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Enalapril STELLA 10 mg
Rx

Enalapril STELLA 10 mg appears to reduce blood pressure in normotensive individuals and hypertensive patients and to produce beneficial hemodynamic effects in patients with congestive heart failure mainly by suppressing the renin-angiotensin-aldosterone system.

Pack size Box of 30 tablets, 100 tablets
Shelf-life 36 months
Composition Enalapril maleate
Dosage forms and strengths Tablet: 10 mg
Product code :

PRESCRIBING INFORMATION

Indications

  • Enalapril STELLA 10 mg is used as monotherapy or in combination with other classes of antihypertensive agents to manage mild to severe hypertension.
  • Enalapril STELLA 10 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 The diuretic should be withdrawn 2 or 3 days before starting enalapril and resumed later if necessary.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: The initial dose: 80 mcg/kg once daily with a maximum of 5 mg.

  • 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.
  • Severe heart failure: 100 – 500 mcg/kg/daily.

Usage

Enalapril STELLA 10 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.
  • Patients with obstruction in the outflow tract of the left ventricle, renal disease, impaired renal function, heart failure and patients who are likely to be sodium or water depleted.
  • 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.
  • Patients should be aware of how they react to drug before driving or operating machinery.