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    3. Polapril 5mg 28 capsules — Made in Poland by Polpharma — Free Delivery

    Polapril 5mg 28 capsules — Made in Poland by Polpharma — Free Delivery


    Brand: POLPHARMA
    Product Code: Polapril
    Availability: In Stock
    $21.88
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    Indications

    Arterial hypertension
    Prevention of cardiovascular disease: reduction of cardiovascular morbidity and mortality in patients with:
    - severe cardiovascular disease of atherothrombotic genesis (presence of a history of coronary artery disease or stroke or peripheral vascular disease);
    - diabetes mellitus with at least one cardiovascular risk factor (see PHARMACOLOGICAL PROPERTIES).
    Treatment of kidney disease:
    - initial glomerular diabetic nephropathy, which is evidenced by the presence of microalbuminuria;
    - severe glomerular diabetic nephropathy, as evidenced by the presence of macroproteinuria, in patients who have at least one cardiovascular risk factor (see PHARMACOLOGICAL PROPERTIES);
    - severe glomerular non-diabetic nephropathy, as evidenced by the presence of macroproteinuria ≥3 g / day (see PHARMACOLOGICAL PROPERTIES).
    Treatment of heart failure, accompanied by clinical manifestations.
    Secondary prevention after acute myocardial infarction: reduction of mortality in the acute stage of myocardial infarction in patients with clinical signs of heart failure when starting treatment more than 48 hours after the onset of acute myocardial infarction.

    Application

    Applied inside.
    Polapril is recommended to be taken every day at the same time. The preparation can be taken before, during and after meals, since food intake does not affect its bioavailability. Polapril capsules should be swallowed whole with water. They must not be chewed or crushed.
    adults
    Patients using diuretics. At the beginning of treatment with Polapril, arterial hypotension may occur, the development of which is more likely in patients receiving diuretics at the same time. In such cases, caution is advised, as these patients may have a decrease in BCC and / or electrolytes.
    It is advisable to stop the use of the diuretic 2-3 days before the start of treatment with Polapril, if possible (see SPECIAL INSTRUCTIONS).
    In patients with hypertension who cannot stop the diuretic, treatment with Polapril should be started with a dose of 1.25 mg. It is necessary to carefully monitor kidney function and the level of potassium in the blood. The further dose of Polapril should be adjusted depending on the target level of blood pressure.
    AG. The dose should be selected individually, depending on the patient's condition (see SPECIAL INSTRUCTIONS) and the results of blood pressure control measurements. Polapril can be used as monotherapy or in combination with other classes of antihypertensive preparations.
    starting dose. Treatment with Polapril should be initiated gradually, starting with the recommended initial dose of 2.5 mg/day.
    In patients with significant activation of the renin-angiotensin-aldosterone system after taking the initial dose, a significant decrease in blood pressure may occur. For such patients, the recommended starting dose is 1.25 mg, and their treatment should be started under medical supervision (see SPECIAL INSTRUCTIONS).
    Dose titration and maintenance dose. The dose can be doubled every 2 to 4 weeks until target BP is reached; the maximum dose of Polapril is 10 mg / day. As a rule, the preparation is taken 1 time per day.
    Prevention of cardiovascular diseases. starting dose. The recommended starting dose of Polapril is 2.5 mg once daily.
    Dose titration and maintenance dose. Depending on the individual tolerability of the preparation, the dose should be gradually increased. It is recommended to double the dose after 1-2 weeks of treatment, and then after 2-3 weeks increase it to the target maintenance dose of 10 mg 1 time per day.
    See the information above regarding the dosing of the preparation for patients receiving diuretics.
    Treatment of kidney disease
    In patients with diabetes mellitus and microalbuminuria. starting dose. The recommended starting dose of Polapril is 1.25 mg once daily.
    Dose titration and maintenance dose. Depending on the individual tolerability of the preparation during further treatment, the dose is increased. After 2 weeks of treatment, a single dose is recommended to be doubled to 2.5 mg, and then to 5 mg after 2 weeks of treatment.
    In patients with diabetes mellitus and at least one cardiovascular risk factor. starting dose. The recommended starting dose of Polapril is 2.5 mg once daily.
    Dose titration and maintenance dose. Depending on the individual tolerability of the preparation during further treatment, the dose is increased. After 1-2 weeks of treatment, the daily dose of Polapril is recommended to be doubled to 5 mg, and then to 10 mg after 2-3 weeks of treatment. The target daily dose is 10 mg.
    In patients with non-diabetic nephropathy, as evidenced by the presence of macroproteinuria ≥3 g / day. starting dose. The recommended starting dose of Polapril is 1.25 mg once daily.
    Dose titration and maintenance dose. Depending on the patient's individual tolerance of the preparation, the dose is increased during further treatment. After 2 weeks of treatment, a single dose is recommended to be doubled to 2.5 mg, and then to 5 mg after 2 weeks of treatment.
    Heart failure with clinical manifestations. starting dose. For patients whose condition has stabilized after treatment with diuretics, the recommended initial dose is 1.25 mg / day.
    Dose titration and maintenance dose. The dose of Polapril is titrated by doubling it every 1 to 2 weeks until a maximum daily dose of 10 mg is reached. It is advisable to divide the dose into 2 doses.
    Secondary prevention after acute myocardial infarction in the presence of heart failure. starting dose. 48 hours after the onset of myocardial infarction, patients whose condition is clinically and hemodynamically stable are prescribed an initial dose of 2.5 mg 2 times a day for 3 days. If the initial dose of 2.5 mg is poorly tolerated, then a dose of 1.25 mg 2 times a day for 2 days should be used, followed by an increase to 2.5 and 5 mg 2 times a day. If the dose cannot be increased to 2.5 mg twice daily, treatment should be discontinued.
    See the information above regarding the dosing of the preparation for patients receiving diuretics.
    Dose titration and maintenance dose. In the future, the daily dose is increased by doubling it with an interval of 1-3 days until the target maintenance dose of 5 mg 2 times a day is reached.
    When possible, the maintenance daily dose is divided into 2 doses.
    If the dose cannot be increased to 2.5 mg twice daily, treatment should be discontinued. There is insufficient experience in the treatment of patients with severe (NYHA Class IV) heart failure immediately after myocardial infarction. If, however, a decision is made to treat such patients with this preparation, it is recommended to start therapy with a dose of 1.25 mg 1 time per day and any increase in it should be carried out with extreme caution.
    Special categories of patients
    Patients with impaired renal function. The daily dose for patients with impaired renal function depends on the creatinine clearance (see PHARMACOLOGICAL PROPERTIES):
    - if creatinine clearance ≥ 60 ml / min, there is no need to adjust the initial dose (2.5 mg / day), and the maximum daily dose is 10 mg;
    - if the creatinine clearance is 30-60 ml / min, there is no need to adjust the initial dose (2.5 mg / day), and the maximum daily dose is 5 mg;
    - if the creatinine clearance is 10-30 ml / min, the initial daily dose is 1.25 mg / day, and the maximum daily dose is 5 mg;
    - patients with hypertension who are on hemodialysis: ramipril is slightly excreted during hemodialysis; the initial dose is 1.25 mg, and the maximum daily dose is 5 mg; the preparation should be taken a few hours after the hemodialysis session.
    Patients with impaired liver function (see PHARMACOLOGICAL PROPERTIES). Treatment with Polapril in patients with impaired liver function should be started under close supervision, and the maximum daily dose in such cases should be 2.5 mg.
    Elderly patients. The initial dose should be lower, and further dose titration should be more gradual, given the high likelihood of adverse effects, especially in very old and frail patients. In such cases, the minimum initial dose is prescribed - 1.25 mg of ramipril.

    Contraindications

    Hypersensitivity to ramipril, other ACE inhibitors or components of the preparation; angioedema in history (hereditary / idiopathic or due to previous therapy with ACE inhibitors or angiotensin II receptor antagonists); stenosis of the renal artery (bilateral or stenosis of the artery of a single kidney); hypotensive or hemodynamically unstable conditions; primary hyperaldosteronism; period of pregnancy; the period of breastfeeding; childhood.
    It is necessary to avoid the use of Polapril or other ACE inhibitors in combination with methods of extracorporeal therapy, which can cause contact of blood with negatively charged surfaces, since there is a risk of developing a severe anaphylactoid reaction, which can sometimes lead to the development of severe anaphylactic shock.
    Thus, when taking Polapril, it is impossible to carry out a dialysis or hemofiltration procedure using polyacrylonitrile, sodium-2-methylsulfonate membranes with high ultrafiltration activity (for example, AN 69) and an LDL apheresis procedure using dextran sulfate.

    Side effects

    The frequency of occurrence of adverse reactions is classified as follows: very often (≥1 / 10); often (≥1/100, 1/10); infrequently (≥1/1000, 1/100); rarely (≥1/10,000, 1/1000); very rare (1/10,000), frequency unknown (frequency cannot be estimated from existing data).
    Cardiovascular system: infrequently - myocardial ischemia, including angina pectoris or myocardial infarction, tachycardia, arrhythmia, a feeling of accelerated heartbeat, peripheral edema.
    Hematological reactions: infrequently - eosinophilia; rarely - a decrease in the number of red blood cells, white blood cells or platelets and a decrease in hemoglobin levels. In isolated cases, agranulocytosis, pancytopenia and bone marrow suppression are noted.
    Hematologic reactions to ACE inhibitors are more likely to occur in patients with impaired renal function, especially those with associated collagen diseases (eg, systemic lupus erythematosus or scleroderma), or in patients taking other preparations that can cause changes in blood composition.
    In rare cases, hemolytic anemia may develop.
    Nervous system: often - headache, dizziness; infrequently - vertigo, paresthesia, ageusia, dysgeusia; rarely - tremor, imbalance; unknown - cerebral ischemia, including ischemic stroke and transient ischemic attack, impaired psychomotor functions, burning sensation, parosmia.
    On the part of the organs of vision: infrequently - visual impairment, including blurred vision; rarely - conjunctivitis.
    On the part of the organ of hearing and the labyrinth: rarely - hearing loss, ringing in the ears.
    Respiratory, thoracic and mediastinal disorders: often - unproductive irritating cough, bronchitis, sinusitis, shortness of breath; infrequently - bronchospasm, including exacerbation of asthma, nasal congestion.
    from the gastrointestinal tract: often - inflammation in the gastrointestinal tract, digestive disorders, abdominal discomfort, dyspepsia, diarrhea, nausea, vomiting; infrequently - pancreatitis (in isolated cases, deaths have been reported during the use of ACE inhibitors), increased levels of pancreatic enzymes, angioedema of the small intestine, pain in the upper abdomen, including gastritis, constipation, dry mouth; rarely - glossitis; unknown - aphthous stomatitis.
    From the side of the kidneys and urinary tract: infrequently - impaired renal function, including acute renal failure, increased urination, worsening of the course of background proteinuria, increased blood urea levels, increased blood creatinine levels.
    Reactions from the skin or mucous membranes: often - a rash, mostly maculopapular in nature; infrequently - angioedema, impaired airway patency due to angioedema, which can be fatal, itching, hyperhidrosis; rarely - exopholitic dermatitis, urticaria, onycholysis; very rarely - photosensitivity reaction; unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme pemphigus, exacerbation of psoriasis, psoriasiform, pemphigoid or lichenoid exanthema and enanthema, alopecia.
    From the musculoskeletal system and connective tissue: often - muscle spasms, myalgia; infrequently - arthralgia.
    Endocrine disorders: unknown - syndrome of impaired secretion of antidiuretic hormone (SIAH).
    Metabolic and nutritional disorders: often - an increase in the level of potassium in the blood; infrequently - anorexia, loss of appetite; unknown - decrease in sodium levels in the blood.
    From the side of the vessels: often - hypertension, orthostatic decrease in blood pressure, syncope; infrequently - tides; rarely - vascular stenosis, hypoperfusion, vasculitis; unknown - Raynaud's phenomenon.
    General disorders: often - chest pain, increased fatigue; infrequently - pyrexia; rarely - asthenia.
    From the immune system: unknown - anaphylactic and anaphylactoid reactions, increased levels of antinuclear antibodies.
    Hepatobiliary disorders: infrequently - increased levels of liver enzymes and / or bilirubin conjugation; rarely - cholestatic jaundice, damage to liver cells; unknown - acute liver failure, cholestatic or cytolytic hepatitis (in exceptional cases - with a fatal outcome).
    From the reproductive system and mammary glands: infrequently - transient erectile dysfunction, decreased libido; unknown - gynecomastia.
    On the part of the psyche: infrequently - mood deterioration, anxiety, nervousness, anxiety, sleep disturbances, including drowsiness; rarely - confusion; unknown - impaired attention.

    special instructions

    Special categories of patients
    Double blockade of the renin-angiotensin-aldosterone system due to preparations that contain aliskiren. Double blockade of the renin-angiotensin-aldosterone system by the combined use of the preparation Polapril and aliskiren is not recommended, since there is a risk of increased hypertension, hyperkalemia and the occurrence of changes in renal function.
    In patients with diabetes mellitus or impaired renal function (GFR 60 ml / min), the combined use of Polapril and aliskiren is contraindicated.
    Patients at risk of developing hypertension.
    Patients with increased activity of the renin-angiotensin system. When treating patients with increased activity of the renin-angiotensin system, special care should be taken. In such patients, there is a risk of an unexpected and significant decrease in blood pressure and deterioration of renal function as a result of ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is prescribed for the first time or for the first time at a higher dose. At the beginning of treatment with the preparation or when increasing the dose, it is necessary to carefully monitor blood pressure until there is a threat of its sharp decrease.
    Increased activity of the renin-angiotensin system can be expected, in particular:
    • in patients with severe, and especially malignant, hypertension. In the initial phase of treatment, special medical supervision is required;
    • in patients with severe heart failure or in the case of the use of other preparations that reduce blood pressure. In case of severe heart failure, strict medical supervision is necessary in the initial phase of treatment;
    • in patients with hemodynamically significant difficulty in the inflow or outflow of blood from the left ventricle (for example, aortic stenosis or mitral valve stenosis or hypertrophic cardiomyopathy). In the initial phase of treatment, strict medical supervision is necessary;
    • in patients with hemodynamically significant renal artery stenosis. In the initial phase of treatment, strict medical supervision is necessary.

    It may be necessary to stop the started treatment with diuretics:

    • in patients previously treated with diuretics. If discontinuation or dose reduction of the diuretic is not possible, strict medical supervision is necessary in the initial phase of treatment;
    • in patients with a threat or electrolyte imbalance (as a result of insufficient intake of fluid or salt or due to their loss - diarrhea, vomiting or increased sweating, in cases where compensation for the lack of fluid and salt in the body is insufficient).
    Correction of the state of dehydration, hypovolemia or electrolyte deficiency is recommended prior to treatment (however, in patients with heart failure, such corrective measures should be carefully evaluated in terms of the possible risk of volume overload). In clinically significant conditions, Polapril can be started or continued while taking appropriate measures to prevent an excessive decrease in blood pressure and kidney function.
    Patients with impaired liver function. In patients with impaired liver function, the response to treatment with Polapril may be either increased or decreased. In addition, in patients with severe cirrhosis of the liver with edema and / or ascites, the activity of the renin-angiotensin system may be significantly increased; therefore, special care must be taken during the treatment of these patients.
    In patients for whom a significant decrease in blood pressure poses a particular risk (for example, patients with hemodynamically significant stenosis of the coronary arteries or cerebral vessels), strict medical supervision is necessary in the initial phase of treatment;
    The elderly. In the elderly, the reaction to ACE inhibitors may be more pronounced. An assessment of renal function is recommended at the start of treatment.
    It is recommended to monitor renal function, especially in the first weeks of treatment with an ACE inhibitor. Particularly careful monitoring is necessary in patients with:
    • heart failure;
    • vasorenal disease, including hemodynamically significant unilateral renal artery stenosis. In the latter group of patients, even a slight increase in plasma creatinine may indicate a decrease in kidney function;
    • decreased kidney function;
    • transplanted kidney.
    Monitoring of electrolyte balance. It is recommended to regularly monitor the concentration of potassium in the blood plasma. More frequent monitoring of plasma potassium levels is necessary in patients with reduced renal function.
    Hematological monitoring. It is recommended to monitor the number of leukocytes in order to timely detect possible leukopenia. More frequent monitoring is recommended in the initial phase of treatment in patients with impaired renal function, with concomitant collagenosis (systemic lupus erythematosus or scleroderma) or in patients treated with other preparations that affect blood counts.
    Use during pregnancy and lactation. During pregnancy, it is forbidden to take Polapril. Thus, before starting the preparation in women of reproductive age, it is necessary to exclude a possible pregnancy. While taking Polapril, women of reproductive age should use reliable contraceptives. If a woman wants to become pregnant, you need to stop using the preparation and replace it with another one (with the exception of ACE inhibitors). If the use of an ACE inhibitor cannot be discontinued, pregnancy should be prevented. In the event that pregnancy occurs during treatment with Polapril, it is necessary to switch as soon as possible (under the supervision of a physician) to an alternative therapeutic agent that poses a lower risk to the fetus (excluding ACE inhibitors).
    Animal studies have shown that ramipril passes into breast milk. Since it is not known whether ramipril passes into human breast milk, the use of Polapril during breastfeeding is contraindicated.
    Children. Due to the lack of sufficient clinical experience, Polapril should not be administered to children.
    The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Some side effects (for example, symptoms of a decrease in blood pressure, in particular nausea, drowsiness, blurred vision, dizziness) may impair the attention and speed of the patient's psychomotor reactions.
    If side effects occur, you should refrain from driving vehicles and working with other mechanisms.
    They can occur especially at the beginning of treatment or when switching from other preparations. After the first dose or further increase in dose, it is not recommended to drive a vehicle and work with machinery for several hours.

    Interactions

    Combinations that are contraindicated. extracorporeal therapies that bring blood into contact with negatively charged surfaces, such as dialysis or hemofiltration using certain high-flow membranes (eg, polyacrylonitrile membranes) and LDL apheresis using dextrin sulfate. if such treatment is necessary, consideration should be given to using a different dialysis membrane or using a different class of antihypertensive agents.
    The combined use of the preparation Polapril with preparations that contain aliskiren is contraindicated in patients with diabetes mellitus or with severely impaired renal function, and is also not recommended for other categories of patients.
    Combinations that are not recommended. Potassium salts, heparin, potassium-sparing diuretics and other active substances that increase the level of potassium in the blood plasma (including angiotensin II antagonists, trimethoprim, tacrolimus, cyclosporine). Hyperkalemia may occur, so it is necessary to constantly monitor the level of potassium in the blood.
    Should be used with caution. Antihypertensive preparations (eg diuretics) and other preparations can reduce blood pressure (eg nitrates, tricyclic antidepressants, anesthetics, alcohol, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): an increase in the hypotensive effect of ramipril can be expected. It is recommended to regularly monitor the plasma concentration of sodium in patients taking diuretics at the same time.
    Vasoconstrictor sympathomimetics and other substances (eg, isoproterenol, dobutamine, dopamine, epinephrine): may weaken the blood pressure lowering effect of Polapril. It is recommended to carefully monitor blood pressure. Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other preparations that can cause changes in the hemogram: may increase the likelihood of hematological reactions when used simultaneously with ramipril.
    Lithium salts. Lithium excretion may be reduced by ACE inhibitors. This can lead to an increase in the concentration of lithium in the blood plasma and an increase in the toxicity of lithium. In this regard, it is necessary to control the concentration of lithium in the blood plasma.
    Antidiabetic agents (eg insulin and sulfonylurea derivatives). ACE inhibitors may increase the effect of insulin. In some cases, this can lead to the development of hypoglycemia in patients who simultaneously use antidiabetic agents. Particularly careful monitoring of blood glucose levels is recommended at the start of treatment.
    It should be taken into account
    NSAIDs (eg indomethacin and acetylsalicylic acid). It is possible to weaken the effect of lowering blood pressure under the action of Polapril. In addition, concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of decreased renal function and increased plasma potassium levels.
    Salt. Increased salt intake may weaken the antihypertensive effect of Polapril.
    Method of specific hyposensitization. Due to ACE inhibition, the likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom increases. It is assumed that this effect can also be observed with respect to other allergens.

    Overdose

    Symptoms of intoxication. overdose can cause excessive expansion of peripheral vessels (with severe hypotension, shock), bradycardia, electrolyte imbalance and renal failure.
    Treatment of intoxication. Primary detoxification, for example, by gastric lavage, the use of adsorbents, sodium thiosulfate (if possible, during the first 30 minutes). In the event of hypotension, in addition to measures aimed at restoring fluid volume and salt balance, α1-adrenergic receptor agonists (eg norepinephrine, dopamine) or angiotensin II (angiotensinamide) should be used, which, as a rule, are only available in selected research laboratories. .
    Ramiprilat, the active metabolite of ramipril, is poorly excreted from the systemic circulation by hemodialysis.

    Storage conditions

    In a dry place protected from light at temperatures up to 25 ° C. Keep out of the reach of children.

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