Egipres caps 5mg + 5mg #30

Egipres user manual

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Egipres is a combined drug with an antihypertensive effect.

Release form and composition

Egipres dosage form - Coni-Snap capsules: hard gelatinous, self-closing; capsules contain a mixture of granules and powders from almost white to white, odorless or almost odorless (in a cardboard box 3 or 9 blisters of 10 capsules or 4 or 8 blisters of 7 capsules):
    Egipres 2.5 + 2.5 mg: size No. 3, body and lid are light pink;
    Egipres 5 + 5 mg: size No. 3, body and lid are light burgundy;
    Egipres 5 + 10 mg: size No. 0, light pink body, light burgundy cap;
    Egipres 10 + 5 mg: size No. 0, body light pink, maroon cap;
    Egipres 10 + 10 mg: size No. 0, body and lid are maroon.
Composition of 1 capsule:
    active ingredients: amlodipine (amlodipine besylate) + ramipril - 2.5 (3.475) mg + 2.5 mg; 5 (6.95) mg + 5 mg; 5 (6.95) mg + 10 mg; 10 (13.9) mg + 5 mg; 10 (13.9) mg + 10 mg;
    auxiliary components: crospovidone, hypromellose, glyceryl dibegenate, microcrystalline cellulose;
    Coni-Snap capsule for a dosage of 2.5 mg + 2.5 mg (capsule color code - 37350): red iron oxide dye (E172), titanium dioxide, gelatin;
    Coni-Snap capsule for a dosage of 5 mg + 5 mg (capsule color code - 51072): brilliant blue dye (E133), charming red dye (E129), titanium dioxide, gelatin;
    Coni-Snap capsule for a dosage of 5 mg + 10 mg (cap color code - 51072, bases - 37350): base - titanium dioxide, iron oxide red dye (E172), gelatin; cover - titanium dioxide, brilliant blue dye (E133), charming red dye (E129), gelatin;
    Coni-Snap capsule for a dosage of 10 mg + 5 mg (cap color code - 33007, bases - 37350): base - titanium dioxide, iron dye red oxide (E172), gelatin; cover - titanium dioxide, indigo carmine (E132), azorubin dye (E122), gelatin;
    Coni-Snap capsule for a dosage of 10 mg + 10 mg (capsule color code - 33007): indigo carmine (E132), titanium dioxide, azorubin dye (E122), gelatin.

Pharmacodynamics

Egipres is one of the combined antihypertensive drugs, contains an ACE (angiotensin converting enzyme) inhibitor and a slow calcium channel blocker.

Amlodipine

Amlodipine is a dihydropyridine derivative. It has antianginal and antihypertensive effects.
Due to the binding to dihydropyridine receptors, slow calcium channels are blocked, the transmembrane transition of calcium into the cells of smooth muscles of the heart and blood vessels is inhibited (it is more pronounced in vascular smooth muscle cells than in cardiomyocytes).
The mechanism of the antihypertensive action of the substance is associated with a direct relaxing effect on vascular smooth muscles.
Reduction of myocardial ischemia occurs in two ways:
    Expansion of peripheral arterioles and, as a consequence, a decrease in the total peripheral vascular resistance (afterload), while the heart rate (heart rate) practically does not change. Due to this, there is a decrease in energy consumption and myocardial oxygen demand.
    Expansion of coronary / peripheral arteries and arterioles in normal and ischemic zones of the myocardium, thereby increasing the supply of oxygen to the myocardium in patients with vasospastic angina (Prinzmetal angina) and preventing the occurrence of smoking-induced coronary spasm.
The daily dose of amlodipine in patients with arterial hypertension provides a decrease in blood pressure (blood pressure) for 24 hours (lying and standing). The onset of action of the substance is slow, so a sharp decrease in blood pressure does not occur.
With angina pectoris, a single daily dose of the drug increases the duration of physical activity, contributes to a delay in the development of the next attack of angina pectoris and depression of the ST segment (by 1 mm) against the background of physical exertion, a decrease in the frequency of angina attacks and the need for nitroglycerin.
In the presence of diseases of the cardiovascular system (including coronary atherosclerosis with damage from one vessel to stenosis of three or more arteries and atherosclerosis of the carotid arteries), as well as in patients who have undergone percutaneous transluminal angioplasty of the coronary arteries (TPA), myocardial infarction or suffering from angina pectoris, amlodipine therapy prevents the onset of thickening of the intima-media complex of the carotid arteries, significantly reduces mortality from cardiovascular pathologies, stroke, myocardial infarction, TLP, coronary artery bypass grafting. Also, taking the drug helps to reduce the number of hospitalizations for unstable angina pectoris and the progression of chronic heart failure, and reduces the frequency of interventions that are aimed at restoring coronary blood flow.
In chronic heart failure of NYHA functional class III – IV, amlodipine does not increase the risk of death or complications and deaths during therapy with digoxin, angiotensin-converting enzyme (ACE) inhibitors and diuretics. In patients with non-ischemic etiology of the disease, when using amlodipine, there is a risk of developing pulmonary edema. It does not cause unfavorable metabolic effects, including does not affect the content of lipid profile indicators.

Ramipril

Ramipril is an ACE inhibitor. Ramiprilat is an active metabolite of ramipril, formed with the participation of liver enzymes and is a long-acting inhibitor of the enzyme dipeptidylcarboxypeptidase I. Promotes the catalization of the conversion of angiotensin I into the active vasoconstrictor substance angiotensin II, as well as the breakdown of bradykinin. Due to a decrease in the formation of angiotensin II and inhibition of the breakdown of bradykinin, vasodilation and a decrease in blood pressure occur. An increase in the activity of the kallikrein-kinin system in tissues and blood determines the endothelioprotective and cardioprotective effect of ramipril (provided by the activation of the prostaglandin system and, accordingly, an increase in the synthesis of prostaglandins, which stimulate the formation of nitric oxide in endothelial cells).
The production of aldosterone is stimulated by angiotensin II, so taking ramipril leads to a decrease in aldosterone secretion and an increase in serum potassium ions.
Against the background of a decrease in the content of angiotensin II in the blood, its inhibitory effect on renin secretion is eliminated by the type of negative feedback, due to which an increase in the activity of blood plasma renin is observed.
There is an assumption that an increase in the activity of bradykinin leads to the occurrence of some undesirable reactions (for example, dry cough).
Taking ramipril in patients with arterial hypertension helps to reduce blood pressure in the standing and lying position, without a compensatory increase in heart rate. Also, the total peripheral vascular resistance is significantly reduced, while renal blood flow and glomerular filtration rate practically do not change. The development of antihypertensive action is manifested within 1-2 hours after ingestion of a single dose of Egipres, the greatest value is achieved after 3-6 hours, its total duration is 24 hours. The antihypertensive effect during the course of administration can gradually increase, usually it stabilizes by the 3-4th week of regular administration and then persists for a long time. A sudden discontinuation of Egipres does not lead to a significant and rapid increase in blood pressure (there is no withdrawal syndrome).
With arterial hypertension, there is a slowdown in the development and progression of hypertrophy of the vascular wall and myocardium.
Against the background of chronic heart failure, ramipril lowers the total peripheral vascular resistance (afterload on the heart decreases), increases the capacity of the venous bed and reduces the filling pressure of the left ventricle. Due to this, there is a decrease in the preload on the heart. In this group of patients, during therapy, there is an increase in cardiac output, ejection fraction, and also improves exercise tolerance.
Taking ramipril for diabetic / nondiabetic nephropathy helps to slow the rate of progression of renal failure and the time to end-stage renal failure, while reducing the need for hemodialysis or kidney transplantation procedures. In the initial stages of the disease, ramipril reduces the severity of albuminuria.
With a high risk of cardiovascular diseases due to the presence of vascular lesions (diagnosed coronary heart disease, aggravated history of stroke and obliterating peripheral arterial disease) or diabetes mellitus with at least one additional risk factor (including microalbuminuria, arterial hypertension, smoking , decrease in high-density lipoprotein cholesterol, increase in total cholesterol), the addition of ramipril to standard therapy can significantly reduce the incidence of stroke, myocardial infarction and mortality from cardiovascular causes. Ramipril also reduces overall mortality rates, slows the onset / progression of chronic heart failure, and the need for revascularization procedures.
Against the background of heart failure, which developed in the first days of acute myocardial infarction (for 2-9 days), when taking ramipril in the period from 3 to 10 days, the following effects are observed (in the form of a decrease in the risk of such diseases / conditions, on average by 26 thirty%):
    Progression of chronic heart failure to severe (NYHA functional class III – IV) resistant to therapy.
    Follow-up hospitalization due to the development of heart failure.
    Mortality rate and sudden death.
Ramipril significantly reduces the likelihood of nephropathy and the development of microalbuminuria in the general population of patients, as well as in diabetes mellitus with / without arterial hypertension.

Pharmacokinetics

Amlodipine

After oral administration of therapeutic doses, it is well absorbed, the time to reach Cmax (maximum concentration of the substance) in blood plasma is from 6 to 12 hours. The absolute bioavailability is in the range of 64–80%. Food intake has no effect on the absorption of amlodipine.
Vd (volume of distribution) - approximately 21 l / kg. Plasma protein binding is about 97.5%. Penetrates the blood-brain barrier.
Css (stationary concentration of a substance in the blood) is in the range of 5-15 ng / ml, the time to reach it is from 7 to 8 days of daily intake of the drug.
It is not known whether amlodipine is excreted in breast milk.
Metabolism occurs in the liver with the formation of inactive metabolites. The unchanged substance and metabolites are excreted by the kidneys (10 and 60%, respectively), through the intestines - about 20% of the dose.
T1 / 2 (half-life) from blood plasma is approximately 35-50 hours, this corresponds to the appointment of the drug once a day. The total ground clearance is 0.43 l / h / kg.
With liver failure and severe chronic heart failure, T1 / 2 increases to 56-60 hours, with renal failure - up to 60 hours. The change in the plasma concentration of amlodipine in the blood does not correlate with the degree of renal dysfunction. Amlodipine is not removed during hemodialysis.
In elderly patients, the indicators Tmax (time to reach the maximum concentration of the substance) and Cmax practically do not differ from those in younger patients. In elderly patients with chronic heart failure, there is a tendency to a decrease in the clearance of amlodipine, this leads to an increase in AUC (area under the pharmacokinetic curve "concentration-time") and T1 / 2.

Ramipril

After oral administration, it is rapidly absorbed from the gastrointestinal tract (approximately 50-60%). Food intake slows down its absorption, but does not affect the degree of absorption.
The bioavailability of ramipril ranges from 15 to 28% (for a dose of 2.5 and 5 mg, respectively), ramiprilat (after oral administration of 2.5 and 5 mg of ramipril) - about 45% (in comparison with its bioavailability after intravenous administration in the same doses).
Cmax in blood plasma of ramipril and ramiprilat after oral administration of ramipril is achieved after 1 and 2-4 hours, respectively. The concentration of ramiprilat in blood plasma decreases in several stages: the distribution / excretion phase with T1 / 2 of ramiprilat (about 3 hours), an intermediate phase with T1 / 2 of ramiprilat (about 15 hours), the final phase with a very low concentration of ramiprilat in blood plasma and T1 / 2 ramiprilat (about 4-5 days). The final phase is caused by the slow release of ramiprilat from a strong bond with ACE receptors. When the drug is taken orally 1 time per day at a dose of 2.5 mg or more, the Css of ramiprilat is achieved after about 4 days of therapy. With the course use of Egipres, the effective T1 / 2 is 13-17 hours (depending on the dose).
The binding of ramipril to blood plasma proteins is about 73%, ramiprilat is 56%.
When administered intravenously, the Vd of ramipril and ramiprilat are approximately 90 and 500 liters (respectively).
Ramipril undergoes intensive first-pass metabolism / activation (mainly by hydrolysis in the liver) as a result of which its only active metabolite, ramiprilat, is formed. The activity of ramiprilat in relation to ACE inhibition is approximately 6 times higher than that of ramipril. Also, in the process of metabolism of ramipril, a pharmacologically inactive diketopiperazine is formed, then it is conjugated with glucuronic acid. In addition, ramiprilat is glucuronid and metabolized to diketopiperazic acid.
Excretion of ramipril after oral administration occurs through the intestines and kidneys (39 and 60%, respectively). After taking 5 mg of ramipril in patients with drainage of the bile ducts, the substance and its metabolites are excreted in almost equal amounts by the kidneys and through the intestines during the first 24 hours after administration.
Approximately 80–90% of metabolites in bile and urine are identified as ramiprilat and ramiprilat metabolites. Ramipril glucuronide and ramipril diketopiperazine make up approximately 10-20% of the total, the content of unchanged ramipril in urine is about 2%.
Excretion by the kidneys of ramiprilat and its metabolites in case of impaired renal function with CC (creatinine clearance) less than 60 ml / min slows down. Because of this, the plasma concentration of ramiprilat in the blood increases, which decreases more slowly than in patients with no renal impairment.
When taking high doses of ramipril (10 mg), impaired hepatic function leads to a slowdown in the first-pass metabolism of ramipril to active ramiprilat and its slower elimination.
In chronic heart failure, after 14 days of therapy with ramipril in a daily dose of 5 mg, a 1.5-1.8-fold increase in AUC and plasma concentrations of ramiprilat in the blood was noted.

Indications for use

According to the instructions, Egipres is prescribed for the treatment of hypertension in cases of indications for combination therapy with amlodipine and ramipril in doses corresponding to those contained in the drug.

Contraindications

Amlodipine

    shock (including cardiogenic), severe arterial hypotension (with systolic blood pressure <90 mm Hg);
    condition after myocardial infarction against the background of hemodynamically unstable heart failure;
    obstructive process, in which the ejection of blood from the left ventricle is difficult (in particular, clinically significant aortic stenosis);
    pregnancy and lactation;
    age under 18;
    individual intolerance to amlodipine and other dihydropyridine derivatives.

Ramipril

    arterial hypotension (with systolic blood pressure <90 mm Hg) or conditions in which unstable hemodynamic parameters are noted;
    burdened history of angioedema (hereditary / idiopathic, as well as associated with previous therapy with ACE inhibitors);
    myocardial infarction in the acute stage against the background of severe heart failure (NYHA functional class IV), life-threatening ventricular arrhythmias, cor pulmonale;
    hypertrophic obstructive cardiomyopathy or hemodynamically significant stenosis of the aortic or mitral valve;
    nephropathy, the treatment of which is carried out with glucocorticosteroids, non-steroidal anti-inflammatory drugs, immunomodulators and / or other cytotoxic drugs (due to lack of experience in clinical use);
    decompensated chronic heart failure (associated with a lack of experience in clinical use);
    primary hyperaldosteronism;
    severe renal failure (CC <20 ml / min / 1.73 m2);
    hemodynamically significant renal artery stenosis (unilateral in the case of a single kidney or bilateral);
    hemodialysis / hemofiltration using certain membranes with a negatively charged surface, such as high-flow polyacrylonitrile membranes (associated with the risk of hypersensitivity reactions);
    hemodialysis (due to lack of experience in clinical use);
    apheresis with low density lipoproteins with the use of dextran sulfate (associated with the risk of hypersensitivity reactions);
    combined therapy with drugs containing aliskiren in patients with impaired renal function (CC less than 60 ml / min) and diabetes mellitus;
    desensitizing treatment against the background of hypersensitivity reactions to insect poisons, including wasps, bees;
    pregnancy and lactation;
    age under 18;
    individual intolerance to ramipril and other ACE inhibitors.

Amlodipine + ramipril

Absolute contraindications:
    severe renal failure (CC <20 ml / min / 1.73 m2);
    pregnancy and lactation;
    age under 18;
    individual intolerance to the components of the drug.
Relative contraindications (Egipres is prescribed under medical supervision):
    an increase in the activity of the RAAS (renin-angiotensin system), in which, due to the inhibition of ACE, there is a risk of a sharp decrease in blood pressure with deterioration of renal function;
    atherosclerotic lesions of the coronary / cerebral arteries (associated with the danger of an excessive decrease in blood pressure);
    chronic heart failure, especially in severe course or for which therapy with other drugs with antihypertensive action is carried out;
    severe arterial hypertension, especially malignant;
    previous diuretic therapy;
    hemodynamically significant unilateral renal artery stenosis (in the presence of two kidneys);
    a decrease in the volume of circulating blood, violations of the water-electrolyte balance (including against the background of adherence to a salt-free diet, taking diuretics, vomiting, diarrhea, profuse sweating);
    impaired hepatic function (associated with a lack of experience in use; there may be an increase / decrease in the effects of ramipril; a significant activation of the RAAS is possible in cirrhosis of the liver with edema and ascites);
    combination therapy with drugs containing aliskiren (with a double blockade of the RAAS, the risk of a sharp decrease in blood pressure, deterioration of renal function and hyperkalemia increases);
    impaired renal function (CC> 20 ml / min);
    systemic connective tissue diseases (including scleroderma, systemic lupus erythematosus), concomitant treatment with drugs that can cause changes in the peripheral blood picture, including allopurinol, procainamide (possible complications - the development of agranulocytosis or neutropenia, inhibition of bone marrow hematopoiesis);
    condition after kidney transplantation;
    diabetes mellitus (associated with the risk of developing hyperkalemia);
    hyponatremia;
    hyperkalemia;
    chronic heart failure of non-ischemic etiology of III – IV functional class according to NYHA classification;
    sick sinus syndrome;
    aortic stenosis;
    arterial hypotension;
    mitral stenosis;
    renovascular hypertension;
    the only functioning kidney;
    general anesthesia / surgery;
    combined use with estramustine, dantrolene, potassium-sparing diuretics and potassium preparations, potassium-containing substitutes for table salt, lithium preparations;
    performing hemodialysis using high-flow membranes (for example, AN69);
    old age (associated with the risk of increased antihypertensive action).

Instructions for the use of Egipres: method and dosage

Egipres is taken orally 1 time per day, 1 capsule, regardless of the meal, preferably at the same time.
The dose is selected on the basis of the previously performed titration of doses of the individual components of Egipres - ramipril and amlodipine. The drug is not intended for initial therapy.
If there are indications for dose adjustment, it should be carried out only by selecting doses of active substances in monotherapy.
The maximum daily dose of Egipres is 10 + 10 mg. Also, the maximum daily doses are considered for individual active components: for amlodipine - 10 mg of amlodipine + 5 mg of ramipril; for ramipril - 5 mg of amlodipine + 10 mg of ramipril.
Against the background of diuretic therapy, Egipres is prescribed with caution, which is associated with the likelihood of a risk of imbalance in water and electrolyte balance. This group of patients is indicated for monitoring renal function and potassium levels in the blood.
In elderly patients and patients with renal insufficiency, the excretion of the active components and metabolites of ramipril is slowed down. Such patients are shown regular monitoring of the content of creatinine and potassium in the blood plasma. With CC <60 ml / min, as well as in patients with arterial hypertension on hemodialysis, Egipres is recommended to be prescribed only if, during the titration of an individual dose, they received 2.5 or 5 mg of ramipril as the optimal maintenance dose. In case of impaired renal function, there is no need to titrate amlodipine.
Caution is required in the case of the appointment of Egipres against the background of hepatic failure, due to the lack of recommendations on the dosage regimen. The drug can only be used in patients who received 2.5 mg of ramipril as the optimal maintenance dose during titration of the individual dose.

Side effects

Estimation of the incidence of adverse reactions (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 0.01% and <0.1% - rarely; < 0.01% - very rare).

Amlodipine

    musculoskeletal system: infrequently - arthrosis, back pain, myalgia, arthralgia, muscle cramps; rarely - myasthenia gravis;
    cardiovascular system: often - palpitations, peripheral edema (feet and ankles); infrequently - orthostatic hypotension, excessive lowering of blood pressure, vasculitis; rarely - development / worsening of heart failure; very rarely - chest pain, myocardial infarction, migraine, cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation);
    digestive system: often - nausea, abdominal pain; infrequently - dyspepsia, anorexia, diarrhea, vomiting, changes in bowel movements (including flatulence, constipation), thirst, xerostomia; rarely - gingival hyperplasia, increased appetite; very rarely - gastritis, hepatitis, increased activity of hepatic transaminases, hyperbilirubinemia, pancreatitis, jaundice (usually cholestatic);
    nervous system: often - increased fatigue, feeling of heat and flushing of the skin of the face, headache, dizziness, drowsiness; infrequently - peripheral neuropathy, mood lability, insomnia, unusual dreams, tremors, fainting, malaise, increased sweating, hypesthesia, asthenia, paresthesia, depression, nervousness, anxiety; rarely - apathy, convulsions; very rarely - amnesia, ataxia; isolated cases - extrapyramidal syndrome;
    urinary system: infrequently - painful / frequent urination, impotence, nocturia; very rarely - polyuria, dysuria;
    hematopoietic system: very rarely - leukopenia, thrombocytopenia, thrombocytopenic purpura;
    respiratory system: infrequently - nosebleeds, rhinitis, shortness of breath; very rarely - cough;
    metabolism: very rarely - hyperglycemia;
    sense organs: infrequently - visual impairment, ringing in the ears, diplopia, taste perversion, accommodation disorder, conjunctivitis, xerophthalmia, eye pain; very rarely - parosmia;
    allergic / dermatological reactions: infrequently - rash, alopecia, pruritus; very rarely - erythema multiforme, angioedema, dermatitis, urticaria; very rarely - a violation of skin pigmentation, xeroderma;
    others: infrequently - weight loss / gain, gynecomastia, chills; very rarely - cold sweat.

Ramipril

    immune system: with an unknown frequency - an increase in the titer of antinuclear antibodies, anaphylactic / anaphylactoid reactions (especially to insect poisons);
    nervous system: often - a feeling of lightness in the head, headache; infrequently - ageusia, dizziness, paresthesia, dysgeusia; rarely - imbalance, tremor; with an unknown frequency - cerebral ischemia, including transient cerebrovascular accident and ischemic stroke, parosmia, impaired psychomotor reactions;
    musculoskeletal system: often - myalgia, muscle cramps; infrequently - arthralgia;
    cardiovascular system: often - excessive lowering of blood pressure, syncope, violation of orthostatic regulation of vascular tone (orthostatic hypotension); infrequently - flushes of blood to the skin of the face, myocardial ischemia, including the development of an attack of angina pectoris or myocardial infarction, tachycardia, the appearance / intensification of arrhythmias, peripheral edema, palpitations; rarely - vasculitis, the appearance / intensification of circulatory disorders against the background of stenosing vascular lesions; with an unknown frequency - Raynaud's syndrome;
    digestive system: often - inflammatory reactions in the intestines and stomach, diarrhea, indigestion, dyspepsia, abdominal discomfort, vomiting, nausea; infrequently - pancreatitis, including fatal (extremely rare), intestinal angioedema, increased activity of pancreatic enzymes in the blood plasma, abdominal pain, constipation, gastritis, xerostomia; rarely - glossitis; with an unknown frequency - aphthous stomatitis;
    reproductive system: infrequently - transient impotence (due to erectile dysfunction), decreased libido; with an unknown frequency - gynecomastia;
    respiratory system: often - dry cough (worse when lying down and at night), shortness of breath, sinusitis, bronchitis; infrequently - nasal congestion, bronchospasm, including aggravation of the course of bronchial asthma;
    urinary system: infrequently - impaired renal function, including an increase in the amount of urine excreted, the development of acute renal failure, an increase in pre-existing proteinuria, an increase in the concentration of creatinine and urea in the blood;
    hematopoietic system: infrequently - eosinophilia; rarely - leukopenia, including agranulocytosis and neutropenia, a decrease in the number of erythrocytes in the peripheral blood, a decrease in hemoglobin, thrombocytopenia; with an unknown frequency - pancytopenia, inhibition of bone marrow hematopoiesis, hemolytic anemia;
    hepatobiliary system: infrequently - an increase in the content of conjugated bilirubin in the blood plasma and the activity of liver enzymes; rarely - hepatocellular lesions, cholestatic jaundice; with an unknown frequency - cholestatic / cytolytic hepatitis (in extremely rare cases with a fatal outcome), acute liver failure;
    psyche: infrequently - sleep disturbances (including drowsiness), anxiety, depressed mood, restlessness, nervousness; rarely - confusion of consciousness; with an unspecified frequency - impaired concentration;
    sense organs: infrequently - visual impairment, including blurred vision; rarely - ringing in the ears, hearing impairment, conjunctivitis;
    skin and subcutaneous tissue: often - skin rash; infrequently - angioedema (with laryngeal edema, a fatal outcome is possible), hyperhidrosis, itching; rarely - onycholysis, urticaria, exfoliative dermatitis; very rarely - photosensitivity reactions; with an unknown frequency - aggravation of the course of psoriasis, Stevens-Johnson syndrome, pemphigus, toxic epidermal necrolysis, erythema multiforme, alopecia, psoriasis-like dermatitis, pemphigoid / lichenoid enanthema or exanthema;
    metabolism: often - an increase in the content of potassium in the blood; infrequently - anorexia, decreased appetite; with an unknown frequency - syndrome of inadequate secretion of antidiuretic hormone, a decrease in the concentration of sodium in the blood;
    others: often - feeling tired, chest pain; infrequently - an increase in body temperature; rarely, weakness.

Overdose

There is no information on an overdose of Egipres.

Amlodipine

The main symptoms: a pronounced decrease in blood pressure, possibly in combination with reflex tachycardia and excessive peripheral vasodilation (there is a risk of persistent and severe arterial hypotension, including with the development of shock and death).
Therapy: activated charcoal (especially in the first 2 hours after an overdose), gastric lavage; limbs should be given an elevated position; also shows the active maintenance of the functions of the cardiovascular system and monitoring the performance of the heart and lungs, control of the volume of circulating blood and urine output. In the absence of contraindications in order to restore blood pressure and vascular tone, it is possible to use drugs with a vasoconstrictor effect. Intravenous calcium gluconate is used. Hemodialysis is ineffective.

Ramipril

The main symptoms: excessive peripheral vasodilation, accompanied by the development of a pronounced decrease in blood pressure, shock; reflex tachycardia or bradycardia, acute renal failure, water-electrolyte disturbances, stupor.
Therapy: gastric lavage, the use of adsorbents, sodium sulfate (if possible, within the first 30 minutes). In cases of a pronounced decrease in blood pressure, the patient must be laid with raised legs, active maintenance of the function of the cardiovascular system is required; in addition to therapy to replenish circulating blood volume and restore electrolyte balance, α1-adrenergic receptor agonists (dopamine, norepinephrine) and angiotensinamide may be prescribed. It may be necessary to install a temporary artificial pacemaker. Shown to control the content of creatinine and electrolytes in the blood serum. With the help of hemodialysis, ramiprilat is poorly excreted from the blood.

Special instructions

Amlodipine

Depending on the indications, amlodipine can be prescribed as part of a combination therapy:
    arterial hypertension: thiazide diuretics, α- and β-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, non-steroidal anti-inflammatory drugs, antibacterial and oral hypoglycemic agents;
    angina pectoris: other antianginal drugs, including in patients refractory to therapy with nitrates and / or β-blockers in adequate doses.
With low body weight, short stature, as well as severe hepatic impairment, a lower dose may be required.
During the period of therapy, control of body weight and observation by a dentist are indicated.

Ramipril

Before using ramipril, hyponatremia and hypovolemia must be eliminated. Patients who have previously taken diuretics should cancel them or at least reduce the dose 2-3 days before starting the drug.
After taking the first dose of ramipril, as well as with an increase in its dose and / or the dose of diuretics (especially loop diuretics), regular medical monitoring of the patient's condition should be provided for at least eight hours.
When using ramipril for the first time or when using it in high doses in patients with increased RAAS activity, regular monitoring of blood pressure is required, especially at the beginning of the course. In case of heart failure and malignant arterial hypertension, the use of the drug should be started only in stationary conditions.
Particular care is required when using the drug in elderly patients, since they may have an increased sensitivity to the action of ACE inhibitors; in the initial phase of therapy, monitoring of renal function indicators is recommended.
Due to the risk of increased sweating and dehydration with arterial hypotension due to a decrease in circulating blood volume, and a decrease in blood sodium content, patients should be careful with physical activity and / or in hot weather.
Drinking alcohol while taking ramipril is not recommended.
Transient arterial hypotension is not a contraindication for continuing treatment; Egipres can be used after BP stabilization. In cases of repeated development of severe arterial hypotension, it is necessary to reduce the dose / cancel therapy.
It is required to take into account the possibility of angioedema of the extremities, face, tongue, lips, larynx or pharynx, as well as intestinal angioedema, manifested by abdominal pain with / without vomiting and nausea.
Against the background of impaired hepatic function, the response to treatment with Egipres can be enhanced or weakened. In severe liver cirrhosis with edema / ascites, significant activation of the RAAS is possible, which requires increased caution.
If it is necessary to carry out a surgical intervention (including dental), the surgeon and anesthesiologist should be warned about the use of Egipres.
The condition of newborns who have been exposed to intrauterine exposure to ramipril is recommended to be closely monitored to detect arterial hypotension, hyperkalemia and oliguria.
Against the background of taking Egipres, a dry cough may be observed, which persists for a long time against the background of the use of ACE inhibitors, but after their cancellation it passes on its own.
Before / during treatment with ramipril (in the first 3-6 months of therapy - up to 1 time per month), the following laboratory parameters are monitored:
    the concentration of bilirubin in the blood and the activity of liver enzymes;
    serum creatinine (to control kidney function);
    electrolyte content;
    hematological parameters (number of platelets, erythrocytes, leukocytes, hemoglobin content, leukocyte formula).

Influence on the ability to drive vehicles and complex mechanisms

Patients during the period of taking Egipres from driving are advised to refrain from driving.

Application during pregnancy and lactation

Egipres is not prescribed during pregnancy / lactation.
Ramipril can negatively affect the fetus, which manifests itself in the form of violations of the development of the kidneys of the fetus, a decrease in blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, hypoplasia of the skull bones, oligohydramnios, contracture of the extremities, deformation of the bones of the skull, hypoplasia of the lungs. In women of childbearing age, pregnancy should be excluded before starting therapy.
When planning a pregnancy, taking Egipres is canceled.

Childhood use

Egipres therapy is contraindicated in patients under 18 years of age.

With impaired renal function

Reception of Egipres is contraindicated in the following kidney pathologies:
    severe renal failure (CC <20 ml / min / 1.73 m2);
    hemodynamically significant renal artery stenosis (bilateral or unilateral in the case of a single kidney);
    nephropathy, for the treatment of which glucocorticosteroids, nonsteroidal anti-inflammatory drugs, immunomodulators and / or other cytotoxic agents are used;
    hemodialysis.
A relative contraindication for the use of the drug is impaired renal function with CC> 20 ml / min.

For violations of liver function

Egipres therapy is carried out with caution in case of liver dysfunction and liver cirrhosis with ascites / edema.

Use in the elderly

Egipres therapy in elderly patients should be carried out with caution.

Drug interactions

Amlodipine

    inducers of enzymes of microsomal liver oxidation: the plasma concentration of amlodipine and the risk of side effects decreases;
    inhibitors of enzymes of microsomal liver oxidation: the plasma concentration of amlodipine and the risk of side effects increases;
    α1-blockers, antipsychotics: the antihypertensive effect is enhanced;
    thiazide and loop diuretics, verapamil, ACE inhibitors, β-blockers, nitrates: antianginal and antihypertensive effects are enhanced;
    lithium preparations: the manifestations of their neurotoxicity increase;
    antiarrhythmic drugs that cause prolongation of the QT interval: amlodipine potentiates the severity of their negative inotropic action;
    dantrolene (intravenously), inducers of CYP3A4 (in particular, St. John's wort preparations, rifampicin) and CYP3A4 inhibitors (antifungal drugs of the azole group, protease inhibitors, macrolides, in particular, clarithromycin or erythromycin, diltiazem or verapipamil): their combined use with amlodine is not recommended ...

Ramipril

Due to the likelihood of developing hyperkalemia, combined use with the following drugs is not recommended: cyclosporine, trimethoprim, tacrolimus, potassium-sparing diuretics (in particular, triamterene, amiloride, spironolactone), potassium salts, angiotensin II receptor antagonists. If a combination therapy is required, regular monitoring of serum potassium is indicated.
Combinations that require caution:
    antihypertensive drugs, especially diuretics, and other drugs that lower blood pressure (tamsulosin, ethanol, alfuzosin, baclofen, prazosin, nitrates, tricyclic antidepressants, drugs for general / local anesthesia, doxazosin, terazosin): associated with the potentiation of the antihypertensive effect; in combination therapy with diuretics, it is necessary to control the sodium content in the blood serum;
    drugs with sleeping pills, narcotic and analgesic effects: associated with the likelihood of a more pronounced decrease in blood pressure;
    vasopressor sympathomimetics (epinephrine, dobutamine, isoproterenol, dopamine): associated with a decrease in the antihypertensive effect of ramipril, regular monitoring of blood pressure is indicated;
    allopurinol, procainamide, cytostatics, immunosuppressants, systemic glucocorticosteroids and other drugs that can affect hematological parameters: associated with an increased risk of leukopenia;
    lithium salts: associated with an increase in serum lithium content and an increase in the neuro- and cardiotoxic effects of lithium;
    oral hypoglycemic drugs (biguanides, sulfonylurea derivatives), insulin: associated with a decrease in insulin resistance and the likelihood of an increase in the hypoglycemic effect (hypoglycemia may develop);
    drugs containing aliskiren (in patients with diabetes mellitus and renal failure with CC <60 ml / min), vildagliptin: associated with an increase in the incidence of angioedema.
Combinations requiring attention:
    desensitizing therapy against a background of increased sensitivity to insect poisons: associated with an increased likelihood of severe anaphylactic / anaphylactoid reactions;
    non-steroidal anti-inflammatory drugs (acetylsalicylic acid, indomethacin): associated with the likelihood of a weakening of the action of ramipril, an increased risk of impaired renal function and an increase in serum potassium in the blood;
    sodium chloride: associated with a decrease in the antihypertensive effect of ramipril and a decrease in the effectiveness of therapy for symptoms of chronic heart failure;
    heparin: associated with the likelihood of an increase in serum potassium in the blood;
    estrogens: associated with a decrease in the antihypertensive effect of ramipril due to fluid retention;
    ethanol: associated with increased vasodilation symptoms; ramipril may contribute to the aggravation of the adverse effects on the body of ethanol.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.

Reviews about Egipres

According to reviews, Egipres is effective in the treatment of arterial hypertension. It is noted that its cost is higher than that of each of the active substances separately. The drug rarely causes side effects. In some cases, they indicate the development of disorders in the form of nausea, abdominal pain, dry cough.

Terms of sell

You don't need a prescription to buy Egipres.