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 75 mg tablet | ৳ 35.15 | ৳ 351.50 |
Description
Overview of the medicine
Ivaten 7.5 mg Tablet contains Ivabradine, a medication used to treat symptomatic stable angina pectoris and chronic heart failure. It works by reducing the heart rate without affecting blood pressure or contractility.
Uses & Indications
Dosage
Adults
Initial dose is 5 mg twice daily. After 3-4 weeks, if heart rate remains >60 bpm, the dose may be increased to 7.5 mg twice daily. The maximum dose is 7.5 mg twice daily.
Elderly
For patients >75 years, consider a lower starting dose of 2.5 mg twice daily, then titrate as needed.
Renal_impairment
No dose adjustment is needed for mild to moderate renal impairment. Not recommended for severe renal impairment (creatinine clearance < 15 mL/min).
How to Take
Take orally, twice daily, with meals.
Mechanism of Action
Ivabradine selectively inhibits the If current in the cardiac sinoatrial node, which controls the spontaneous diastolic depolarization in the sinoatrial node and regulates heart rate. This leads to a dose-dependent reduction in heart rate.
Pharmacokinetics
Onset
Within 1 hour after oral administration.
Excretion
Excretion occurs mainly via feces (approximately 85%) and urine (approximately 15%).
Half life
Effective half-life of 6 hours, terminal half-life of approximately 11 hours.
Absorption
Rapid and almost complete oral absorption. Extensive first-pass metabolism. Absolute bioavailability is approximately 40%.
Metabolism
Primarily metabolized in the liver and intestines via cytochrome P450 3A4 (CYP3A4).
Side Effects
Contraindications
- Hypersensitivity to ivabradine or any excipients.
- Resting heart rate < 60 bpm before treatment.
- Cardiogenic shock.
- Acute myocardial infarction.
- Severe hypotension (blood pressure < 90/50 mmHg).
- Severe hepatic impairment.
- Sick sinus syndrome, sinoatrial block, 3rd-degree AV block or pacemaker dependence.
- Unstable angina.
- Pregnancy and lactation.
- Concomitant use with strong CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone).
Drug Interactions
Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil)
Concomitant use is contraindicated due to an increased risk of excessive bradycardia.
CYP3A4 inducers (e.g., rifampicin, barbiturates, phenytoin, St. John's Wort)
May decrease ivabradine exposure and reduce its efficacy.
QT-prolonging drugs (e.g., quinidine, disopyramide, sotalol, amiodarone, cisapride, pimozide, ziprasidone)
Caution advised as ivabradine may potentiate QT prolongation.
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, nefazodone)
Concomitant use is contraindicated as it significantly increases ivabradine exposure.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe and prolonged bradycardia. Management should be symptomatic and supportive, including close monitoring of cardiac function. Intravenous beta-agonists or temporary cardiac pacing may be necessary in severe cases.
Pregnancy & Lactation
Contraindicated during pregnancy due to potential fetal toxicity. Also contraindicated during breastfeeding as ivabradine is excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to ivabradine or any excipients.
- Resting heart rate < 60 bpm before treatment.
- Cardiogenic shock.
- Acute myocardial infarction.
- Severe hypotension (blood pressure < 90/50 mmHg).
- Severe hepatic impairment.
- Sick sinus syndrome, sinoatrial block, 3rd-degree AV block or pacemaker dependence.
- Unstable angina.
- Pregnancy and lactation.
- Concomitant use with strong CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone).
Drug Interactions
Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil)
Concomitant use is contraindicated due to an increased risk of excessive bradycardia.
CYP3A4 inducers (e.g., rifampicin, barbiturates, phenytoin, St. John's Wort)
May decrease ivabradine exposure and reduce its efficacy.
QT-prolonging drugs (e.g., quinidine, disopyramide, sotalol, amiodarone, cisapride, pimozide, ziprasidone)
Caution advised as ivabradine may potentiate QT prolongation.
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, nefazodone)
Concomitant use is contraindicated as it significantly increases ivabradine exposure.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe and prolonged bradycardia. Management should be symptomatic and supportive, including close monitoring of cardiac function. Intravenous beta-agonists or temporary cardiac pacing may be necessary in severe cases.
Pregnancy & Lactation
Contraindicated during pregnancy due to potential fetal toxicity. Also contraindicated during breastfeeding as ivabradine is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date
Availability
Pharmacies, hospitals
Approval Status
DGDA Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Ivabradine's efficacy and safety have been demonstrated in large-scale clinical trials such as SIGNIFY (Stable Angina) and SHIFT (Heart Failure), which showed significant reductions in cardiovascular events in specific patient populations.
Lab Monitoring
- Regular heart rate monitoring
- Electrocardiogram (ECG) monitoring
- Blood pressure monitoring
Doctor Notes
- Carefully assess patient's heart rate before initiating and during therapy.
- Avoid concomitant use with strong CYP3A4 inhibitors and moderate CYP3A4 inhibitors (diltiazem, verapamil).
- Educate patients about potential visual disturbances and the importance of reporting them.
Patient Guidelines
- Take the medicine regularly as prescribed, with meals.
- Do not stop treatment abruptly without consulting your doctor.
- Report any visual disturbances, severe bradycardia (slow heart rate), or symptoms of atrial fibrillation (e.g., rapid, irregular heartbeat) to your doctor immediately.
Missed Dose Advice
If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a missed one.
Driving Precautions
Ivabradine may cause luminous phenomena or dizziness, which could impair your ability to drive or operate machinery. Exercise caution until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy lifestyle, including regular exercise (as advised by your doctor) and a balanced diet.
- Avoid smoking and excessive alcohol consumption.
- Monitor your heart rate regularly as instructed by your healthcare provider.
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