Description

Ivabradine Hydrochloride Film-Coated Tablets (5 mg / 7.5 mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, electrophysiology, and heart-failure therapeutics. We provide ultra-high-purity, kinetically precise Ivabradine Hydrochloride Film-Coated Tablets (5 mg / 7.5 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Selective SA Node If-Channel Inhibitor” is a massive-volume, highly lucrative export to cardiology centers, heart failure clinics, specialized geriatric networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for Chronic Heart Failure (HFrEF) and Chronic Stable Angina Pectoris in patients who cannot tolerate beta-blockers.

Product Overview

This highly advanced formulation operates as a pure electrical governor for the human heart. It specifically slows the cardiac pacemaker without altering the physical strength of the heart muscle or constricting the blood vessels, providing a massive clinical lifeline to patients with severely compromised cardiovascular systems.

The “SA Node Pacemaker & Contractility Sparing” Specialist:

• Mechanism 1 (The Selective I_f Channel Blockade): The heart’s electrical rhythm is controlled by the sinoatrial (SA) node, driven by a specific electrical current known as the “funny” current (I_f). Ivabradine aggressively and exclusively binds to these specific channels from the inside of the cell. By restricting this current, it drastically slows down the spontaneous electrical firing of the pacemaker, smoothly lowering the resting heart rate.
• Mechanism 2 (The Contractility & Blood Pressure Sparing Effect): This is Ivabradine’s absolute clinical superpower. Unlike beta-blockers or calcium channel blockers, Ivabradine does not affect myocardial contractility (the squeeze of the heart) or ventricular repolarization, and it does not drop blood pressure. The heart beats slower, allowing more time for the ventricles to fill with blood (diastole), vastly improving cardiac output without weakening a heart that is already failing.
• The Heart Failure Lifeline: In patients with Chronic Heart Failure with reduced Ejection Fraction (HFrEF), a high resting heart rate is a primary predictor of death. Adding Ivabradine to standard therapy rapidly crashes the heart rate to the optimal 50-60 bpm range, massively reducing cardiovascular mortality and keeping patients out of the hospital.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly hygroscopic hydrochloride salt.

*Pack Sizes: 10×10 Blisters or Bottles of 56 (Optimized specifically for strict 28-day chronic cardiology dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Cardiology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Micro-Dose Content Uniformity & Titration Engineering (CRITICAL COMPLIANCE): The clinical safety of Ivabradine relies 100% on extreme dosage accuracy. If a generic manufacturer fails to achieve Content Uniformity, a 7.5mg tablet might accidentally contain 9mg, instantly plunging the patient into fatal bradycardia (heart stoppage). Our specialized cardiology suites utilize high-shear dry blending and multi-stage geometric dilution to guarantee Relative Standard Deviations (RSD) below 3%. We deliver absolute, hospital-grade precision to the international market.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of severe cardiovascular disease:

• Chronic Heart Failure (HFrEF): To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure, a left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with a resting heart rate ≥ 70 bpm.
• Chronic Stable Angina Pectoris: Symptomatic treatment in adults with normal sinus rhythm who cannot tolerate or have a contraindication to beta-blockers, or in combination with beta-blockers.

Dosage & Administration

Recommended Dosage (Strictly as per Cardiologist Guidelines):

• Standard Adult Dosing: Initially 5 mg taken twice daily. After 2 to 4 weeks, the dose is assessed based on the resting heart rate and titrated to 7.5 mg twice daily.
• Administration (The Mealtime Rule): Tablets MUST be taken during meals (morning and evening). Food drastically increases the absorption and ensures steady-state plasma concentrations, preventing sudden cardiac drops.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Fetal Toxicity (Absolute Contraindication): FATAL WARNING: Ivabradine can cause severe embryo-fetal toxicity and cardiac birth defects. It is strictly contraindicated in pregnancy, and highly effective contraception must be utilized by women of childbearing age during therapy.
• Luminous Phenomena (Phosphenes): A highly unique side effect. Because Ivabradine also slightly blocks the I_h current in the retina, over 15% of patients experience transient, enhanced brightness in their visual field (phosphenes). Patients must be warned about sudden visual flashes, especially when driving at night.
• Atrial Fibrillation (A-Fib) Risk: While it slows the SA node, Ivabradine paradoxically increases the risk of the heart slipping into Atrial Fibrillation. Regular ECG monitoring is mandatory. If A-Fib develops, the drug must be discontinued immediately.
• Severe Bradycardia: Therapy must be halted if the resting heart rate drops below 50 bpm or if the patient experiences severe dizziness, fatigue, or hypotension.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Cardiology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Cardiovascular, Heart Failure, and Micro-Dosed Formulations. Whether you are looking for a reliable Government Tender Supplier for cardiac step-down units in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.