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Brand Names: Renitec, Vaseretic
Generic Name:
Enalapril maleate
Manufacturer: MSD

RENITEC (enalapril maleate, MSD) is the maleate salt of enalapril, a derivative of two amino-acids,
L-alanine and L-proline. Following oral administration enalapril is rapidly absorbed and then hydrolysed to enalaprilat which is a highly specific long-acting, non-sulphydryl angiotensin converting enzyme inhibitor.
RENITEC is indicated in the treatment of all grades of essential hypertension , and in renovascular hypertension. It may be used alone as initial therapy or concomitantly with other antihypertensive agents, especially diuretics.

RENITEC is also indicated in the treatment and prevention of heart failure.
A multicenter, placebo-controlled, double-blind study of left ventricular dysfunction (SOLVD) assessed the effects or RENITEC in 6.797 patients 2 569 patients with all degrees of symptomatic heart failure (primarily mild to moderate New York Heart Association Class II and III) were randomized into the Treatment Arm, and 4.228 patients with asymptomatic left ventricular dysfunction were randomized into the Prevention Arm.
The combined results demonstrated an overall reduced risk for the development of major ischemic events. RENITEC decreased the incidence of myocardial infarction and reduced the number of hospitalizations for unstable angina pectoris in patients with left ventricular dysfunction.
In addition in the Prevention Arm, RENITEC significantly prevented the development of symptomatic heart failure and reduced the number of hospitalizations for heart failure. In the Treatment Arm, RENITEC, as an adjunct to conventional therapy significantly reduced overall mortality and hospitalization for heart failure and improved NYHA functional class.

In a similar study involving 253 patients with severe heart failure (New York Heart Association Class IV), RENITEC was shown to improve symptoms and reduce mortality significantly.

Treatment of

  • dotAll Grades of Essential Hypertension
  • dotRenovascular Hypertension
  • dotAll Degrees of Heart Failure

In patients with symptomatic heart failure RENITEC is also indicated to
  • dotImprove Survival
  • dotRetard the Progression of Heart Failure
  • dotReduce Hospitalization for Heart Failure

In asymptomatic patients with demonstrated left ventricular dysfunction RENITEC is indicated to
  • dotRetard the Development of Symptomatic Heart Failure
  • dotReduce Hospitalization for Heart Failure
Since absorption of Tablets RENITEC is not affected by food, the tablets may be administered before, during or after meals.

Essential Hypertension
The initial dose is 10 to 20 mg depending on the degree of hypertension and is given once daily. In mild hypertension the recommended initial dose is 10 mg daily For other degrees of hypertension the initial dose is 20 mg daily The usual maintenance dose is one 20 mg tablet taken once daily The dosage should be adjusted according to the needs of the patient to a maximum of 40 mg daily

Renovascular Hypertension
Since blood pressure and renal function such patients may be particularly sensitive to ACE inhibition therapy should be initiated with a lower starting dose (e.g. 5 mg or less) The dosage should then be adjusted according to the needs of the patient. Most patents may be expected to respond to one 20 mg tablet taken once daily. For patients with hypertension who have been treated recently with diuretics, caution is recommended (see next paragraph).

Concomitant Diuretic Therapy In Hypertension

Symptomatic hypertension may occur following the initial dose of RENITEC this is more likely in patients who are being treated currently with diuretics. Caution is recommended, therefore, since these patients may be volume- or salt-depleted.  The diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with RENITEC. If this is not possible, the initial dose of RENITEC should be low (5 mg or less) to determine the initial effect on the blood pressure.  Dosage should then be adjusted according to the needs of the patient.

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