Description

Amlodipine & Hydrochlorothiazide Tablets (5 mg / 12.5 mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiology, nephrology, and targeted cardiovascular therapeutics. We provide ultra-high-purity, kinetically balanced Amlodipine & Hydrochlorothiazide FDC Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Calcium Channel Blocker (CCB) & Thiazide Diuretic FDC” is a massive-volume strategic export to hypertension clinics, general hospitals, and government health ministries, serving as the globally preferred intervention for Essential Hypertension that is not adequately controlled by monotherapy.

Product Overview

This formulation operates as a “Dual-Front Hemodynamic System.” It addresses the two primary physical causes of high blood pressure: constricted arteries and excessive salt/water retention.

  • Mechanism 1 (The Vessel Relaxant – Amlodipine): As a Dihydropyridine Calcium Channel Blocker, Amlodipine inhibits the influx of calcium ions into vascular smooth muscle. This physically relaxes the arteries (Vasodilation), lowering peripheral resistance and making it easier for the heart to pump.

  • Mechanism 2 (The Fluid Controller – Hydrochlorothiazide): HCTZ is a Thiazide Diuretic that acts on the Distal Convoluted Tubules of the kidney. It inhibits sodium reabsorption, causing the body to excrete more salt and water. This reduces the total volume of blood circulating in the system, naturally lowering pressure.

  • Mechanism 3 (The Edema Offset): Amlodipine monotherapy can sometimes cause ankle swelling (Edema) due to localized pressure changes. The addition of HCTZ helps pull excess fluid from the tissues back into the circulation to be excreted, significantly improving patient comfort and compliance.


Product Composition & Strength

We supply this product as a Precision-Blended, Film-Coated Tablet, engineered for synchronized 24-hour hemodynamic control.

Active IngredientStrengthPrimary Clinical Function
Amlodipine (as Besylate) USP/BP5 mg / 10 mgThe Vasodilator: Reduces the resistance of blood vessels to lower systemic pressure.
Hydrochlorothiazide USP/BP12.5 mg / 25 mgThe Volume Reducer: Excretes excess sodium and water to reduce circulatory load.
ExcipientsProprietary MatrixSteady-State System: Engineered to ensure consistent plasma concentrations of both drugs to prevent “dips” in BP control.

Technical & Logistics Specifications

  • HS Code: 3004.90.69 (Medicaments containing other active substances – Cardiovascular)

  • CAS Numbers: 88150-42-9 (Amlodipine) / 58-93-5 (Hydrochlorothiazide)

  • Dosage Form: Film-Coated Tablet

  • Packaging: Alu-Alu or Alu-PVC Blisters. Requires protection from environmental light and humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.


Manufacturing Authority & Compliance

  • Content Uniformity Excellence: Our facility utilizes High-Shear Mixing to ensure the 5 mg Amlodipine and 12.5 mg HCTZ are distributed with 100% uniformity, critical for maintaining stable blood pressure.

  • Nitrosamine-Free Synthesis: We utilize high-purity APIs that meet the latest global safety standards (EDQM/FDA), ensuring maximum safety for patients requiring lifetime hypertensive therapy.

Primary Indications

  • Cardiology: Treatment of Stage II Hypertension (High Blood Pressure).

  • Nephrology: Management of hypertension in patients with mild renal impairment (under specialist supervision).

  • Preventative: Reducing the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

Dosage & Administration

  • Standard Adult Dosing: 1 tablet once daily, preferably in the morning to prevent nighttime urination (Nocturia) from the diuretic.

  • Administration: Can be taken with or without food.

Safety Warning: Monitor for Electrolyte Imbalance (Low Potassium/Sodium). Use with caution in patients with severe renal or hepatic impairment. Strictly contraindicated in patients with Anuria (inability to produce urine) or sulfonamide-derived drug allergies.


Global Export & Contract Manufacturing

Healthy Inc is a premier Cardiovascular Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for essential Hypertension FDCs. Whether you are a Public Health Tender Buyer in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.

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