In the pharmaceutical industry, Diltiazem Hydrochloride 60 mg is a benzothiazepine-class Calcium Channel Blocker (CCB). As a pharmacist, I classify this as a “Non-Dihydropyridine” CCB, which is technically significant because unlike Amlodipine (which mainly affects blood vessels), Diltiazem has a balanced effect on both the coronary arteries and the heart’s conduction system.
Primary Clinical Uses
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Angina Pectoris: Used for the chronic management of stable angina (chest pain) and vasospastic (Prinzmetal’s) angina by increasing oxygen delivery to the heart muscle.
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Hypertension: Used as a standalone or adjunctive therapy to lower blood pressure, particularly in patients who cannot tolerate beta-blockers.
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Atrial Fibrillation and Flutter: Utilized to control the ventricular heart rate in patients with supraventricular tachyarrhythmias.
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Raynaud’s Phenomenon: Occasionally used off-label to improve peripheral circulation and reduce the frequency of vasospasms in the fingers and toes.Mechanism of Action
Diltiazem works by inhibiting the influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle.
Coronary Vasodilation: It relaxes the smooth muscles of the coronary arteries, increasing blood flow and oxygen to the myocardium.
Peripheral Vasodilation: It reduces peripheral vascular resistance, which lowers systemic blood pressure.
Negative Chronotropic/Dromotropic Effects: It slows the conduction through the Atrioventricular (AV) node and decreases the heart rate, reducing the workload on the heart.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Diltiazem 60 mg is a precision cardiovascular product:
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Immediate vs. Extended Release: The 60 mg tablet is typically the Immediate Release (IR) version, often dosed three to four times daily. As a WHO-GMP manufacturer, we ensure the dissolution profile is tightly controlled to avoid “dose dumping.”
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API Stability: Diltiazem is sensitive to moisture and light. We utilize Alu-Alu blister packaging to ensure a stable 36-month shelf life, which is a critical requirement for export to Zone IVb regions (hot and humid climates).
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Bioequivalence: We maintain rigorous standards to ensure our generic version matches the innovator (Cardizem) in plasma concentration levels.
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Global Regulatory Support: Our Mumbai facility provides full CTD/eCTD Dossiers and stability data to facilitate rapid registration for international B2B partners and government tenders.