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Vasoretec

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

Vasoretec

Manufacturer

Joswe Medical, Na'ur, Jordan.

Therapeutic Class

Angiotensin converting enzyme (ACE) inhibitors

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablets (NRN:04-2792): Enalapril maleate 5 mg, 10 mg, 20 mg.

Pack size: Box of 30 blistered tablets.

Pharmacology

Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.

The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system (RAS). Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. Although the later decrease is small, it results in small increases of serum potassium.

Indications

Essential hypertension; Renovascular hypertension; Symptomatic improvement of heart failure and reduction of mortality in patients with all degrees of heart failure.

Contra-indications

Hypertensitivity to any component of this product, and in patients with a history of angioneurotic edema, relating to previous treatment with an Angiotensin-converting enzyme inhibitor. The use of Vasoretec in children has not been studied.

Use in pregnancy and during lactation: There are no adequate and well-controlled studies of Enalapril in pregnant women. However, data are available that indicate that ACE inhibitors can cause fetal and neonatal morbidity and mortalllity when administered to pregnant women, therefore, the use of Vasoretec during pregnancy is not recommended unless needed in a situation where other drugs can not be used or are inactive.

Vasoretec is secreted in human milk in trace amounts. Therefore, caution should be exercised if Vasoretec is given to a nursing mother.

Precautions/Warnings

Symptomatic hypotension: Symptomatic hypotension may occur sometimes after the first dose of Vasoretec.

Impaired renal function: Since Enalapril and Enalaprilat are almost completely excreted by the kidneys, patients with renal insufficiency require reduced and/or less frequent dosage of Vasoretec, and their renal function should be monitored. In the majority, renal function will not alter, and in some it may improve. In patients with renal failure, the administration of Vasoretec leads to the elevation of serum potassium.

Hypersensitivity/angioneurotic edema: Angioneurotic edema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in individual patients treated with angiotensin-converting enzyme inhibitors, including Vasoretec which should be discontinued promptly and the patient observed carefully until the swelling disappears. In those instances where swelling has been confined to the face and lips, the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms.

Angioneurotic edema associated with laryngeal edema may be fatal. Where there is no involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, appropriate therapy such as subcutaneous Epinephrine solution 1:1000 (0.3 mL to 0.5 mL) should be administered promptly. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at an increased risk of angioedema while receiving an ACE inhibitor.

Haemodialysis patients: Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Therefore, it is recommended not to use such membranes in these patients.

Surgery/anesthesia: In patients undergoing surgery, major surgery or during anesthesia 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.

Pediatric use: Vasoretec has not been studied in children.

Effects on ability to drive and use machines: No data are known about the effect on the ability to drive in connection with the possible occurrence of dizziness; a negative effect on the ability to drive and to use machines should be taken into account.

Interactions

Antihypertensive therapy: The combination of Vasoretec with other antihypertensive drugs may increase the antihypertensive effect, especially in combination with diuretics.

Serum potassium: Serum potassium usually remains within normal limits. In patients treated with Vasoretec plus a thiazide diuretic, there are essentially no changes in serum potassium. If Vasoretec is given with a potassium-lowering diuretic, diuretic-induced hypokalemia may be ameliorated. The use of potassium supplements, potassium-containing salt substitute, potassium-sparing diuretics in particular in patients with impaired renal function may lead to significant increase in serum potassium. If concomitant use of the above mentioned agents is deemed appropriate, they should be used with frequent monitoring of serum potassium.

Lithium: As with other drugs which eliminate sodium, the lithium elimination may be reduced. Therefore, the lithium levels of serum should be carefully compared if lithium salts are to be administered.

Adverse Effects

The following effects have been associated with the use of Vasoretec, dizziness and headache were the most reported side effects, fatigue and asthma were reported in 2-3% of patients.

Other side effects occurred in less than 2% of patients and included hypotension, orthostatic hypotension, syncope, nausea, diarrhoea, muscule cramps, rash and cough. Less frequently, renal dysfunction, renal failure and oliguria have been reported.

Other side effects may also occur rarely, and some of them may be serious.

Dosage & Administration

Adults:

Usual maintenance dosage for adults: 10 to 20 mg once or twice daily depending on the indications. Initial dose may vary depending on the severity of the condition treated.

Overdosage:

Limited data are available for overdosage in humans. The most prominent feature of overdosage reported to date is marked hypotension, beginning some six hours after ingestion of tablets concomitant with blockage of the renin-angiotensin system, and stupor.

The recommended treatment for overdosage is intravaneous infusion of normal saline solution. If ingestion is recent, induce emesis and/or gastric lavage. Enalaprilat may be removed from the general circulation by hemodialysis.

Storage/Handling Recommendations

Store in a cool dry place.

Keep out of the reach of children.

Review Date

2015-08-19 10:51:50