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "Advise patients if body temperature increases, or they are not sweating in warm environmental conditions, to remove the transdermal system and contact their healthcare provider [see Warnings and Precautions ( 5.5 )] . 8.6 Renal or Hepatic Impairment TRANSDERM SCŌP has not been studied in patients with renal or hepatic impairment.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "Consider more frequent monitoring during treatment with TRANSDERM SCŌP in patients with renal or hepatic impairment because of the increased risk of CNS adverse reactions [see Warnings and Precautions ( 5.2 )].",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "Avoid use of TRANSDERM SCOP in patients with severe preeclampsia [see Warnings and Precautions ( 5.3 ) and Data] .",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "Available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by TRANSDERM SCŌP did not affect uterine contractions or increase the duration of labor. 8.2 Lactation Risk Summary Scopolamine is present in human milk.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "There are no available data on the effects of scopolamine on the breastfed infant or the effects on milk production.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRANSDERM SCŌP and any potential adverse effects on the breastfed child from TRANSDERM SCŌP or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of TRANSDERM SCŌP have not been established in pediatric patients.",
        "source": "US FDA label for scopolamine (Transderm Scop), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/scopolamine.json",
        "verbatim": true
      }
    ]
  }
}