Ivacard
Generic Name
Ivabradine
Manufacturer
ACI Pharmaceuticals Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ivacard 75 mg tablet | ৳ 35.00 | ৳ 350.00 |
Description
Overview of the medicine
Ivacard contains Ivabradine, a medication used to treat symptomatic stable chronic angina pectoris and chronic heart failure. It works by specifically reducing the heart rate without affecting blood pressure.
Uses & Indications
Dosage
Adults
Initial dosage is typically 5 mg twice daily. After 3-4 weeks, dosage may be adjusted to 7.5 mg twice daily based on heart rate and symptom control. Maximum dose is 7.5 mg twice daily. For heart failure, initial dose is 5 mg twice daily, and after two weeks, if resting heart rate is consistently between 50-60 bpm, dose can be maintained or reduced to 2.5 mg twice daily. If heart rate is >60 bpm, dose can be increased to 7.5 mg twice daily. If heart rate is <50 bpm or symptoms of bradycardia, reduce to 2.5 mg twice daily or stop if bradycardia persists.
Elderly
(Over 75 years) Initial dosage of 2.5 mg twice daily is recommended, then titrated upwards if necessary, based on heart rate and symptoms.
Renal_impairment
No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance > 15 mL/min). Use with caution and consider a lower starting dose in severe renal impairment (CrCl < 15 mL/min).
How to Take
Take orally, twice daily (morning and evening), with meals.
Mechanism of Action
Ivabradine acts by selectively and specifically inhibiting the cardiac pacemaker If current (funny current) in the sinoatrial node. This inhibition reduces the slope of the diastolic depolarization, thereby slowing the heart rate.
Pharmacokinetics
Onset
Heart rate reduction typically begins within 1 hour of administration.
Excretion
Excreted primarily via feces (approximately 70%) and urine (approximately 20%) as metabolites.
Half life
The terminal half-life of Ivabradine is approximately 11 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations are reached in about 1 hour. Extensive first-pass metabolism results in absolute oral bioavailability of about 40%. Food delays absorption by approximately 1 hour and increases exposure by 20-40%.
Metabolism
Extensively metabolized in the liver and gut via cytochrome P450 3A4 (CYP3A4). The main active metabolite is N-demethylated derivative.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Resting heart rate below 70 beats per minute before treatment.
- Cardiogenic shock, acute myocardial infarction.
- Severe hypotension (< 90/50 mmHg).
- Severe hepatic impairment.
- Sick sinus syndrome, sinoatrial block, or 3rd degree atrioventricular block.
- Pacemaker dependence.
- Unstable angina.
- Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, diltiazem, verapamil).
- Pregnancy and lactation.
- Women of childbearing potential not using appropriate contraceptive measures.
Drug Interactions
Diuretics (e.g., thiazide diuretics and loop diuretics)
Concomitant use may increase the risk of bradycardia.
Moderate CYP3A4 inhibitors (e.g., fluconazole, grapefruit juice)
Should be used with caution, dose adjustment may be necessary or avoided if possible.
CYP3A4 inducers (e.g., rifampicin, barbiturates, phenytoin, St. John's wort)
May significantly decrease Ivabradine exposure, leading to reduced efficacy. Concomitant use should be avoided.
QT-prolonging medicinal products (e.g., quinidine, disopyramide, sotalol, amiodarone, pimozide, ziprasidone)
Caution advised as Ivabradine has not been studied with these drugs, and QT prolongation may occur.
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, diltiazem, verapamil)
Concomitant use is contraindicated as they significantly increase Ivabradine plasma levels and can lead to excessive bradycardia.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to severe and prolonged bradycardia. Management should be symptomatic and supportive, including beta-adrenergic agonists for bradycardia or temporary cardiac pacing if severe and unresponsive to drugs.
Pregnancy & Lactation
Ivacard is 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 3 years from the date of manufacture.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Patent expired for generic Ivabradine, but specific brands might have regional patents.
Clinical Trials
Key clinical trials for Ivabradine include SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) and SIGNIFY (Study assessing the morbidity-mortality benefits of the If inhibitor ivabradine in patients with coronary artery disease).
Lab Monitoring
- Regular monitoring of heart rate (including ECG) is recommended, especially during dose titration. Blood pressure should also be monitored.
Doctor Notes
- Carefully assess resting heart rate before initiating treatment and during dose titration.
- Avoid concomitant use with strong CYP3A4 inhibitors and inducers.
- Regularly monitor for symptoms of bradycardia and visual disturbances.
Patient Guidelines
- Take Ivacard exactly as prescribed by your doctor, do not exceed the recommended dose.
- Take the tablet twice daily, once in the morning and once in the evening, with meals.
- Do not stop taking Ivacard suddenly without consulting your doctor, as this may worsen your condition.
- Report any visual disturbances (like bright spots or halos) or symptoms of very slow heart rate (dizziness, fatigue) to your doctor immediately.
Missed Dose Advice
If you miss a dose, do not take a double dose to make up for it. Just take your next dose at the usual time.
Driving Precautions
Ivacard may cause transient luminous phenomena (phosphenes) or dizziness, which can impair your ability to drive or operate machinery. Exercise caution, especially at night or when vision changes occur.
Lifestyle Advice
- Maintain a healthy lifestyle, including a balanced diet and regular physical activity, as recommended by your doctor.
- Avoid smoking and limit alcohol consumption.
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Global Brand Names
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