Description

Nebivolol & Hydrochlorothiazide (HCTZ) Film-Coated Tablets (5mg/12.5mg & 5mg/25mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, anti-hypertensive, and diuretic therapeutics. We provide ultra-high-purity, kinetically synchronized Nebivolol Hydrochloride & Hydrochlorothiazide Film-Coated Tablets (5mg/12.5mg & 5mg/25mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Nitric Oxide-Donating Beta-Blocker & Diuretic Synergy” is a highly lucrative, massive-volume export to cardiology centers, internal medicine 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 Essential Hypertension complicated by volume overload.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes an elite, third-generation beta-blocker with a classic thiazide diuretic. It delivers profound, dual-pathway blood pressure reduction while aggressively protecting the patient’s peripheral circulation and quality of life.

The “Volume-Depleting & Hemodynamic” Specialist:

• Mechanism 1 (The Diuretic Volume Controller – HCTZ): Hydrochlorothiazide acts directly on the distal convoluted tubules of the kidneys. It aggressively blocks the reabsorption of sodium and chloride, forcing the kidneys to flush excess salt and water out of the body through urine. This physically reduces the total volume of fluid circulating in the cardiovascular system, massively dropping the pressure against the arterial walls.
• Mechanism 2 (The NO-Donating Cardiac Shield – Nebivolol): While HCTZ reduces the fluid volume, Nebivolol specifically targets the Beta-1 receptors in the heart, slowing the resting heart rate and shielding the myocardium from adrenaline spikes. Simultaneously, it stimulates the release of Nitric Oxide (NO) in the blood vessels, forcing the arteries to actively dilate and relax.
• The Synergistic “ED-Sparing” Rescue: Diuretics heavily activate the body’s sympathetic nervous system (causing reflex racing heart) and constrict blood vessels, which is why older beta-blocker/diuretic combos cause severe Erectile Dysfunction (ED) and cold extremities. Nebivolol completely neutralizes these side effects. It stops the reflex tachycardia and uses Nitric Oxide to force blood into the extremities and reproductive organs, creating an exceptionally powerful, highly compliant antihypertensive therapy.

Product Composition & Strength

We supply this product as a Precision-Blended, Dual-Active Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu or high-density PVC/PVDC blister strips to ensure the absolute chemical stability of the active ingredients.

*Pack Sizes: 10×10 Blisters or 28/30-Tablet Calendar Packs (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.

• Micro-Dose Uniformity & Moisture-Barrier Engineering: Combining a low-dose, highly potent racemic mixture (5 mg Nebivolol) with a higher-dose diuretic requires elite pharmaceutical blending. Our facilities utilize advanced high-shear wet granulation and strict geometric dilution protocols to ensure that neither API segregates during compression. This guarantees that every single tablet delivers flawless, identical dual-action hemodynamics, completely avoiding the risk of sudden hypotension caused by batch variance.

Therapeutic Indications (Human Use)

Indicated for the comprehensive, step-up management of severe cardiovascular disease:

• Essential Hypertension: Treatment of high blood pressure, specifically indicated as substitution therapy for patients whose blood pressure is already adequately controlled on Nebivolol and HCTZ given concurrently, or for those failing Nebivolol monotherapy who require a volume-depleting adjunct.
• Note: This potent combination is not indicated for initial therapy (first-line) of hypertension.

Dosage & Administration

Recommended Dosage (Strictly as per Cardiologist Guidelines):

• Standard Adult Dosing: One tablet (e.g., 5mg/12.5mg) taken orally once daily.
• Administration (THE MORNING DIURETIC RULE – CRITICAL): Because HCTZ forces the body to rapidly excrete urine, this medication MUST be taken in the morning. Taking it at night will cause severe nocturia (waking up multiple times to urinate), destroying the patient’s sleep architecture and leading to immediate therapy abandonment.
• Abrupt Cessation Warning: Therapy MUST NOT be stopped abruptly due to the risk of severe rebound tachycardia and myocardial infarction.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Severe Hypokalemia & Electrolyte Imbalance: HCTZ forcefully flushes potassium and magnesium out of the body. Severe hypokalemia can trigger fatal, chaotic cardiac arrhythmias. Patients must have their serum electrolytes monitored and may require dietary potassium supplementation.
• BLACK BOX WARNING (Abrupt Cessation): Sudden discontinuation of beta-blockers can cause severe exacerbation of angina and dangerous ventricular arrhythmias. The dose must be tapered over 1 to 2 weeks.
• Hyperuricemia & Acute Gout: Thiazide diuretics reduce the clearance of uric acid by the kidneys. This can cause massive spikes in blood uric acid levels, potentially triggering agonizing, acute gout attacks in susceptible patients.
• 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.

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 Diuretic FDC Formulations. Whether you are looking for a reliable Government Tender Supplier for hypertension clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.