Ivabradine

DRUG INFORMATION

  ADULT
    - 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
    - ( 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
    - 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

  CHILD
    - 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

  RENAL IMPAIRMENT
    - 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
    - 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

  HEPATIC IMPAIRMENT
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - • Lactation: Breastfeeding not recommended.
      Source: US FDA label for ivabradine (Ivabradine), section 'use in specific
      populations', retrieved 2026-08-29