In the pharmaceutical industry, Enalapril Maleate 2.5 mg is a potent, long-acting ACE (Angiotensin-Converting Enzyme) inhibitor. As a pharmacist, I characterize the 2.5 mg strength as the critical “initiation dose,” specifically used to prevent first-dose hypotension in high-risk patients or as a maintenance dose for pediatric populations and those with renal impairment.

Primary Clinical Uses

• Hypertension Initiation: Used as the starting dose for treating high blood pressure, especially in patients also taking diuretics, to allow the body to adjust to the medication.

• Heart Failure (Early Stage): Indicated for the management of symptomatic heart failure, usually in combination with diuretics and digitalis.

• Left Ventricular Dysfunction: Prescribed for asymptomatic patients with a reduced ejection fraction ($LVEF < 35\%$) to improve survival and reduce the rate of hospitalization.

• Diabetic Nephropathy: Frequently used off-label at low doses to protect kidney function in diabetic patients by reducing intraglomerular pressure.

• Pediatric Hypertension: A standard dose for children where weight-based titration is required.

Mechanism of Action

Enalapril is a prodrug that is bioactivated in the liver to its active metabolite, Enalaprilat.

Enzyme Inhibition: It inhibits the ACE enzyme, which is responsible for converting Angiotensin I to Angiotensin II (a potent vasoconstrictor).

Vasodilation: By reducing Angiotensin II levels, it promotes systemic vasodilation, thereby lowering peripheral vascular resistance.

Aldosterone Reduction: It also reduces the secretion of aldosterone, leading to decreased sodium and water retention, which further lowers blood pressure and eases the workload on the heart.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Enalapril 2.5 mg is a high-precision cardiovascular product:

• Micro-Dose Content Uniformity: Since 2.5 mg is a small amount of active ingredient per tablet, as a WHO-GMP manufacturer, we utilize validated wet granulation or direct compression with high-precision blending to ensure the API is perfectly distributed.

• Stability for Global Trade: Enalapril Maleate is susceptible to hydrolysis and cyclization (forming a diketopiperazine impurity). We utilize Alu-Alu blister packaging or desiccants in HDPE bottles to ensure a 36-month shelf life in Zone IVb (hot/humid) climates.

• Dossier Support: We provide comprehensive CTD/eCTD Dossiers and bioequivalence data against the innovator (Vasotec/Renitec) to support our B2B partners in international registration.

• Market Positioning: This “low-strength” SKU is essential for hospital tenders and cardiology clinics where precise titration is a clinical requirement.