Enalapril Maleate Tablets

Generic Name:
Enalapril Maleate Tablets
Therapeutic Category:
Antihypertensive / Heart Failure Therapy / Angiotensin-Converting Enzyme (ACE) Inhibitor
Mechanism of Action:
Enalapril is a prodrug that is bioactivated in the liver to enalaprilat. It competitively inhibits the ACE enzyme, blocking the conversion of Angiotensin I to the potent vasoconstrictor Angiotensin II. This leads to decreased vasopressor activity, reduced aldosterone secretion, and lowered peripheral arterial resistance.

Indications

Dosage & Administration

Contraindications & Precautions

Potential Side Effects

Indications (Therapeutic Uses)

Enalapril Maleate 10 mg is indicated for the management of cardiovascular and renal conditions:

  • Hypertension (High Blood Pressure): Used as monotherapy or in combination with other antihypertensive agents (especially thiazide diuretics) to reduce blood pressure and lower the risk of stroke and myocardial infarction.
  • Symptomatic Heart Failure: Administered alongside diuretics and digitalis to improve survival rates, increase exercise tolerance, and reduce the frequency of hospitalization in patients with heart failure.
  • Asymptomatic Left Ventricular Dysfunction: For clinically stable patients with a left ventricular ejection fraction less than or equal to 35%, it delays the development of symptomatic heart failure and reduces hospitalization risk.

Dosage & Administration

Website Note: Dosage must be individualized by a registered medical practitioner based on the patient’s therapeutic response, renal function, and concurrent use of diuretics.

  • Standard Dose:
    • Hypertension: The initial dose is typically 5 mg once daily. The maintenance dose is commonly 10 mg to 20 mg taken orally once daily, adjusted based on blood pressure response.
    • Heart Failure / Left Ventricular Dysfunction: The initial dose is usually 2.5 mg once daily. The dose is titrated upward gradually over several weeks to a target maintenance dose of 10 mg twice daily.
  • Administration: Tablets must be swallowed whole with water. They can be taken with or without food.
  • First-Dose Hypotension Caution: In patients concurrently taking diuretics or those who are severely volume/salt depleted, the initial dose may cause a sharp drop in blood pressure. The first dose should ideally be administered under medical supervision.
  • Renal Impairment Modification: Dosage reduction or extended dosing intervals are required for patients with a creatinine clearance less than 30 mL/min, as enalaprilat is primarily eliminated by the kidneys.

Contraindications & Precautions

  • Absolute Contraindications: Do not use in patients with a history of angioedema (swelling of the face, lips, tongue, or airway) related to previous treatment with an ACE inhibitor, or hereditary/idiopathic angioedema. Co-administration with aliskiren is strictly contraindicated in patients with diabetes. Do not use within 36 hours of switching to or from a neprilysin inhibitor (e.g., sacubitril/valsartan).
  • Pregnancy Warning (Black Box Warning): Do not use during pregnancy. ACE inhibitors can cause serious injury, developmental abnormalities, or death to the developing fetus when administered during the second and third trimesters. If pregnancy is detected, discontinue enalapril immediately.
  • Angioedema Risk: Can cause life-threatening angioedema. If swelling of the face, extremities, eyes, lips, or tongue occurs, or if difficulty breathing develops, the patient must stop taking the medication and seek emergency medical care.
  • Hyperkalemia (High Potassium Levels): Elevated serum potassium can occur, especially in patients with renal impairment, diabetes mellitus, or those taking potassium-sparing diuretics or potassium supplements. Regular monitoring of serum electrolytes is advised.
  • Persistent Dry Cough: A benign, non-productive, drug-induced dry cough frequently develops due to the accumulation of bradykinin in the respiratory tract. It typically resolves only after discontinuing the medication.

Potential Side Effects

  • Common / Mild: Persistent dry cough, dizziness, headache, orthostatic hypotension (dizziness upon standing), fatigue, nausea, and diarrhea.
  • Less Common / Severe: Severe hypotension, angioedema, neutropenia or agranulocytosis (severe drop in white blood cell count), acute kidney failure (particularly in patients with bilateral renal artery stenosis), and hepatotoxicity (cholestatic jaundice progressing to hepatic necrosis).
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