Ivabradine works by affecting your heart's electrical activity in order to slow the heart rate.

Ivabradine is used in adults with chronic heart failure, to help lower the risk of needing to be hospitalized when symptoms get worse.

Ivabradine is also used in children at least 6 months old who have stable heart failure caused by an enlarged heart.

Ivabradine may also be used for purposes not listed in this medication guide.

You should not use ivabradine if you have severe liver disease, very low blood pressure, a slow resting heart rate, a serious heart condition such as "sick sinus syndrome" or 3rd-degree "AV block" (unless you have a pacemaker), or if you depend on a pacemaker to control your heart rate.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Ivabradine may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

Ivabradine can cause serious heart rhythm problems. Call your doctor at once if you have chest pressure, racing or pounding heartbeats, very slow heartbeats, weakness, tiredness, severe dizziness, or shortness of breath that is worse than usual.

If your baby is taking ivabradine, watch for symptoms of feeding problems, trouble breathing, or turning blue.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Ivabradine is usually taken 2 times per day with food. Avoid grapefruit or grapefruit juice.

Tell your doctor if you have trouble swallowing a ivabradine tablet.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Each plastic ampule is for one use only. Throw it away after one use, even if there is still medicine left inside.

If a child taking ivabradine spits outs the medicine shortly after taking, do not give another dose. Wait until the next scheduled dose time to give the medicine again.

You may also need to take another medicine called a beta-blocker. Use all medications as directed and read all medication guides you receive. Do not stop taking your medication or change your doses without your doctor's advice.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture, heat, and light. Keep the ampules of liquid ivabradine in the foil pouch and use the medicine right away after opening.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 5 mg orally twice a day with meals
Maximum dose: 7.5 mg orally twice a day

Comments:
-In patients with a history of conduction defects or in patients whom bradycardia could lead to hemodynamic compromise, start with 2.5 mg orally twice a day.
-Assess after 2 weeks and adjust dose to maintain tolerability and achieve resting heart rate between 50 and 60 beats per minute (bpm); if resting heart rate is greater than 60 bpm, increase by 2.5 mg twice daily to a maximum of 7.5 mg twice daily; if resting heart rate is less than 50 bpm or bradycardia signs and symptoms occur, decrease by 2.5 mg twice daily (discontinue if current dose is 2.5 mg orally twice a day).

Use: To reduce worsening heart failure hospitalization risk in patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) at or below 35%, who are in sinus rhythm with resting heart rate at or above 70 bpm and are either unable to tolerate or have a contraindication to beta-blockers.

Usual Pediatric Dose for Congestive Heart Failure:

6 Months or Older:
Less than 40 kg (oral solution):
-Initial dose: 0.05 mg/kg orally twice a day with food; assess patient at 2-week intervals and adjust dose by 0.05 mg/kg to target a heart rate reduction of at least 20%, based on tolerability.
-Maximum dose: 6 months to less than 1 year old: 0.2 mg/kg orally twice a day, up to a total of 7.5 mg orally twice a day; 1 year or older: 0.3 mg/kg orally twice a day, up to a total of 7.5 mg orally twice a day.

40 kg or more (tablets):
-Initial dose: 2.5 mg orally twice a day with food; assess patient at 2-week intervals and adjust dose by 2.5 mg to target a heart rate reduction of at least 20%, based on tolerability.
-Maximum dose: 7.5 mg orally twice a day

Use: Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients 6 months or older who are in sinus rhythm with an elevated heart rate.

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;

• very low blood pressure;

• a slow resting heart rate;

• severe liver disease; or

• if you depend on a pacemaker to control 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;

• antiviral medicine to treat hepatitis C or HIV/AIDS; or

• other heart medicine or blood pressure medication (such as amiodarone, digoxin, diltiazem, or verapamil).

Tell your doctor if you have any other heart problems not being treated with ivabradine.

Taking ivabradine during pregnancy may harm an unborn baby or lead to premature birth. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

You should not breastfeed while using ivabradine.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Discard any unused oral solution left in the medication cup or the ampule.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Grapefruit may interact with ivabradine and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

Avoid driving or hazardous activity until you know how ivabradine will affect you. Your reactions could be impaired.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ivabradine may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• very slow heartbeats;

• severe headache, blurred vision, pounding in your neck or ears;

• racing heartbeats with dizziness, tiredness, or a lack of energy;

• chest tightness; or

• shortness of breath that is worse than usual.

If your baby is taking ivabradine, watch for symptoms of feeding problems, trouble breathing, or turning blue.

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.

Common side effects of ivabradine may include:

• slow or irregular heartbeats;

• high blood pressure; 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.

Ivabradine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect ivabradine, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor. Your doctor will check your heartbeat and blood pressure from time to time to check your body's response to ivabradine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.