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International generic name
Enalapril
Drug form and composition
Tablets. One tablet contains 5 mg, 10 mg or 20 mg of Enalapril maleate.
Indications
Arterial hypertension (essential and renal). The drug is used as a single therapy
or in combination with other antihypertensive agents. Heart failure: The drug is
indicated as a component in the complex treatment of the congestive heart failure.
In cases of myocardial ischemia and infarction enalapril exerts protective action
on the myocardium.
Dosage and administration
Vasopren is given orally, once a day or bid with no relation to meals, because
its absorption is not dependent on the food. In hypertension, the recommended doses
are 10 to 20 mg daily. When the drug is used in combination with diuretics or other
antihypertensive agents, the starting dose should be low, followed by a stepwise
increase in dosage to the point of achieving optimal blood pressure control. In
patients with renal hypertension, the treatment must be started with low doses -
5 mg daily. Later the dose is modified depending on the individual response. In
engorged heart failure patients, the treatment starts with doses of 2.5 to 5 mg
daily under strict control by the physician on the initial drug effect. After that
the dose may be gradually increased to the maintenance dose of 20 mg divided in
1 or 2 doses.
Contraindications
Vasopren is not used in patients showing hypersensitivity to the product, and
also in patients with a history of edema of the larynx during previous treatment
with preparation of this group. The drug is contraindicated in pregnancy, lactation,
and in children.
Special warnings and precautions
In patients with sharp blood pressure decrease, especially in heart failure patients,
individuals with reduced blood sodium levels, or people treated by hemodialysis,
Vasopren should be given under strict control by a physician. The drug must be administered
cautiously in patients suffering from liver diseases, particularly in cases of hepatic
failure. Vasopren is not used in pregnant women, but if the woman got pregnant during
treatment with Vasopren, the therapy can be continued only in cases when the benefit
for the mother outweighs the possible risks for the fetus. Because of the risk of
sharp blood pressure drop, especially in the beginning of the treatment, the drug
should be used with caution by car drivers or people working with machines.
Drug interactions
The combination treatment using Vasopren and diuretics and β-blockers (propranolol,
atenolol, etc.) leads to increased antihypertensive effect. Vasopren can reduce
the lithium clearance. Simultaneous administration of Vasopren oral antidiabetic
agents can provoke hypoglycemia. In patients treated with potassium containing agents
(panangin, pamaton) and potassium sparing diuretics (spironolacton, triamteren and
amiloride), hyperkalemia can be observed. There is a risk of orthostatic hypotension,
when the drug is used in combination with neuroleptics.
Adverse reactions
Sharp blood pressure drop, skin rash, cough, laryngeal edema, taste disturbances,
fatigue, headache, syncope, nausea, diarrhea, and muscle cramps. Cases of leucopenia,
proteinuria or glucosuria, and decreased urine quantity have been observed. The
side effects are inconsistent, mild, and reversible.
Pharmacological mechanisms
Vasopren is a competitive inhibitor of the angiotensin-converting enzyme which
inhibits conversion of angiotensin 1 to angiotensin 2, exerts strong vasoconstrictive
action stimulates aldosterone biosynthesis. Enalapril suppresses the renin-angiotensin
system and decreases the systemic vascular resistance, reduces blood pressure and
improves the blood supply of the vital organs, e.g. heart, brain, and kidneys. In
heart failure patients, in addition to the hypotensive effect, decrease in the left
heart pressure and improvement of the pump function are achieved. Heart rate decreases
and cardiac output raises.
Supplied
28 tablets of 5 mg, 10 mg, or 20 mg (“calendar” package)
Expiry
3 years
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