NameRamilong tabl. The main active ingredient Ramipril Release form Tablets Dosage 2.5 mg Indications for use Treatment of arterial hypertension: to lower blood pressure both in monotherapy and in combination with other antihypertensive drugs; Prevention of cardiovascular disorders: reduction in the number of cardiovascular complications (myocardial infarction, stroke and death) in patients with: severe atherothrombotic cardiovascular diseases (history of coronary heart disease or stroke, obliterating diseases of the arteries of the lower extremities) or diabetes mellitus and with at least one cardiovascular risk factor (see Pharmacological properties); Secondary prevention in patients with acute myocardial infarction: reduced risk of death, starting from the acute phase of myocardial infarction, in patients with clinical signs of heart failure when prescribed 48 hours after the onset of the disease; Treatment of glomerular kidney disease: initial stage of dia betic nephropathy with microalbuminuria; overt diabetic nephropathy with macroproteinuria in patients with at least one cardiovascular risk factor (see section 4.4). Pharmacological properties); obvious non-diabetic nephropathy with the presence of macroproteinuria? 3 g / day; Treatment of chronic heart failure. Dosage and administration of Ramilong is recommended to be taken daily at the same time of the day. Tablets should be taken with or without food (that is, tablets can be taken before, during, or after a meal) and should be taken with a sufficient amount (1/2 cup) of water. Do not chew or crush tablets before taking. The dose is selected depending on the therapeutic effect and tolerability of the drug by the patient. This drug does not provide a dosage of 1.25 mg, if you need to use ramipril at a dose of 1.25 mg, you must use a drug from another manufacturer. Treatment with Ramilong is usually long-term, and its duration in each case is determined by the doctor. An excessive decrease in blood pressure at the beginning of treatment with the drug is possible, especially in patients with a low content of salts and fluids in the body (for example, vomiting, diarrhea, treatment with diuretics), heart failure (especially after acute myocardial infarction) or severe hypertension. Adults Patients treated with diuretics The lack of salts and fluids in the body is subject to preliminary adjustment before taking ramipril, the diuretic should be limited or discontinued, no later than 2 to 3 days (see Precautions, application features). Treatment of patients who have not canceled the diuretic should begin with a dose of 1.25 mg. It is necessary to monitor kidney function and the content of potassium in the blood serum. The subsequent dosage of Ramilong should be adjusted according to the target blood pressure levels. Treatment of arterial hypertension The dose is calculated depending on the expected therapeutic effect and the tolerability of the drug in each case. Ramilong can be used both as monotherapy and in combination with other classes of drugs for the treatment of arterial hypertension. The initial recommended dose of ramipril is 2.5 mg. Patients with a highly activated renin-angiotensin-aldosterone system may experience an excessive decrease in blood pressure after taking the initial dose. For such patients, the recommended starting dose is 1.25 mg, and the initiation of treatment should be under the supervision of a physician. The dose may be doubled at intervals of 2-4 weeks to achieve the target blood pressure level. The maximum allowable daily dose of ramipril is 10 mg. The daily dose is taken once a day. Prevention of cardiovascular disorders The recommended initial dose of ramipril is 2.5 mg once a day. The dose should be increased gradually, depending on the patient’s tolerance to the active substance. It is recommended to double the dose after 1-2 weeks of treatment, and after the next 2-3 weeks – increase it to the target maintenance dose of 10 mg of ramipril once a day. Secondary prophylaxis in patients after acute myocardial infarction with heart failure 48 hours after myocardial infarction in clinically and hemodynamically stable patients, the initial dose is 2.5 mg twice a day for three days. If the initial dose of 2.5 mg is not tolerated by the patient, a dose of 1.25 mg twice daily for 2 days should be given before increasing the dose to 2.5 mg and 5 mg twice daily. If the dose cannot be increased to 2.5 mg twice daily, treatment should be discontinued. (See also Dosing in Patients Treated with Diuretics.) Titration and individual maintenance dose The daily dose is sequentially increased by doubling it at intervals of 1 to 3 days until the target maintenance dose of 5 mg twice a day is reached. The maintenance daily dose is recommended to be divided into 2 doses. To date, there is no sufficient experience in the treatment of patients in the state immediately after myocardial infarction with concomitant severe chronic heart failure (NYHA grade IV). If a decision is made to prescribe ramipril to such patients, it is recommended to start treatment with a dose of 1.25 mg once a day, taking special care when increasing the dose. Treatment of kidney disease In patients with diabetes mellitus and microalbuminuria: The recommended starting dose of ramipril is 1.25 mg once daily. The daily dose is increased depending on the patient’s tolerance of the active substance. It is recommended to double the daily dose to 2.5 mg after 2 weeks of treatment, and then to 5 mg after the next 2 weeks. In patients with diabetes mellitus and at least one cardiovascular risk factor. The recommended starting dose of ramipril is 2.5 mg once daily. Depending on the patient’s tolerance of the active substance, the dose is sequentially increased: it is recommended to double the daily dose to 5 mg after 1-2 weeks of treatment, and then to 10 mg after the next 2-3 weeks. The maximum daily dose of ramipril is 10 mg. In patients with non-diabetic nephropathy with macroproteinuria? 3 g/day. The recommended starting dose is 1.25 mg ramipril once daily. The daily dose is increased depending on the patient’s tolerance of the active substance. It is recommended to double the daily dose to 2.5 mg after 2 weeks of treatment, and then to 5 mg after the next two weeks. Treatment of chronic heart failure In patients receiving diuretic therapy, the recommended initial dose is 1.25 mg per day. Ramilong should be titrated by doubling the dose every two weeks up to a maximum daily dose of 10 mg. It is preferable to divide the daily dose into 2 doses. Special groups of patients Patients with impaired renal function The daily dose for patients with impaired renal function is prescribed taking into account creatinine clearance: if creatinine clearance ? 60 ml / min, no need to adjust the initial dose (2.5 mg daily), maximum daily dose of 10 mg; if creatinine clearance is in the range of 30-60 ml / min, there is no need to adjust the initial dose (2.5 mg daily), the maximum daily dose is 5 mg; if creatinine clearance is in the range of 10-30 ml/min, the initial dose is 1.25 mg daily and the maximum daily dose is 5 mg; in patients with hypertension undergoing hemodialysis: ramipril is poorly dialyzed; the initial dose is 1.25 mg daily and the maximum daily dose is 5 mg; the drug must be taken a few hours after hemodialysis. Patients with impaired liver function Treatment of such patients should be carried out with extreme caution and only under medical supervision. The maximum allowable daily dose in such cases is 2.5 mg of ramipril. Elderly patients Initial doses should be lower and their administration should be more gradual due to the increased risk of adverse reactions, especially in elderly and debilitated patients. The recommended starting daily dose is 1.25 mg ramipril. Children The use of the drug in pediatrics is not recommended, due to the lack of sufficient relevant data on the safety and efficacy of the drug. Use during pregnancy and lactation The use of the drug is not recommended in the first trimester of pregnancy. The use of the drug is contraindicated in the second and third trimesters of pregnancy. Pregnancy Epidemiological data on the risk of teratogenicity when taking ACE inhibitors in the first trimester of pregnancy do not allow a definitive conclusion, but some increased risk cannot be ruled out. Unless it is not possible to replace an ACE inhibitor with another alternative therapy, patients planning pregnancy should be switched to antihypertensive therapy with drugs whose safety profile for pregnant women is well established. If pregnancy occurs, the ACE inhibitor should be discontinued immediately and, if necessary, other antihypertensive therapy should be prescribed. When using ACE inhibitors in the second and third trimesters of pregnancy, a manifestation of a fetotoxic effect (impaired kidney function, oligohydramniosis, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia) was established. If an ACE inhibitor was taken from the second trimester of pregnancy, ultrasound of the function of the kidneys and bones of the skull is recommended. In newborns whose mothers have taken ACE inhibitors, blood pressure should be carefully monitored to prevent the possible development of hypotension. The period of breastfeeding It is not recommended to prescribe ramipril during breastfeeding due to lack of information. It is desirable to give preference to other drugs, the use of which during breastfeeding is safer. Influence on the ability to drive vehicles or potentially dangerous mechanisms Some adverse reactions (such symptoms of low blood pressure as heaviness, dizziness) can reduce the reaction and concentration of the patient, which may affect his ability to drive a car and mechanisms. This is most likely at the start of treatment, during dose increases, drug changes, and interactions with alcohol. It is not recommended to drive a car or operate machinery within a few hours after taking the first dose or increasing the dose. PrecautionsTreatment with ramipril is usually long-term, its duration in each case is determined by the doctor. It also requires regular medical supervision, in particular in patients with impaired liver and kidney function. It is usually recommended to correct dehydration, hypovolemia or salt deficiency before starting treatment. If absolutely necessary, treatment with the drug can be started or continued only if appropriate precautions are taken at the same time to prevent an excessive decrease in blood pressure and impaired renal function. Special categories of patients Monitoring of renal function Monitoring of renal function is necessary, especially during the first weeks of treatment. Patients with renal vascular disease (eg, with renal artery stenosis that is not yet clinically significant, or with unilateral hemodynamically significant renal artery stenosis), in cases of pre-existing renal dysfunction, as well as in patients who have undergone a kidney transplant, especially careful monitoring is necessary . Hyperkalemia The concentration of potassium and sodium in the blood serum should be regularly monitored. In patients with impaired renal function, more frequent monitoring of their serum concentrations is required. It is necessary to control the number of leukocytes in order to quickly diagnose leukopenia. Hyperkalemia has been observed in some patients taking ACE inhibitors, including ramipril. Patients at increased risk of developing hyperkalemia include patients with renal insufficiency, elderly patients (over 70 years of age), patients with uncontrolled diabetes mellitus, or patients taking potassium salts, potassium-sparing diuretics and other active substances that increase plasma potassium levels blood, as well as patients with conditions such as dehydration, acute heart failure or metabolic acidosis. If the simultaneous use of the above-mentioned drugs is deemed appropriate, regular monitoring of the level of potassium in the blood serum is recommended. Neutropenia / agranulocytosis If there are signs of impaired immunity due to leukopenia (for example, fever, swollen lymph nodes, tonsillitis), urgent monitoring of the peripheral blood picture is necessary. In the event of signs of bleeding (the smallest petechiae, red-brown rashes on the skin and mucous membranes), it is also necessary to control the number of platelets in the peripheral blood. Before and during treatment, it is necessary to control blood pressure, kidney function, hemoglobin levels in peripheral blood, creatinine, urea, electrolyte concentrations and the activity of “liver” enzymes in the blood. Care must be taken when prescribing the drug to patients on a low-salt or salt-free diet (increased risk of arterial hypotension). Patients at risk of hypotension Patients with increased activity of the renin-angiotensin-aldosterone system Patients with increased activity of the renin-angiotensin-aldosterone system are at risk of a sharp drop in blood pressure and deterioration of renal function during ACE inhibition, especially at the beginning of treatment or when the dose of inhibitors is first increased ACE or concomitant diuretics. Possible manifestations of increased activity of the renin-angiotensin-aldosterone system must be taken into account by carrying out constant medical supervision, including monitoring of blood pressure, in cases, for example: patients with severe hypertension; patients with decompensated congestive heart failure; patients with clinically significant hemodynamic disorders (inflow and outflow) in the left ventricle (for example, aortic stenosis, mitral stenosis); patients with unilateral renal artery stenosis with a second functional kidney; patients with a deficiency of electrolytes and (or) fluid (vk patients previously treated with diuretics); patients with cirrhosis of the liver and / or ascites; patients undergoing major surgery or during anesthesia with agents that cause hypotension. Before starting treatment, it is recommended to correct dehydration, hypovolemia or electrolyte deficiency (in patients with heart failure, such corrective action should be assessed against the risk of over-volume). Transient or permanent heart failure after myocardial infarction. Patients at risk of cardiac or cerebral ischemia due to acute hypotension. Transient arterial hypotension is not a contraindication for continuing treatment after stabilization of blood pressure. In case of recurrence of severe arterial hypotension, the dose should be reduced or the drug should be discontinued. If the anamnesis indicates the development of angioedema, not associated with the use of ACE inhibitors, then in such patients there is still an increased risk of its development when taking Ramilong. Double blockade of the renin-angiotensin-aldosterone system Double blockade of the renin-angiotensin-aldosterone system is associated with an increased risk of hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy. Dual RAAS blockade with ACE inhibitors, AT II receptor blockers (ARB II), or Aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This refers to the use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with chronic heart failure. Conducting a double blockade of the RAAS under the close supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy. During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, because. dizziness is possible, especially after the initial dose of an ACE inhibitor in patients taking diuretics. Caution should be exercised when exercising or in hot weather due to the risk of dehydration and hypotension due to reduced fluid volume. Ethanol is not recommended. Surgery Treatment with ACE inhibitors such as ramipril should, if possible, be stopped one day before the planned surgery. Angioedema Angioedema in the tongue, pharynx, or larynx (possible symptoms: difficulty swallowing or breathing) can be life-threatening and lead to the need for emergency care. After taking the first dose, as well as with an increase in the dosage of a diuretic and / or ramipril, patients should be under medical supervision for 8 hours to avoid the development of an uncontrolled hypotensive reaction. In patients with chronic heart failure, 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. Patients with malignant arterial hypertension or concomitant severe heart failure should begin treatment in a hospital setting. Anaphylactic reactions When using ACE inhibitors (see also membrane manufacturer’s instructions), life-threatening, rapidly developing, allergic-like (anaphylactoid) hypersensitivity reactions, sometimes leading to shock, have been described in patients undergoing hemodialysis using certain high-flow membranes (for example, , polyacrylonitrile membranes). The combined use of Ramilong and this kind of membrane should be avoided, for example, for urgent hemodialysis or hemofiltration. In this case, it is preferable to use other membranes or avoid taking ACE inhibitors. Similar reactions have been observed with low-density lipoprotein apheresis using dextran sulfate. Therefore, this method should not be used in patients treated with ACE inhibitors. When taking ACE inhibitors, the likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens increases. Consideration should be given to temporarily discontinuing ramipril before desensitization. Cough Cough has been reported during treatment with ACE inhibitors. The cough is unproductive, persistent and occurs after cessation of therapy. When making a differential diagnosis of cough in a patient, the possibility of its association with the use of ACE inhibitors should be taken into account. Ethnic Differences ACE inhibitors contribute to an increased incidence of angioedema in black patients compared to patients of other skin colors. Like other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black patients than in patients of color. This may be due to the high prevalence of low renin hypertension in the black hypertensive population. Interaction with other drugs Not recommended combinations: potassium salts, potassium-sparing diuretics (for example, amiloride, triamterene, spironolactone): simultaneous use leads to hyperkalemia (monitoring of potassium in the blood serum is necessary); antihypertensive drugs (in particular, diuretics) and other drugs that reduce blood pressure: simultaneous administration leads to an increase in the action of ramipril; hypnotics, narcotic and painkillers: they can cause a sharp decrease in blood pressure; vasopressor sympathomimetic drugs (epinephrine) and estrogens can cause a weakening of the action of ramipril; allopurinol, procainamide, cytostatic agents, immunosuppressants, systemic corticosteroids and other drugs, which can change the blood picture, in particular, reduce the number of leukocytes in the blood; lithium: an increase in the concentration of serum lithium and, as a result, an increase in the cardio- and neurotic action of lithium; oral hypoglycemic agents (sulfonylurea derivatives, biguanides), insulin: increased hypoglycemia; non-steroidal anti-inflammatory drugs (indomethacin, acetylsalicylic acid): a possible weakening of the action of ramipril; heparin: a possible increase in the concentration of potassium in the blood serum; salt: a weakening of the action of ramipril; alcohol: an increase in the hypotensive effect of ramipril. double blockade of the RAAS with the use of ACE inhibitors, AT II receptor blockers (ARB II) or Aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In patients with diabetes mellitus or moderate/severe renal insufficiency (GFR < 60 ml/min/1.73 m2), concomitant use of Aliskiren with ACE inhibitors or ARBs II is contraindicated. In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful supervision of a specialist and mandatory monitoring of renal function, water and electrolyte balance, and blood pressure are necessary. other components of the drug; patients who, according to anamnestic data, had previously experienced angioedema (risk of rapid development of angioedema, including while taking ACE inhibitors); hemodialysis; hemodynamically significant stenosis of the renal arteries (bilateral, in the case of one kidney - unilateral) arterial hypotension (systolic blood pressure less than 90 mm Hg) or conditions with unstable hemodynamic parameters; pregnancy and lactation (see Use in pregnancy and lactation); age up to 18 years (efficacy and safety have not been established); in combination with lek artificial drugs containing Aliskiren in patients with diabetes mellitus (type I or II) or with moderate and severe renal insufficiency (glomerular filtration rate less than 60 ml / min / 1.73 m2); nephropathy, which is treated with glucocorticosteroids, non-steroidal anti-inflammatory drugs , immunomodulators and / or other cytotoxic drugs; simultaneous use with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy. Composition Each 2.5 mg tablet contains: active substance: ramipril - 2.5 mg. excipients: corn starch (modified by Starch 1500), hypromellose, sodium starch glycolate, magnesium stearate, microcrystalline cellulose. OverdosageSymptoms: pronounced decrease in blood pressure, shock, severe bradycardia, disturbances in water and electrolyte balance, acute renal failure, stupor. Treatment: gastric lavage, intake of adsorbents, sodium sulfate (if possible, within the first 30 minutes). In the event of arterial hypotension, the administration of alpha-1-adrenergic agonists (norepinephrine, dopamine) and angiotensin-II (angiotensinamide) can be added to therapy to replenish the volume of circulating blood and restore salt balance. Ramiprilat, the active metabolite of ramipril, is almost never dialyzed. Side effects During therapy with ramipril, side effects such as persistent dry cough and hypotensive reactions may occur. Serious adverse reactions include angioedema, hyperkalemia, deterioration of kidney and liver function, pancreatitis, some skin reactions, and neutropenia/agranulocytosis. The frequency of occurrence of adverse reactions is determined as follows: very frequent (> 1/10), frequent (> 1/100, < 1/10), infrequent (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/10000) and the frequency is unknown (cannot be estimated from the available data). Within each group of defined frequency criteria, adverse reactions are presented in descending order of their severity. From the side of the cardiovascular system: infrequently - myocardial ischemia, including angina pectoris or myocardial infarction, cardiac arrhythmia, arrhythmia, palpitations, peripheral edema. On the part of the blood and lymphatic system: infrequently - eosinophilia; rarely - a decrease in the number of leukocytes (including neutropenia and agranulocytosis), a decrease in the number of erythrocytes, a decrease in hemoglobin, a decrease in the number of platelets; frequency unknown - bone marrow depression, pancytopenia, hemolytic anemia. From the nervous system: often - headache, dizziness; infrequently - dizziness, paresthesia, ageusia (loss of taste), dysgeusia (taste disorder); rarely - tremor, imbalance; the frequency is unknown - cerebral ischemia, including ischemic stroke and transient ischemic cerebrovascular accident, impaired psychomotor functions (impaired reaction), burning sensation, impaired sense of smell. From the senses: infrequently - visual disturbances, including blurred vision; rarely - conjunctivitis, hearing loss, tinnitus. On the part of the respiratory system, chest and mediastinum: often - dry, unproductive cough, bronchitis, sinusitis, dyspnea; infrequently - bronchospasm, including exacerbation of asthma, runny nose. From the gastrointestinal tract: often - inflammatory reactions of the gastrointestinal tract, indigestion, gastrointestinal discomfort, dyspepsia, diarrhea, nausea, vomiting; infrequently - pancreatitis, increased pancreatic enzymes, angioedema of the small intestine, pain in the gastrointestinal tract, including gastritis, intestinal obstruction, dry mouth; rarely - glossitis; the frequency is unknown - aphthous stomatitis (inflammatory reactions of the oral cavity). From the side of the kidneys and urinary system: infrequently - impaired renal function, including acute renal failure, increased existing proteinuria, increased blood urea levels, increased blood creatinine levels. On the part of the skin and subcutaneous tissue: often - rashes; infrequently - angioedema, itching, increased sweating; rarely - exfoliative dermatitis, urticaria, onycholysis; very rarely - photosensitive reactions; the frequency is unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, worsening of the course of psoriasis, psoriasiform dermatitis, pemphigoid and lichenoid exanthemas or enanthemas, alopecia. From the musculoskeletal system and connective tissue: often - muscle spasms (muscle cramps), myalgia; infrequently - arthralgia. From the immune system: the frequency is unknown - anaphylactic or anaphylactoid reactions, increased levels of antinuclear antibodies. From the side of the liver: infrequently - increased levels of liver enzymes and / or bilirubin; rarely - cholestatic jaundice, hepatocellular disorder; the frequency is unknown - impaired liver function, cholestatic or cytolytic hepatitis. From the side of metabolism and nutrition: often - an increase in the content of potassium in the blood; infrequently - anorexia, loss of appetite; frequency is unknown - a decrease in the content of sodium in the blood. From the reproductive system and mammary glands: infrequently - decreased erection and libido; frequency unknown - gynecomastia. On the part of the psyche: infrequently - depressive mood, anxiety, nervousness, agitation, sleep disturbance, including drowsiness (hypersomnia); rarely - confusion; frequency unknown - attention disorder. General disorders: often - chest pain, fatigue; infrequently - fever (fever); rarely - asthenia (weakness). Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Ramilong tab 2.5mg №10x3 Price for Ramilong tab 2.5mg №10x3
INN | RAMIPRIL |
---|---|
The code | 95 393 |
Barcode | 4 812 608 006 942 |
Dosage | 2.5mg |
Active substance | Ramipril |
Manufacturer | Lekpharm SOOO, Belarus |
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