Ramipril-Acrihin pills 5mg, 30pcs

Composition

One 5 mg tablet contains: Active ingredient:  ramipril in terms of 100% substance -5 mg; excipients:  lactose monohydrate – 103,4 mg; sodium bicarbonate to 1.2 mg;cellulose microcrystalline – 13 mg; hypromellose – 0,65 mg; arginine -0,2 mg; croscarmellose sodium 2.6 mg; silicon dioxide colloidal – 1.3 mg;silicon dioxide methylated (silicon dioxide colloidal hydrophobic) 1.3 mg;sodium fumarate -1,3 mg;dye iron oxide red – 0.05 mg.

Pharmacological action

ACE inhibitor, blocks the conversion of angiotensin I to angiotensin II, as a result of which (regardless of the plasma renin activity) a hypotensive effect occurs (in the patient’s “lying” and “standing” positions) without a compensatory increase in heart rate. Reduces the production of aldosterone. Reduces OPSS (afterload), jamming pressure in the pulmonary capillaries (preload), resistance in the pulmonary vessels; increases IOC and load tolerance. Long-term use of the drug promotes the reverse development of myocardial hypertrophy in patients with arterial hypertension and reduces the frequency of arrhythmias during myocardial reperfusion; improves blood supply to the ischemic myocardium; prevents vascular endothelial changes caused by a high-cholesterol diet. Cardioprotective effect during treatment with the drug is due to the effect on prostaglandin synthesis, induction of nitric oxide (NO) formation in endotheliocytes. Activates the kallikrein-kinin system, prevents the breakdown of bradykinin (increases its concentration), increases the synthesis of Pg. Increases coronary and renal blood flow. Reduces platelet aggregation. Increases the sensitivity of tissues to insulin, fibrinogen concentration, stimulates the synthesis of the tissue activator profibrinolysin (plasminogen), promoting thrombolysis. The beginning of the antihypertensive effect of the drug is 1.5 hours after oral use, the maximum effect is 5-9 hours, and the duration of action is 24 hours. There is no “withdrawal”syndrome. Reduces mortality in the early and late periods of myocardial infarction, the frequency of recurrent heart attacks and the development of HF. Increases the survival rate and improves the quality of life of patients with CHF. In patients with congenital and acquired heart defects, drug therapy reduces the severity of hypertension in the “small” circulatory circle when taken for at least 6 months. With portal hypertension, it reduces blood pressure. Reduces the degree of microalbuminuria (in the initial stage) and the progression of chronic renal failure in patients with severe kidney damage in diabetic nephropathy.

Indications

Taking the drug is indicated for arterial hypertension, malignant and refractory hypertension, vasorenal hypertension, chronic heart failure II-III art.

Also indications are: nephropathy against the background of chronic diffuse kidney diseases (preclinical and clinical stages), diabetic nephropathy.

Contraindications

Treatment with the drug is contraindicated in diseases and conditions: individual intolerance to the drug or other ACE inhibitors, angioedema in the anamnesis against the background of ACE inhibitor therapy, hereditary or idiopathic angioedema, bilateral renal artery stenosis, stenosis of the artery of a single kidney, condition after kidney transplantation, hemodynamically significant aortic or mitral stenosis, HOCMP, primary hyperaldosteronism, during pregnancy, period lactation. With caution, prescribe the drug in the following cases: : severe lesions of the coronary and cerebral arteries (risk of reduced blood flow due to excessive blood pressure reduction), unstable angina, severe ventricular arrhythmias, end – stage CHF, decompensated “pulmonary” heart, diseases requiring the use of corticosteroids and immunosuppressants (lack of clinical experience) – including systemic connective tissue diseases, renal and/or liver failure, hyperkalemia, hyponatremia (including on the background of diuretics and a diet with restricted Na+ intake), conditions accompanied by a decrease in BCC (including diarrhea, vomiting), elderly age, age 18 years (safety and efficacy of use have not been studied).

Side effects

When using the drug, side effects from various systems may occur: 1. From the cardiovascular system: decreased blood pressure, orthostatic collapse, tachycardia, arrhythmias, angina pectoris, myocardial infarction. 2. From the genitourinary system: development or strengthening of CRF, proteinuria, decreased libido and potency. 3. From the nervous system: cerebral ischemia, stroke, dizziness, headache, weakness, drowsiness, paresthesia; when used in high doses – insomnia, anxiety, depression, confusion. 4. Sensory disorders: vestibular disorders, taste, smell, hearing and vision disorders, tinnitus. 5. From the digestive system:  nausea, vomiting, diarrhea or constipation, intestinal obstruction, pancreatitis, hepatitis, cholestatic jaundice, impaired liver function with acute liver failure, epigastric pain, dry mouth, thirst, decreased appetite, stomatitis, glossitis. 5. From the respiratory system: “dry” cough, bronchospasm, shortness of breath, rhinorrhea. 6. Allergic reactions: skin rash, pruritus, urticaria, photosensitization; angioedema of the face, limbs, lips, tongue, glottis and/or larynx, exfoliative dermatitis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), pemphigus (Pemphigus), serositis, vasculitis, myositis, myalgia, arthralgia, arthritis, eosinophilia. 7. Hematopoietic disorders: anemia, decreased Hb and hematocrit, neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia. 8. Other: seizures, alopecia, hyperthermia. Laboratory parameters: hypercreatininemia, hyperammonemia, increased activity of “hepatic” transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia, the appearance of antinuclear antibodies. Effects on the fetus: impaired renal development of the fetus, decreased blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, cranial hypoplasia, oligohydramnion, limb contracture, cranial deformity, lung hypoplasia. Overdose. Symptoms:  marked decrease in blood pressure, bradycardia, shock, impaired water-electrolyte balance, acute renal failure, stupor. Treatment: in mild cases of overdose when taking the drug-gastric lavage, use of adsorbents and sodium sulfate (preferably within 30 minutes after use). With a pronounced decrease in blood pressure – intravenous use of catecholamines, angiotensin II; with bradycardia – the use of a pacemaker. It is not excreted during hemodialysis.

Interaction

Therapy with the use of the drug increases the hypoglycemic effect of sulfonylureas and insulin derivatives. Increases the risk of leukopenia when used concomitantly with allopurinol, cytostatic drugs, immunosuppressants, procainamide. Enhances the depressing effect of ethanol on the central nervous system. Antihypertensive drugs, diuretics, narcotic analgesics, and drugs for general anesthesia enhance the antihypertensive effect of the drug. NSAIDs, table salt weaken the effect. Potassium supplements, potassium-sparing diuretics (amiloride, spironolactone, triamterene) increase the risk of hyperkalemia. When taken simultaneously with lithium preparations-an increase in their concentration in the blood. Estrogens-weakening of the antihypertensive effect of the drug (retain fluid).

How to take, course of use and dosage

Capsules and tablets of the drug are prescribed for arterial hypertension: inside, the initial dose is 2.5 mg, once, in the morning, on an empty stomach or 2 times a day. In case of insufficient hypotensive effect, the dose is gradually increased every 2-3 weeks. The maximum daily dose is 10 mg, the maintenance dose is 2.5-5 mg. In the absence of an optimal reduction in blood pressure, diuretic drugs are additionally prescribed. Chronic heart failure: the initial dose is 1.25 mg / day; if necessary, increase the dose to 2.5 mg for 1-2 weeks. In the treatment of patients who have suffered a myocardial infarction, the initial dose is 2.5 mg 2 times a day (if poorly tolerated during the first 2 days, take 1.25 mg). Renal insufficiency (creatinine clearance 30-60 ml / min), age over 65 years, diabetes mellitus: initial dose-1.25 mg, maintenance dose-2.5 mg; maximum dose-5 mg / day.

Special instructions

After taking the first dose of the drug, as well as with an increase in the dosage of the diuretic and/or the drug, patients should be under medical supervision for 8 hours to avoid the development of an uncontrolled hypotensive reaction. In patients with CHF, taking the drug can lead to the development of severe arterial hypotension, which in some cases is accompanied by oliguria or azotemia, and rarely-the development of acute renal failure. The lower limit of systolic blood pressure for therapy in the early stages of myocardial infarction is considered to be 100 mm Hg. Patients with malignant arterial hypertension or concomitant decompensated CHF should start treatment in a hospital setting.Before and during therapy with the drug, it is necessary to count the total number of white blood cells and determine the white blood cell formula (up to 1 time per month in the first 3-6 months of treatment in patients with an increased risk of neutropenia – with impaired renal function, systemic connective tissue diseases or receiving high doses, as well as at the first signs of infection). If neutropenia is confirmed (the number of neutrophils is less than 2 thousand/µl), ACE inhibitor therapy should be discontinued. Before and during treatment, it is necessary to monitor blood pressure, kidney function (creatinine, urea), K+ and other electrolytes in plasma, Hb, and the activity of” liver ” enzymes in the blood. Caution should be exercised when prescribing the drug to patients on a low-salt or salt-free diet (increased risk of hypotension). Symptomatic hypotension may occur in patients with reduced BCC (due to diuretic therapy), salt restriction, dialysis, diarrhea, and vomiting. Transient hypotension is not a contraindication for continuing treatment after BP stabilization. In case of repeated occurrence of severe hypotension, the dose should be reduced or the drug should be discontinued. The use of AN69 dialysis membranes in combination with ACE inhibitors is not recommended (due to the possibility of developing anaphylactoid reactions in patients). If there is a history of angioedema that is not associated with the use of ACE inhibitors, then such patients still have an increased risk of developing it when taking it. Safety and efficacy in pediatric practice: newborns who have been exposed to intrauterine ACE inhibitors should be closely monitored for hypotension, oliguria, and hyperkalemia. With oliguria, it is necessary to maintain blood pressure and renal perfusion by introducing appropriate fluids and vasoconstrictor drugs. Newborns and children are at risk of oliguria and neurological disorders, possibly due to reduced renal and cerebral blood flow due to a decrease in blood pressure caused by ACE inhibitors (received by pregnant women and after childbirth); lower initial doses and careful monitoring are recommended. Caution should be exercised when exercising or in hot weather because of the risk of dehydration and hypotension due to reduced fluid volume. It is not recommended to use ethanol. Before surgery (including dentistry), the surgeon/anesthesiologist should be warned about the use of the drug. During the treatment period, care should be taken when driving vehicles and doing other activities. potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (dizziness may occur, especially after the initial dose of an ACE inhibitor in patients taking diuretic drugs).

Active ingredient

Ramipril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Heart Failure