{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "pantoprazole",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "GERD and a History of EE Adults: • The recommended dosage is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days.",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Pathological Hypersecretion Conditions, Including ZE Syndrome • The recommended adult dosage is 80 mg every 12 hours by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes).",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      },
      {
        "text": "( 2.3 , 2.4 ) 2.1 Recommended Dosage for GERD Associated with a History of EE Adult Patients The recommended adult dosage of pantoprazole sodium for injection is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days.",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of pantoprazole sodium for injection have not been established in patients less than 3 months of age for the treatment of GERD and a history of EE. The safety and effectiveness of pantoprazole sodium for injection have not been established in pediatric patients for the treatment of pathological hypersecretory conditions including ZE syndrome.",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      },
      {
        "text": "GERD and a History of EE Adults: • The recommended dosage is 40 mg once daily by intravenous injection (over at least 2 minutes) or intravenous infusion (for 15 minutes) for up to 10 days. ( 2.1 ) • Discontinue as soon as the patient is able to receive oral treatment. Switch to an appropriate oral medication within 10 days of starting pantoprazole sodium for injection.",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.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 pantoprazole (PANTOPRAZOLE SODIUM I.V.), retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.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 pantoprazole (PANTOPRAZOLE SODIUM I.V.), retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole.",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole sodium.",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      },
      {
        "text": "Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see Data ) .",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21.",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      },
      {
        "text": "Changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (PND) 4 through PND 21 [see Use in Specific Populations (8.4) ] .",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      },
      {
        "text": "Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21.",
        "source": "US FDA label for pantoprazole (PANTOPRAZOLE SODIUM I.V.), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/pantoprazole.json",
        "verbatim": true
      }
    ]
  }
}