Description

Ranolazine Extended-Release (ER) Tablets (500 mg / 1000 mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, ischemic, and critical-care therapeutics. We provide ultra-high-purity, kinetically controlled Ranolazine Extended-Release Film-Coated Tablets (500 mg / 1000 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Late Sodium Current Inhibitor” is a highly lucrative, premium export to cardiology centers, specialized ischemia clinics, retail pharmacy networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, hemodynamic-sparing intervention for the treatment of refractory chronic angina.

Product Overview

This highly advanced Extended-Release formulation utilizes a sophisticated structural matrix to continuously feed a powerful, novel anti-ischemic agent into the bloodstream, protecting the heart muscle from oxygen starvation without causing extreme fatigue or dizziness.

The “Hemodynamic-Sparing Anti-Anginal” Specialist:

• Mechanism 1 (The Late Sodium Channel Blockade): In a heart suffering from chronic ischemia (lack of oxygen), the cardiac cells struggle to close their sodium channels. This allows toxic levels of sodium to rush in, which in turn drags massive amounts of calcium into the cell. This calcium overload forces the heart muscle to stay physically stiff and tense, choking off its own blood supply. Ranolazine acts as a highly selective chemical shield. It directly inhibits this “late inward sodium current.”
• Mechanism 2 (Relieving Diastolic Wall Tension): By blocking the sodium, Ranolazine prevents the deadly calcium overload. This allows the stiff, ischemic heart muscle to finally relax during its resting phase (diastole), vastly improving blood flow and oxygen delivery to the deep tissues of the heart wall, completely stopping the angina chest pain.
• The “Zero-Drop” Hemodynamic Advantage: Standard angina drugs (beta-blockers, nitrates, diltiazem) lower blood pressure and heart rate, which limits their use in patients who already have low blood pressure or severe fatigue. Ranolazine exerts its profound anti-anginal effects without significantly reducing heart rate or blood pressure, making it the supreme add-on therapy for patients whose lives are limited by chest pain.

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.

• Hydrophilic Matrix Swelling Engineering: Manufacturing a massive 500 mg or 1000 mg 12-hour ER tablet is highly complex. Our facilities utilize advanced high-viscosity Hypromellose (HPMC) and methacrylic blending. When the patient swallows the tablet, the gastrointestinal fluids interact with the polymers, instantly forming a thick, gelatinous outer barrier. This gel barrier precisely controls the rate at which water enters the tablet and the rate at which the highly soluble Ranolazine diffuses out, guaranteeing identical, sustained pharmacokinetic release in every single batch.

Therapeutic Indications (Human Use)

Indicated for the targeted management of severe cardiovascular ischemia:

• Chronic Angina: Treatment of chronic angina. It may be used as monotherapy or in combination with beta-blockers, calcium channel blockers, or nitrates when standard therapies are insufficient or poorly tolerated.

Dosage & Administration

Recommended Dosage (Strictly as per Cardiologist Guidelines):

• Standard Adult Dosing: Initiate at 500 mg twice daily (BID). Based on clinical response and tolerance, the dose may be increased to the maximum recommended dose of 1000 mg twice daily.
• Administration (THE INTACT TABLET RULE): Tablets MUST be swallowed completely whole with water. They must never be chewed, crushed, or divided. Breaking the tablet physically destroys the ER polymer matrix, causing a massive, potentially toxic dose to dump into the patient’s system all at once.
• Food Independence: Can be taken with or without meals.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• QT Prolongation Risk: Ranolazine causes a dose-dependent prolongation of the QT interval on an ECG. It should be avoided in patients with a history of familial long QT syndrome, uncorrected hypokalemia, or those taking other drugs that heavily prolong the QT interval (like Amiodarone, Sotalol, or certain antipsychotics) due to the risk of fatal ventricular arrhythmias (Torsades de Pointes).
• CYP3A4 Drug Interactions (Absolute Contraindication): Ranolazine is heavily metabolized by the CYP3A4 liver enzyme. Co-administration with strong CYP3A4 inhibitors (like Ketoconazole, Clarithromycin, or Ritonavir) will cause massive, toxic accumulation of Ranolazine. It is also contraindicated with CYP3A4 inducers (like Rifampin or Phenytoin), which will completely destroy the drug’s efficacy.
• Diltiazem/Verapamil Interaction: Moderate CYP3A4 inhibitors like Diltiazem and Verapamil (which are also anti-anginals) increase Ranolazine levels. If co-administered, the Ranolazine dose must not exceed 500 mg twice daily.
• Hepatic Impairment: Contraindicated in patients with clinically significant hepatic cirrhosis.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Cardiovascular and Modified-Release Formulations. Whether you are looking for a reliable Hospital Tender Supplier for ischemic heart disease clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Bulk Indenting, ensuring that every Authorized Medicine Wholesaler receives WHO-GMP certified products at competitive rates.