Enalapril-FPO
Enalapril-FPO: 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-FPO
ATX code: C09AA02
Active ingredient: enalapril (enalapril)
Producer: CJSC Pharmaceutical Enterprise Obolenskoe (Russia)
Description and photo update: 28.11.2018
Prices in pharmacies: from 30 rubles.
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Enalapril-FPO is an antihypertensive drug.
Release form and composition
Dosage form - tablets: flat-cylindrical, almost white or white; 5 and 10 mg each - with a chamfer, 20 mg each - with a chamfer and a line (7, 10, 14, 15, 20, 28 or 30 pcs. in blisters, in a cardboard box 1, 2, 3, 4, 5 or 10 packages and instructions for the use of Enalapril-FPO).
Composition of 1 tablet:
- active substance: enalapril maleate - 5, 10 or 20 mg;
- auxiliary components: colloidal silicon dioxide (aerosil), lactose (milk sugar), magnesium stearate, microcrystalline cellulose, talc, potato starch.
Pharmacological properties
Pharmacodynamics
The active substance of Enalapril-FPO - enalapril maleate, is a prodrug: due to its hydrolysis, enalaprilat is formed in the body, which inhibits the angiotensin-converting enzyme (ACE).
The mechanism of action is due to the ability of the drug to reduce the formation of angiotensin II from angiotensin I, as a result of which the release of aldosterone decreases. This process is accompanied by a decrease in systolic and diastolic blood pressure (BP), total peripheral vascular resistance (OPSR), pre- and afterload on the myocardium.
Enalapril-FPO dilates arteries more than veins, which is not accompanied by a reflex increase in heart rate (HR). The antihypertensive effect of enalaprilat in patients with high blood plasma renin levels is more pronounced than in patients with normal or reduced levels. A decrease in blood pressure within the therapeutic range does not affect cerebral circulation; even with low blood pressure, blood flow in the vessels of the brain is maintained at a sufficient level. The drug increases renal and coronary blood flow.
With prolonged use of Enalapril-FPO helps to reduce hypertrophy of the left ventricular myocardium and myocytes of the walls of the arteries of the resistive type, slows down the development of left ventricular dilatation, and prevents the progression of heart failure.
Enalapril-FPO reduces platelet aggregation, improves blood supply to the ischemic myocardium, and produces some diuretic effect.
The antihypertensive effect develops within 1 hour, reaches a maximum after 4–6 hours, and lasts up to 24 hours. To achieve an optimal blood pressure level, in some cases, regular therapy is required for several weeks. In patients with heart failure, an adequate therapeutic effect develops with prolonged use of Enalapril-FPO - from 6 months.
Pharmacokinetics
When administered orally, about 60% of enalapril maleate is absorbed; food intake does not affect the degree of absorption. Bioavailability is about 40%.
Enalapril is metabolized in the liver, resulting in the formation of the metabolite enalaprilat, a more active ACE inhibitor.
The maximum plasma concentration of enalapril is achieved within 1 hour, enalaprilat - 3-4 hours.
The connection with plasma proteins is no more than 50%.
Enalaprilat easily penetrates the blood-brain barriers, with the exception of the blood-brain barrier. In a small amount, it crosses the placenta. Excreted in breast milk.
The drug is excreted: by the kidneys - 60% (enalapril - 20%, enalaprilat - 40%), through the intestines - 33% (enalapril - 6%, enalaprilat - 27%).
The half-life of enalaprilat is approximately 11 hours.
The drug is excreted from the body during peritoneal dialysis and hemodialysis (speed 62 ml / min).
Indications for use
- treatment of arterial hypertension;
- combination therapy for chronic heart failure.
Contraindications
- hereditary or idiopathic angioedema;
- a history of angioedema associated with the use of ACE inhibitors;
- age up to 18 years;
- the period of pregnancy and breastfeeding;
- hypersensitivity to any component of the drug or other ACE inhibitors.
Enalapril-FPO tablets should be used with caution in the following cases:
- primary hyperaldosteronism;
- bilateral stenosis of the renal arteries or stenosis of an artery of a single kidney, conditions after kidney transplantation, renal failure (proteinuria more than 1 g / day), hemodialysis sessions;
- hyperkalemia;
- liver failure;
- adherence to a diet with limited salt;
- ischemic heart disease, mitral stenosis (with hemodynamic disturbances), aortic stenosis, idiopathic hypertrophic subaortic stenosis;
- systemic connective tissue diseases;
- diabetes;
- cerebrovascular diseases;
- conditions accompanied by a decrease in the volume of circulating blood (including due to diarrhea / vomiting);
- oppression of bone marrow hematopoiesis;
- simultaneous use of saluretics or immunosuppressants;
- advanced age (over 65).
Enalapril-FPO, instructions for use: method and dosage
Enalapril-FPO tablets should be taken orally (time of meals does not matter).
For monotherapy of arterial hypertension, the drug is prescribed at an initial dose of 5 mg once a day. If there is no clinical effect after 1–2 weeks, the dose is increased to 10 mg. After taking the initial dose, the patient should be under the supervision of medical personnel for at least 3 hours until the blood pressure stabilizes.
If, when using a dose of 10 mg, the severity of the effect is not enough, it is possible to increase the daily dose to 40 mg (20 mg 2 times a day), provided that Enalapril-FPO is well tolerated. After 2-3 weeks, the patient is transferred to a maintenance dose, which is determined individually and can range from 10 to 40 mg per day in 1 or 2 doses. Patients with moderate arterial hypertension, as a rule, need a daily dose of 10 mg.
No more than 40 mg of enalapril is allowed per day.
In patients receiving diuretics, the diuretic should be discontinued 2-3 days before starting Enalapril-FPO. If this is not possible, treatment with enalapril begins with a daily dose of 2.5 mg.
In hyponatremia (the concentration of sodium ions in the blood serum is 0.14 mmol / l, the initial dose of enalapril should be 2.5 mg once a day.
In renovascular hypertension, treatment with the drug begins with a daily dose of 2.5–5 mg. If necessary, the dose is increased, but not more than 20 mg per day.
For patients with chronic heart failure, Enalapril-FPO is prescribed at the beginning of treatment at a dose of 2.5 mg once a day. In the future, every 3-4 days, depending on the clinical response, the dose is increased by 2.5-5 mg to the maximum tolerated dose, taking into account blood pressure indicators, but not more than up to 40 mg per day (in 1 or 2 doses). At low systolic pressure (<110 mm Hg), treatment is started with a dose of 1.25 mg of enalapril. Dose titration is carried out within 2-4 weeks (a shorter dose selection period is possible). The maintenance daily dose, depending on individual circumstances, can be from 5 to 20 mg in 1 or 2 doses.
In the elderly, the rate of excretion of enalapril decreases, which is manifested by a lengthening of the duration of action of Enalapril-FPO and a more pronounced hypotensive effect. For this reason, the recommended starting dose is 1.25 mg.
Dosing in patients with renal insufficiency depending on creatinine clearance (CC):
- CC 80-30 ml / min - 5-10 mg per day;
- CC 30-10 ml / min - 2.5-5 mg per day;
- CC <10 ml / min - 1.25–2.5 mg per day only on dialysis days.
Enalapril-FPO can be used as a monopreparation or in combination with other antihypertensive agents.
Side effects
In general, Enalapril-FPO is well tolerated and does not cause the development of side effects that would have to interrupt therapy.
Possible unwanted violations:
- on the part of the cardiovascular system: excessive decrease in blood pressure, orthostatic collapse; rarely - chest pain, angina pectoris, stroke / myocardial infarction (mainly due to a pronounced decrease in blood pressure); extremely rarely - a feeling of palpitations, arrhythmias (atrial fibrillation, atrial brady or tachycardia), Raynaud's syndrome, thromboembolism of the branches of the pulmonary artery;
- from the respiratory system: sore throat, hoarseness, unproductive dry cough, pharyngitis, rhinorrhea, shortness of breath, interstitial pneumonitis, bronchospasm, pulmonary infiltrates;
- from the nervous system: insomnia / drowsiness, headache, dizziness, increased fatigue, anxiety, weakness, confusion; very rarely when using high doses - paresthesia, depression, nervousness;
- from the digestive system: dry mouth, dyspeptic disorders (abdominal pain, nausea, vomiting, diarrhea / constipation), intestinal obstruction, jaundice, hepatocellular or cholestatic hepatitis, liver dysfunction, pancreatitis, anorexia, impaired bile secretion;
- from the senses: tinnitus, hearing impairment, vestibular apparatus and vision;
- from the urinary system: impaired renal function; rarely - proteinuria;
- allergic reactions: urticaria, itching, skin rashes, angioedema; extremely rare - glossitis, stomatitis, pemphigus, dysphonia, arthritis, myositis, vasculitis, arthralgia, serositis, photosensitization, intestinal edema, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
- on the part of laboratory indicators: hyponatremia, hyperkalemia, hyperbilirubinemia, increased activity of liver enzymes, increased urea, hypercreatininemia; in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents - hypoglycemia; in rare cases - eosinophilia, neutropenia, thrombocytopenia, increased ESR, decreased hemoglobin and hematocrit; in patients with autoimmune diseases - agranulocytosis;
- others: alopecia, hot flashes, decreased libido, impotence.
Overdose
An overdose of Enalapril-FPO is manifested by a pronounced decrease in blood pressure, up to seizures, stupor, acute cerebrovascular accident or thromboembolic complications, myocardial infarction, collapse.
In the event of an excessive dose, the patient should be given a horizontal position with a low headboard. With moderate symptoms, gastric lavage and saline intake are sufficient. In severe cases, measures are required to stabilize blood pressure: intravenous administration of saline and plasma substitutes, if necessary, hemodialysis and administration of angiotensin II.
special instructions
Before the appointment of Enalapril-FPO and during the period of its use, it is necessary to regularly monitor blood pressure, urine protein and blood parameters (creatinine, potassium, hemoglobin, activity of liver enzymes).
With ischemic heart disease, severe chronic heart failure and cerebrovascular disease, a sharp decrease in blood pressure is fraught with the development of renal dysfunction, stroke or myocardial infarction. Patients with these diseases during therapy should be under special medical supervision.
In the case of a decrease in the volume of circulating blood (due to restriction of salt intake, diarrhea, vomiting, diuretic therapy, hemodialysis), the risk of a sudden and pronounced decrease in blood pressure is increased, even after taking the first dose, therefore, patients need observation.
When exercising and in hot weather, patients receiving an ACE inhibitor should be careful, which is associated with the likelihood of an excessive decrease in blood pressure and the development of dehydration (due to a decrease in circulating blood volume).
With transient arterial hypotension, there is no need to discontinue drug therapy after pressure stabilization. If there are repeated episodes of a pronounced decrease in blood pressure, it is necessary to reduce the dose of Enalapril-FPO or cancel it altogether.
The use of high-flow dialysis membranes during dialysis increases the risk of anaphylactic reactions. On days free from dialysis, the dose of the drug is adjusted depending on the level of blood pressure.
During the period of therapy, one should not consume alcoholic beverages, since ethanol enhances the antihypertensive effect of Enalapril-FPO.
In the case of surgical intervention (including dental manipulations), the patient should warn the doctor about taking an ACE inhibitor.
Enalapril-FPO must be canceled before conducting a study of the function of the parathyroid glands.
Abrupt withdrawal of the drug does not contribute to the development of rebound syndrome (a sharp rise in blood pressure).
Influence on the ability to drive vehicles and complex mechanisms
At the beginning of the use of Enalapril-FPO (until the selection of the optimal therapeutic dose), patients are advised to refrain from performing potentially hazardous activities, since the drug can cause dizziness, especially after taking the initial dose with the concomitant use of diuretics.
Application during pregnancy and lactation
Enalapril is contraindicated during pregnancy and lactation.
If Enalapril-FPO was used during pregnancy for some reason, newborns and infants should be under close medical supervision in order to detect in time a possible decrease in blood pressure, hyperkalemia, oliguria and the development of neurological disorders due to a decrease in cerebral and renal blood flow against the background of a decrease in blood pressure.
Pediatric use
Age under 18 is a contraindication to the use of Enalapril-FPO.
With impaired renal function
With caution, Enalapril-FPO should be used in renal failure (in case of proteinuria more than 1 g / day), bilateral renal artery stenosis or stenosis of an artery of a single kidney, in conditions after kidney transplantation, as well as in patients undergoing hemodialysis.
In renal failure, the dose of enalapril is reduced depending on the level of creatinine clearance.
For violations of liver function
Enalapril-FPO should be used with caution in liver failure.
Use in the elderly
Enalapril-FPO should be used with caution in the elderly (over 65 years).
Drug interactions
- nonsteroidal anti-inflammatory drugs, including selective inhibitors of COX-2: the antihypertensive effect of enalapril may decrease; in some patients with impaired renal function, further deterioration of the renal condition is possible (usually these changes are reversible);
- antipyretic and analgesic drugs: it is possible to reduce the effect of enalapril;
- ethanol: there is a mutual enhancement of the effects;
- theophylline: its effectiveness is weakened;
- blockers of slow calcium channels of the dihydropyridine series, beta-blockers, diuretics, agents for general anesthesia, nitrates, prazosin, hydralazine, methyldopa: the hypotensive effect of enalapril is enhanced;
- cytostatics, immunosuppressants, allopurinol: hematotoxicity increases;
- lithium preparations: the excretion of lithium by the kidneys decreases, the risk of developing intoxication increases;
- drugs that cause bone marrow suppression: the likelihood of developing neutropenia and / or agranulocytosis increases;
- potassium-sparing diuretics (eg, triamterene, spironolactone, amiloride): hyperkalemia may develop;
- oral hypoglycemic agents and insulin: an increase in the hypoglycemic effect is possible, which is fraught with the development of hypoglycemia (most often observed in renal failure, as well as in the first weeks of simultaneous use of drugs; blood glucose levels should be monitored);
- gold preparations for parenteral use (for example, sodium aurothiomalate): in rare cases, a symptom complex develops, including facial flushing, arterial hypotension, nausea and vomiting.
Analogs
Enalapril-FPO analogues are: Zokardis 7.5, Zokardis 30, Angiopril-25, Captopril, Epsitron, Dapril, Lizakard, Irumed, Lizoril, Sinopril, Arentopres, Parnavel, Perineva, Amprilan, Vasolong, Corpril, Pyramil, Hartil Fosinap, Bagopril, Korandil, Renitek, Enalapril, Enam, Enap, etc.
Terms and conditions of storage
Store at temperatures up to 25 ° C out of reach of children, protected from light and moisture.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Enalapril-FPO
According to reviews, Enalapril-FPO is an effective antihypertensive agent, and therefore it is often prescribed for arterial hypertension. However, it has a number of contraindications and can cause side effects, therefore it should be used only as directed by a doctor and under his supervision.
Price for Enalapril-FPO in pharmacies
Approximate prices for Enalapril-FPO (20 tablets per pack): 5 mg - 30-44 rubles, 10 mg - 36-43 rubles, 20 mg - 42-59 rubles.
Enalapril-FPO: prices in online pharmacies
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Drug name Price Pharmacy |
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Enalapril-FPO 20 mg tablets 20 pcs. RUB 30 Buy |
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Enalapril-FPO 5 mg tablets 20 pcs. RUB 30 Buy |
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Enalapril-FPO 10 mg tablets 20 pcs. 35 RUB Buy |
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Enalapril-FPO 10mg tablets 20 pcs. RUB 38 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!
