Ivacard 5mg Tablet 1 Strip

✔️ Side Effects: Ivacard 5

• Slow heart rate (bradycardia)
• Headache
• Dizziness
• Temporary visual brightness or luminous phenomena (phosphenes)
• Increased blood pressure
• Atrial fibrillation
• Blurred vision
• First-degree AV block
• Ventricular extrasystoles

✔️ Drug Interactions

Ivabradine is metabolized mainly through CYP3A4, making interactions with medicines that affect this enzyme clinically important.

Medicines that should be avoided or are contraindicated:

• Potent CYP3A4 inhibitors such as ketoconazole and itraconazole
• Certain macrolide antibiotics, including clarithromycin and oral erythromycin
• HIV protease inhibitors such as ritonavir and nelfinavir
• Nefazodone

Other important interactions:

• Verapamil and diltiazem are not recommended because they may increase ivabradine exposure and further reduce heart rate.
• Other moderate CYP3A4 inhibitors, such as fluconazole, may require a lower starting dose and close heart-rate monitoring.
• CYP3A4 inducers such as rifampicin, barbiturates, phenytoin, and St John's wort may reduce ivabradine concentrations and potentially decrease its effectiveness.
• Concomitant use with QT-prolonging medicines should generally be avoided because slowing the heart rate may further increase the risk associated with QT prolongation. Examples include quinidine, disopyramide, sotalol, amiodarone, pimozide, ziprasidone, mefloquine, halofantrine, pentamidine, cisapride, and intravenous erythromycin.

✔️ Ivacard should not be used in patients with:

• Allergy to ivabradine or any component of the formulation
• Resting heart rate below 60 bpm before treatment
• Cardiogenic shock
• Acute myocardial infarction
• Severe hypotension, particularly blood pressure below 90/50 mmHg
• Severe hepatic impairment
• Sick sinus syndrome
• Sinoatrial block
• Unstable angina
• Third-degree AV block
• Pacemaker dependence
• Certain severe or unstable heart-failure conditions, including NYHA class III–IV where contraindicated
• Pregnancy
• Breastfeeding
• Concomitant treatment with potent CYP3A4 inhibitors

✔️ Dosage & Administration of Ivacard 5

Adult Dose

Chronic Stable Angina

The usual starting dose is 5 mg twice daily, generally taken with breakfast and the evening meal.

After approximately 3–4 weeks, the dose may be increased to 7.5 mg twice daily depending on the therapeutic response and heart rate.

If the resting heart rate remains below 50 beats/minute, or symptoms of bradycardia such as dizziness, fatigue, or weakness develop, the dose should be reduced, potentially to 2.5 mg twice daily. Treatment should be discontinued if the heart rate remains below 50 beats/minute or bradycardia-related symptoms persist.

Chronic Heart Failure

The usual initial dose is 5 mg twice daily with meals. After approximately 2 weeks, the patient's resting heart rate should be assessed and the dose adjusted according to response and tolerability.

• Resting heart rate >60 bpm: dose may be increased by 2.5 mg twice daily, up to a maximum of 7.5 mg twice daily.
• Resting heart rate 50–60 bpm: maintain the current dose.
• Resting heart rate <50 bpm or symptoms of bradycardia: reduce the dose by 2.5 mg twice daily. If already receiving 2.5 mg twice daily, treatment should be discontinued.

Elderly Patients

For patients aged 75 years or older, treatment may be started at 2.5 mg twice daily, with gradual dose adjustment if required and tolerated.

Children and Adolescents

The safety and effectiveness of ivabradine in children and adolescents have not been established. Therefore, its use is not routinely recommended in this age group.

Renal Impairment

No dose adjustment is generally required in patients with a creatinine clearance above 15 mL/min. There is limited information in patients with creatinine clearance below 15 mL/min; use should therefore be undertaken with caution and medical supervision.

Hepatic Impairment

• Mild hepatic impairment: generally no dose adjustment required.
• Moderate hepatic impairment: use with caution.
• Severe hepatic impairment: contraindicated.

✔️ Pregnancy & Lactation

Pregnancy:
Ivacard is contraindicated during pregnancy. Women who are pregnant, planning to become pregnant, or who could become pregnant should discuss appropriate treatment options with their doctor.

Breastfeeding:
Ivabradine is contraindicated during breastfeeding because animal studies indicate that the medicine can pass into milk. Consult your doctor regarding an appropriate alternative.

✔️ Safety Information:

• Monitor the resting heart rate regularly during treatment.
• The dose should be reduced if the resting heart rate persistently falls below 50 bpm or if symptoms of bradycardia occur.
• Ivabradine is not recommended in patients with atrial fibrillation or other arrhythmias that interfere with normal sinus-node function. Periodic monitoring for atrial fibrillation may be required.
• Concomitant use with verapamil or diltiazem is not recommended because these medicines can further lower heart rate and affect ivabradine levels.
• Use caution in patients with severe renal impairment or moderate hepatic impairment.
• Patients with congenital long-QT syndrome or those taking QT-prolonging medicines require particular caution.
• Temporary changes in visual brightness may occur, especially during the first few months of treatment. Inform your doctor if visual symptoms are persistent, severe, or associated with visual-field changes.
• Avoid driving or operating machinery if dizziness or visual disturbances affect your ability to see or concentrate.
• Elderly patients should take particular care because excessive slowing of the heart rate may cause weakness or dizziness.

✔️ Storage:

• Store below 30°C.
• Protect from direct light and moisture.
• Keep the medicine in a dry place.
• Keep out of reach of children.