Ivabeat 5 Mg Tablet (10 Tab)

IVABEAT 5 MG TABLET

Name

• Common Name: Ivabradine
• Brand Names: IVABEAT, Corlanor, Procoralan (International)

Composition

• Active Ingredient: Ivabradine (5 mg)

Uses IVABEAT 5 MG TABLET is primarily used to treat certain heart conditions by reducing the heart rate.

• Chronic Heart Failure: Used in adult patients with stable, symptomatic chronic heart failure with a reduced left ventricular ejection fraction (≤ 35%), who are in sinus rhythm with a resting heart rate of ≥ 70 beats per minute. It helps to reduce the risk of hospitalization for worsening heart failure, especially when patients are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.
• Chronic Stable Angina Pectoris: Prescribed for the symptomatic treatment of chronic stable angina (heart-related chest pain) in patients with normal sinus rhythm who cannot take beta-blockers.
• Pediatric Heart Failure: Indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients aged 6 months and older who are in sinus rhythm with an elevated heart rate.

Dosage and Administration IVABEAT 5 MG TABLET is typically taken orally, twice daily with food, at around the same times each day.

• Adults:
  • Initial Dose: 5 mg orally twice daily with meals.
  • Adjustment: After two weeks, the dose can be adjusted based on the resting heart rate to achieve a target of 50-60 bpm.
  • Maximum Dose: The dose should not exceed 7.5 mg twice daily.
  • Patients with conduction defects or those where bradycardia could compromise hemodynamics might start at 2.5 mg twice daily.
• Pediatric Patients: Dosing depends on weight and age, starting from 0.05 mg/kg twice daily for those weighing less than 40 kg, with dose adjustments made every two weeks.

Side Effects Common Side Effects:

• Slow heartbeat (bradycardia), which can lead to dizziness, fatigue, or lack of energy.
• Luminous phenomena (phosphenes), described as temporary bright spots or flashes in vision, usually occurring within the first two months of treatment.
• Increased blood pressure.
• Atrial fibrillation (irregular or rapid heartbeat).
• Headache, dizziness.
• Nausea, abdominal pain, diarrhea, constipation.

Serious Side Effects (Seek immediate medical attention if experienced):

• Severe allergic reactions (skin rash, itching, hives, swelling of the face, lips, tongue, or throat).
• Worsening heart rhythm problems, chest pain, or trouble breathing.
• Very slow or stopped heartbeat.

Precautions

• Contraindications: Do not take IVABEAT if you have severe heart disease, clinically significant low blood pressure, sick sinus syndrome, sinoatrial block, third-degree AV block (unless a functioning pacemaker is present), clinically significant bradycardia, severe hepatic impairment, or are pacemaker-dependent.
• Pregnancy and Breastfeeding: Ivabradine may cause harm to an unborn baby. Females of childbearing potential must use effective contraception during treatment. It is not known if Ivabradine passes into breast milk, so breastfeeding should be discontinued if taking this medicine.
• Drug Interactions: Avoid concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, certain HIV medications, nefazodone), calcium channel blockers like diltiazem and verapamil, and St. John's Wort. Caution is also advised with other drugs that slow heart rate (e.g., digoxin, amiodarone, beta-blockers) due to increased risk of bradycardia.
• Vision: May cause temporary vision changes. Exercise caution when driving or operating machinery, especially at night or in suddenly changing light conditions.
• Kidney and Liver Impairment: Use with caution in patients with kidney or moderate liver impairment; dose adjustments may be needed.
• Monitoring: Regular monitoring of heart rate and for the occurrence of atrial fibrillation is recommended.

Storage Store IVABEAT tablets at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It can tolerate excursions between 15°C to 30°C (59°F to 86°F). Protect from light and moisture. Keep out of the reach of children.

IVABEAT 5 MG TABLET (10 TAB) by CIPLA LTD. contains the active ingredient Ivabradine. This medication is used to treat certain heart conditions by specifically lowering the heart rate.

What is IVABEAT 5 MG TABLET used for?

IVABEAT 5 MG TABLET is primarily used to treat adults with chronic heart failure to reduce the risk of hospitalization for worsening heart failure, and to manage symptomatic stable angina (heart-related chest pain) in adults. It is also used to treat heart failure in children aged 6 months and older who have stable heart failure caused by an enlarged heart (dilated cardiomyopathy).

How does IVABEAT 5 MG TABLET work?

This medicine works by selectively inhibiting the "funny" channel (If) in the sinoatrial node of the heart. This action slows down the heart rate, allowing the heart to pump more blood efficiently and reducing its workload and oxygen demand without affecting myocardial contractility or blood pressure.

What is the usual dosage for IVABEAT 5 MG TABLET?

For adults, the typical starting dose is 5 mg taken twice daily with food. Your doctor may adjust the dose based on your resting heart rate and how well you tolerate the medication, up to a maximum of 7.5 mg twice daily, or down to 2.5 mg twice daily if needed. For children 6 months and older, the dose is determined by body weight, starting typically at 0.05 mg/kg twice daily, and can be adjusted up to a total maximum of 7.5 mg twice daily. Always take this medication with food.

What are the possible side effects of IVABEAT 5 MG TABLET?

Common side effects include a slow heart rate (bradycardia), temporary visual brightness or flashes (luminous phenomena), headache, dizziness, and increased blood pressure. More serious but less common side effects can include atrial fibrillation (an irregular heart rhythm) or very slow heart rates that cause dizziness or fainting.

Is IVABEAT 5 MG TABLET safe during pregnancy or breastfeeding?

No, IVABEAT 5 MG TABLET is highly unsafe and not recommended during pregnancy as it can harm the unborn baby and cause birth defects. Women who could become pregnant must use effective contraception while taking this medicine. It is also not recommended during breastfeeding, as Ivabradine can pass into breast milk, and its effects on a nursing infant are unknown.

Can IVABEAT 5 MG TABLET be taken with other medications?

IVABEAT 5 MG TABLET should not be taken with certain medications, including strong CYP3A4 inhibitors such as some antifungals (e.g., ketoconazole, itraconazole), macrolide antibiotics (e.g., clarithromycin), HIV medications (e.g., nelfinavir, ritonavir), nefazodone, and certain calcium channel blockers (diltiazem, verapamil), as these can increase the risk of serious side effects. Use with caution when taking other heart rate-lowering drugs like beta-blockers, digoxin, or amiodarone, as this can further slow the heart rate. Avoid consuming grapefruit juice while on this medication.

What precautions should be taken while using IVABEAT 5 MG TABLET?

You should not use this medicine if you have severe liver disease, very low blood pressure, a very low resting heart rate (below 60 bpm before treatment), certain serious heart conditions (e.g., sick sinus syndrome, third-degree AV block) unless you have a pacemaker, or recently worsening heart failure. Regular monitoring of your heart rate and blood pressure is important. Be cautious when driving or operating machinery, especially at night or in situations with sudden changes in light, due to potential visual disturbances and dizziness. Do not stop taking the medication abruptly without consulting your doctor.

What happens if a dose of IVABEAT 5 MG TABLET is missed?

If you miss a dose, skip the missed dose entirely and take your next dose at your regularly scheduled time. Do not take a double dose to make up for the missed one.

How should IVABEAT 5 MG TABLET be stored?

Store IVABEAT 5 MG TABLET in a closed container at room temperature, typically between 20°C and 25°C (68°F and 77°F). Keep it away from excessive heat, moisture, and direct light. Ensure it is kept out of the reach of children.