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Cardiovascular Agents

Enalapril STADA® 5 mg

 

Pack size:

Box of 3 blisters x 10 tablets. 

 

Composition: 

Each tablet contains enalapril maleate 5 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be given to patient with renal impairment or to those who are receiving a diuretic; if possible, the diuretic should be withdrawn 2 or 3 days before enalapril is started and resumed later if necessary.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.
    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 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.
  • Asymptomatic left ventricular dysfunction:
    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:
    There is limited clinical trial experience of the use of enalapril in hypertensive paediatric patients.
    For patients who can swallow tablets, the dose should be individualised according to patient profile and blood pressure response. The recommended initial dose is 2.5 mg in patients 20 to < 50 kg and 5 mg in patients ≥ 50 kg. Enalapril is given once daily. The dosage should be adjusted according to the needs of the patient to a maximum of 20 mg daily in patients 20 to < 50 kg and 40 mg in patients ≥ 50 kg.
    Enalapril is not recommended in neonates and in paediatric patients with glomerular filtration rate < 30 ml/min/1.73 m2, as no data are available.
    Use of suitable tablet is 2.5 mg enalapril maleate when using 2.5 mg.

Or as prescribed by physicians.

 

  • Known hypersensitivity to enalapril or 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.

Adverse reactions to enalapril usually are mild and transient but have required discontinuance of therapy in about 3 to 6% of patients treated.
Symptomatic hypotension after the first dose of enalapril has been so severe that 2 – 3% of the patients in clinical trials needed to stop treatment. This is particular in patients with heart failure, hyponatremia, and with the elderly, who are treated concomitantly with diuretic agents.
In patients with congestive heart failure, symptomatic hypotension, deterioration of renal function, and increased serum potassium concentration appear most frequently, particulary during initiation of enalapril therapy in patients that receive concomitantly diuretic agents.
Deterioration in renal function (transient increase in blood urea nitrogen and serum creatinin concentrations) has occurred in about 20% of patients with renovascular hypertension, especially those with bilateral renal-artery stenosis or those with renal-artery stenosis in a solitary kidney.

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, depression, blurred vision, nasal obstruction, muscle pain, bronchospasm, and asthma.

Instructions about how to manage adverse and side effects
Drugs should be given with slow initial dosage. Check serum sodium level when treatment starts. Angioedema may occur, especially following the first dose of enalapril, and if associated with laryngeal edema, may be fatal. Patients should be informed that swelling of the face, eyes, lips, or toungue or difficulty in breathing may be signs and symptoms of angioedema, and that they should discontinue enalapril and notify their physician immediately if any of these conditions occurs. Treatment of angioedema involving the tongue, glottis or larynx may include the following:
Withdrawal of enalapril and hospitalization of the patient; subcutaneous adrenaline; intravenous diphenhydramine hydrochloride; intravenous hydrocortisone.
Periodic monitoring of leukocyte counts in patients using enalapril, especially in patients with renal impairment.
Blood pressure and kidney function must be monitored closely before and after start of treatment.
If sufficient treatment response has not been achieved within 4 weeks, dose should be increased, or addition of other antihypertensive drugs should be considered.
In case of severe hypotension, intravenous injection of sodium chloride 0.9% shall be given as treatment. Enalapril usually does not affect serum potassium (K+) levels. If enalapril is combined with a diuretic drug, this can reduce the risk of secondary aldosteronism with hypokalemia. In patients with kidney failure, enalapril may lead to elevated serum potassium levels. Potassium saving diuretic drugs and potassium supplements are therefore recommended to patients with reduced kidney function, since this way lead to hyperkalemia. If concomitant treatment still is judged to be needed, this must be done under extreme caution and with frequent measurement of serum potassium levels. For patients where there is suspicion of renal artery stenosis, serum creatinine measurements need to be done, before treatment is started.
During major surgery or during anesthesia with drug with hypotensive effect, enalapril may block the angiotensin II formation, sencondary to compensatory rennin release. This can lead to aggravated hypotension, which can be corrected through increasing the plasma volume (infusion solution).

 

  • Dual blockade of the rennin - angiotensin - aldosterone system (RAAS):
    There is evidence that the concomitant use of ACE - inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE - inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended. If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE - inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
  • Symptomatic hypotension:
    Symptomatic hypotension is rarely seen in uncomplicated hypertensive patients. In hypertensive patients receiving enalapril, 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. In patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed. This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment. In these patients, therapy should be started under medical supervision and the patients should be followed closely whenever the dose of enalapril and/or diuretic is adjusted. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
    If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.
    In some patients with heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with enalapril. This effect is anticipated, and usually is not a reason to discontinue treatment. If hypotension becomes symptomatic, a reduction of dose and/or discontinuation of the diuretic and/or enalapril may be necessary.
  • Aortic or mitral valve stenosis/Hypertrophic cardiomyopathy:
    As with all vasodilators, ACE inhibitors should be given with caution in patients with left ventricular valvular and outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically significant obstruction.
  • Renal function impairment:
    In cases of renal impairment (creatinine clearance < 80 ml/min) the initial enalapril dosage should be adjusted according to the patient's creatinine clearance and then as a function of the patient's response to treatment. Routine monitoring of potassium and creatinine are part of normal medical practice for these patients. 
    Renal failure has been reported in association with enalapril and has been mainly in patients with severe heart failure or underlying renal disease, including renal artery stenosis. If recognised promptly and treated appropriately, renal failure when associated with therapy with enalapril is usually reversible.
    Some hypertensive patients, with no apparent pre - existing renal disease have developed increases in blood urea and creatinine when enalapril has been given concurrently with a diuretic. Dosage reduction of enalapril and/or discontinuation of the diuretic may be required. This situation should raise the possibility of underlying renal artery stenosis.
  • Renovascular hypertension:
    There is an increased risk of hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors. Loss of renal function may occur with only mild changes in serum creatinine. In these patients, therapy should be initiated under close medical supervision with low doses, careful titration, and monitoring of renal function.
  • Kidney transplantation:
    There is no experience regarding the administration of enalapril in patients with a recent kidney transplantation. Treatment with enalapril is therefore not recommended.
  • Hepatic failure:
    Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow - up.
  • Neutropenia/ Agranulocytosis:
    Neutropenia/ agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. 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. Some of these patients developed serious infections which in a few instances did not respond to intensive antibiotic therapy. If enalapril is used in such patients, periodic monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection.
  • Hypersensitivity/ Angioneurotic oedema:
    Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including enalapril. This 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. Even in those instances where swelling of only the tongue is involved, without respiratory distress, patients may require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor.
  • Anaphylactoid reactions during Hymenoptera desensitization:
    Rarely, patients receiving ACE inhibitors during desensitisation with hymenoptera venom have experienced lifethreatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each desensitisation.
  • Anaphylactoid reactions during LDL apheresis:
    Rarely, patients receiving ACE inhibitors during low density lipoprotein (LDL) apheresis with dextran sulfate have experienced life threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE inhibitor therapy prior to each apheresis.
  • Haemodialysis patients:
    Anaphylactoid reactions have been reported in patients dialysed with high flux membranes and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
  • Hypoglycaemia:
    Diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor, should be told to closely monitor for hypoglycaemia, especially during the first month of combined use.
  • Cough:
    Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor induced cough should be considered as part of the differential diagnosis of cough.
  • Surgery/Anaesthesia:
    In patients undergoing major surgery or during anaesthesia with agents that produce hypotension, enalapril blocks angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
  • Hyperkalaemia:
    Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including enalapril. Risk factors for the development of hyperkalaemia include those with renal insufficiency, worsening of renal function, age (> 70 years), diabetes mellitus, inter current events in particular dehydration, acute cardiac decompensation, metabolic acidosis and concomitant use of potassium sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements or potassium­containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). The use of potassium supplements, potassium­sparing diuretics, or potassium­containing salt substitutes particularly in patients with impaired renal function may lead to a significant increase in serum potassium. Hyperkalaemia can cause serious, sometimes fatal arrhythmias. If concomitant use of enalapril and any of the above­ mentioned agents is deemed appropriate, they should be used with caution and with frequent monitoring of serum potassium.
  • Lithium:
    The combination of lithium and enalapril is generally not recommended.
  • Lactose:
    Enalapril STADA® 5 mg contains lactose and therefore should not be used by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.
  • 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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