Ednit - Instructions For The Use Of Tablets, Analogues, Price, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ednith

Ednit: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Ednyt

ATX code: C09AA02

Active ingredient: enalapril (Enalapril)

Manufacturer: Gedeon Richter (Hungary)

Description and photo updated: 30.11.2018

Prices in pharmacies: from 53 rubles.

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Ednit is an oral antihypertensive drug.

Release form and composition

Dosage form - tablets: white, round, flat-cylindrical, beveled; on one side of the risk, on the other there is a marking for a dosage of 2.5 mg - "ED 2.5"; for a dosage of 5 mg - "ED 5"; for a dosage of 10 mg - "ED 10"; for a dosage of 20 mg - "ED 20" (in blisters of 10 pcs., in a cardboard box 2 blisters and instructions for the use of Ednit).

Composition of 1 tablet:

• active substance: enalapril maleate - 2.5; 5, 10 or 20 mg;
• auxiliary ingredients: microcrystalline cellulose, talc, sodium hydroxide, magnesium stearate, crospovidone, povidone K30, lactose monohydrate, colloidal silicon dioxide.

Pharmacological properties

Pharmacodynamics

Ednita's active ingredient, enalapril maleate, is an angiotensin-converting enzyme (ACE) inhibitor with antihypertensive efficacy. The mechanism of its action is due to the ability to reduce the formation of angiotensin II from angiotensin I, as a result of which the release of aldosterone decreases. At the same time, there is a decrease in systolic and diastolic blood pressure (BP) and total peripheral vascular resistance (OPSS), a decrease in post- and preload on the myocardium.

Ednit reduces the degradation of bradykinin. Arteries expand more than veins, which is not accompanied by a reflex increase in heart rate (HR).

The hypotensive effect of enalapril is more pronounced in patients with high plasma renin activity than in patients with normal or reduced activity.

Enalapril increases renal and coronary blood flow. Cerebral circulation with a decrease in blood pressure within the therapeutic limits does not change (blood flow in the vessels of the brain is maintained at a sufficient level).

In the case of prolonged treatment, Ednit helps to reduce hypertrophy of the left ventricular myocardium, as well as myocytes of the walls of resistive arteries, reduces the rate of development of left ventricular dilatation, and prevents further progress of heart failure.

The drug improves blood flow to the ischemic myocardium by reducing platelet aggregation. With chronic heart failure, the life expectancy of patients increases. After suffering myocardial infarction (in the absence of clinical manifestations of heart failure), the progression of left ventricular dysfunction slows down.

Enalapril has some diuretic effect. Reducing intraglomerular hypertension, inhibits the progress of glomerulosclerosis, reduces the risk of the onset and development of chronic renal failure.

After oral administration, the hypotensive effect develops after 1 hour, reaches a maximum after 4-6 hours, and lasts up to 24 hours. In some cases, it takes several weeks to achieve an optimal decrease in blood pressure. In patients with chronic heart failure, a visible clinical effect is observed with prolonged therapy - from 6 months.

Pharmacokinetics

Approximately 60% of the oral dose of the drug is absorbed. Food does not affect the absorption of enalapril.

It binds to plasma proteins up to 50%.

Enalapril is a prodrug: it is rapidly metabolized in the liver by hydrolysis, resulting in the formation of enalaprilat, an active metabolite that is a stronger ACE inhibitor than enalapril itself.

The bioavailability of the drug is 40%.

The maximum plasma concentration of enalapril is observed after 1 hour, enalaprilat - after 3-4 hours.

Enalaprilat easily penetrates the histohematogenous barriers, with the exception of the blood-brain. In a small amount, it passes through the placental barrier, and is also excreted during lactation with breast milk. The half-life of enalaprilat is approximately 11 hours.

The drug is excreted: by the kidneys - 60% (enalapril - 20%, enalaprilat - 40%); through the intestines - 33% (enalapril - 6%, enalaprilat - 27%).

The drug is excreted from the body during hemodialysis (speed 62 ml / min) and peritoneal dialysis.

Indications for use

• arterial hypertension;
• chronic heart failure (as part of complex treatment);
• asymptomatic left ventricular dysfunction - in order to prevent the development of chronic heart failure.

Contraindications

Absolute:

• lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• porphyria;
• pregnancy;
• lactation;
• children and adolescents up to 18 years old;
• angioedema (hereditary or idiopathic);
• a history of angioneurotic edema, which developed with the use of ACE inhibitors;
• hypersensitivity to any component of the drug.

Relative (Ednit tablets should be used with caution):

• systemic connective tissue diseases;
• cerebrovascular diseases;
• inhibition of the function of bone marrow hematopoiesis;
• idiopathic hypertrophic subaortic stenosis;
• diabetes;
• aortic / mitral stenosis with hemodynamic impairment;
• cardiac ischemia;
• hyperkalemia;
• renal failure with proteinuria more than 1 g / day;
• condition after kidney transplantation;
• bilateral stenosis of the renal arteries or stenosis of an artery of a solitary kidney;
• primary hyperaldosteronism;
• liver failure;
• conditions with a concomitant decrease in the volume of circulating blood (diarrhea, vomiting, adherence to a diet with limited salt, taking diuretics, hemodialysis);
• simultaneous use of saluretics or immunosuppressants;
• age over 65.

Ednit, instructions for use: method and dosage

Ednit tablets should be taken orally, swallowed whole and washed down with plenty of liquid. Meal time does not matter.

After taking the first dose, the patient should be under medical supervision for at least 3 hours, until blood pressure stabilizes.

In case of arterial hypertension, Ednit is prescribed as a monopreparation at an initial dose of 5 mg once a day. After 1-2 weeks, if there is no clinical effect, the daily dose is increased to 10 mg. If in this case the decrease in blood pressure is not enough, it is possible to further increase the dose of the drug, up to the maximum allowable 40 mg in 1-2 doses, provided that the treatment is well tolerated. After 2–3 weeks, maintenance therapy is started in a daily dose of 10–40 mg (in 1–2 doses), depending on the degree of arterial hypertension.

For patients with arterial hypertension receiving diuretics, the diuretic should be discontinued 2-3 days before Ednit is prescribed. If this is not possible, treatment with enalapril should be started with a daily dose of 2.5 mg. With concomitant hyponatremia (the concentration of sodium ions in the blood serum is less than 130 mmol / l) or an increased concentration of creatinine in the blood serum (more than 0.14 mmol / l), the initial dose of Ednit is 2.5 mg once a day.

For patients with renovascular hypertension, Ednit is prescribed in a daily dose of 2.5–5 mg. If necessary, it is gradually increased, but not more than up to 20 mg per day.

Treatment of chronic heart failure begins with a dose of 2.5 mg once a day. Then, every 3-4 days, depending on the clinical response to the drug, the dose is increased by 2.5-5 mg. The maximum allowable daily dose is 40 mg in 1–2 doses. Patients with low systolic blood pressure (<110 mmHg. V.) Ednit administered in a starting daily dosage of 1.25 mg (¹ / ₂tablets at a dosage of 2.5 mg). The optimal therapeutic dose is selected within 2-4 weeks (if necessary, the terms can be reduced). The maintenance dose can be from 5 to 20 mg in 1-2 doses. An initial dose of 1.25 mg per day is also recommended for elderly patients, since, due to a decrease in the rate of elimination of enalapril, they have a more pronounced antihypertensive effect and a lengthening of the duration of the action of Ednit.

When preventing the development of chronic heart failure in patients with asymptomatic left ventricular dysfunction, Ednit is prescribed in a daily dose of 5 mg - 2.5 mg 2 times a day. The maintenance dose is selected individually depending on the tolerance and can reach 20 mg in 2 divided doses.

For patients with concomitant renal insufficiency, the daily dose of Ednit is adjusted depending on the creatinine clearance (CC):

• CC 30–80 ml / min - from 5 to 10 mg;
• CC 10-30 ml / min - from 2.5 to 5 mg;
• CC less than 10 ml / min - from 1.25 to 2.5 mg only on the days of dialysis.

The duration of the course of therapy depends on the clinical effectiveness.

In case of an excessive decrease in blood pressure, the dose of Ednit is gradually reduced.

Ednit can be used as the main drug of therapy or in combination with other antihypertensive drugs.

Side effects

• from the immune system: skin rashes, angioedema of the lips, edema of the face, tongue, glottis, larynx and / or extremities; extremely rarely - urticaria, pruritus, photosensitivity, arthralgia, vasculitis, arthritis, myositis, serositis, pemphigus, exfoliative dermatitis, intestinal angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme;
• on the part of the cardiovascular system: excessive drop in blood pressure, orthostatic collapse; rarely - angina pectoris, chest pain, stroke / myocardial infarction (usually due to a pronounced decrease in blood pressure); extremely rare - palpitations, thromboembolism of the branches of the pulmonary artery, arrhythmias (atrial fibrillation, atrial brady or tachycardia), Raynaud's syndrome;
• from the side of metabolism: hyperbilirubinemia, increased blood urea, hypercreatininemia; in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents - hypoglycemia;
• on the part of the senses: visual and hearing impairment, tinnitus, imbalance;
• from the central and peripheral nervous system: anxiety, weakness, headache, dizziness, drowsiness, insomnia, fatigue, confusion; very rarely when taking Ednit in high doses - nervousness, paresthesia, depression;
• from the urinary system: impaired renal function; rarely - proteinuria;
• from the respiratory system: pharyngitis, rhinorrhea, hoarseness, sore throat, unproductive dry cough, shortness of breath, bronchospasm, interstitial pneumonitis, pulmonary infiltrates;
• from the digestive system: dry mouth, abdominal pain, diarrhea or constipation, nausea, vomiting, dyspeptic disorders, anorexia, intestinal obstruction, impaired liver function and bile secretion, pancreatitis, jaundice, hepatitis (hepatocellular or cholestatic); extremely rarely - glossitis, stomatitis, increased activity of liver enzymes;
• on the part of water and electrolyte balance: hyponatremia, hyperkalemia; sometimes - thrombocytopenia, eosinophilia, neutropenia, agranulocytosis (in patients with autoimmune diseases), increased erythrocyte sedimentation rate (ESR), decreased hemoglobin and hematocrit;
• others: hot flashes, alopecia, decreased libido, impotence.

Overdose

In case of an overdose, blood pressure decreases, up to the development of thromboembolic complications, acute cerebrovascular accident, seizures, collapse, myocardial infarction - depending on the dose of Ednita taken. Stupor is possible.

The patient should be placed in a horizontal position with a low headboard. With a moderate overdose, gastric lavage is performed, and saline is prescribed inside. In the case of severe intoxication, measures are taken to stabilize blood pressure, including the intravenous administration of sodium chloride 0.9% and plasma substitutes, if necessary, angiotensin II. To remove enalapril from the body, hemodialysis is used (on average, the excretion rate is 62 ml / min).

special instructions

During therapy and after using Ednit, the following indicators should be monitored: blood pressure, protein concentration in urine, blood picture (content of urea, potassium, creatinine and hemoglobin, liver enzyme activity).

Transient arterial hypotension is not a contraindication to the use of Ednit after BP stabilization. In case of repeated pronounced decrease in blood pressure, it is necessary to reduce the dose of the drug or cancel it.

Patients with a history of the development of angioedema have an increased risk of its occurrence during therapy with ACE inhibitors.

The likelihood of developing an anaphylactic reaction increases with the use of high-flow dialysis membranes.

On days free from dialysis, the dose is adjusted depending on the blood pressure.

Ednit should be discontinued before examining the function of the parathyroid glands.

It is required to warn the doctor / surgeon / anesthesiologist about taking an ACE inhibitor in the event of a planned surgical intervention, including dental.

Intensive monitoring is necessary for patients with cerebrovascular disease, ischemic heart disease and severe heart failure, since in these cases, a sharp decrease in blood pressure is fraught with the development of stroke, myocardial infarction, or impaired renal function.

During the period of therapy, you should not consume alcoholic beverages. It is important to exercise caution in hot weather and exercise because of the risk of dehydration and an excessive drop in blood pressure due to reduced blood volume.

With a sharp withdrawal of Ednit, withdrawal syndrome (sudden rise in blood pressure) does not occur.

Influence on the ability to drive vehicles and complex mechanisms

In the event of the development of negative side reactions from the central nervous system, patients should refrain from performing potentially hazardous types of work that require a quick reaction and increased attention.

Application during pregnancy and lactation

Ednit is prohibited during pregnancy. In newborns exposed to intrauterine exposure to ACE inhibitors, hyperkalemia, oliguria and neurological disorders may develop due to a decrease in cerebral and renal blood flow with a decrease in blood pressure.

The active metabolite of enalapril passes into the mother's milk. If treatment is necessary during lactation, breastfeeding should be discontinued.

Pediatric use

Due to the lack of data on the safety of the use of enalapril in childhood and adolescence, Ednit is contraindicated in patients under 18 years of age.

With impaired renal function

Ednit should be used with caution in renal failure (proteinuria exceeding 1 g / day), bilateral renal artery stenosis or stenosis of a solitary kidney artery, condition after kidney transplantation. A decrease in the dose of the drug or an increase in the intervals between doses is required.

For violations of liver function

In liver failure, Ednit is used with extreme caution.

Use in the elderly

Observing precautions, Ednit is prescribed to patients over 65 years of age.

Drug interactions

• non-steroidal anti-inflammatory drugs, including selective inhibitors of cyclooxygenase-2 (COX-2): it is possible to reduce the hypotensive effect. With functional disorders of the kidneys, there is a risk of further deterioration in organ function (changes are reversible);
• theophylline: its effect decreases;
• methyldopa, hydralazine, prazosin, beta-blockers, slow calcium channel blockers, diuretics, nitrates: the antihypertensive effect of enalapril is enhanced;
• drugs that inhibit bone marrow function: the risk of developing neutropenia and / or agranulocytosis increases, up to and including death;
• allopurinol, immunosuppressants, cytostatics: hematotoxicity increases;
• potassium-sparing diuretics (triamterene, spironolactone, amiloride): hyperkalemia may develop;
• lithium salts: lithium excretion slows down (it is necessary to control its plasma concentration);
• gold preparations (intravenous forms): there are rare cases of the development of a symptom complex, including facial flushing, arterial hypotension, nausea and vomiting;
• oral hypoglycemic agents and insulin: the hypoglycemic effect may increase, up to the development of hypoglycemia, especially in the first few weeks of combination therapy, as well as in patients with renal insufficiency (careful monitoring of blood glucose levels is required).

Analogs

Ednit's analogs are Akcupro, Amprilan, Arentopres, Vasolong, Hypernik, Diroton, Dilaprel, Dapril, Irumed, Kapoten, Captopril, Lizacard, Lisinopril, Parnavel, Perineva, Pyramil, Ramepress, Ramiprilce, Renitek, Eritaprilina, Enapharm, etc.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C out of reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ednith

Reviews about Ednite are few, but mostly positive: the drug is effective for arterial hypertension, is inexpensive, well tolerated even after many years of use.

Price for Ednite in pharmacies

Approximate prices for Ednit per pack of 20 tablets:

• dosage 2.5 mg - 36 rubles;
• dosage of 5 mg - 42–59 rubles;
• dosage of 10 mg - 57–78 rubles;
• dosage 20 mg - 90-124 rubles.

Ednit: prices in online pharmacies

Drug name Price Pharmacy

Ednit 5 mg tablets 20 pcs. RUB 53 Buy

Ednit 10 mg tablets 20 pcs. 73 rbl. Buy

Ednit 20 mg tablets 20 pcs. 109 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!