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CORLANOR- ivabradine tablet, film coatedCORLANOR- ivabradine solution

Patient Information

Advise the patient to read the FDA-approved patient labeling[seeMedication GuideandInstructions for Use].

  • Fetal Toxicity
    Advise pregnant women of the potential risks to a fetus.
    Advise females of reproductive potential to use effective contraception and to notify their healthcare provider with a known or suspected pregnancy[see Warnings and Precautions (5.1) and Use in Specific Populations (8.1),(8.3)].
  • Low Heart Rate
    Advise patients to report significant decreases in heart rate or symptoms such as dizziness, fatigue, or hypotension[seeWarnings and Precautions(5.3)].
  • AtrialFibrillation
    Advise patients to report symptoms of atrial fibrillation, such as heart palpitations or racing, chest pressure, or worsened shortness of breath[see Warnings and Precautions (5.2)].
  • Phosphenes
    Advise patients about the possible occurrence of luminous phenomena (phosphenes). Advise patients to use caution if they are driving or using machines in situations where sudden changes in light intensity may occur, especially when driving at night. Advise patients that phosphenes may subside spontaneously during continued treatment with Corlanor[seeAdverse Reactions(6.1)].
  • Drug Interactions
    Advise patients to avoid ingestion of grapefruit juice and St. John s wort[seeDrugInteractions(7.1)].
  • Intake with Food
    Advise patients to take Corlanor twice daily with food[seeDosage and Administration(2)].
  • Oral Solution
    Advise parents/caregivers on preparation and administration instructions including the use of a calibrated oral syringe and a medicine cup (provided by the pharmacy) to avoid dosing errors[see Dosage and Administration (2.2)].
    Advise parents/caregivers that the oral solution should not be administered by the child.
    Advise parents/caregivers to not double up doses (e.g., if patient spits out the drug or caregiver forgets to give the drug at the prescribed time).
    Advise parents/caregivers to throw away the unused product remaining in the cup immediately after drawing up the prescribed dose in the syringe.

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Thousand Oaks, California 91320-1799


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