What is the most important information I should know about ivabradine?
You should not use ivabradine if you have severe liver disease, if you depend on a pacemaker to regulate your heart rate, or if you have a serious heart condition such as "sick sinus syndrome" or 3rd-degree "AV block" (unless you have a pacemaker).
You also should not use ivabradine if your heart failure symptoms recently got worse, if your resting heart rate is less than 60 bpm, or if your blood pressure is less than 90 over 50.
Avoid becoming pregnant while you are taking ivabradine. Use effective birth control and tell your doctor right away if you become pregnant.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with ivabradine, and some drugs should not be used together.
Ivabradine can cause serious heart rhythm problems. Call your doctor at once if you have chest tightness, racing or pounding heartbeats, very slow heartbeats, weakness, tiredness, severe dizziness, or shortness of breath that is worse than usual.
What is ivabradine?
Ivabradine works by affecting your heart's electrical activity in order to slow the heart rate.
Ivabradine is used in certain people with chronic heart failure, to help lower the risk of needing to be hospitalized when symptoms get worse. Ivabradine is not for use if you already have heart failure symptoms that recently got worse before starting this medicine.
Ivabradine may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking ivabradine?
You should not use ivabradine if you are allergic to it, or if you have:
- a serious heart condition such as "sick sinus syndrome" or 3rd-degree "AV block" (unless you have a pacemaker);
- heart failure symptoms that recently got worse;
- severe liver disease;
- a resting heart rate of less than 60 beats per minute;
- blood pressure lower than 90 over 50; or
- if you depend on a pacemaker to regulate your heart rate.
Some medicines can cause unwanted or dangerous effects when used with ivabradine. Your doctor may need to change your treatment plan if you use any of the following drugs:
- an antibiotic or antifungal medicine;
- an antidepressant;
- heart or blood pressure medicine; or
- antiviral medicine to treat hepatitis C or HIV/AIDS.
To make sure ivabradine is safe for you, tell your doctor if you have:
- other heart problems not being treated with ivabradine;
- liver disease;
- high or low blood pressure;
- if you have a pacemaker; or
- if you take other heart medicine or blood pressure medication, such as amiodarone, digoxin, diltiazem, or verapamil.
Use effective birth control to prevent pregnancy while you are taking this medicine. Taking ivabradine during pregnancy could harm the unborn baby or lead to premature birth. Tell your doctor right away if you become pregnant while taking ivabradine.
It is not known whether ivabradine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take ivabradine?
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Ivabradine is usually taken 2 times per day with meals. Avoid eating grapefruit or drinking grapefruit juice with this medicine.
You may also need to take another medicine called a beta-blocker. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.
Ivabradine can cause a temporary brightness in your vision, especially during the first 2 months of treatment. This can make you see halos around lights, see colors within lights, or see multiple images while looking at an object. You may also see kaleidoscope colors or flashes of movement in certain parts of your vision. Sudden bright light can make these vision changes more noticeable. These effects usually go away as you continue taking ivabradine or after you stop taking it.
While using ivabradine, you may need frequent medical tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Skip the missed dose and take the medicine when it is time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking ivabradine?
Ivabradine may cause dizziness or vision changes, which could impair your thinking or reactions. Be careful if you drive (especially at night) or do anything that requires you to be alert and able to see clearly.
Avoid sudden changes in the intensity of light around you, such as going outside in sunlight after being in a dark place. Allow your eyes time to adjust slowly to the light.
Grapefruit and grapefruit juice may interact with ivabradine and lead to unwanted side effects. Avoid the use of grapefruit products while taking ivabradine.
Avoid taking an herbal supplement containing St. John's wort at the same time you are taking ivabradine.
What are the possible side effects of ivabradine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- chest tightness, racing or pounding heartbeats, fluttering in your chest;
- shortness of breath that is worse than usual;
- a light-headed feeling, like you might pass out; or
- very slow heartbeats with dizziness, tiredness, or a lack of energy.
Common side effects may include:
- slow heart rate;
- high blood pressure (severe headache, blurred vision, pounding in your neck or ears); or
- your eyes may be more sensitive to light.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect ivabradine?
Ivabradine can cause a serious heart rhythm problems, especially if you use certain medicines at the same time, such as antibiotics, antifungal medicine, antidepressants, anti-malaria medicine, asthma inhalers, antipsychotic medicine, cancer medicine, certain HIV/AIDS medicine, heart or blood pressure medicine, or medicine to prevent vomiting.
Many other drugs can interact with ivabradine, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about ivabradine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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