Enalapril Maleate

What it is and how it works

Mechanism of Action Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion.

Indications

INDICATIONS AND USAGE Hypertension Enalapril maleate tablets are indicated for the treatment of hypertension. Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive. Heart Failure Enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets improve symptoms, increase survival, and decrease the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials).

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Hypertension In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate tablets. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with enalapril maleate tablets to reduce the likelihood of hypotension (see WARNINGS, Hypotension ). If the patient's blood pressure is not controlled with enalapril maleate tablets alone, diuretic therapy may be resumed.

Contraindications

CONTRAINDICATIONS Enalapril maleate tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Do not coadminister aliskiren with enalapril maleate tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions ).

Warnings and precautions

WARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including enalapril maleate tablets) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors, including enalapril maleate tablets.

Storage and supply

HOW SUPPLIED 10 mg (with desiccant) Red, rounded triangle shaped scored tablet debossed with “S 7” on one side and scored on the other side. NDC 68071-3537-3 BOTTLES OF 30 Storage Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15° to 30°C (59° to 86°F) . Keep container tightly closed. Protect from moisture.

Source: Enalapril Maleate (Enalapril Maleate) — US FDA prescribing information, 2025-02-03, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.