Enalapril 5mg tabs 20 pcs Hemofarm


Enalapril 5mg tabs 20 pcs Hemofarm


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Active substance:
1 tablet contains enalapril maleate – 5 mg, 10 mg, 20 mg.
Lactose monohydrate, magnesium carbonate, gelatin, crospovidone, magnesium stearate.
For tablets 5 mg, 10 mg and 20 mg – Round, biconvex tablets with a white scored on one side.
Product form:
Tablets 5 mg, 10 mg, 20 mg.
10 tablets in the blister of Al / Al, PVC and polyamide laminate film. 2 blisters together with instructions for use placed into cardboard pack.
Hypersensitivity to enalapril and other ACE inhibitors, history of angioneurotic edema associated with treatment with ACE inhibitors, porphyria, pregnancy, lactation, age 18 years (effectiveness and safety are installed).
Be wary of primary hyperaldosteronism, bilateral renal artery stenosis, stenosis of the artery to a solitary kidney, hyperkalemia, condition after kidney transplantation; aortic stenosis, mitral stenosis (with impaired hemodynamics), idiopathic hypertrophic subaortic stenosis, systemic connective tissue diseases, ischemic heart diseases, cerebrovascular diseases, diabetes, renal disease (proteinuria – more than 1 g / day), liver failure, patients complying diet with salt restriction, or on hemodialysis, while admission to immunosuppressants and saluretikami in the elderly (over 65 years).
5 mg
Hypertension, chronic heart failure (in a combination therapy).
Interaction with other drugs
When concomitant administration Enalapril with nonsteroidal antiinflammatory drugs (NSAIDs) may reduce the hypotensive effect; potassium-sparing diuretics (spironolactone, triamterene, amiloride) may cause hyperkalemia; with the salts of lithium – lithium down hatching (shown control the concentration of lithium in the blood plasma).
Simultaneous treatment with antipyretic analgesics and can reduce the effectiveness of enalapril.
Enalapril reduces the effect of formulations containing theophylline.
Hypotensive effect of enalapril increase diuretics, beta-blockers, methyldopa, nitrates, blockers “slow” calcium channel blockers, hydralazine, prazosin.
Immunosuppressants, allopurinol, cytostatics reinforce haematotoxicity.
Drugs that cause bone marrow suppression, increase the risk of neutropenia and / or agranulocytosis.
Symptoms: marked reduction of blood pressure until the development of collapse, myocardial infarction, acute stroke or thromboembolic complications, convulsions, stupor.
Treatment: the patient is transferred to a horizontal position with a low headboard. In mild cases shown gastric lavage and intake of brine, in more severe cases – actions to stabilize blood pressure: intravenous administration of saline, plasma expanders, optionally – administering angiotensin II, hemodialysis (speed enalaprilat excretion averages 62 ml / min ).
pharmachologic effect
Pharmacological group:
Angiotensin-converting enzyme inhibitor.
Enalapril – antihypertensive from the group of ACE inhibitors. Enalapril is a “prodrug”: as a result of hydrolysis enalaprilat is formed, which inhibits ACE. Its mechanism of action is associated with a decrease in the formation of angiotensin I angiotensin II, reduction of which leads to a direct decrease in aldosterone release. In this decreases total peripheral vascular resistance, systolic and diastolic blood pressure (BP), and post-preload on the myocardium.
Artery expands to a greater extent than the vein, the reflex increase of heart rate frequency is not observed.
The hypotensive effect is more pronounced at high plasma renin level than at normal or reduced its level. Reduction of blood pressure in the therapeutic range has no effect on cerebral blood flow, cerebral blood flow in vessels is maintained at a sufficient level and the background of decrease in blood pressure. Strengthens the coronary and renal blood flow.
With prolonged use of reduced left ventricular hypertrophy and myocyte walls resistive arteries prevents the progression of heart failure and slows the development of left ventricular dilation. It improves blood flow to the ischemic myocardium.
Reduces platelet aggregation.
It has some diuretic effect.
onset of antihypertensive effect during ingestion -. 1 h, reaching a maximum after 4-6 hours and lasts up to 24 hours in some patients to achieve optimal blood pressure level needed therapy for a few weeks… In heart failure, a significant clinical benefit observed with prolonged use – more than 6 months.
After ingestion absorbed 60% of the formulation. Eating does not affect the absorption of enalapril. Enalapril and 50% bound to blood proteins. Enalapril is rapidly metabolized in the liver to form the active metabolite enalaprilat, which is a more potent inhibitor of ACE than enalapril. Bioavailability – 40%. The maximum concentration of enalapril in plasma is reached after 1 hour, enalaprilat – 3-4 hours. Enalaprilat easily passes through the blood-tissue barriers, except for the blood-brain, a small amount crosses the placenta and breast milk.
The half-life enalaprilat -. About 11 hours Return enalapril mainly kidneys – 60% (20% – as enalapril and 40% – in the form enalaprilat) through the intestine – 33% (6% – as enalapril and 27% – in the form of enalaprilate ).
Removed during hemodialysis (rate – 62 ml / min) and the peritoneal dialysis.
Conditions of supply of pharmacies
On prescription.
side effects
Enalapril is generally well tolerated and in most cases does not cause side effects requiring discontinuation of the drug.
Cardio-vascular system: excessive fall in blood pressure, orthostatic collapse, rarely – chest pain, angina pectoris, myocardial infarction (usually associated with a marked decrease in blood pressure), rarely – arrhythmias (atrial or bradi- tachycardia, atrial fibrillation), palpitations, thromboembolism branches of the pulmonary artery.
From the nervous system: dizziness, headache, fatigue, insomnia, anxiety, confusion, fatigue, sleepiness (2-3%), rarely with high doses – nervousness, depression, paresthesia.
From the senses: vestibular disorders, hearing and visual impairment, tinnitus.
On the part of the digestive tract: dry mouth, anorexia, dyspepsia (nausea, diarrhea or constipation, vomiting, abdominal pain), ileus, pancreatitis, liver dysfunction and biliary excretion, hepatitis, jaundice.
The respiratory system: nonproductive dry cough, interstitial pneumonitis, bronchospasm, dyspnea, rhinorrhea, pharyngitis.
Allergic reactions: skin rash, pruritus, urticaria, angioneurotic edema, rarely – dysphonia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, photosensitivity, serositis, vasculitis, myositis, arthralgia, arthritis, stomatitis, glossitis .
From the laboratory parameters: hypercreatininemia, increasing urea content, increased activity of “liver” enzymes, hyperbilirubinemia, hyperkalemia, hyponatremia. There have been, in some cases, decrease in hematocrit, increased erythrocyte sedimentation rate, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia.
From the urinary system: renal dysfunction, proteinuria.
Other: alopecia, decreased libido, hot flashes.
special instructions
Care must be taken when assigning Enalapril in patients with reduced circulating blood volume (as a result of diuretic therapy, while limiting the consumption of salt, hemodialysis, diarrhea and vomiting) – increased risk of sudden and pronounced blood pressure lowering even after applying the initial dose of ACE inhibitor. Transient hypotension is not a contraindication for the continuation of treatment after stabilization of blood pressure. In the case of re-expressed BP reduction should reduce or stop the drug dose.
The use of highly permeable dialysis membranes increases the risk of an anaphylactic reaction. Correction of dosing regimen in days free from dialysis, must be carried out depending on the blood pressure level.
Prior to and during treatment with ACE inhibitors requires periodic monitoring of blood pressure, blood parameters (hemoglobin, potassium, creatinine, urea, “liver” enzymes), protein in the urine.
Should be carefully observed for patients with severe heart failure, coronary heart disease and diseases of the brain, in which a sharp decrease in blood pressure can lead to heart attack, stroke, or renal dysfunction.
The sudden cancellation of treatment does not lead to a syndrome “cancel” (a sharp rise in blood pressure).
For newborns and infants who have been exposed in utero ACE inhibitors should be closely monitored for early detection of significant decrease in blood pressure, oliguria, hyperkalemia and neurological disorders, possible due to the reduction of renal and cerebral blood flow with a decrease in blood pressure caused by ACE inhibitors. When oliguria need to maintain blood pressure and renal perfusion by introducing the liquids and vasoconstrictors. In the presence of renal failure may be reduced excretion of the active metabolite, resulting in an increase in its concentration in plasma. Such patients may require the appointment of lower doses of the drug.
In patients with hypertension and unilateral or bilateral renal artery stenosis may increase the content of urea and creatinine in serum.
These patients need to monitor renal function during the first few weeks of therapy. You may need to reduce the dosage of the drug.
risk ratio should be considered and the potential benefits with enalapril in patients with coronary artery and cerebrovascular insufficiency, due to the increased threat of ischemia in excessive hypotension.
The drug should be used with caution in patients with diabetes because of the risk of hyperkalemia.
Patients with a history of instructions to angioedema may be at increased risk of angioedema during treatment with enalapril.
In patients with severe autoimmune diseases such as systemic lupus erythematosus or scleroderma, increased risk of neutropenia or agranulocytosis in patients receiving enalapril.
Caution is recommended when enalapril for the treatment of chronic heart failure in patients treated with cardiac glycosides and / or diuretics.
Before examining the function of the parathyroid glands drug should be discontinued.
Alcohol enhances the hypotensive effect of the drug.
At the beginning of the treatment until the completion of dose titration period, you must refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and psychomotor speed reactions as dizziness, especially after the initial dose of ACE inhibitor in patients taking diuretics.
Prior to surgery (including dental), you must notify the surgeon / anesthetist on the use of ACE inhibitors.
Storage conditions
Stored in a dry place at a temperature of 15 to 25C.
Keep out of the reach of children.
Dosing and Administration
Assign inside regardless of mealtime.
In monotherapy hypertension initial dose of – 5 mg once a day.
In the absence of clinical effect after 1-2 weeks the dose was raised to 5 mg. After receiving the initial dose, patients should be under medical observation for a further 2 hours and 1 hour, until it stabilizes blood pressure. If necessary and sufficiently well tolerated dose could be increased to 40 mg / day in 2 divided doses. After 2-3 weeks, transferred to a maintenance dose – 10-40 mg / day, divided into 1-2 doses. At moderate hypertension average daily dose is about 10 mg.
The maximum daily dose of 40 mg / day.
In the case of appointment to patients concomitantly receiving diuretics, diuretic therapy should be discontinued for 2-3 days prior to enalapril. If this is not possible, the initial dose should be 2.5 mg / day.
Patients with hyponatremia (concentration of sodium ions in serum of less than 130 mmol / l) or creatinine concentration in the serum of more than 0.14 mmol / l initial dose – 2.5 mg 1 time per day.
When renovascular hypertension initial dose – 2.5-5 mg / day. The maximum daily dose is 20 mg.
In chronic heart failure the initial dose of 2.5 mg once, then increase the dose of 2,5 – 5 mg every 3-4 days according to the clinical response to the maximum tolerable doses depending on the values ​​of blood pressure, but not exceeding 40 mg / day in single or 2 divided doses. Patients with low systolic blood pressure (less than 110 mm Hg. V.) Therapy should be initiated with a dose of 1.25 mg / day. dose selection should be carried out within 2-4 weeks or in a shorter time. The average maintenance dose – 5-20 mg / day. 1-2 reception.
Older people more likely to occur more pronounced antihypertensive effect and the elongation of the preparation time, which is associated with a decrease in the rate of elimination of enalapril, therefore, the recommended initial dose to elderly – 1.25 mg.
In chronic renal failure accumulation occurs at lower filtration of less than 10 ml / min. If creatinine clearance (CC) 80-30 ml / min dose is usually 5-10 mg / day, with CC to 30-10 ml / min -. 2.5-5 mg / day, with CC less than 10 ml / min. – 1.25-2.5 mg / day. Only in the days of dialysis.
The duration of treatment depends on the effectiveness of therapy. Too marked decrease in blood pressure dose gradually.
The drug used in both monotherapy and in combination with other antihypertensive agents.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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