Europe — EMA
Ivabradin Sandoz
GNH USA supplies Ivabradin Sandoz (Ivabradine), a If channel inhibitor for chronic stable angina and heart failure with reduced EF. Request a quote.
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What is Ivabradine Oxalate?
Ivabradine, the active ingredient in Ivabradin Sandoz, is a If channel inhibitor presented as an oral tablet for oral use. It lowers heart rate and is indicated for chronic stable angina and heart failure with reduced ejection fraction in adult patients. The product is formulated for once‑daily administration and is marketed throughout the European Union.
GNH USA supplies Ivabradin Sandoz as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing regulatory‑approved batches and supporting import documentation for global distribution.
What is Ivabradine Oxalate used for?
Ivabradin Sandoz acts on the cardiac If current to reduce heart rate in specific cardiovascular conditions.
Chronic stable angina: reduces frequency of angina attacks by lowering heart rate. Heart failure with reduced ejection fraction: improves symptoms and may decrease hospitalization by decreasing heart rate. Coronary artery disease with angina symptoms: alleviates chest pain through heart‑rate reduction.
What are the side effects of Ivabradine Oxalate?
Ivabradin Sandoz may cause a range of adverse reactions, which are categorised by frequency and severity.
Common Side Effects: - Bradycardia: resting heart rate falls below 50 bpm, which may cause fatigue or dizziness. - Visual disturbances (phosphenes): transient luminous phenomena, often described as bright spots in the visual field. - Headache: mild to moderate intensity, typically occurring shortly after dose initiation. - Dizziness: sensation of light‑headedness, especially when standing quickly.
Serious or Rare Side Effects: - Severe bradycardia with syncope: profound slowing of heart rate leading to fainting and possible need for emergency care. - Atrial fibrillation: irregular heart rhythm that may increase stroke risk and require cardiology assessment. - Hypotension: symptomatic low blood pressure causing weakness, blurred vision, or collapse.
What precautions apply to Ivabradine Oxalate?
Before prescribing Ivabradin Sandoz, clinicians should consider several precautionary measures to ensure safe use.
- Monitor heart rate: confirm resting heart rate is ≥ 50 bpm before initiation and check regularly during therapy to avoid excessive bradycardia. - Avoid in severe hepatic impairment: reduced metabolism can increase drug exposure and risk of adverse events. - Use caution with concomitant CYP3A4 inhibitors: these agents may raise plasma concentrations and require closer monitoring. - Assess for sick sinus syndrome: the drug is contraindicated in patients with this intrinsic rhythm disorder. - Store at ambient temperature below 25 °C: keep in the original packaging, protect from moisture and direct sunlight.
What does Ivabradine Oxalate interact with?
Ivabradin Sandoz can interact with other medicines, some of which require avoidance and others close monitoring.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may cause excessive bradycardia by increasing ivabradine levels. - Other heart‑rate lowering agents (beta‑blockers, digoxin, verapamil) without dose adjustment: risk of severe bradycardia. - Concomitant use with verapamil (a CYP3A4 inhibitor) together with ivabradine: markedly increased exposure, should be avoided.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may elevate ivabradine concentrations; monitor heart rate. - Drugs that prolong the QT interval (e.g., sotalol, amiodarone): combined effect may increase arrhythmia risk; ECG monitoring recommended.
Frequently asked questions
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Product details
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