Ivaten
Generic Name
Ivabradine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
ivaten 5 mg tablet | ৳ 25.10 | ৳ 251.00 |
Description
Overview of the medicine
Ivabradine is used to treat chronic stable angina and chronic heart failure. It works by reducing heart rate.
Uses & Indications
Dosage
Adults
Initial: 5 mg twice daily. May be increased to 7.5 mg twice daily after 3-4 weeks based on heart rate response. Max: 7.5 mg twice daily.
Elderly
Initial: 2.5 mg twice daily for patients aged 75 years and above, then adjust as needed.
Renal_impairment
No dose adjustment needed for mild to moderate renal impairment. Use with caution in severe impairment (CrCl <15 mL/min).
How to Take
Oral. Take tablets twice daily, with meals.
Mechanism of Action
Ivabradine selectively and specifically inhibits the If current in the cardiac sinoatrial node, leading to heart rate reduction without affecting myocardial contractility, conduction, or blood pressure.
Pharmacokinetics
Onset
Heart rate reduction seen within 1 hour.
Excretion
Primarily via feces and urine as metabolites.
Half life
Effective half-life of approximately 6 hours, apparent half-life approximately 11 hours.
Absorption
Rapidly absorbed. Peak plasma concentration within 1 hour. Bioavailability approximately 40%.
Metabolism
Extensively metabolized in the liver and gut via CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to ivabradine.
- Resting heart rate below 60 bpm before treatment.
- Cardiogenic shock.
- Sick sinus syndrome, SA block, 3rd-degree AV block.
- Pacemaker dependence.
- Unstable angina.
- Severe hypotension.
- Severe hepatic impairment.
- Pregnancy and lactation.
- Concomitant use with strong CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone).
Drug Interactions
CYP3A4 inducers
May decrease ivabradine levels (e.g., rifampicin, phenytoin, phenobarbital, St. John's Wort).
QT-prolonging drugs
Increased risk of QT prolongation (e.g., quinidine, disopyramide, sotalol, pentamidine, cisapride, IV erythromycin).
Strong CYP3A4 inhibitors
Contraindicated (e.g., ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone).
Moderate CYP3A4 inhibitors
Should be avoided (e.g., diltiazem, verapamil, grapefruit juice).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms: Severe bradycardia. Management: Symptomatic treatment, including atropine, beta-adrenergic agents, or temporary cardiac pacing if bradycardia is severe and symptomatic.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception.
Side Effects
Contraindications
- Hypersensitivity to ivabradine.
- Resting heart rate below 60 bpm before treatment.
- Cardiogenic shock.
- Sick sinus syndrome, SA block, 3rd-degree AV block.
- Pacemaker dependence.
- Unstable angina.
- Severe hypotension.
- Severe hepatic impairment.
- Pregnancy and lactation.
- Concomitant use with strong CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone).
Drug Interactions
CYP3A4 inducers
May decrease ivabradine levels (e.g., rifampicin, phenytoin, phenobarbital, St. John's Wort).
QT-prolonging drugs
Increased risk of QT prolongation (e.g., quinidine, disopyramide, sotalol, pentamidine, cisapride, IV erythromycin).
Strong CYP3A4 inhibitors
Contraindicated (e.g., ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone).
Moderate CYP3A4 inhibitors
Should be avoided (e.g., diltiazem, verapamil, grapefruit juice).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms: Severe bradycardia. Management: Symptomatic treatment, including atropine, beta-adrenergic agents, or temporary cardiac pacing if bradycardia is severe and symptomatic.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, Hospitals
Approval Status
DGDA Approved
Patent Status
Expired/Generic available
Clinical Trials
Numerous clinical trials, such as BEAUTIFUL, SIGNIFY (for angina), and SHIFT (for heart failure), have established the efficacy and safety of ivabradine.
Lab Monitoring
- Monitor heart rate regularly.
- Liver function tests may be considered in patients with hepatic impairment.
Doctor Notes
- Monitor heart rate closely before initiation and during treatment. Adjust dose to maintain target heart rate (50-60 bpm).
- Ivabradine is not indicated for acute relief of angina or for patients with unstable angina.
- Contraindicated in patients with atrial fibrillation or other arrhythmias where heart rate is not regulated by the sinus node.
Patient Guidelines
- Take Ivabradine exactly as prescribed by your doctor and do not stop suddenly.
- Report any visual disturbances or symptoms of a very slow heart rate (e.g., dizziness, fainting) to your doctor.
- Avoid grapefruit juice while taking this medicine.
Missed Dose Advice
If a dose is missed, take the next dose at the usual time. Do not take a double dose.
Driving Precautions
May cause temporary visual disturbances (luminous phenomena), especially at the start of treatment. Caution is advised when driving or operating machinery.
Lifestyle Advice
- Maintain a healthy lifestyle, including regular exercise and a balanced diet, as advised by your doctor.
- Avoid smoking and excessive alcohol consumption.
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