Enalapril STELLA 5 mg

Rx

Indications

• Enalapril STELLA 5 mg is used as monotherapy or in combination with other classes of antihypertensive agents to manage mild to severe hypertension.
• Enalapril STELLA 5 mg usually is used in conjunction with cardiac glycosides, diuretics, and beta- adrenergic blocking agents to manage symptomatic congestive heart.
• Prophylaxis in patients with asymptomatic left ventricular dysfunction to delay the onset of symptomatic heart failure and in patients with left ventricular dysfunction to reduce the incidence of coronary ischaemic events, including myocardial infarction.

Dosage

Hypertension: An initial dose is 5 mg daily. Patients with renal impairment or to those who are receiving a diuretic: an initial dose of 2.5 mg daily. The diuretic should be withdrawn 2 or 3 days before starting enalapril and resumed later if necessary. Maintenance dose: 10 – 20 mg once daily, maximum 40 mg daily.

Heart failure: Start with 2.5 mg daily. Maintenance dose: 20 mg daily as a single dose or in 2 divided doses, maximum 40 mg daily in 2 divided doses.

Asymptomatic left ventricular dysfunction: 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).

Patients with heart failure and renal impairment or hyponatremia: In patients with heart failure who have hyponatremia (serum sodium < 130 mEq/L) or with serum creatinine > 1.6 mg/dL, start at 2.5 mg daily under close medical supervision. Doses can up to 2.5 mg twice daily, then 5 mg twice daily and higher as needed, usually at intervals of four days or more if at the time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. The maximum daily dose is 40 mg.

Children:

• 20 – 50 kg: an initial dose of 2.5 mg once daily with a maximum of 20 mg daily.
• ≥ 50 kg: an initial dose of 5 mg once daily with a maximum of 40 mg daily.
• Enalapril is not recommended in neonates and in paediatric patients with glomerular filtration rate < 30 ml/min/1.73 m².

Use of suitable tablet is 2.5 mg enalapril maleate when using 2.5 mg.

Usage

Enalapril STELLA 5 mg is administered orally.

• Known hypersensitivity to any of the ingredients.
• Angioedema or a history of angioedema related to ACE inhibitor therapy.
• Bilateral renal-artery stenosis or with renal-artery stenosis in a solitary kidney.
• Aortic stenosis and severe obstructive cardiomyopathy.
• Preexisting hypotension.
• Second and third trimesters of pregnancy.

• Headache, dizziness, fatigue, insomnia, paresthesia, dysesthesia.
• Taste disturbance, diarrhoea, nausea, vomiting and abdominal pain.
• Angioedema, severe hypotension, orthostatic hypotension, syncope, palpitation, and chest pain.
• Rashes.
• Dry, nonproductive cough.
• Renal failure.

• Dual blockade of RAAS through the combined use of ACE – inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended. ACE – inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
• Symptomatic hypotension is more likely to occur if the patient has been volume – depleted, e.g., by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting.
• Use with caution for patients with ischemic heart or cerebrovascular disease, patients with left ventricular valvular and outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically significant obstruction.
• Patients with severe heart failure or underlying renal disease, including bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney.
• Treatment with enalapril is therefore not recommended in patients with a recently kidney transplantation.
• Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow – up.
• Enalapril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function, patients with serious infections, because neutropenia/ agranulocytosis, thrombocytopenia and anaemia can occur.
• Hypersensitivity/ angioneurotic oedema may occur at any time during treatment. In such cases, enalapril should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient.
• Patients with diabetes, patients receiving LDL apheresis, haemodialysis, hypoglycaemia, patients undergoing major surgery or during anesthesia with agents that produce hypotension.
• Hyperkalaemia can cause serious, sometimes fatal arrhythmias. If concomitant use of enalapril and any agents which can cause hyperkalaemia is deemed appropriate, they should be used with caution and with frequent monitoring of serum potassium.
• Characteristically, the cough caused by ACE inhibitors is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor induced cough should be considered as part of the differential diagnosis of cough.
• Enalapril STELLA 5 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible. Use with caution on breastfeeding women.
• Patients should be aware of how they react to drug before driving or operating machinery.