{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "ivabradine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Adult patients Starting dose is 2.5 (vulnerable adults) or 5 mg twice daily with food.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) 2.1 Adults The recommended starting dose of ivabradine tablets are 5 mg twice daily with food.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      },
      {
        "text": "In patients with a history of conduction defects or other patients in whom bradycardia could lead to hemodynamic compromise, initiate therapy at 2.5 mg twice daily before increasing the dose based on heart rate [see Warnings and Precautions (5.3)] .",
        "source": "US FDA label for ivabradine (Ivabradine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and efficacy of ivabradine have not been established in patients less than 6 months of age.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Ivabradine is contraindicated in patients with severe hepatic impairment (Child-Pugh C) as it has not been studied in this population and an increase in systemic exposure is anticipated [ see Contraindications (4) and Clinical Pharmacology (12.3) ] . 8.7 Renal Impairment No dosage adjustment is required for patients with creatinine clearance 15 to 60 mL/min.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      },
      {
        "text": "No data are available for patients with creatinine clearance below 15 mL/min [ see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for ivabradine (Ivabradine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "However, ivabradine has only been studied in a limited number of patients ≥ 75 years of age. 8.6 Hepatic Impairment No dose adjustment is required in patients with mild or moderate hepatic impairment.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      },
      {
        "text": "Ivabradine is contraindicated in patients with severe hepatic impairment (Child-Pugh C) as it has not been studied in this population and an increase in systemic exposure is anticipated [ see Contraindications (4) and Clinical Pharmacology (12.3) ] . 8.7 Renal Impairment No dosage adjustment is required for patients with creatinine clearance 15 to 60 mL/min.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Based on findings in animals, ivabradine may cause fetal harm when administered to a pregnant woman.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies of ivabradine in pregnant women to inform any drug-associated risks.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, oral administration of ivabradine to pregnant rats during organogenesis at a dosage providing 1 to 3 times the human exposure (AUC 0-24hr ) at the MRHD resulted in embryo-fetal toxicity and teratogenicity manifested as abnormal shape of the heart, interventricular septal defect, and complex anomalies of primary arteries.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Contraception Females Ivabradine may cause fetal harm, based on animal data.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      },
      {
        "text": "Advise females of reproductive potential to use effective contraception during ivabradine treatment [ see Use in Specific Populations (8.1) ] .",
        "source": "US FDA label for ivabradine (Ivabradine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      },
      {
        "text": "• Lactation: Breastfeeding not recommended.",
        "source": "US FDA label for ivabradine (Ivabradine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ivabradine.json",
        "verbatim": true
      }
    ]
  }
}