ENALAPRIL MALEATE TABLETS

THERAPEUTIC CATEGOGY

ACE inhibitor for the treatment of hypertension

Composition

1 Each uncoated tablet contains
Enalapril Maleate   USP   5/10mg

MECHANISM OF ACTION:

Following oral administration, Enalapril Maleate is rapidly absorbed and hydrolysed to Enalapriat, a highly specific , long-acting, non-sulphydryl ACE (angiotensin-coverting enzyme) inhibitor. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin to the vasoconstrictor substance, angiotensin ll. Angiotensin ii also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin ii. Which leads to decreased vasopressor activity and aldosterone secretion, thus exerting antihypertensive action.

INDICATIONS:

All grades of essential hypertension and renovascular hypertension (exept in artery stenosis)
Hypertension complicated be diabetes mellitus, gout, asthma etc. As adjunctive therapy in comgestive cardiac failure with digitalis and/or diuretics, asmpomatic left ventricular dysfunction.

SIDE EFFECTS:

Mild headache, dizziness, gastro-intestinal upsets and angiodema are noted in few patients. Cough can be a trouble some side effect occasionally.

SPECIAL PRECAUTIONS:

In patients with severe congestive cardiac failure, treatment with ACE inhibitors  may lead to oligouria and acute renal failure. Angioedema has  been reported in patients treated with ACE inhibitors  including enalapril maleate. Pretreatment assessment of renal function is a must in renal faipure (less than 30ml/min) the dose of enalapril maleate should be reduced. It should be used with caution in patient’s with renal insufficiency. In hypertensive patients receving enalapril hypertension is more likely to occur if the patient has been volume depeted (e.g by diuretic  therapy, dietary salt restriction dialysis, diarrhoea or vomiting) similar consideration may apply to patients with ischaemic heart or cerebrovascula diesase in whom an excessive fall in blood pressure could result in a myocardial infarction. Enalapril should not be used in patients with aortic stenosis or outflow obstruction. Other antihypertensive agents may increase the antihypertensive efficacy. Enalapril is exxcreted in human milk. Caution should be exercised if it  is given to breast feeding mothers. 

CONTRAINDICATIONS:

Hypersensitivity to ACE inhibitors,pregnancy,children. Having a history of angioedema due to previous treatment ACE inhibitors.

DOSAGE AND ADMINISTRATION:

The recommenede initial dose in patients not on diuretics is 5 mg once a day. The usual dailly dose is 2.5 mg to 40 mg per day in a single dose or in two divided doses. The maximum daily dose is 40 g.

1)- Essential and renovascular hypertension:
Treatment should be initiated with 5 mg once a day. Dosage should be adjusted according to blood pressure response. Maintenace dose is 10-20 mg giving once daily. In severe hyperetnsion , the dosage may be increased to  maximum of 40 mg once daily. Where cocomitant therapy is a diuretic, the recommended initial dose is 2.5 mg.

2)- Heart failure/ symptomatic left ventricular dysfunction:
Initial dose is 2.5 mg once daily. The dose should be titrated gradually to the usual maintenace dose of 20 mg given as a single dose or two divided doses. Accoding to the tolerability of the patient.

3)- dosage adujustment in patients with heart failure and renal impairment or hyponatremia.
Dosage adujustment in patients with heart faifure and renal impairment or hyponatremia.
Therapy should be initiated at 2.5 mg daily under close medical supervision. The dose may be increased to 2.5 mg twice daily than 5 mg twice daily and higher ad needed. The maximum daily dose is 40 mg.

STORAGE:
Store at a temperature not exceeding 30o c in a dry place.