Ivacard (Ivabradine INN) is a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker. It is a heart rate lowering agent that acts by selectively & specifically inhibiting the cardiac pacemaker current (if), a mixed sodium-potassium inward current that controls the spontaneous diastolic depolarization in the sinoatrial (SA) node and hence regulates the heart rate.
Ivacard (Ivabradine INN) is a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker. It is a heart rate lowering agent that acts by selectively & specifically inhibiting the cardiac pacemaker current (if), a mixed sodium-potassium inward current that controls the spontaneous diastolic depolarization in the sinoatrial (SA) node and hence regulates the heart rate. It is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients. It also reduces the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure.
Ivacard-5 Tablet: Each film-coated tablet contains Ivabradine Hydrochloride INN 5.39 mg equivalent to Ivabradine 5 mg.
Ivacard-7.5 Tablet: Each film-coated tablet contains Ivabradine Hydrochloride INN 8.085 mg equivalent to Ivabradine 7.5 mg.
Ivacard is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated:
The starting dose is 2.5 (pediatrics and vulnerable adults) or 5 mg twice daily with food. After 2 weeks of treatment, adjust the dose based on heart rate. The maximum dose is 7.5 mg twice daily. In patients with a history of conduction defects or other patients in whom bradycardia could lead to hemodynamic compromise, initiate therapy at 2.5 mg twice daily before increasing the dose based on heart rate.
Dose Adjustment:
|
Heart Rate |
Dose Adjustment |
|
> 60 bpm |
Increase dose by 2.5 mg (given twice daily) up to a maximum dose of 7.5 mg twice daily |
|
50-60 bpm |
Maintain the dose above |
|
< 50 bpm or signs and symptoms of bradycardia |
Decrease dose by 2.5 mg (given twice daily); if the current dose is 2.5 mg twice daily, discontinue therapy |
Ivabradine is hypersensitive to any component of this preparation, Acute decompensated heart failure, significant hypotension, Sick sinus syndrome, sinoatrial block or 3rd degree AV block, significant bradycardia, severe hepatic impairment, Heart rate maintained exclusively by the pacemaker & in combination with strong cytochrome CYP3A4 inhibitors, etc.
For fetal toxicity, women should refrain from pregnancy while taking Ivabradine; Monitor patients for atrial fibrillation; Monitor heart rate decreases and bradycardia symptoms during treatment & not recommended in patients with 2nd-degree AV block.
Bradycardia, hypertension, atrial fibrillation, luminous phenomena, first-degree heart block, ventricular extrasystoles, headache, dizziness, visual disturbances including phosphenes and blurred vision; less commonly nausea, constipation, diarrhea, palpitation, dyspnoea, vertigo, muscle cramp, eosinophilia, hyperuricemia and raised plasma-creatinine concentration.
The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (Ketoconazole, Itraconazole) and macrolide antibiotics (Clarithromycin, Erythromycin, Telithromycin) is contraindicated, the concomitant use of Ivabradine with the heart rate reducing agent Digoxin, Amiodarone, Beta-Blockers, Diltiazem, or Verapamil resulted in an increase in additional heart rate reduction
Use in pregnancy: Ivabradine may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of Ivabradine in pregnant women to inform any drug-associated risks; Use in lactation: Breastfeeding is not recommended; Use in children & adolescents: The safety and effectiveness of Ivabradine have been established in pediatric patients (age 6 months to less than 18 years old). Safety and efficacy of Ivabradine have not
been established in patients less than 6 months of age; Geriatric use: Ivabradine has only been studied in a limited number of patients ≥ 75 years of age; Hepatic Impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. Ivabradine is contraindicated in patients with severe hepatic impairment; Renal Impairment: No dosage adjustment is required for patients with creatinine clearance of 15 to 60 mL/min. No data are available for patients with creatinine clearance below 15 mL/min.
Ivacard-5 Tablet: Each box contains 20 tablets in a blister pack
Ivacard-7.5 Tablet: Each box contains 10 tablets in a blister pack.
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