Enalozide Mono 10 mg Pills No. 30 *

Enalozid Mono (Enalapril) Instructions for use

Composition:

active ingredient : enalapril; 1 tablet contains enalapril maleate, based on 100% substance 5 mg or 10 mg;
auxiliary substances (5 mg tablets): lactose, monohydrate, corn starch, povidone, calcium stearate.
auxiliary substances (10 mg tablets): lactose monohydrate, corn starch, povidone, calcium stearate.

Dosage form

Tablets.

Pharmacotherapeutic group

Angiotensin converting enzyme (ACE) inhibitors. ATC code C09AA02.

Indications

Essential hypertension, renovascular hypertension, heart failure.

Contraindications

Hypersensitivity to enalapril and other components of the drug;

• angioneurotic edema in the history associated with the appointment of ACE inhibitors;
• Bilateral stenosis of the renal arteries or renal artery stenosis of a single kidney;
• primary hyperaldosteronism;
• aortic or mitral valve stenosis, hypertrophic cardiomyopathy;
• collagenose;
• porphyria;
• severe hepatic impairment (precoma, hepatic coma);
• pregnancy and breastfeeding period;
• children under the age of 18 (due to lack of sufficient clinical experience).

Method of administration and dose

The drug can be taken regardless of the meal. The dose of the drug should be corrected in accordance with the patient's condition and his needs. The duration of treatment depends on its effectiveness and is determined by the physician.

Indications	Recommended daily dosages and
	Initial dose	Supportive dose	Maximum dose
Essential hypertension	Once 5 mg, sometimes 2 times 5 mg	10 - 20 mg, in exceptional cases 40 mg once or 2 x 20 mg	40 mg once or 2 times 20 mg
Heart failure	One time 2.5 mg	5 - 10 mg	20 mg
Renovascular hypertension	2.5 - 5 mg *	5 - 10 mg	10-20 mg *

* The initial and maximum daily dose is determined depending on the creatinine clearance rate. If it exceeds 0.5 ml / sec (30 ml / min), the initial dose is 5 mg / day, the maximum dose is 20 mg / day, if clearance is less than 0.5 ml / sec (30 ml / min), the initial dose is 2 , 5 mg / day, maximum - 10 mg / day.

In the case of the appointment of Enalozide Mono, patients receiving simultaneously diuretics, the initial dose of the drug should be 2.5 mg / day. In the future it is possible to increase the dose.

For elderly patients, the recommended starting dose is 1.25 mg, however, this category of patients is more likely to have a more pronounced hypotensive effect and prolong the duration of the drug, which is associated with a decrease in the rate of excretion of enalaprilat.

Patients with hyponatremia (the concentration of sodium ions in serum less than 130 mmol / l) the initial dose of Enalozide Mono should be 2.5 mg 1 time / day.

The dose selection should be done within 2-4 weeks or in less time. The average maintenance dose is 5 - 20 mg / day for 1 - 2 admissions.

The drug is used in both monotherapy and in combination with other antihypertensive drugs.

Adverse reactions

Side effects observed during the Enalozide Mono treatment are usually mild, transient and do not require withdrawal of the drug.

From the cardiovascular system: excessive reduction of blood pressure, orthostatic collapse, rarely - back pain, angina pectoris, myocardial infarction (usually associated with pronounced decrease in blood pressure), arrhythmias (brady or tachycardia, atrial fibrillation), palpitation, thromboembolism in the branches of the pulmonary artery , pain in the area of the heart, fainting, Raynaud's syndrome.

From the central nervous system: dizziness, headache, insomnia, weakness, increased fatigability, drowsiness (2-3%), rarely confusion, increased fatigue, very rarely when using high doses - increased excitability, depression, paresthesia.

From the sensory organs: violations of the vestibular apparatus, hearing impairment, taste, noise in the ears.

From the organs of vision: maybe a temporary disorder of vision, xanthopsis, and, in rare cases, visual hallucinations.

On the digestive system: dry mouth, anorexia, dyspeptic disorders (nausea, diarrhea or constipation, vomiting, pain in the abdomen), intestinal obstruction, pancreatitis, impaired liver function and biliary excretion, hepatitis (hepatocellular or cholestatic), jaundice.

From the respiratory system: non-productive dry cough, interstitial pneumonitis, bronchospasm / asthma, shortness of breath, rhinorrhea, pharyngitis, sore throat, hoarseness of the voice.

Allergic reactions: skin rash, angioneurotic edema of the face, extremities, lips, tongue, vocal cavity and / or larynx, dysphonia, polymorphic erythema, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, itching, urticaria, photosensitization, serositis, vasculitis

On the side of laboratory parameters: hypercalaminemia, increased urea, increased activity of hepatic transaminases, hyperbilirubinemia, hypercalemia, hyponatremia, decreased hemoglobin and hematocrit concentrations, increased erythrocyte sedimentation rate (ESR), thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases) , eosinophilia.

From the urinary system: impaired renal function, proteinuria.

From the musculoskeletal system: muscle cramps, muscle weakness, myalgia, back pain, arthralgia.

Endocrine disorders: antidiabetic hormone secretion syndrome, hypoglycaemia in patients who take anti-depressant drugs.

Other: alopecia, decreased libido, tides, stomatitis, glossitis, increased sweating, decreased potency.

Possible cases of paradoxical reaction in the form of increase of arterial pressure in the use of enalapril.

Overdose

Symptoms of overdose: excessive reduction of blood pressure up to the development of collapse, myocardial infarction, acute cerebrovascular accident or thromboembolic complications, convulsions, stupor.

Treatment: the patient is transferred to a horizontal position with a low head, immediately call the doctor if the dose received exceeds the prescribed. In mild cases, gastric lavage and intake of saline solution are indicated; in more serious cases, interventions aimed at stabilizing blood pressure, intravenous saline administration, plasma substitutes, and, if necessary, intravenous administration of angiotensin II, hemodialysis (enalaprilat elimination rate is 62 ml / min) .

Use during pregnancy and breastfeeding

Contraindicated in pregnancy. At the onset of pregnancy, enalapril should be stopped immediately. Enalapril is excreted in breast milk. If it needs to be used during lactation, the issue of discontinuation of breastfeeding should be solved.

Where are you

The safety and efficacy of the medication for the treatment of children has not been established, therefore it should not be prescribed to children under the age of 18 years.

Application features

Caution should be taken Enalozide Mono with primary hyperaldosteronism, bilateral renal artery stenosis, kidney artery stenosis, hypercalieemia, renal transplant status, aortic stenosis, mitral stenosis with hemodynamic disorders, idiopathic hypertrophic subareal stenosis, connective tissue diseases, coronary heart disease (CHD) ), cerebrovascular diseases, diabetes mellitus, renal failure (proteinuria more than 1 g / day), liver failure, with simultaneous administration with immunosuppressants and salurethics, in elderly patients (over 65 years of age).

If there is a high risk of developing arterial hypotension (vomiting, diarrhea, hemodialysis, diuretic treatment, severe heart failure), then the patient should receive the first dose of the drug in a medical facility and observe the patient for at least 5 hours. During the observation, the patient should be in the lying position.

It is recommended that patients with suspected vasorenic hypertension be treated in specialized hospitals.

Careful medical supervision should be performed when Enalozide Mono is administered to patients with severe heart failure, IBD and brain vessel diseases, in which a sharp decrease in blood pressure can lead to myocardial infarction, stroke, or impaired kidney function.

Caution is given to Enalozide Mono for patients with a reduced volume of circulating blood (as a result of diuretic therapy, with limited consumption of cooking salt, hemodialysis, diarrhea and vomiting), since the risk of a sudden and pronounced decrease in blood pressure after application of even the minimal dose of an ACE inhibitor is increased.Transient arterial hypotension is not a contraindication for continued treatment with Enalozide Mono after stabilizing the blood pressure. In the case of a repeated severe decrease in blood pressure, the dose should be reduced or the drug should be discontinued.

When appointing Enalozide Mono to patients on hemodialysis, it should be taken into account that the use of high-speed dialysis membranes increases the risk of anaphylactic reaction. Adjustment of the dosing regimen on days free of dialysis should be done depending on the level of blood pressure. Before and after the administration of Enalozide Mono, control of blood pressure, hemoglobin, potassium, creatinine, urea, liver enzyme activity, and protein in the urine are necessary.

Patients with an indication of the development of angioneurotic edema in the history of an increased risk of its development when receiving inhibitors ACE.

Sudden discontinuation of Enalozide Mono does not lead to a withdrawal syndrome (a sharp rise in blood pressure).

When oliguria it is necessary to maintain blood pressure and renal perfusion by introducing appropriate liquids and vasodilators.

Before examining the function of parathyroid glands, Enalozide Mono should be discontinued.

During the treatment with Enalozide Mono, it is possible to increase potassium content in serum, especially in patients with chronic renal failure, diabetes mellitus, with the simultaneous appointment of potassium-sparing diuretics (spirolonolactone, amiloride and triamterene is not recommended) or potassium preparations. Such patients should be advised of the need to seek medical advice in case of muscle weakness and arrhythmia. During the treatment with Enalozide Mono, caution should be exercised when exercising during hot weather, since there is a risk of dehydration and excessive reduction of blood pressure due to lowering the volume of circulating blood. During the treatment with Enalozide, Mono is not advised to consume alcoholic beverages.

Prior to surgical intervention (including dentistry), an anesthetist / surgeon should be warned about the use of ACE inhibitors.

The enalozide mono contains lactose, therefore this preparation is not recommended for patients with congenital galactose intolerance, lactase deficiency or glucose or galactose absorption.

Ability to influence the reaction speed when driving or operating with other mechanisms

During the treatment period, it is necessary to refrain from driving motor vehicles and occupations as potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions, since possibly dizziness, especially after the initial dose of ACE inhibitor and in patients taking diuretic drugs.

Interaction with other drugs and other types of interactions

• Simultaneous administration with non-steroidal anti-inflammatory drugs (NSAIDs) can reduce the hypotensive effect of Enalozide Mono;
• joint use with potassium-sparing diuretics can cause hyperkalemia;
• the simultaneous application of Enalozide Mono and lithium salts leads to slowing down the release of lithium;
• simultaneous administration of the drug with antipyretic and analgesics may reduce the effectiveness of Enalozide Mono;
• Enalozide Mono weakens the effect of the drugs containing theophylline;
• cimetidine prolongs the period of Enalozide Mono;
• estrogens reduce the effectiveness of the drug;
• when applied with Nimodipine, heart rhythm disorders may occur, and congestive heart failure is increased;
• when combined with allopurinol, cytostatics, immunosuppressants, systemic corticosteroids, leukopenia, anemia, pancytopenia may occur;
• at the simultaneous appointment with pressor amines - the mutual weakening of the effects;
• During treatment it is forbidden to use alcoholic beverages, since alcohol strengthens hypotensive action of the preparation.

Pharmacological properties

Pharmacodynamics. Angiotensin converting enzyme inhibitor (ACE). Enalozide Mono belongs to a group of antihypertensive drugs. Pharmacological activity has the enalapril metabolite enalaprilat. It suppresses the formation of angiotensin II and eliminates its vasoconstrictor effect, causes a gradual decrease in systolic and diastolic blood pressure without significantly altering the heart rate and minute volume of blood, reduces left ventricular hypertrophy, increases renal blood flow, improves renal function and prevents the progression of diabetic nephropathy.

Pharmacokinetics . After ingestion from the gastrointestinal tract, about 60% of enalapril is absorbed. The reception of food does not affect its suction. The therapeutic effect develops 1 hour after receiving, reaches a maximum in 4 - 6 hours and lasts for 24 hours. Enalapril is subjected to hydrolysis with the formation of enalaprilat, whose maximum concentration in the blood is observed after 3 - 4 hours. The half-life of enalaprilat is 11 hours. The drug is excreted by the kidneys (60%) and feces (33%). In patients with severe renal insufficiency, the half-life of enalaprilat is increased.Penetrates through the placenta and into breast milk. Is excreted from the body during hemodialysis.

Pharmaceutical characteristics

Basic physical and chemical properties:

Pills of white or white with a creamy shade of color, with a flat surface, a facet and a risk, or without risk.

Shelf life.

3 years. Do not apply after the expiry date stated on the packaging.

Storage conditions

Keep out of the reach of children, protected from light at a temperature not exceeding 25 ° C.

Packaging

10 tablets in a blister. 2 blister packs.

Vacation category.

By recipe