EGIPRES CAPSULES 5MG + 10MG

Indications

- arterial hypertension (to patients who have been shown combination therapy with Amlodipine and Ramipril in doses appropriate to the drug Egipres®).

Dosage and administration

Egipres® prescribed inside for adults 1 capsule 1 time / day, at the same time, regardless of the meal.

Egipres dose® selected after a previous titration of doses of individual components of the drug ramipril and amlodipine in patients with arterial hypertension. Egipres® with fixed doses of active ingredients is not used for initial therapy. If patients need dose adjustment, then it should be carried out only by titrating doses of the active components in monotherapy. Only after that it is possible to use the drug Egipres® with fixed doses of active ingredients in the combinations below

With therapeutic need dose of the drug Egipres® can be changed on the basis of individual titration of doses of individual components: 5 mg of amlodipine + 5 mg of ramipril or 5 mg of amlodipine + 10 mg of ramipril or 10 mg of amlodipine + 5 mg of ramipril or 10 mg of amlodipine + 10 mg of ramipril.

The maximum daily dose of the drug Egipres® makes 10 mg of amlodipine + 10 mg of ramipril; exceeding the maximum dose is not recommended.Dosages of 10 mg of amlodipine + 5 mg of ramipril (for amlodipine) and 5 mg of amlodipine + 10 mg of ramipril (for ramipril) are the maximum daily doses.

Precautions should be prescribed to patients receiving diuretics, due to the risk of impaired water and electrolyte balance. In these patients, kidney function and potassium should be monitored.

Have elderly patients and patients with renal failure elimination of amlodipine and ramipril and its metabolites is slowed down. Therefore, in these patients it is necessary to regularly monitor the content of creatinine and potassium in the blood plasma. Egipres® can be administered to patients with QA ≥ 60 mL / min. At QC <60 ml / min, as well as patients with arterial hypertension who are on hemodialysis, Egipres® It is recommended to appoint only if they received ramipril in a dose of 2.5 mg or 5 mg as the optimal maintenance dose during the titration of the individual dose. No need to titrate individual dose of amlodipine in patients with impaired renal function. Egipres® contraindicated in patients with QC <20 ml / min / 1.73 m2 surface area of ​​the body. Changes in the concentration of amlodipine in the blood plasma do not correlate with the severity of renal failure.

Caution should be prescribed Egipres®in patients with liver failure due to the lack of recommendations on the dosing of the drug in these patients. Egipres® recommended only for patients receiving ramipril in a dose of 2.5 mg as the optimal maintenance dose during the titration of the individual dose.

Adverse effects

Determination of the frequency of adverse reactions according to the WHO classification: very often -> 1/10 (> 10%); often -> 1/100, but <1/10 (> 1%, but <10%); infrequently -> 1/1000, but <1/100 (> 0.1%, but <1%); rarely> 1/10 000, but <1/1000 (> 0.01%, but <0.1%); very rarely - <1/10 000 (<0.01%).

Amlodipine

Cardiovascular: often - peripheral edema (ankles and feet), palpitations; infrequently - excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely, development or worsening of heart failure; very rarely - cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, migraine.

From the musculoskeletal system and connective tissue: infrequently - arthralgia, muscle cramps, myalgia, back pain, arthrosis; rarely - myasthenia.

Nervous system: often - a sensation of heat and hot flushes to the skin of the face, fatigue, dizziness, headache, drowsiness; infrequently - malaise, fainting, increased sweating, asthenia, hypesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, mood lability, unusual dreams, nervousness, depression, anxiety; seldom - spasms, apathy; very rarely - ataxia, amnesia, isolated cases of extrapyramidal syndrome.

Gastrointestinal: often - abdominal pain, nausea; infrequently - vomiting, changes in the mode of bowel movement (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dryness of the oral mucosa, thirst; rarely - gingival hyperplasia, increased appetite; very rarely - gastritis, pancreatitis,hyperbilirubinemia, jaundice (usually cholestatic), increased activity of hepatic transaminases, hepatitis.

Hemic and lymphatic: very rarely - thrombocytopenic purpura, thrombocytopenia, leukopenia.

Metabolic disorders: very rarely - hyperglycemia.

Respiratory: infrequently - shortness of breath, rhinitis, nosebleeds; very rarely - cough.

Urogenital: infrequently - frequent urination, painful urination, nocturia, impotence; very rarely - dysuria, polyuria.

Allergic reactions: infrequently - pruritus, rash; very rarely - angioedema, erythema multiforme, urticaria.

Special senses: infrequently - tinnitus, blurred vision, diplopia, disturbance of accommodation, xerophthalmia, conjunctivitis, pain in the eyes, taste perversion; very rarely - parosmia.

Dermatologic: infrequently - alopecia; rarely - dermatitis; very rarely - xerodermia, a violation of skin pigmentation.

Other: infrequently - gynecomastia, increase / decrease in body weight, chills; very rarely - "cold" sweat.

Ramipril

Cardiovascular: often - an excessive decrease in blood pressure, impaired orthostatic regulation of vascular tone (orthostatic hypotension), syncopal conditions; 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, arrhythmias (appearance or intensification), palpitations,peripheral edema; rarely - the occurrence or enhancement of circulatory disorders on the background of stenotic vascular lesions, vasculitis; frequency not known - Raynaud's syndrome.

Nervous system: often - headache, feeling of "lightness" in the head; infrequently - dizziness, agevziya (loss of taste sensitivity), dysgeusia (violation of taste sensitivity), paresthesia (burning sensation); rarely - tremor, imbalance; frequency is unknown - cerebral ischemia, including ischemic stroke and transient cerebral circulation disturbance, impaired psychomotor reactions, parosmia (impaired perception of smells).

Special senses: infrequently - visual impairment, including blurred vision; rarely - conjunctivitis.

From the organ of hearing: rarely - hearing loss, ringing in the ears.

From the psyche: infrequently - depressed mood, anxiety, nervousness, motor restlessness, sleep disturbances, including drowsiness; rarely - confusion; frequency unknown - impaired concentration.

Respiratory: often - dry cough (worse at night and lying down), bronchitis, sinusitis, shortness of breath; infrequently - bronchospasm, including worsening of the course of bronchial asthma, nasal congestion.

From the digestive system: often - inflammatory reactions in the stomach and intestines, indigestion, abdominal discomfort, dyspepsia, diarrhea, nausea, vomiting; Infrequently - pancreatitis, incl.and fatal (cases of pancreatitis with a fatal outcome when taking ACE inhibitors were extremely rare), increased activity of pancreatic enzymes in the blood plasma, intestinal angioedema, edema, gastritis, constipation, dry oral mucosa; rarely - glossitis; unknown frequency - aphthous stomatitis (inflammatory reaction of the oral mucosa).

From the hepatobiliary system: infrequently - increased activity of liver enzymes and the content of conjugated bilirubin in the blood plasma; rarely - cholestatic jaundice, hepatocellular lesions; frequency is unknown - acute liver failure, cholestatic or cytolytic hepatitis (death was rarely observed).

Urogenital: infrequently - impaired renal function, including the development of acute renal failure, an increase in the excretion of urine, an increase in pre-existing proteinuria, an increase in the concentration of urea and creatinine in the blood.

From the reproductive system: infrequently - transient impotence due to erectile dysfunction, decreased libido; frequency unknown - gynecomastia.

Hemic and lymphatic: infrequently - eosinophilia; rarely, leukopenia, including neutropenia and agranulocytosis, a decrease in the number of erythrocytes in peripheral blood, a decrease in hemoglobin, thrombocytopenia; frequency is unknown - oppression of bone marrow hematopoiesis, pancytopenia, hemolytic anemia.

Skin and Subcutaneous Tissues: often - skin rash, in particular, makulo-papular; infrequently - angioedema, incl. and fatal (laryngeal edema can cause airway obstruction, leading to death), pruritus, hyperhidrosis (sweating); rarely - exfoliative dermatitis, urticaria, onycholysis; very rarely - photosensitivity reactions; frequency is unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, worsening of the course of psoriasis, psoriasis-like dermatitis, pemphigoid or lichenoid (desiccous) exanthema or enanthema, alopecia.

From the musculoskeletal system: often - muscle cramps, myalgia; infrequently - arthralgia.

Metabolism: often - an increase in the content of potassium in the blood; infrequently - anorexia, loss of appetite; frequency is unknown - decrease in sodium concentration in the blood, syndrome of inadequate secretion of ADH.

On the part of the immune system: frequency unknown - anaphylactic or anaphylactoid reactions (with inhibition of ACE increases the number of anaphylactic or anaphylactoid reactions to insect venoms), an increase in the titer of antinuclear antibodies.

General violations: often - chest pain, feeling tired; infrequently - fever; rarely - asthenia (weakness).

Contraindications

Amlodipine

- hypersensitivity to amlodipine and other dihydropyridine derivatives;

- severe hypotension (systolic blood pressure less than 90 mm Hg), shock (including cardiogenic);

- an obstructive process that impedes the release of blood from the left ventricle (for example, clinically significant aortic stenosis);

- hemodynamically unstable heart failure after myocardial infarction;

- pregnancy;

- lactation period (breastfeeding);

- children's and teenage age till 18 years (safety and efficiency are not defined).

Ramipril

- hypersensitivity to ramipril, other ACE inhibitors;

- angioedema in history (hereditary or idiopathic, as well as associated with previous therapy with ACE inhibitors);

- arterial hypotension (systolic blood pressure <90 mm Hg) or conditions with unstable hemodynamic parameters;

- hemodynamically significant stenosis of the aortic or mitral valve, or hypertrophic obstructive cardiomyopathy;

- acute stage of myocardial infarction in patients with diseases such as severe heart failure (IV functional class according to NYHA), life-threatening ventricular arrhythmias, and pulmonary heart;

- primary hyper aldosteronism;

- hemodynamically significant renal artery stenosis (bilateral or unilateral in the case of a single kidney);

- severe renal failure (CC <20 ml / min / 1.73 m2);

- hemodialysis (experience with clinical use is insufficient);

- nephropathy, the treatment of which is carried out by GCS, NSAIDs, immunomodulators and / or other cytotoxic agents (clinical experience is insufficient);

- hemodialysis or hemofiltration using some membranes with a negatively charged surface, such as high-flow polyacrylonitrile membranes (risk of hypersensitivity reactions);

- decompensated chronic heart failure (experience with clinical use is insufficient);

- LDL apheresis using dextran sulfate (risk of hypersensitivity reactions);

- desensitization therapy in case of hypersensitivity reactions to the poisons of insects - bees, wasps;

- simultaneous use of drugs containing aliskiren in patients with impaired renal function (CC less than 60 ml / min) and patients with diabetes mellitus;

- pregnancy;

- lactation period (breastfeeding);

- children's and teenage age up to 18 years (experience of clinical use is insufficient);

Amlodipine + ramipril

- hypersensitivity to the drug;

- renal failure (CC <20 ml / min / 1.73 m2);

- pregnancy;

- breastfeeding period;

- children's and teenage age up to 18 years (experience of clinical use is insufficient).

Carefully use the combination amlodipine + ramipril in the following diseases and conditions:

- atherosclerotic lesions of the coronary and cerebral arteries (the danger of an excessive decrease in blood pressure);

- increased activity of the RAAS, in which, when ACE is inhibited, there is a risk of a sharp decrease in blood pressure with a deterioration in renal function;

- severe, especially malignant arterial hypertension;

- chronic heart failure, especially severe or about which other medicines are taken with antihypertensive effect;

- hemodynamically significant unilateral stenosis of the renal artery (in the presence of both kidneys);

- prior diuretic intake;

- violations of water and electrolyte balance, reduction of bcc (including while taking diuretics, salt-free diet, diarrhea, vomiting, excessive sweating);

- simultaneous use with drugs containing aliskiren (with double blockade of RAAS increases the risk of a sharp decrease in blood pressure, hyperkalemia and deterioration of renal function);

- dysfunction of the liver (lack of experience with the application): both strengthening and weakening of the effects of ramipril is possible; in patients with cirrhosis of the liver with ascites and edema, significant activation of the RAAS is possible;

- impaired renal function (CC> 20 ml / min);

- condition after kidney transplantation;

- Systemic diseases of the connective tissue, incl. systemic lupus erythematosus, scleroderma, concomitant therapy with drugs that can cause changes in the pattern of peripheral blood (including Allopurinol, procainamide) - bone marrow hematopoiesis can be inhibited, neutropenia or agranulocytosis can develop;

- diabetes mellitus - the risk of hyperkalemia;

- old age - the risk of increased antihypertensive action;

- hyperkalemia;

- hyponatremia;

- chronic heart failure of the non-ischemic etiology of the III-IV functional class according to the NYHA classification;

- aortic stenosis;

- SSSU;

- mitral stenosis;

- arterial hypotension;

- the only functioning kidney;

- Renovascular hypertension;

- simultaneous use of dantrolen, estramustine, potassium-saving diuretics and potassium preparations, potassium-containing food salt substitutes, lithium preparations;

- surgery / general anesthesia;

- conducting hemodialysis using high-flow membranes (for example, AN69®).

Use during pregnancy and lactation