Ivabradine

What it is used for

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. 1.1 Heart Failure in Adult Patients Ivabradine tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.

The most important thing to know

Ivabradine tablets may cause serious side effects in adults and children, including: ● Harm to an unborn baby. Females who are able to get pregnant: ○ Must use effective birth control during treatment with ivabradine tablets. ○ Tell your doctor right away if you become pregnant during treatment with ivabradine tablets. ● Increased risk of irregular or rapid heartbeat (atrial fibrillation or heart rhythm problems).

Tell your doctor if you feel any of the following symptoms of an irregular or rapid heartbeat: ○ heart is pounding or racing (palpitations). ○ chest pressure. ○ worsened shortness of breath. ○ near fainting or fainting. ● Slower than normal heart rate (bradycardia). Tell your doctor if you have: ○ a slowing of heart rate, or ○ symptoms of a slow heart rate such as dizziness, fatigue, lack of energy.

In young children signs and symptoms of slow heart rate may include: poor feeding, difficulty breathing or turning blue What is ivabradine tablets? Ivabradine tablets is a prescription medicine used: ● to treat adults who have chronic (lasting a long time) heart failure, with symptoms, to reduce their risk of hospitalization for worsening heart failure.

Side effects, and when to stop

Ivabradine tablets may cause serious side effects. The most common side effects of ivabradine tablets are: ● increased blood pressure ● temporary brightness in part of your field of vision. This is usually caused by sudden changes in light (luminous phenomena). This brightness usually happens within the first 2 months of treatment with ivabradine tablets and may go away during or after treatment with ivabradine tablets.

Be careful when driving or operating machinery where sudden changes in light can happen, especially when driving at night. These are not all the side effects of ivabradine tablets. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take ivabradine tablets if you have: ● symptoms of heart failure that recently worsened ● very low blood pressure (hypotension) ● certain heart conditions: sick sinus syndrome, sinoatrial block, or 3 rd degree atrioventricular block ● a slow resting heart rate before treatment with ivabradine tablets. Ask your doctor what a slow resting heart rate is for you.

● certain liver problems ● been prescribed any medicines that can increase the effects of ivabradine tablets. Ask your doctor if you are not sure if you have any of the medical conditions listed above.

What to say before you start

Before you take ivabradine tablets, tell your doctor about all of your medical conditions, Including if you: ● have any other heart problems, including heart rhythm problems, a slow heart rate, or a heart conduction problem. ● are breastfeeding or planning to breastfeed. It is not known if ivabradine passes into breast milk.

You and your doctor should decide if you will take ivabradine tablets or breastfeed; do not do both. ● are pregnant or planning to become pregnant. - Harm to an unborn baby" section. Tell your doctor about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements.

Ivabradine tablets may affect the way other medicines work, and other medicines may affect how ivabradine tablets works. This could cause serious side effects. How should you take ivabradine tablets? ● Take ivabradine tablets exactly as your doctor tells you. ● Do not stop taking ivabradine tablets without talking with your doctor.

● Ivabradine tablets comes as a tablet. ○ Tell your doctor if you have trouble swallowing tablets. ○ Your doctor may change your dose of ivabradine tablets during treatment. ● Take ivabradine tablets 2 times each day with food. ● If you miss a dose of ivabradine tablets, do not give another dose. Give the next dose at the usual time.

● If you or your child take too much ivabradine tablets, call your doctor or go to the nearest emergency room right away. What should you avoid while taking ivabradine tablets? ● Avoid drinking grapefruit juice and taking St. John's wort during treatment with ivabradine tablets. These can affect the way ivabradine tablets works and may cause serious side effects.

Storing it

Store ivabradine tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep ivabradine tablets and all medicines out of the reach of children.