LOTRIAL 5 & LOTRIAL 10 TABLETS    Back to Products

 

Lotrial 5 & 10mg contains Enalapril Maleate 5 & 10 mg respectively. Enalapril is a potent inhibitor of Angiotensin Converting Enzyme (ACE). Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) which converts angiotensin I to angiotensin II. Inhibition of ACE results in decrease plasma angiotensin II, which leads to decreased vasopressor activity and to decrease aldosterone secretion leading to a decrease in Total Peripheral Vascular Resistance (TPVR).

 

 

While the mechanism through which enalapril maleate lowers blood pressure is believed to be primarily by the suppression of the renin-angiotensin-aldosterone system, enalapril maleate is effective as an antihypertensive agent even in patients with low-renin hypertension.

 

COMPOSITION

Lotrial 5: Each film coated, scored tablet contains 5mg Enalapril Maleate.

Lotrial 10:  Each film coated, scored tablet contains 10mg Enalapril Maleate.

 

INDICATION

Hypertension

Lotrial is indicated for the treatment of mild, moderate and severe forms of essential and renovascular hypertension. It is effective alone or in combination with other antihypertensive agents, especially the thiazide-type diuretics.

 

Heart Failure

Lotrial is indicated for the treatment of congestive heart failure and prevention of symptomatic heart failure. It is used in combination with diuretics and digitalis. In these patients Lotrial improves symptoms, increases survival, and decreases the frequency of hospitalization.

 

Asymptomatic Left Ventricular Dysfunction.

In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤ 35%), Lotrial decreases the rate of development of overt heart failure. Also used for the prevention of coronary ischaemic events in patients with left ventricular dysfunction.

 

Diabetic Neuropathy

In diabetic hypertensives, Lotrial is able to decrease proteinuria and preserve renal function. More recently, enalapril maleate has been shown to decrease the progression of neuropathy in normotensive patients with Type 2 diabetes mellitus.

 

DOSAGE AND ADMINISTRATION

Hypertension

The recommended initial dose in patients not on diuretics is 5mg once a day. Patients on diuretic therapy should commence therapy with 2.5mg. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10-40mg/day administered as a single dose or 2 divided doses. If blood pressure is not controlled with enalapril alone, a diuretic may be added.

Concomitant administration of Lotrial and potassium supplements may lead to increase in serum potassium levels.

 

Heart Failure

The recommended initial dose is 2.5mg usually in combination with diuretics and digitalis. The recommended dosing range is 2.5-20mg given twice a day. Doses could be titrated upwards, as tolerated to a maximum of 40mg/day.

 

Asymptomatic Left Ventricular Dysfunction

The recommended initial dose is 2.5mg daily, the dosing range is 2.5-20mg/day given once or twice daily.

 

Dosage Adjustment in Hypertensive Patients with Renal Impairment.

 

*The dosage may be titrated upwards until blood pressure is controlled or to a maximum of 40mg daily.

 

SIDE EFFECTS

Lotrial is generally well tolerated. Nausea, vomiting, dyspepsia, diarrhea and constipation have been reported following treatment with Lotrial.

ACE inhibitors may cause profound hypotension especially with concomitant diuretic therapy. Persistent dry cough has also been reported. They may also cause angioedema, (onset may be delayed) rash, pancreatitis, and upper respiratory tract symptoms such as sinusitis, rhinitis and sore throat.

 

NURSING MOTHERS

Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for serious adverse reactions in nursing infants from enalapril, the physician has to evaluate the benefit against the risk of usage.

 

CONTRAINDICATIONS

Enalapril maleate is contraindicated in patients who are hypersensitive to the product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor and in patients with hereditary or idiopathic angioedema.

ACE inhibitors should not be used in pregnancy.

 

PRESENTATION

Lotrial Tablets 5mg, pack of 30ís and 100ís

Lotrial Tablets 10mg, pack of 30ís and 100ís

 

For more information, please contact productmanager@solidumpharma.com                       Back to top