Corazon
Generic Name
Ivabradine
Manufacturer
Servier (original), various generics
Country
France (original), various countries for generics
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
corazon 5 mg tablet | ৳ 75.00 | ৳ 750.00 |
Description
Overview of the medicine
Corazon 5 mg tablet contains Ivabradine, a heart rate-lowering agent used to treat chronic stable angina and chronic heart failure in patients with sinus rhythm whose heart rate is above 70 bpm.
Uses & Indications
Dosage
Adults
Initial dose 5 mg twice daily, adjusted if necessary after 3-4 weeks to 7.5 mg twice daily. Dose should be reduced to 2.5 mg twice daily if heart rate drops below 50 bpm or symptoms of bradycardia occur. Maximum dose is 7.5 mg twice daily.
Elderly
For patients aged ≥75 years, an initial dose of 2.5 mg twice daily should be considered before increasing.
Renal_impairment
No dose adjustment required for mild to moderate renal impairment. Use with caution in severe renal impairment (creatinine clearance <15 mL/min) due to lack of data.
How to Take
Take orally twice daily, with meals.
Mechanism of Action
Ivabradine selectively and specifically inhibits the If current (funny current) in the cardiac sinoatrial node, which is responsible for the spontaneous diastolic depolarization and thus for heart rate regulation. This leads to a dose-dependent reduction in heart rate.
Pharmacokinetics
Onset
Heart rate reduction typically within 1 hour.
Excretion
Mainly excreted via feces (approximately 70%) and urine (approximately 20%) as metabolites.
Half life
Effective half-life of approximately 11 hours.
Absorption
Rapidly absorbed, peak plasma concentrations reached in about 1 hour. Absolute bioavailability is approximately 40% due to first-pass effect.
Metabolism
Extensively metabolized by CYP3A4 in the liver and intestine. Main metabolite is N-demethylated derivative.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients
- Heart rate less than 70 bpm at rest before treatment
- Cardiogenic shock
- Acute myocardial infarction
- Severe hypotension
- Unstable angina pectoris
- Sick sinus syndrome, sino-atrial block, 3rd degree AV block
- Pacemaker dependence (heart rate exclusively imposed by the pacemaker)
- Severe hepatic insufficiency
- Concomitant use with strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole, macrolide antibiotics, nefazodone, ritonavir, nelfinavir)
- Pregnancy and lactation
Drug Interactions
Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil)
Concomitant use is contraindicated as they increase ivabradine exposure and reduce heart rate.
QT prolonging medicinal products (e.g., quinidine, disopyramide, sotalol)
Concurrent use may exacerbate QT prolongation. Caution advised.
CYP3A4 inducers (e.g., rifampicin, barbiturates, phenytoin, St. John's Wort)
May decrease ivabradine exposure and efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone, ritonavir, nelfinavir)
Concomitant use is contraindicated due to increased plasma concentrations of ivabradine.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include severe bradycardia. Treatment involves symptomatic and supportive measures, including atropine, beta-stimulants (e.g., isoprenaline), or temporary cardiac pacing if necessary.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients
- Heart rate less than 70 bpm at rest before treatment
- Cardiogenic shock
- Acute myocardial infarction
- Severe hypotension
- Unstable angina pectoris
- Sick sinus syndrome, sino-atrial block, 3rd degree AV block
- Pacemaker dependence (heart rate exclusively imposed by the pacemaker)
- Severe hepatic insufficiency
- Concomitant use with strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole, macrolide antibiotics, nefazodone, ritonavir, nelfinavir)
- Pregnancy and lactation
Drug Interactions
Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil)
Concomitant use is contraindicated as they increase ivabradine exposure and reduce heart rate.
QT prolonging medicinal products (e.g., quinidine, disopyramide, sotalol)
Concurrent use may exacerbate QT prolongation. Caution advised.
CYP3A4 inducers (e.g., rifampicin, barbiturates, phenytoin, St. John's Wort)
May decrease ivabradine exposure and efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone, ritonavir, nelfinavir)
Concomitant use is contraindicated due to increased plasma concentrations of ivabradine.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include severe bradycardia. Treatment involves symptomatic and supportive measures, including atropine, beta-stimulants (e.g., isoprenaline), or temporary cardiac pacing if necessary.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., EMA, FDA, DGDA)
Patent Status
Patents expired in some regions, generic versions available
Clinical Trials
Key trials include BEAUTIFUL (chronic stable angina with LV dysfunction), SHIFT (chronic heart failure), and SIGNIFY (coronary artery disease without clinical heart failure).
Lab Monitoring
- Regular monitoring of heart rate is recommended. ECG may be performed periodically to monitor for bradycardia or atrial fibrillation.
Doctor Notes
- Always check resting heart rate before initiating and adjusting dose. Target heart rate usually 50-60 bpm.
- Monitor for signs of atrial fibrillation.
- Avoid concomitant use with strong and moderate CYP3A4 inhibitors.
Patient Guidelines
- Take with meals.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Report any visual disturbances or symptoms of very slow heart rate immediately.
- Avoid grapefruit juice.
Missed Dose Advice
If you miss a dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a missed one.
Driving Precautions
Ivabradine may cause transient luminous phenomena (phosphenes) or blurred vision, which could impair ability to drive or operate machinery, especially at night. Patients should be warned of this potential and exercise caution.
Lifestyle Advice
- Maintain a healthy diet and regular exercise as advised by your doctor.
- Quit smoking and limit alcohol intake.
- Manage stress effectively.
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