Description

Nebivolol & Telmisartan Bilayer Tablets (2.5mg/40mg & 5mg/40mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, anti-hypertensive, and metabolic-protective therapeutics. We provide ultra-high-purity, kinetically synchronized Nebivolol Hydrochloride & Telmisartan Film-Coated Bilayer Tablets (2.5mg/40mg & 5mg/40mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Metabolically Positive Dual-Action Antihypertensive” is an ultra-high-value, premium export to cardiology centers, specialized metabolic clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, high-compliance intervention for severe Essential Hypertension complicated by Type 2 Diabetes, Obesity, or Metabolic Syndrome.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes the two most physiologically sophisticated molecules in cardiovascular medicine. It delivers profound 24-hour blood pressure control while actively reversing the vascular and metabolic damage caused by chronic hypertension.

The “Metabolic Synergy & Endothelial Healing” Specialist:

• Mechanism 1 (The Long-Acting ARB & PPAR-γ Agonist): Telmisartan is a unique Angiotensin II Receptor Blocker (ARB). Not only does it physically relax the arteries by blocking Angiotensin II, but it boasts the longest half-life of any ARB (24 hours), guaranteeing perfect trough-to-peak control. Furthermore, Telmisartan is the only ARB that acts as a partial PPAR-γ agonist—meaning it actively improves the body’s sensitivity to insulin, lowering blood sugar and reducing diabetic cardiovascular risk.
• Mechanism 2 (The Nitric Oxide Beta-Blocker): Standard beta-blockers severely restrict peripheral blood flow, causing extreme fatigue, icy extremities, and Erectile Dysfunction (ED). Nebivolol completely circumvents this. While it shields the heart by selectively blocking Beta-1 receptors, it actively stimulates the release of Nitric Oxide (NO) in the blood vessels. This forces active vasodilation, guaranteeing rich, oxygenated blood flow to the limbs and reproductive organs.
• The “Executive” Compliance Advantage: When hypertensive patients (especially younger or middle-aged men) are prescribed older drugs, they frequently abandon the therapy due to weight gain, lethargy, and sexual dysfunction. The Nebivolol + Telmisartan FDC is globally recognized as the “premium” choice because it preserves energy, protects sexual function, and improves metabolic markers, resulting in near-perfect patient compliance.

Product Composition & Strength

We supply this product as a Precision-Engineered, API-Segregated Bilayer Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly hygroscopic and pH-sensitive active ingredients.

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict 30-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.

• Alkaline Bilayer Segregation Engineering (CRITICAL COMPLIANCE): Telmisartan is practically insoluble in water. To make it absorbable, it must be formulated with strong alkaline agents like Meglumine and Sodium Hydroxide. However, this hyper-alkaline environment will instantly destroy Nebivolol Hydrochloride. Our facilities utilize advanced, climate-controlled Bilayer Rotary Presses. We physically separate the two APIs into distinct, color-coded layers within the same tablet, ensuring complete chemical isolation during shelf-life and flawless, synchronized dissolution in the stomach.

Therapeutic Indications (Human Use)

Indicated for the comprehensive, metabolically protective management of severe cardiovascular disease:

• Essential Hypertension with Metabolic Comorbidities: Treatment of high blood pressure, specifically indicated as substitution therapy for patients whose blood pressure is adequately controlled on Nebivolol and Telmisartan given concurrently, or for those failing monotherapy who require a metabolically neutral/positive intervention.
• Diabetic Hypertensive Patients: Highly preferred therapy for hypertensive patients suffering from Type 2 Diabetes, insulin resistance, or severe dyslipidemia due to its combined renoprotective and PPAR-γ properties.

Dosage & Administration

Recommended Dosage (Strictly as per Cardiologist Guidelines):

• Standard Adult Dosing: One tablet (e.g., 5mg/40mg) taken orally once daily.
• Administration: Can be taken with or without food. Tablets must be swallowed completely whole with water to preserve the bilayer matrix integrity.
• Abrupt Cessation Warning: Because this FDC contains a beta-blocker, therapy MUST NOT be stopped abruptly. Sudden discontinuation can trigger severe rebound hypertension, angina, or a fatal myocardial infarction. It must be tapered under medical supervision.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Fetal Toxicity): Like all drugs acting directly on the renin-angiotensin system (Telmisartan), this FDC must be discontinued immediately upon detection of pregnancy, as it can cause profound injury and death to the developing fetus.
• Severe Bradycardia & Heart Block: Nebivolol significantly slows the heart. It is strictly contraindicated in patients with severe bradycardia (< 60 bpm), second or third-degree heart block, or cardiogenic shock.
• Hyperkalemia: Telmisartan forces the body to retain potassium. Concurrent use of potassium-sparing diuretics (like Spironolactone) or potassium supplements can lead to fatal cardiac arrhythmias. Renal function and serum electrolytes must be monitored.
• Hypoglycemic Masking: Beta-blockers can mask the physical symptoms of severe low blood sugar (like tremors and rapid heartbeat) in diabetic patients, though Nebivolol’s high Beta-1 selectivity mitigates this risk compared to older agents.

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 and Bilayer FDC Formulations. Whether you are looking for a reliable Private Hospital Supplier for premium cardiology clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.