Enalapril Hexal
Enalapril Hexal: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Enalapril HEXAL
ATX code: C09AA02
Active ingredient: Enalapril (Enalapril)
Manufacturer: Salutas Pharma GmbH (Germany)
Description and photo update: 2018-25-10
Prices in pharmacies: from 44 rubles.
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Enalapril Hexal is an antihypertensive agent, an ACE (angiotensin converting enzyme) inhibitor.
Release form and composition
Dosage form - tablets: oblong, biconvex, with a smooth surface; on one of the sides - a notch at an angle of 140 degrees ("Snap-tab"); at a dosage of 5 mg - white, with a notch and the inscription "EN 5" on the other side; at a dosage of 10 mg - red-brown color with lighter and darker blotches, with a notch and the inscription "EN 10" on the other side; at a dosage of 20 mg - light orange with lighter and darker blotches, with a notch and the inscription "EN 20" on the other side (in a blister 10 pcs., in a cardboard box 1, 2, 3, 4 or 5 blisters).
Composition of one tablet:
- active substance: enalapril maleate - 5, 10 or 20 mg;
- auxiliary components: sodium bicarbonate, lactose monohydrate, corn starch, hyprolose, talc, magnesium stearate, dye red iron oxide (for a dosage of 10 and 20 mg), a dye yellow iron oxide (for a dosage of 20 mg).
Pharmacological properties
Pharmacodynamics
The effect of the drug is due to the pharmacological activity of the metabolite of enalapril - enalaprilat, which suppresses the conversion of biologically inactive angiotensin I into the hormone angiotensin II, eliminating its vasoconstrictor effect. Enalaprilat helps to lower OPSS (total peripheral vascular resistance) and systemic blood pressure (blood pressure), increase cardiac output, reduce afterload and preload on the myocardium in heart failure. The action of the active substance leads to the expansion of mainly arteries and not veins. There is no reflex increase in heart rate (heart rate).
Enalapril helps to reduce pressure in the right atrium in the pulmonary circulation, reduce left ventricular hypertrophy, and suppress intraglomerular hypertension, which slows down the development of diabetic glomerulosclerosis and reduces the risk of chronic renal failure.
Enalapril maleate has no effect on the metabolism of lipoproteins, glucose and sexual function.
When the drug is taken orally, the antihypertensive effect is observed after 1 hour, the maximum effect is achieved after 6-8 hours and lasts for 24 hours. The therapeutic effect develops within a few weeks from the start of therapy.
Pharmacokinetics
- absorption: after ingestion, about 60% of enalapril is absorbed in the gastrointestinal tract; food intake has no effect on absorption; the maximum concentration of enalapril in the blood serum is reached after 1 hour, enalaprilat - after 3-4 hours;
- distribution: up to 50% of the active substance binds to blood plasma proteins;
- metabolism: in the process of hydrolysis, enalaprilat is formed, which has a pronounced pharmacological activity;
- Excretion: T 1/2 (half-life) after 4 days from the start of taking the drug is 11 hours; 60% of the active substance is excreted by the kidneys (in the form of enalapril - 20%, enalaprilat - 40%), through the intestines - 33% (in the form of enalapril - 6%, enalaprilat - 27%).
Indications for use
- arterial hypertension;
- chronic heart failure (as part of combination therapy);
- dysfunction of the left ventricle.
Contraindications
Absolute:
- unilateral or bilateral renal artery stenosis;
- a history of angioneurotic edema, including with the use of ACE inhibitors;
- kidney and / or liver disease;
- pregnancy and lactation period;
- age up to 18 years;
- increased individual sensitivity to enalapril, other ACE inhibitors or any auxiliary component of the drug.
The use of Enalapril Hexal requires caution in case of hypovolemia (decrease in BCC) resulting from diuretic treatment, limited NaCl intake, hemodialysis, vomiting or diarrhea, due to the increased risk of a sudden and significant decrease in blood pressure after taking even a starting dose of an ACE inhibitor.
Instructions for use of Enalapril Hexal: method and dosage
Enalapril Hexal is taken orally with a sufficient amount of liquid, regardless of food intake. The daily dose is usually taken in the morning, but it can be divided into two doses - morning and evening.
The recommended dosage regimen depending on the disease:
- arterial hypertension: the initial dose is 5 mg of enalapril in the morning. If the desired hypotensive effect is not achieved, the daily dose can be increased to 10 mg. It is recommended to increase the dose no more than once every 3 weeks. The maintenance dose is usually 10 mg. The maximum daily dose should not exceed 40 mg of enalapril (twice 20 mg - in the morning and in the evening);
- chronic heart failure: the initial dose is 2.5 mg of enalapril in the morning. The dose should be increased gradually, depending on the therapeutic effect and the patient's condition. The maintenance dose is 5-10 mg. The maximum daily dose should not exceed 20 mg of enalapril;
- left ventricular dysfunction: the initial dose is 2.5 mg of enalapril twice a day. The dose can be adjusted depending on the patient's condition and the therapeutic effect. The maintenance dose averages 10 mg of enalapril twice a day.
With impaired renal function of moderate severity (creatinine clearance rate from 30 to 60 ml / min) and in old age (from 65 years), the initial dose is 2.5 mg of enalapril in the morning. The maintenance dose is usually 5-10 mg per day. The maximum daily dose should not exceed 20 mg of enalapril.
With severe renal failure (creatinine clearance rate below 30 ml / min) and hemodialysis procedure, the initial dose is 2.5 mg of enalapril per day. Patients on hemodialysis should take Enalapril Hexal after the procedure. The maintenance dose is usually 5 mg per day. The maximum daily dose should not exceed 10 mg of enalapril.
The use of Enalapril Hexal is possible both in monotherapy and as part of combination therapy with other antihypertensive, especially diuretic, drugs.
Side effects
As a rule, most of the adverse reactions are temporary and do not require discontinuation of the drug.
The following side effects from systems and organs are possible when using Enalapril Hexal:
- cardiovascular system: rarely (at the initial stage of therapy) - arterial hypotension (including orthostatic), visual impairment, weakness, dizziness; very rarely - angina pectoris, chest pain, thromboembolism of the branches of the pulmonary artery, palpitations;
- respiratory system: bronchospasm, interstitial pneumonitis, non-productive dry cough, pharyngitis, rhinorrhea, shortness of breath;
- digestive tract: dyspeptic disorders (nausea / vomiting, diarrhea, constipation, abdominal pain), anorexia, dry mouth, intestinal obstruction, impaired liver function and biliary excretion, pancreatitis, jaundice, hepatitis;
- nervous system and sensory organs: rarely - dizziness, headache, drowsiness, increased fatigue, stunning syndrome, weakness; very rarely (when using high doses) - sleep disturbance, depression, paresthesia and peripheral neuropathy, muscle cramps, blurred vision, tinnitus, nervousness, taste disturbances. These disorders are temporary and disappear after drug withdrawal;
- reproductive system: very rarely (when using high doses) - impotence;
- urinary system: rarely - proteinuria, hyperkalemia, hyponatremia, renal dysfunction. Deviations are temporary; after drug withdrawal they disappear;
- allergic reactions: pruritus, rash, urticaria, pemphigus, stomatitis, arthritis, arthralgia, myositis, vasculitis, photosensitization, angioedema of the face, tongue, lips, larynx / glottis, extremities, exfoliative dermatitis, dysphonia, toxic epidermal necrolysis, multivariate erythema (including Stevens-Johnson syndrome);
- laboratory tests: a decrease in platelet count, hemoglobin and hematocrit. It is extremely rare (especially in patients with diffuse connective tissue diseases, impaired renal function, or with the combined use of enalapril with allopurinol, novocainamide or immunosuppressants) - anemia, neuropathy, thrombocytopenia, eosinophilia, hypercreatininemia, increased urea concentration. In some cases, there was an increase in the activity of hepatic transaminases, pancytopenia or agranulocytosis.
Before and throughout the course of therapy, the indicators of the above laboratory parameters should be regularly monitored, especially in patients at risk.
Overdose
In the case of taking high doses of Enalapril Hexal, the following symptoms may appear: a significant decrease in blood pressure, which can lead to the development of myocardial infarction, collapse, acute cerebrovascular accident and / or thromboembolic abnormalities, stupor, seizures.
In case of an overdose of the drug, the patient must be transferred to a horizontal position with a low head position. In mild cases, treatment consists of gastric lavage and ingestion of saline. In more severe cases, measures to stabilize blood pressure are recommended: intravenous administration of 0.9% sodium chloride solution, plasma substitutes, administration of angiotensin II if necessary, hemodialysis (enalaprilat is excreted at an average rate of 62 ml / min).
special instructions
Symptomatic arterial hypotension, the likelihood of which is quite high during therapy with enalapril after intensive use of diuretic drugs, dietary restriction of salt intake or hemodialysis procedure, is not a contraindication for further treatment with Enalapril Hexal after blood pressure stabilization. If necessary (in case of repeated significant decrease in blood pressure), it is recommended to reduce the dose of the drug or cancel it.
Patients who use polyacrylonitrile membranes (AN69) during dialysis should not be prescribed Enalapril Hexal due to the high likelihood of developing anaphylactic reactions.
Before you start taking the drug, you need to check your kidney function. Patients with impaired renal function require a decrease in a single dose or an increase in the interval between doses of enalapril.
Before and during the entire course of therapy, it is necessary to monitor blood pressure and analyze laboratory parameters, especially in case of impaired renal function, loss of fluid and / or electrolytes, heart failure, renal or severe hypertension and over the age of 65 years.
If therapy with Enalapril Hexal was preceded by treatment with diuretic drugs, the risk of developing orthostatic hypotension increases, in particular in patients with chronic heart failure. In this case, you need to restore the water-salt balance before you start taking enalapril.
Patients with diabetes mellitus should be prescribed the drug with caution, as there is a risk of hyperkalemia.
If angioedema of the face, lips, larynx or extremities occurs, you must immediately stop taking Enalapril Hexal and consult a specialist.
The cough that may occur during treatment with the drug is temporary and stops after the end of therapy.
With the sudden cancellation of enalapril, the withdrawal syndrome (a sharp increase in blood pressure) is not observed.
Before surgical manipulations (including dentistry), the surgeon / anesthesiologist should be warned about the use of Enalapril Hexal, since the hypotensive effect of drugs used for general anesthesia can be enhanced by ACE inhibitors.
If it is necessary to conduct a study of the functions of the parathyroid glands, the drug should be canceled before the analysis.
Influence on the ability to drive vehicles and complex mechanisms
When driving vehicles and performing work that requires increased attention and a quick motor / mental reaction, it is necessary to take into account the possibility of developing individual reactions during the use of enalapril (especially when increasing the dose or simultaneously drinking alcohol) and be careful.
Application during pregnancy and lactation
According to the instructions, Enalapril Hexal is contraindicated for use during pregnancy and breastfeeding.
Newborns and infants whose mothers took ACE inhibitors during pregnancy require careful medical supervision for the timely detection of oliguria, a pronounced decrease in blood pressure, hyperkalemia and neurological abnormalities, the development of which could lead to a decrease in renal and cerebral blood flow. In oliguria, it is recommended to maintain blood pressure and renal perfusion by administering vasoconstrictors and appropriate fluids.
Pediatric use
The safety and efficacy of Enalapril Hexal in pediatrics has not been established, therefore, it is prohibited to prescribe it to children and adolescents under 18 years of age.
With impaired renal function
The drug is contraindicated in severe kidney disease.
For patients with moderate renal impairment (creatinine clearance from 30 to 60 ml / min), the initial dose of enalapril is 2.5 mg / day, the maintenance dose is 5-10 mg / day, the maximum dose is not more than 20 mg / day.
With severe renal failure (creatinine clearance less than 30 ml / min), the initial dose of enalapril is 2.5 mg / day, the maintenance dose is 5 mg / day, the maximum dose is not more than 10 mg / day.
Bilateral stenosis of the renal arteries or stenosis of an artery of a single kidney is an absolute contraindication to the use of Enalapril Hexal.
For violations of liver function
It is not recommended to prescribe the drug to patients with liver disease.
Use in the elderly
In elderly patients (over 65 years), blood pressure and laboratory parameters should be monitored before and during treatment.
The following dosing regimen is recommended for such patients: the initial dose of enalapril is 2.5 mg / day, the maintenance dose is 5-10 mg / day, the maximum dose is not more than 20 mg / day.
Drug interactions
The use of enalapril concurrently with some drugs can lead to the development of the following effects:
- analgesics, non-steroidal anti-inflammatory drugs (for example, indomethacin, acetylsalicylic acid): weakening the antihypertensive effect of enalapril;
- antihypertensive drugs: enhancing the hypotensive effect of enalapril, especially when used together with diuretics;
- potassium preparations, potassium-sparing diuretics (including amiloride, triamterene, spironolactone) and other drugs that cause an increase in serum potassium concentration (for example, heparin): an increased risk of hyperkalemia;
- sodium chloride (table salt): reducing the hypotensive effect of enalapril;
- lithium preparations: an increase in the concentration of lithium in the blood serum (regular monitoring of the corresponding indicator is needed);
- drugs and anesthetics: enhancing the antihypertensive effect of enalapril;
- insulin, oral antidiabetic drugs: in some cases, an increase in their hypoglycemic effect is observed (a decrease in the dose of antidiabetic drugs is required);
- cytostatics, allopurinol, systemic corticosteroids, immunosuppressants, novocainamide: a decrease in the number of leukocytes in the blood, an increased risk of developing leukopenia;
- alcohol: increasing its influence.
Analogs
Enalapril Hexal analogs are: Enalapril, Enap, Renitek, Berlipril and others.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C out of reach of children.
Shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Enalapril Hexal
Reviews about Enalapril Hexal are positive. The drug helps to reduce blood pressure, while acting gradually, gently, without sudden jumps. It is usually well tolerated by patients, there are no special complaints about side effects.
In addition, users note the relatively low cost of tablets.
The price of Enalapril Hexal in pharmacies
The average price for Enalapril Hexal is approximately:
- for a pack of 20 tablets: in a dosage of 5 mg - 60 rubles, in a dosage of 10 mg - 80 rubles, in a dosage of 20 mg - 93 rubles;
- for a pack of 50 tablets: at a dosage of 10 mg - 196 rubles, at a dosage of 20 mg - 209 rubles.
Enalapril Hexal: prices in online pharmacies
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Drug name Price Pharmacy |
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Enalapril Hexal 5mg tablets 20 pcs. RUB 44 Buy |
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Enalapril Hexal 10 mg tablets 50 pcs. 148 RUB Buy |
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Enalapril Hexal tablets 20mg 50 pcs. 172 r Buy |
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Enalapril Hexal 20 mg tablets 50 pcs. 172 r Buy |
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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!
