Ivabradine

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• slow heart beat
• dizziness
• excessive tiredness
• lack of energy

Ivabradine is part of the drug class:

• OTHER CARDIAC PREPARATIONS

Serious side effects have been reported with ivabradine including the following:

• Increased risk of irregular heartbeat (atrial fibrillation or heart rhythm problems). Tell your doctor if you have symptoms of an irregular heartbeat, such as feeling that your heart is pounding or racing (palpitations), chest pressure, or worsened shortness of breath.
• Low heart rate (bradycardia). Tell your doctor if you have a slowing of your heart rate or if you have symptoms of a low heart rate such as dizziness, fatigue, lack of energy, or have low blood pressure. Low heart rate is a common side effect of ivabradine and can be serious.

Ivabradine can cause dizziness. Do not drive or operate heavy machinery until you know how ivabradine affects you.

Do not take ivabradine if you:

• are allergic to ivabradine or to any of its ingredients
• have symptoms of heart failure that recently worsened
• have low blood pressure (less than 90/50 mmHg)
• have certain heart conditions called sick sinus syndrome, sinoatrial block, or 3rd degree atrioventricular block
• have a resting heart rate lower than 60 beats per minute
• have severe liver disease
• have pacemaker dependence
• are using other medications that are strong inhibitors of enzymes that metabolize ivabradine

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

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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• chest pain or discomfort
• dizziness
• fainting
• fast or irregular heartbeat
• headache
• lightheadedness, dizziness, or fainting
• nervousness
• pounding in the ears
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

• Confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Seeing flashes of light

• Double vision
• feeling of constant movement of self or surroundings
• flushing or redness of the skin
• hives or welts, itching, or skin rash
• seeing double
• sensation of spinning
• trouble seeing
• unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with meals.
• To gain the most benefit, do not miss doses.
• Keep taking ivabradine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

(eye VAB ra deen)

• Cardiovascular Agent, Miscellaneous

Acute decompensated heart failure; blood pressure <90/50 mm Hg; sick sinus syndrome, sinoatrial block, or third-degree AV block (unless a functioning demand pacemaker is present); resting heart rate <60 bpm prior to treatment; severe hepatic impairment; pacemaker dependence (heart rate maintained exclusively by the pacemaker); concomitant use with strong CYP3A4 inhibitors

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to ivabradine or any component of the formulation; resting heart rate <70 bpm prior to treatment; prolonged QT interval (eg, congenital long QT syndrome); cardiogenic shock; acute myocardial infarction; concomitant use of verapamil or diltiazem; pregnancy, breastfeeding, or women of child-bearing potential not using appropriate contraception; hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency

Heart failure: Refer to adult dosing.

Stable angina (off-label use): Adults ≥75 years: Initial: Oral: Consider 2.5 mg twice daily. Titration and maintenance: Refer to adult dosing.