Hartil tablets 10mg №7×4

Name:
Chartil.
Description:
Tablets are white or almost white, oval, flat, beveled, scored and engraved “R4” on one side and scored on the side surfaces. The main active ingredient is ramipril. Release form Tablets. Dosage 10 mg. Special instructionsDuring treatment with Hartil®, regular medical monitoring is necessary. After taking the first dose, as well as with an increase in the dose of a diuretic and / or Hartil, patients should be under medical supervision for 8 hours to avoid the development of an uncontrolled hypotensive reaction; repeated measurement of blood pressure is recommended. If possible, dehydration, hypovolemia, and a decrease in the number of red blood cells should be corrected before starting the drug. If these disorders are severe, ramipril should not be started or continued until measures have been taken to prevent an excessive fall in blood pressure and impaired renal function. Careful monitoring is required in patients with renal vascular disease (for example, clinically insignificant renal artery stenosis or hemodynamically significant stenosis of the artery of a single kidney), impaired renal function, with a pronounced decrease in blood pressure, mainly in patients with heart failure, and also after kidney transplantation. Impaired renal function can be identified by elevated levels of urea and serum creatinine, especially if the patient is taking diuretics. Due to a decrease in the synthesis of angiotensin II and the secretion of aldosterone in the blood serum, a decrease in sodium levels and an increase in potassium levels are possible. Hyperkalemia is more common in patients with impaired renal function (eg, diabetic nephropathy) or when taken concomitantly with potassium-sparing diuretics. In case of an excessive decrease in blood pressure, the patient should be laid down, legs raised; fluid administration and other measures may also be required. Blood changes are more likely in patients with impaired renal function and concomitant connective tissue disease (eg, SLE and scleroderma), as well as in the case of other drugs that affect the hematopoietic and immune systems. Serum sodium levels should also be regularly monitored in patients taking diuretics at the same time as Hartil®. You should also regularly check the number of leukocytes to avoid the development of leukopenia. Monitoring should be more frequent at the start of therapy and in patients belonging to any risk group. There are reports of life-threatening anaphylactoid reactions, sometimes turning into shock, in patients on hemodialysis using membranes with high hydraulic permeability (for example, from polyacrylonitrile) while the introduction of ACE inhibitors. Anaphylactoid reactions have also been reported in patients undergoing LDL apheresis with dextran sulfate ingestion. When desensitizing therapy is carried out to reduce an allergic reaction to insect stings (for example, bees and wasps), a severe, life-threatening anaphylactoid reaction (falling blood pressure, respiratory failure, vomiting, skin reactions) may occur while taking ACE inhibitors. Therefore, ACE inhibitors should not be given to patients receiving desensitizing therapy. In case of lactase deficiency, galactosemia or glucose / lactose malabsorption syndrome, it should be borne in mind that each Hartil® tablet contains the following amounts of lactose: 5 mg tablets – 96.47 mg, 10 mg tablets – 193.2 mg. Use in pediatrics Experience with the use of ramipril in children with severe renal insufficiency (CC <20 ml / min / 1.73 m2 of body surface) and during dialysis is limited. Influence on the ability to drive vehicles and control mechanisms At the beginning of treatment, a decrease in blood pressure may affect the ability to concentrate. In this case, patients are advised to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions. In the future, the degree of restriction is determined for each patient individually. Pharmacological action Antihypertensive drug, ACE inhibitor. As a result of the suppression of ACE activity (regardless of plasma renin activity), a hypotensive effect develops (in the position of the patient lying and standing) without a compensatory increase in heart rate. Suppression of ACE activity reduces the level of angiotensin II, which leads, in turn, to a decrease in aldosterone secretion. As a result of a decrease in the concentration of angiotensin II, due to the elimination of negative feedback, an increase in plasma renin activity occurs. Ramipril acts on ACE, circulating in the blood and located in tissues, incl. vascular wall. Reduces OPSS (afterload), pressure in the pulmonary capillaries (preload); increases cardiac output and increases exercise tolerance. With prolonged use, ramipril promotes the regression of myocardial hypertrophy in patients with arterial hypertension. Ramipril reduces the incidence of arrhythmias during myocardial reperfusion; improves blood supply to ischemic myocardium. Ramipril prevents the breakdown of bradykinin and stimulates the formation of nitric oxide (NO) in the endothelium. The antihypertensive effect begins 1-2 hours after taking the drug orally, the maximum effect develops within 3-6 hours and lasts for 24 hours. With daily use, the antihypertensive effect increases within 3-4 weeks and persists with long-term treatment (1-2 of the year). Antihypertensive efficacy does not depend on the sex, age and body weight of the patient. In patients with acute myocardial infarction, ramipril limits the area of necrosis, improves life prognosis; reduces mortality in the early and late periods of myocardial infarction, the incidence of recurrent heart attacks; reduces the severity of manifestations of heart failure, slows down its progression. Long-term use (at least 6 months) reduces the degree of pulmonary hypertension in patients with congenital and acquired heart defects. Ramipril reduces pressure in the portal vein in portal hypertension; inhibits microalbuminuria (in the initial stages) and deterioration of renal function in patients with severe diabetic nephropathy. With non-diabetic nephropathy, accompanied by proteinuria (more than 3 g / day) and renal failure, it slows down the further deterioration of kidney function, reduces proteinuria, reduces the risk of increasing creatinine levels or developing end-stage renal failure. Pharmacokinetics Ramipril has a multiphasic pharmacokinetic profile. Absorption Following oral administration, ramipril is rapidly absorbed from the gastrointestinal tract. The degree of absorption is not less than 50-60% of the administered dose. Cmax in plasma is achieved within 1 hour. Distribution and metabolism Almost completely metabolized (mainly in the liver) to form active and inactive metabolites. Its active metabolite, ramiprilat, inhibits ACE activity by about 6 times more than ramipril. Cmax of ramiprilat in plasma is reached after 2-4 hours. Among the known inactive metabolites are diketopiperazine ester, diketopiperazic acid, as well as ramipril and ramiprilat glucuronides. The binding of ramipril and ramiprilat to plasma proteins is approximately 73% and 56%, respectively. When taken in normal doses 1 time / day, Css of ramipril in blood plasma is reached by the 4th day of taking the drug. Withdrawal T1 / 2 ramipril - 5.1 hours, T1 / 2 ramiprilat 13-17 hours. After oral administration, 60% of the dose is excreted in the urine (mainly in the form of metabolites) and about 40% - with feces. About 2% of the administered dose is excreted in the urine unchanged. Pharmacokinetics in special clinical situations The excretion of ramipril, ramiprilat and inactive metabolites in the urine is reduced in renal failure (leading to an increase in the concentration of ramiprilat). A decrease in enzymatic activity in the liver in violation of its function leads to a slowdown in the conversion of ramipril to ramiprilat, which can cause an increase in the concentration of ramipril in the blood plasma. Indications for use - arterial hypertension; - chronic heart failure; - chronic heart failure after acute myocardial infarction in patients with stable hemodynamics; - diabetic nephropathy and chronic diffuse kidney disease (non-diabetic nephropathy); - reducing the risk of myocardial infarction, stroke or coronary death in patients with high cardiovascular risk with coronary artery disease, including patients who have had myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting. Dosing and Administration Tablets should be taken orally, swallowing them whole, without chewing, drinking plenty of liquid (about 1 cup). Tablets can be taken regardless of meal times. Tablets can be divided in half, breaking at risk. The dose is set individually, taking into account the therapeutic effect and tolerability. With arterial hypertension, the recommended initial dose is 2.5 mg 1 time / day. Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. The standard maintenance dose is 2.5-5 mg/day. The maximum daily dose is 10 mg. In chronic heart failure, the recommended initial dose is 1.25 mg 1 time / day. Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. If it is necessary to use the drug in a dose of more than 2.5 mg, this dose can be taken immediately or divided into 2 doses. The maximum daily dose is 10 mg. For treatment after myocardial infarction, it is recommended to start taking the drug 3-10 days after acute myocardial infarction. The recommended initial dose, depending on the patient's condition and the time elapsed after acute myocardial infarction, is 2.5 mg 2 times / day. Depending on the therapeutic effect, the initial dose can be doubled to 5 mg 2 times / day. The maximum daily dose is 10 mg. In case of intolerance to the drug, the dose should be reduced. For non-diabetic or diabetic nephropathy, the recommended starting dose is 1.25 mg once daily. Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. If you need to take more than 2.5 mg of the drug, this dose can be taken immediately or divided into 2 doses. The recommended maximum daily dose is 5 mg. Prevention of myocardial infarction, stroke or death from cardiovascular disorders: the recommended initial dose is 2.5 mg 1 time / day. Depending on the tolerability of the drug, after 1 week of administration, the dose should be doubled compared to the initial dose. This dose should be doubled again after 3 weeks of use. The recommended maintenance dose is 10 mg 1 time / day. In elderly patients taking diuretics and / or with heart failure, as well as with impaired liver or kidney function, the dose should be set by individual selection, depending on the patient's response to treatment. Patients with renal insufficiency require correction of the dosing regimen. With moderate renal dysfunction (CC from 20 to 50 ml / min per 1.73 m2 of body surface), the initial dose is usually 1.25 mg 1 time / day. The maximum daily dose is 5 mg. If CC is not measured, it can be calculated from serum creatinine using the Cockcroft formula. For men: CC (ml / min) u003d (140 - age)? body weight (kg)/72 ? Serum creatinine (mg/dl) For women: the result of the calculation should be multiplied by 0.85. In case of impaired liver function, a reduced or increased effect of Hartil® can equally often be observed, therefore, careful medical supervision is required in the early stages of treatment in this category of patients. The maximum daily dose in such cases is 2.5 mg. In patients receiving diuretic therapy, due to the risk of a significant decrease in blood pressure, consideration should be given to temporarily canceling or at least reducing the dose of diuretics at least 2-3 days (or longer, depending on the duration of the diuretic action) before starting Hartil. For patients previously treated with diuretics, the usual initial dose is 1.25 mg. Use during pregnancy and lactation text Contraindicated in pregnancy and lactation. The drug causes a violation of the development of the kidneys of the fetus, a decrease in blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, skull hypoplasia, oligohydramnios, limb contracture, skull deformity, lung hypoplasia. Precautions Use with caution in hemodynamically significant aortic or mitral stenosis (risk of excessive reduction in blood pressure with subsequent impaired renal function), severe primary malignant arterial hypertension, severe lesions of the coronary and cerebral arteries (danger of reducing blood flow with excessive reduction in blood pressure), unstable angina pectoris, severe ventricular rhythm disturbances; terminal stage of chronic heart failure; decompensated pulmonary heart; in diseases requiring the appointment of corticosteroids and immunosuppressants (lack of clinical experience) - incl. with systemic connective tissue diseases, severe renal and / or hepatic insufficiency, hyperkalemia, hyponatremia (including against the background of taking diuretics and a diet with limited sodium intake); with initial or pronounced manifestations of fluid and electrolyte deficiency, conditions accompanied by a decrease in BCC (including diarrhea, vomiting); diabetes mellitus; oppression of bone marrow hematopoiesis; condition after kidney transplant; in elderly patients, in children and adolescents under the age of 18 years (efficacy and safety have not been established). There is only limited experience with the use of ramipril in dialysis patients. Interaction with other drugs With the simultaneous use of Hartil with allopurinol, corticosteroids, procainamide, cytostatics and other substances that cause blood changes, the risk of disorders of the hematopoietic system increases. With the simultaneous use of Hartil with hypoglycemic drugs (insulin or sulfonylurea derivatives), an excessive decrease in blood glucose levels is possible. This phenomenon may be due to the fact that ACE inhibitors can increase tissue sensitivity to insulin. With simultaneous use with other antihypertensive agents (including diuretics) or other agents with an antihypertensive effect (for example, nitrates, tricyclic antidepressants and anesthetics), an increase in the antihypertensive effect is possible. Simultaneous administration of potassium salts and potassium-sparing diuretics, heparin with ramipril is not recommended due to the risk of hyperkalemia. With simultaneous use with lithium preparations, an increase in the concentration of lithium in the blood serum is observed, which leads to an increased risk of cardio- and nephrotoxicity. NSAIDs and sodium salts reduce the effectiveness of ACE inhibitors. Ramipril may enhance the effect of ethanol. Contraindications - angioedema in history, incl. associated with previous therapy with ACE inhibitors; - hemodynamically significant bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney; - arterial hypotension or unstable hemodynamics; - pregnancy; - lactation period (breastfeeding); - primary hyperaldosteronism; - renal failure (CC <20 ml / min); - hypersensitivity to ramipril and other components of the drug. Ingredients of Ramipril 10 mg. Excipients: sodium bicarbonate - 10 mg, lactose monohydrate - 193.2 mg, pregelatinized starch 1500 - 39 mg, croscarmellose sodium - 5.2 mg, sodium stearyl fumarate - 2.6 mg. OverdoseSymptoms: pronounced decrease in blood pressure, bradycardia, shock, impaired water and electrolyte balance, acute renal failure. Treatment: in case of mild overdose - gastric lavage, administration of adsorbents and sodium sulfate (preferably within 30 minutes after ingestion). In acute overdose: control and support of vital functions in the ICU; with a decrease in blood pressure - the introduction of catecholamines and angiotensin II. The patient should be placed on his back with the legs elevated, and additional fluids and sodium administered. It is not known whether forced diuresis, hemofiltration, and correction of urinary pH accelerate the excretion of ramipril. This should be considered when considering hemodialysis and hemofiltration. Side effects From the side of the cardiovascular system: lowering blood pressure, orthostatic hypotension, tachycardia; rarely - arrhythmia, increased circulatory disorders of organs caused by narrowing of blood vessels. With an excessive decrease in blood pressure, mainly in patients with coronary artery disease and clinically significant vasoconstriction of the brain, myocardial ischemia (angina pectoris or myocardial infarction) and cerebral ischemia (possibly with dynamic cerebrovascular accident or stroke) may develop. From the urinary system: the development or strengthening of renal failure, the strengthening of existing proteinuria, a decrease in the volume of urine (at the beginning of the drug). From the side of the central nervous system and peripheral nervous system: dizziness, headache, weakness, drowsiness, paresthesia, nervous irritability, anxiety, tremor, muscle spasm, mood disorders, convulsions; when used in high doses - insomnia, anxiety, depression, confusion, fainting. From the senses: vestibular disorders, taste disorders (eg, metallic taste), smell, hearing and vision, tinnitus. From the digestive system: nausea, vomiting, diarrhea or constipation, pain in the epigastric region, dry mouth, thirst, loss of appetite, stomatitis, hypersensitivity or inflammation of the buccal mucosa, pancreatitis; rarely - hepatitis, cholestatic jaundice, impaired liver function with the development of acute liver failure. From the respiratory system: dry cough, bronchospasm (in patients with increased excitability of the cough reflex), shortness of breath, rhinorrhea, rhinitis, sinusitis, bronchitis. On the part of the hematopoietic organs: anemia, a decrease in the concentration of hemoglobin and hematocrit, thrombocytopenia, leukocytopenia, neutropenia, agranulocytosis, pancytopenia, hemolytic anemia, a decrease in the number of red blood cells, inhibition of bone marrow hematopoiesis. Allergic reactions: skin rash, itching, urticaria, conjunctivitis, photosensitivity; rarely - angioedema of the face, limbs, lips, tongue, pharynx or larynx, exfoliative dermatitis, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), pemphigus (pemphigus), serositis, onycholysis , vasculitis, myositis, myalgia, arthralgia, arthritis, eosinophilia. On the part of laboratory parameters: hypercreatininemia, increased levels of urea nitrogen, increased activity of hepatic transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia; extremely rarely - an increase in the titer of antinuclear factor. Others: decreased libido, alopecia, hyperthermia, sweating. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 2 years. Buy Hartil tablets 10mg No. 7x4 Price for Hartil tablets 10mg No. 7x4