Ivabradine 5mg Tablets

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker that selectively and specifically inhibits the If (funny) current in the sinoatrial node. This inhibition slows the spontaneous depolarization of the sinoatrial node, leading to a reduction in heart rate. The effect is dose-dependent and primarily affects the heart rate, without affecting myocardial contractility, cardiac repolarization, or intracardiac conduction times.

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Abnormal heart rhythms, such as:
+ Slow heartbeat
+ Irregular heartbeat
Chest pain or pressure
Passing out
New or worsening shortness of breath
Feeling dizzy, tired, or weak

Special Considerations for Children

In young children, signs of slow heartbeat may include:
Poor feeding
Blue or gray skin
Trouble breathing
If your child exhibits any of these symptoms, contact their doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you have any symptoms that bother you or persist. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as liver problems, low blood pressure, or a slow heartbeat.
If you have severe or worsening heart failure (a weak heart).
Specific types of abnormal heartbeats (heart block or sick sinus syndrome) without a functioning pacemaker.
The presence of a defibrillator or pacemaker.
Any medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, that may interact with this medication. This includes certain medications used to treat HIV, infections, depression, and other conditions. Your doctor or pharmacist can help you determine if any of your medications should not be taken with this drug.

Additionally, if you are breast-feeding, please note that you should not breast-feed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor first. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

While taking this drug, you may experience changes in your vision, such as increased sensitivity to light, which can cause discomfort or difficulty adjusting to sudden changes in brightness. To ensure your safety, exercise caution when driving, especially at night, and when performing any activities that require clear vision. If you have concerns, discuss them with your doctor.

As directed by your doctor, regularly monitor your blood pressure and heart rate. Before starting this medication and during treatment, you may need to undergo heart checks, which could include an electrocardiogram (ECG).

To avoid potential interactions, refrain from consuming grapefruit and grapefruit juice while taking this drug.

If you are pregnant or could become pregnant, it is crucial to be aware that this medication may harm an unborn baby. To prevent pregnancy, use effective birth control methods while taking this drug. If you become pregnant, notify your doctor immediately.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone, ritonavir, nelfinavir)
• Verapamil
• Diltiazem

• Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin, grapefruit juice)
• CYP3A4 inducers (e.g., rifampin, barbiturates, phenytoin, St. John's Wort)
• Other heart rate-lowering drugs (e.g., beta-blockers, amiodarone, digoxin, clonidine, guanfacine)

• QT-prolonging drugs (e.g., quinidine, disopyramide, sotalol, ibutilide, amiodarone, cisapride, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, intravenous erythromycin, terfenadine, astemizole, moxifloxacin, sparfloxacin, bepridil)

• Not available

• Bradycardia (dizziness, fatigue, lightheadedness, syncope)
• Visual disturbances (luminous phenomena, blurred vision, phosphenes)
• Symptoms of atrial fibrillation (palpitations, irregular heartbeat, shortness of breath, chest discomfort)
• Symptoms of heart failure worsening

Contraindicated. Ivabradine can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 5 days after the last dose.

Contraindicated. It is not known whether ivabradine is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with ivabradine.

Safety and effectiveness have not been established in pediatric patients with heart failure. Use is not recommended.

No specific dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the effects of ivabradine, particularly bradycardia. Monitor heart rate closely.

• Ivabradine is not a beta-blocker and does not affect blood pressure or myocardial contractility directly, making it an option for patients who cannot tolerate beta-blockers.
• Always take with meals to optimize absorption and reduce variability.
• Heart rate must be in sinus rhythm and ≥70 bpm at rest for initiation.
• Regular heart rate monitoring is crucial for dose titration and safety.
• Patients should be educated about luminous phenomena (phosphenes), which are common and usually transient, but can impact night vision.
• Contraindicated with strong CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics, HIV protease inhibitors, verapamil, diltiazem) due to significant increase in ivabradine exposure and risk of severe bradycardia.

• Beta-blockers (e.g., carvedilol, metoprolol succinate, bisoprolol) - first-line for heart rate control in HFrEF, but Ivabradine is an alternative for those intolerant or with contraindications.
• Digoxin (for heart rate control in AF with HFrEF, or for symptom control in HFrEF, but different mechanism and side effect profile).

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the incident, including the medication taken, the quantity, and the time it occurred.