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ENARIL - 5mg 10mg

COMPOSITION:
Each ENARIL 5 tablet contains:
Active ingredient:  Enalapril maleate…………… 5 mg    
Excipients: Lactose, Maize starch, Primellose, Prejel, Sodium hydrocarbonate, Magnesium stearate.
Each ENARIL 10 tablet contains:
Active ingredient:  Enalapril maleate…………… 10 mg    
Excipients: Lactose, Maize starch, Primellose, Prejel, Sodium hydrocarbonate, Magnesium stearate.
 

Rx PRESCRIPTION ONLY MEDICINE
COMPOSITION:

Each ENARIL 5 tablet contains:
Active ingredient:  Enalapril maleate…………… 5 mg    
Excipients: Lactose, Maize starch, Primellose, Prejel, Sodium hydrocarbonate, Magnesium stearate.
Each ENARIL 10 tablet contains:
Active ingredient:  Enalapril maleate…………… 10 mg    
Excipients: Lactose, Maize starch, Primellose, Prejel, Sodium hydrocarbonate, Magnesium stearate.
PHARMACODYNAMIC:
Enalapril is angiotensin-converting enzyme (ACE) inhibitors with antihypertensive activity and hemodynamic effects in patients with heart failure due to primarily suppression of the renin-angiotensin-aldosterone system. It inhibits the production of vasoconstrictor (angiotensin II), increases kallikrein - kinin system, blocks the degradation of vasodilator (bradykinin), changes prostanoid metabolic and inhibits  sympathetic nervous system.
In patients with hypertension, enalapril decreases systolic and diastolic pressure by 10-15% in both the supine and standing positions by decreasing total peripheral resistance due to arterial and possibly venous dilation. The drug produces a slightly increase or no change in heart rate; orthostatic hypotension occurs infrequently
In patients with congestive heart failure, enalapril, usually in conjunction with cardiac glycosides and diuretics, decreases total peripheral resistance, pulmonary capillary wedge pressure, mean arterial and right atrial pressures, heart size, afterload. Cardiac index, cardiac output, stroke volume, and exercise tolerance increase in these patients.
Enalapril decreases proteinuria in diabetic patients and improves insulin sensitivity in hypertensive patients with or without diabetes mellitus.
Enalapril does not reduce the lipid metabolism.
PHARMACOKINETIC:     
About 60% of an oral dose of enalapril is absorbed from the gastrointestinal tract and peak plasma concentrations are achieved within about 0.5-1.5 hours. The half-life is about 11 hours, The haemodynamic action lasts for about 24 hours. Enalapril is extensively hydrolysed in the liver to  enalaprilate; peak plasma concentrations of enalaprilate are achieved 3 to 4 hours after an oral dose of enalapril.
The hypotensive effect of an oral dose of enalapril is usually apparent within 1 hour and maximum in 4-6 hours. It persists for 12-24 hours.
About 50 to 60% of Enalapril is bound to plasma proteins.
About 60% of an oral dose is excreted in the urine as enalaprilate and unchanged drug, the remainder is excreted in faeces.
INDICATION:
Essential hypertension.
Heart failure
Chronic renal impairment, diabetic renal disease in patients with or without hypertension.
After myocardial infarction when blood circulation was stable.
CONTRAINDICATION:
Known hypersensitive to enalapril or any ingredient of the drug.
Angioedema related to angiotensin-converting enzyme inhibitor therapy .
Patients with renal artery stenosis, aortic stenosis, hypertrophic cardiomyopathy.
Pregnancy and lactation.
DOSAGE AND ADMINISTRATION:
Administration: Oral route, without regard to meals.
Dosage:  Dosage must be adjusted according to each patients and diseases.
Essential hypertension:  
•    The usual initial dose for adults: 2.5 – 5 mg once daily.
•    The maintenance dose: 10 – 20 mg once daily, the maximum dose is 40 mg daily in 2 divided doses.
Concomitant diuretic therapy: The diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with enalapril. If this is not possible, the initial dose of enalapril should be low (5 mg or less) to determine the initial effect on the blood pressure. Dosage should then be adjusted according to the needs of the patient.
Heart failure, asymptomatic left ventricular sysfunction:
•    The initial dose is 2.5 mg daily, and it should be administered under close medical supervision to determine the initial effect on the blood pressure.
•    The dose should be increased gradually to the usual maintenance dose of 20 mg daily, given in a single dose or two divided doses
•    This dose titration is recommended to be performed over a 2 to 4 week period.
Dosage in renal insufficiency: the dosage should be reduced or the intervals between the administration should be prolonged. If patient’s response is not inadequate in 4 weeks, the dosage should be increased or combined with antihypertensive drugs.

 

Renal Status

Creatinine Clearance
mL/min

Initial Dose
mg/day

Mild impairment

80 – 30

5 – 10

Moderate impairment

29 – 10

2.5 – 5

Severe  impairment. (Normally these patients will be on dialysis)

< 10

2.5 mg on dialysis

 

  
The safety and effectiveness of enalapril have not been established in children.
PRECAUTION:
Patients with impaired renal function.
In patients with renal artery stenosis, serum creatinine should be evaluated before therapy with enalapril.
DRUG INTERACTION:  
Concomitant use of enalapril and some vasodilating agents (e.g., nitrates) or anesthetic agents may cause an exaggerated hypotensive response.
Concomitant use of enalapril and with diuretics may result in hypotension when initiating therapy with enalapril.
Concomitant use of enalapril and with agents causing renin release may increase the antihypertensive effect of enalapril
Concomitant use of enalapril and potassium-sparing diuretics, potassium-containing salt substitutes or potassium supplements may lead to a significant increase in serum potassium, particularly in patients with impaired renal function.
Concomitant administration of enalapril with lithium may increase serum lithium levels and enhance the risk of lithium toxicity.
Concomitant administration of enalapril with sympathomimetics, NSAIDs may reduce the antihypertensive effect of enalapril.
Concomitant use of enalpril  with oral contraceptive may result in risk of vascular damage and uncontrolled blood pressure.
PREGNANCY AND LACTATION:
The use of enalapril during pregnancy is not recommended. When pregnancy is detected, the drug should be discontinued as soon as possible. Because ACE inhibitors can cause fetal and neonatal morbidity and mortality when administered to pregnant women during the second and third trimesters.
Enalapril and enalaprilat are secreted in human milk. Caution should be exercised if the drug is given to a nursing mother.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
ADVERSE EFFECT:
Enalapril is well tolerated. Adverse reactions of enalapril are usually mild and transient and have not required discontinuation of therapy (discontinuance of therapy in about 3 or 6% of patients). Symptomatic hypotension occurred more frequently following an initial dose of enalapril, especially in patients receiving diuretic therapy.
The common adverse effects include headache, dizziness, fatigue, asthenia, abdominal pain, diarrhea, nausea, edema, hypotension, rash, cough…
The uncommon adverse effects are decreases in hemoglobin, agranulocytosis, neutropenia, proteinuria… and rare adverse effects include ileus, pancreatitis, hepatitis including cholestasis…
Notify your physicians if you should experience any of adverse effects
OVERDOSAGE:
Limited data are available for overdosage in humans. The most prominent features of overdosage reported to date are marked hypotension.
The recommended treatment of overdosage is symptomatic and supportive:  induction of emesis, gastric lavage, intravenous infusion of normal saline solution, hemodialysis.
STORAGE: In a dry place, below 30oC, protect from light.
SHELF-LIFE: 24 months from the date of manufacturing. Do not use after the expiry date.
PACKAGING: Box of 5 blisters x 10 tablets.
SPECIFICATION: Manufacturer’s specifications.
KEEP OUT OF REACH OF CHILDREN
USE ONLY AS DIRECTED BY YOUR PHYSICIAN
CAREFULLY READ THE PACKAGE INSERT BEFORE USE
FOR FURTHER INFORMATION, DO NOT HESISTATE TO ASK YOUR PHYSICIANS
Manufactured by:
BOSTON VIETNAM PHARMACEUTICAL JOINT STOCK COMPANY
No. 43, Street no. 8, VSIP, Thuan An, Binh Duong, Vietnam
Tel: 06503 769 606 - Fax: 06503 769 601



 


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