Ivabrad Od 15 Mg Tablet (10 Tab)

IVABRAD OD 15 MG TABLET

Name

• Common Name: Ivabradine
• Brand Name: IVABRAD OD 15 MG TABLET (by Lupin Ltd.)

Composition

Each tablet contains Ivabradine 15 mg as the active ingredient.

Uses

IVABRAD OD 15 MG TABLET is prescribed for adults to treat:

• Chronic Heart Failure: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure, particularly those with a left ventricular ejection fraction of ≤35%, in sinus rhythm with a resting heart rate ≥70 beats per minute, and who are either on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. It is also used to treat symptomatic heart failure in pediatric patients aged 6 months and older due to dilated cardiomyopathy.
• Stable Angina Pectoris (Chest Pain): For symptomatic treatment in patients with normal sinus rhythm and a heart rate ≥70 bpm, especially when beta-blockers are not suitable or not fully effective. It helps in reducing the heart's oxygen demand by slowing the heart rate, thereby improving heart efficiency and reducing angina attacks.

Dosage and Administration

IVABRAD OD 15 MG TABLET is for oral administration and should be taken with food, usually twice daily, at around the same times each day.

• Adults: The typical starting dose is 5 mg twice daily. The dose may be adjusted after two weeks based on the patient's resting heart rate and tolerability, aiming for a resting heart rate between 50 and 60 beats per minute. The maximum recommended dose is generally 7.5 mg twice daily.
• Elderly (≥75 years): An initial dose of 2.5 mg twice daily may be considered.
• Pediatric Patients (≥40 kg): Initial dose is 2.5 mg twice daily with food, with adjustments made every two weeks based on heart rate and tolerability, up to a maximum of 7.5 mg twice daily.
• If a dose is missed, do not take a double dose; continue with the next scheduled dose.

Side Effects

Common Side Effects:

• Bradycardia (slow heart rate).
• Luminous phenomena (phosphenes) or visual disturbances, such as temporary brightness, bright spots, or seeing circles around lights, especially with sudden changes in light intensity. These usually occur within the first two months and may fade over time.
• Headache.
• Dizziness, lightheadedness.
• Increased blood pressure.
• Atrial fibrillation (irregular heartbeat).
• Nausea, abdominal pain, diarrhea, constipation.
• Excessive tiredness, lack of energy.

Serious Side Effects (Seek immediate medical attention if you experience any of these):

• Very slow, irregular, or pounding heartbeat.
• Chest pain or pressure.
• Worsening shortness of breath.
• Swelling of the face, throat, tongue, lips, or eyes; difficulty swallowing or breathing; hoarseness (signs of a severe allergic reaction).

Precautions

• Contraindications: Do not take if you have acute decompensated heart failure, clinically significant hypotension (low blood pressure), a resting heart rate below 70 bpm before treatment (unless pacemaker dependent), severe liver impairment, or certain heart rhythm disorders (e.g., sick sinus syndrome, third-degree AV block) without a pacemaker.
• Drug Interactions: Avoid concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, nelfinavir, ritonavir, nefazodone). Concomitant use with moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil) should also be avoided as they can increase ivabradine concentration and its heart rate-lowering effects. The risk of bradycardia increases when Ivabradine is combined with other heart rate-lowering medications like beta-blockers, digoxin, or amiodarone. St. John's Wort may decrease the effect of ivabradine.
• Pregnancy and Breastfeeding: Ivabradine may cause harm to an unborn baby. Females of childbearing potential must use effective contraception during treatment. Ivabradine is not recommended during breastfeeding.
• Vision: Be cautious when driving or operating machinery, especially at night or in situations with sudden light changes, due to potential visual disturbances.
• Other Conditions: Inform your doctor if you have irregular heartbeat, low blood pressure, a pacemaker, recently worsened heart failure symptoms, or liver disease.

Storage

Store the medicine in a closed container at room temperature, ideally between 20°C and 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep it away from heat, moisture, direct light, and out of the reach of children. Do not freeze.

IVABRAD OD 15 MG TABLET is a medication primarily used to manage certain heart conditions. It contains the active ingredient ivabradine.

Here are some frequently asked questions about IVABRAD OD 15 MG TABLET:

What is IVABRAD OD 15 MG TABLET used for?

IVABRAD OD 15 MG TABLET is used to treat stable angina pectoris (chest pain) in adults who cannot tolerate beta-blockers and have a resting heart rate of 70 beats per minute or more. It is also used to manage chronic heart failure in adult patients, especially those with a resting heart rate of 75 beats per minute or higher, to reduce the risk of hospitalization for worsening heart failure.

How does IVABRAD OD 15 MG TABLET work?

IVABRAD OD 15 MG TABLET works by selectively inhibiting the "funny current" (I(f)) in the heart's sinoatrial node, which is the natural pacemaker. This action slows down the electrical activity in the heart's pacemaker cells, leading to a reduced heart rate. By slowing the heart rate, it decreases the heart's workload and oxygen demand, improving the heart's efficiency without affecting heart muscle contraction or blood pressure.

What is the usual dosage for IVABRAD OD 15 MG TABLET?

IVABRAD OD 15 MG TABLET is usually taken twice a day, once in the morning and once in the evening, with food. Your doctor will determine the appropriate dose based on your heart rate, condition, and response to treatment. Do not take more or less than prescribed, and continue taking it unless your doctor tells you to stop.

What are the possible side effects of IVABRAD OD 15 MG TABLET?

Common side effects can include a slow heart rate (bradycardia), visual disturbances (such as temporary bright spots, flashes of light, or halos around lights, especially with sudden changes in brightness), increased blood pressure, and an irregular heart rhythm (atrial fibrillation). Serious side effects like very slow or irregular heartbeat, chest pain, worsening shortness of breath, severe dizziness, or swelling of the face, throat, tongue, lips, and eyes should be reported to your doctor immediately.

Is IVABRAD OD 15 MG TABLET safe during pregnancy or breastfeeding?

No, IVABRAD OD 15 MG TABLET is not recommended during pregnancy or if you are trying to become pregnant, as it may cause harm to an unborn baby. Women who can become pregnant should use effective contraception during treatment. Breastfeeding is also not recommended while taking IVABRAD OD 15 MG TABLET, as it is not known if it passes into breast milk and could potentially harm a nursing infant.

Can IVABRAD OD 15 MG TABLET be taken with other medications?

IVABRAD OD 15 MG TABLET can interact with many medications. You should inform your doctor about all prescription, over-the-counter, herbal, and vitamin supplements you are taking. It should not be taken with strong CYP3A4 inhibitors, such as certain antifungals (e.g., ketoconazole, itraconazole), antibiotics (e.g., clarithromycin), HIV medications (e.g., nelfinavir, ritonavir), certain antidepressants (e.g., nefazodone), and some calcium channel blockers (e.g., diltiazem, verapamil). Taking it with other heart rate-lowering drugs (e.g., digoxin, amiodarone, beta-blockers) may increase the risk of bradycardia. Avoid consuming grapefruit or grapefruit juice, as it can increase the medication's levels in the bloodstream and lead to serious side effects.

What precautions should be taken while using IVABRAD OD 15 MG TABLET?

Before taking this medicine, tell your doctor if you have an irregular or slow heartbeat, low blood pressure, a pacemaker, severe liver problems, or heart failure that has recently worsened. Ivabradine may affect your vision, so be careful when driving or operating machinery, especially at night or in places with sudden changes in light. Regular monitoring of your heart rate and blood pressure by your doctor is important.

What happens if a dose of IVABRAD OD 15 MG TABLET is missed?

If you miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should IVABRAD OD 15 MG TABLET be stored?

Store IVABRAD OD 15 MG TABLET at room temperature, typically between 68°F to 77°F (20°C to 25°C), away from heat, moisture, and direct light. Keep it out of reach of children.