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Renitec
Oral (enalapril maleate, MSD)


RENITEC (enalapril maleate, MSD) is the maleate salt of enalapril, a derivative of two amino-acids, Lalanine and L-proline. Following oral tablet or wafer administration, enalapril is rapidly absorbed and then hydrolyzed 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 anti hypertensive 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 of 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.


The cardioprotective properties of RENITEC were demonstrated in these studies by the beneficial effects on survival and retardation of the progression of heart failure in patients with symptomatic heart failure; retardation of the development of symptomatic heart failure in asymptomatic patients with left ventricular dysfunction; and prevention of coronary ischemic events in patients with left ventricular dysfunction, specifically reduction in the incidence of myocardial infarction and reduction in hospitalization for unstable angina pectoris.

INDICATIONS
Treatment of:
* All Grades of Essential Hypertension
* Renovascular Hypertension

* All Degrees of Heart Failure
 

In patients with symptomatic heart failure, RENITEC is also indicated to:
Improve Survival
Retard the Progression of Heart Failure
Reduce Hospitalization for Heart Failure
* Prevention of Symptomatic Heart Failure
 

In asymptomatic patients with left ventricular dysfunction, RENITEC is indicated to:
Retard the Development of Symptomatic Heart Failure
Reduce Hospitalization for Heart Failure
* Prevention of Coronary Ischemic Events in Patients with Left Ventricular Dysfunction
 

RENITEC is indicated to:
Reduce the Incidence of Myocardial Infarction
Reduce Hospitalization for Unstable Angina Pectoris

DOSAGE AND ADMINISTRATION
Oral:

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 or wafer 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 in 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 patients may be expected to respond to one 20 mg tablet or
wafer 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 hypotension 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.


DOSAGE IN RENAL INSUFFICIENCY

Generally, the intervals between the administration of enalapril should be prolonged and/or the dosage reduced.

Rena Status

Creatinine Clearance mL/min

Initial Dose mg/day

Mild Impairment

<80  >30 mL/min.

5 - 10 mg

Moderate Impairment

≤30  >10 mL/min.

2.5 - 5 mg

Severe Impairment. Normally,

these patients will be on dialysis.*

≤10 mL/min

2.5 mg on dialysis days**

 

* See PRECAUTIONS - Hemodialysis Patients.

** Enalaprilat is dialyzable. Dosage on nondialysis days should be adjusted depending on the blood pressure response.

 

HEART FAILURE / ASYMPTOMATIC LEFT VENTRICULAR DYSFUNCTION
The initial dose of RENITEC in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5 mg, and it should be administered under close medical supervision to determine the initial effect on the blood pressure. RENITEC may be used in the management of symptomatic heart failure usually with diuretics and, where appropriate, digitalis. In the absence of, or after effective management of, symptomatic hypotension following initiation of therapy with RENITEC in heart failure, the dose should be increased gradually to the usual maintenance dose of 20 mg, given in a single dose or two divided doses, as tolerated by the patient. This dose titration may be performed over a 2 to 4 week period, or more rapidly if indicated by the presence of residual signs and symptoms of heart failure. In patients with symptomatic heart failure, this dosage regimen was effective in reducing mortality.


Blood pressure and renal function should be monitored closely both before and after starting treatment with RENITEC (see PRECAUTIONS) because hypotension and (more rarely) consequent renal failure have been reported. In patients treated with diuretics, the dose should be reduced if possible before beginning treatment with RENITEC. The appearance of hypotension after the initial dose of RENITEC does not imply that hypotension will recur during chronic therapy with RENITEC and does not preclude continued use of the drug. Serum potassium also should be monitored (see DRUG INTERACTIONS).


CONTRAINDICATIONS
RENITEC is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioneurotic edema relating to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.

 

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