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Cardiovascular Agents

Enalapril STADA® 10 mg

 

Pack size:

Box of 3 blisters x 10 tablets.

 

Composition:

Each tablet contains enalapril maleate 10 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Hypertension
    Management of mild to severe hypertension. The drug has been used as monotherapy or in combination with other classes of antihypertensive agents.
    An initial dose of 5 mg of enalapril maleate daily may be given. Since there may be a precipitous fall in blood pressure in some patients when starting therapy with an ACE inhibitor, the first dose should preferably be given at bedtime.
    An initial dose of 2.5 mg daily should be given to patient with renal impairment or to those who are receiving a diuretic; if possible, the diuretic should be withdrawn 2 or 3 days before enalapril is started and resumed later if necessary.
    The usual maintenance dose is 10 to 20 mg given once daily, although doses of up to 40 mg daily may be required in severe hypertension. It may be given in 2 divided doses if control is inadequate with single dose.
  • Congestive heart failure
    Enalapril usually is used in conjunction with cardiac glycosides, diuretics, and beta- adrenergic blocking agents in the management of symptomatic congestive heart.
    Patients with heart failure or asymptomatic left ventricular dysfunction: Enalapril maleate is given by mouth in an initial dose of 2.5 mg daily.
    The usual maintenance dose is 20 mg daily as a single dose or in 2 divided doses although up to 40 mg daily in 2 divided doses has been given.
  • It may also be given prophylactically to patients with asymptomatic left ventricular dysfunction to delay the onset of symptomatic heart failure, and has been used in patients with left ventricular dysfunction to reduce the incidence of coronary ischaemic events, including myocardial infarction.
    Patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).
    Dosage adjustment in patients with heart failure and renal impairment or hyponatremia.
    In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision. The dose may be increased 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:
    Enalapril may be used in the management of hypertension in children.
    The initial dose is 80 mcg/kg once daily, with a maximum of 5 mg, adjusted according to response. Alternatively, children weighing 20 to below 50 kg may be given an initial dose of 2.5 mg once daily, increased to a maximum of 20 mg daily; children weighing 50 kg or over may be given an initial dose of 5 mg once daily, increased to a maximum of 40 mg daily.
    Enalapril has also been given to infants with severe heart failure in doses of 100 to 500 mcg/kg daily.

Or as prescribed by physicians.

 

  • Known hypersensitivity to any ingredient of the drug.
  • A history of angioedema related to ACE inhibitor therapy and patients with hereditary or idiopathic angioedema.
  • Bilateral renal-artery stenosis or with renal-artery stenosis in a solitary kidney.
  • Aortic stenosis, and severe obstructive cardiomyopathy.
  • Preexisting hypotension.

     

Common

  • 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 may be caused by potentiation of tissue kinins or prostaglandin in the lung.
  • Renal failure.

Uncommon

  • Decrease in hemoglobin and hematocrit, agranulocytosis, neutropenia.
  • Proteinurea.
  •  Agitation, panic, extreme depression.

Rare

  • Ileus, pancreatitis, cholestatic hepatotoxicity, hyperesthesia of the oral mucosa.
  • Hypersensitivity, CNS depression, blurred vision, nasal obstruction, muscle pain, bronchospasm, and asthma.

     

  • ACE inhibitors should not be used in patients with obstruction in the outflow tract of the left ventricle (e.g., aortic stenosis, hypertrophic cardiomyopathy).
  • It should not generally be used in patients with renovascular disease or suspected renovascular disease, but are occasionally necessary for severe resistant hypertension in such patients, when they should only be given with great caution and under close specialist supervision.
  • Impaired renal function:
    Renal function should be assessed in all patients before administration of ACE inhibitors  and should be monitored during therapy.
    Patients with existing renal disease or taking high doses should be monitored regularly for proteinuria.
  • Regular white blood cell counts may be necessary in patients with collagen vascular disorders, such as systemic lupus erythematosus and scleroderma, or in patients receiving immunosuppressive therapy, especially when they also have impaired renal function.
  • Patients with heart failure and patients who are likely to be sodium or water depleted may experience symptomatic hypotension during the initial stages of ACE inhibitor therapy.
  • Pregnancy: When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible.
  • Lactation: Enalapril has been detected in human breast milk. The risk of effects on children is considered very small at normal therapeutic doses.
  • When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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