Ivabradine 7.5mg Tablets

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker that selectively and specifically inhibits the cardiac pacemaker If current (funny current) in the sinoatrial (SA) node. This inhibition reduces the spontaneous diastolic depolarization rate in the SA node, thereby slowing heart rate. Ivabradine's effect is heart rate-dependent, meaning the heart rate reduction increases with higher baseline heart rates. It does not affect myocardial contractility, cardiac repolarization, or intracardiac conduction times.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you or your child experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

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 or fainting
+ Changes in eyesight
Abnormal heart rhythms, such as:
+ Slow heartbeat
+ Irregular heartbeat
Chest pain or pressure, or fainting
New or worsening shortness of breath
Feeling dizzy, tired, or weak

Special Considerations for Children

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

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 report any symptoms that bother you or persist. These may include, but are not limited to, various reactions that can affect different parts of your body.

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online 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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Liver problems
+ Low blood pressure
+ Slow heartbeat
+ Severe or worsening heart failure (weak heart)
+ Specific types of abnormal heartbeats (heart block, sick sinus syndrome) without a functioning pacemaker
+ The presence of a defibrillator or pacemaker
Medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. This is particularly important for certain medications used to treat HIV, infections, depression, and other conditions. Your doctor or pharmacist can advise you on potential interactions.
If you are breast-feeding, as 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 initiate, discontinue, or modify the dosage of any medication without consulting your doctor.

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 tasks that require clear vision. If you have concerns about your vision, 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, your doctor may recommend that you undergo heart checks, which may include an electrocardiogram (ECG).

To avoid potential interactions, do not consume grapefruit or grapefruit juice while taking this medication.

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

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone, ritonavir, nelfinavir)
• Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) due to additive heart rate lowering effects.

• Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin, grapefruit juice) - avoid concomitant use.
• Strong CYP3A4 inducers (e.g., rifampin, barbiturates, phenytoin, St. John's Wort) - avoid concomitant use as they can decrease ivabradine exposure and efficacy.

• Other heart rate lowering drugs (e.g., beta-blockers, digoxin, amiodarone, clonidine) - use with caution and monitor heart rate closely.
• QT prolonging drugs (e.g., quinidine, disopyramide, sotalol, ibutilide, amiodarone, cisapride, pimozide, thioridazine, moxifloxacin, erythromycin IV) - caution due to potential for additive QT prolongation, though ivabradine itself does not prolong QT.

• Not available (most interactions are significant due to CYP3A4 metabolism or HR effects)

• Bradycardia (e.g., dizziness, fatigue, lightheadedness, syncope)
• Visual disturbances (e.g., luminous phenomena, phosphenes, blurred vision)
• Symptoms of atrial fibrillation (e.g., palpitations, irregular heartbeat, shortness of breath, chest discomfort)
• Hypotension (e.g., dizziness, lightheadedness)

Ivabradine is contraindicated in pregnancy. Based on animal studies, ivabradine may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. 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.

Ivabradine is contraindicated during breastfeeding. It is excreted in animal milk, and there is a potential for serious adverse reactions in breastfed infants (e.g., bradycardia). Advise women not to breastfeed during treatment with ivabradine.

Approved for symptomatic stable heart failure due to dilated cardiomyopathy in pediatric patients ≥ 6 months of age. Dosing is weight-based and requires careful titration and monitoring of heart rate. Not indicated for pediatric patients with heart failure due to structural heart disease or for angina.

No specific dose adjustment is required based on age alone. However, elderly patients (≥75 years) may be at increased risk of bradycardia and should be monitored closely. Initiate at 2.5 mg twice daily if clinically indicated for this population.

• Always take Ivabradine with meals to optimize absorption and reduce variability.
• The primary goal of therapy is to reduce heart rate to 50-60 bpm, not necessarily to reach the maximum dose.
• Patients should be educated on how to check their pulse and recognize symptoms of bradycardia.
• Discontinue ivabradine if atrial fibrillation develops, as it is not effective for AFib and may worsen outcomes.
• Visual side effects (phosphenes) are common, usually mild, and often resolve with continued use or dose adjustment. Reassure patients about this transient effect.
• Strictly avoid concomitant use with strong CYP3A4 inhibitors (e.g., grapefruit juice, certain antifungals, macrolide antibiotics) and non-DHP calcium channel blockers (verapamil, diltiazem) due to significant interaction risks.

• Beta-blockers (e.g., carvedilol, metoprolol succinate) - cornerstone therapy for heart failure with reduced ejection fraction, also reduce heart rate.
• ACE inhibitors/ARBs (e.g., lisinopril, valsartan) - foundational therapy for heart failure.
• Mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) - foundational therapy for heart failure.
• Sacubitril/valsartan (Entresto) - ARNI, another foundational therapy for heart failure.
• SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) - emerging foundational therapy for heart failure.
• For angina: Beta-blockers, calcium channel blockers, nitrates, ranolazine.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you 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. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.