Active substancePerindoprilPerindopril
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains active ingredient perindopril erbumine 8 mg

    Auxiliary matter: lactose monohydrate, cellulose microcrystalline, sodium hydrogen carbonate, silicon dioxide colloidal anhydrous, magnesium stearate.

    Description:Tablets 8 mg - round, slightly biconcave tablets with a bevel, white or almost white, with a risk on one side.
    Pharmacotherapeutic group:an angiotensin-converting enzyme (ACE) inhibitor
    ATX: & nbsp

    C.09.A.A.04   Perindopril

    Pharmacodynamics:

    Perindopril is an antihypertensive drug whose mechanism of action is associated with inhibition of the activity of the angiotensin converting enzyme, leading to a decrease in the formation of angiotensin II, eliminates the vasoconstrictive effect of angiotensin II, reduces the secretion of aldosterone. Helps restore the elasticity of large arterial; vessels, reduces left ventricular hypertrophy, pressure in the pulmonary capillaries. Reduces hypertrophy of the myocardium, normalizes the work of the heart. Reduces preload and postload, the filling pressure of the left ventricle,general peripheral vascular resistance, moderately reduces the heart rate (heart rate), increases regional blood flow in the muscles. After ingestion of the median single dose, the maximum hypotensive effect is achieved after 4-6 hours and persists for 24 hours.

    A stable therapeutic effect is achieved after several weeks of treatment.

    Pharmacokinetics:

    After oral administration, it is rapidly absorbed from the gastrointestinal tract. The bioavailability of perindopril is 65 to 70%. Eating food reduces the conversion of perindopril to perindoprilat.

    The maximum concentration is achieved 1 hour after ingestion. In the liver is metabolized with the formation of an active metabolite perindoprilata. The connection with the proteins of the blood plasma perindoprilata - 50 - 60%. The maximum concentrations of perindoprilat in the blood serum are observed after 3-4 hours. Perindoprilat easily passes through the histohematological barriers, excluding the blood-brain barrier, a small amount penetrates through the placenta and into breast milk. It is excreted by the kidneys. Do not cumulate. In elderly patients, in patients with renal and cardiac failure, excretionperindoprilata is slowed down.

    Removed during hemodialysis (rate 70 ml / min 1.17 ml / sec.) And peritoneal dialysis.

    Indications:

    Arterial hypertension.

    Chronic heart failure.

    Contraindications:

    Hypersensitivity to perindopril and any other ingredient of the drug or other ACE inhibitors, angioedema in the anamnesis (hereditary, idiopathic or angioedema due to the administration of ACE inhibitors), pregnancy and lactation.

    Age to 18 years (effectiveness and safety not established).

    Carefully:

    primary hyperaldosteronism, diseases

    connective tissue (including systemic lupus erythematosus, scleroderma), bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney.

    condition after kidney transplantation, aortic stenosis, chronic heart failure in decompensation stage, arterial hypotension, severe renal failure (azotemia), significant hypovolemia and loss of sodium (salt-free diet and / or treatment with diuretics, diarrhea),

    hypertrophic obstructive cardiomyopathy,cerebrovascular diseases (including cerebrovascular insufficiency, coronary heart disease, coronary insufficiency - the risk of excessive reduction of blood pressure), inhibition of bone marrow hematopoiesis in patients receiving immunosuppressive drugs (risk of neutropenia), diabetes, advanced age, surgery (general anesthesia).
    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    To ensure the following dosing regimen, it is possible to take the drug at other registered dosages (Prenessa tablets, 2 mg and 4 mg).

    Inside, before eating.

    Arterial hypertension: In patients with essential hypertension, the recommended initial dose is 4 mg per day - in the morning. After one month of treatment, the dose may be increased to 8 mg per day. Adding ACE inhibitors to patients taking diuretics can cause arterial hypotension. In this regard, it is recommended to cancel diuretics for 2 - 3 days before treatment or Prenessoy Prenessoy begin treatment with the initial dose of 2 mg per day in one portion.

    For patients with renovascular hypertension, the recommended initial dose is 2 mg per day in one session. Further, if necessary, the dose can be changed.

    Treatment of elderly patients should begin with a dose of 2 mg, which can if necessary gradually increase to 8 mg.

    Heart failure: the recommended initial dose is 2 mg in the morning. After 1-2 weeks, the dose can be increased to 4 mg per day in a single dose.

    Treatment of chronic heart failure are usually combined with non-potassium-sparing diuretics and / or digoxin. The start of treatment should be under strict medical supervision using the recommended initial doses.

    Renal insufficiency: in patients with renal insufficiency, the dose of Prenes should be selected depending on the degree of renal failure (creatinine clearance). Patient monitoring usually involves regular determination of potassium levels and creatinine levels in the blood.

    Recommended doses:

    Creatinine clearance

    The recommended dose

    Creatinine clearance> 60 ml / min

    4 mg per day

    Creatinine clearance 30 - 60 ml / min

    2 mg per day

    Creatinine clearance 15-30 ml / min

    2 mg per day every other day

    Dialysis clearance of perindoprilat 70 ml / min. When appointing patients with dysfunction binge, dose adjustments are not required.

    The recommended dose for patients on hemodialysis (creatinine clearance less than 15 ml / min) is 2 mg per day of dialysis, administered after the dialysis procedure.
    Side effects:

    From the cardiovascular system: often excessive decrease in blood pressure and related symptoms, rarely - arrhythmia, angina, myocardial infarction, stroke.

    From the urinary system: decreased kidney function, acute renal failure.

    On the part of the respiratory system: often - a "dry" cough, difficulty breathing; rarely - bronchospasm, rhinorrhea.

    From the digestive system: often - nausea, vomiting, abdominal pain, taste change, diarrhea or constipation, dry mouth, decreased appetite, cholus static jaundice, pancreatitis.

    From the central nervous system: often - headache, asthenia, increased fatigue, dizziness, ringing in the ears, visual impairment, muscle cramps, paresthesia, rarely - decreased I, insomnia; very rarely confusion.

    Allergic reactions: often - skin rash, itching; rarely - hives, angioedema; extremely rarely - multiforme exudative erythema.

    Laboratory indicators: often - hypercreatininaemia, proteinuria, hyperkalemia, hyperuricemia; rarely (with prolonged use in high doses) - neutropenia, leukopenia, hypohemoglobinaemia, thrombocytopenia, a decrease in hematocrit; extremely rare - agranulocytosis, pancytopenia, increased activity of "hepatic" enzymes, hyperbilirubinemia, hemolytic anemia (against a background of deficiency of glucose-6-phosphate dehydrogenase).

    Other: increased sweating, decreased potency.

    Overdose:

    Symptoms: marked decrease in blood pressure, shock, stupor, bradycardia, electrolyte disorders (hyperkalemia, hyponatremia), renal failure.

    Treatment: the patient is transferred to a horizontal position with a low headboard. In mild cases, gastric lavage and ingestion of saline are shown, in more serious cases, measures aimed at stabilizing blood pressure, iv administration of saline, plasma substitutes, if necessary, intravenous injection of angiotensin II, with bradycardia, atropine, an artificial pacemaker may be required. Removed during hemodialysis (rate 70 ml / min 1.17 ml / sec.) And peritoneal dialysis - do not use high permeability polyacrylonitrile membranes.

    Interaction:

    Increases the severity of hypoglycemic action of insulin and sulfonylurea derivatives.

    Baclofen, tricyclic antidepressants, antipsychotic drugs (antipsychotics), saluretics increase the hypotensive effect and increase the risk of orthostatic hypotension (additive effect), antacids reduce the bioavailability of ACE inhibitors.

    Glucocorticosteroids (GCS), non-steroidal anti-inflammatory drugs (NSAIDs) reduce the severity of hypotensive action (fluid retention and electrolytes).

    Potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations increase the risk of hypokalemia.

    It is not recommended simultaneous use of drugs that can cause hyperkalemia and ACE inhibitors, except for severe hypokalemia (control of potassium in the blood serum).

    With the simultaneous use of perindopril with lithium preparations, it is possible to slow the excretion of lithium from the body (regular monitoring of the lithium content in the blood is necessary).

    Diuretics, medicines for general anesthesia and muscle relaxants, ethanol increase the risk of excessive blood pressure lowering.

    The risk of developing clinically pronounced arterial hypotension can be reduced by stopping diuretics several days before starting treatment with perindopril.

    Special instructions:

    Use with caution in renal failure and severe arterial hypertension. Before and during treatment with Prenese, renal function testing is recommended: determination of the concentration of creatinine, electrolytes and urea. During treatment Prenese should regularly monitor kidney function, the activity of "liver" enzymes in the blood, the picture of peripheral blood (especially in patients with diffuse connective tissue diseases, in patients who receive immunosuppressive drugs, allopurinol). Patients with sodium and liquid deficiency before the start of treatment should be corrected water-electrolyte disorders.

    When using ACE inhibitors, careful monitoring of blood pressure and kidney function is required. It is also necessary to monitor the concentration of potassium in the blood serum.

    In patients with severe heart failure and other patients from high-risk groups (patients with renal insufficiency and a tendency to electrolyte imbalance, patients concomitantly taking diuretics and / or vasodilators) treatment should begin under strict medical supervision.

    To reduce the risk of symptomatic hypotension, high doses of diuretics must be reduced before treatment with Prenes.

    In patients at risk, especially those with chronic heart failure in the stage of decompensation, elderly patients, as well as patients with initially low blood pressure, impaired renal function or receiving large doses of diuretics, the beginning of the drug should be administered under the supervision of a doctor.

    It is necessary to stop taking the drug before the forthcoming surgery for 12 hours and to warn the anesthesia doctor about taking Prenessa.

    During treatment with Prenese, hemodialysis can not be performed using polyacrylonitrile membranes (risk of developing anaphylactic reactions).

    Effect on the ability to drive transp. cf. and fur:In connection with the danger of developing arterial hypotension and dizziness, ACE inhibitors should be cautiously prescribed to persons managing motor vehicles and engaged in activities requiring speed of psychomotor and motor reactions.
    Form release / dosage:

    Tablets 8 mg.

    Packaging:By 7, 10, 14, 15 or 30 tablets in a contour acheikova packing of the combined material (polyvinyl chloride / polyethylene / polyvinylidene chloride) and aluminum foil.

    2 contour packs (7 tablets each) along with the instructions for use are placed in a pack of cardboard.

    3, 6 or 9 contour packs (10 tablets each), together with instructions for use, are placed in a pack of cardboard.

    1 outline package (14 tablets each), together with instructions for use, is placed in a pack of cardboard.

    2, 4 or 6 contour packs (15 tablets each), together with instructions for use, are placed in a pack of cardboard.

    1, 2 or 3 contour packs (30 tablets each) along with the instructions for use are placed in a pack of cardboard.

    Storage conditions:Store at a temperature not higher than 30 ° C. Keep out of the reach of children.
    Shelf life:

    2 years

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-004450/07
    Date of registration:04.12.2007
    Date of cancellation:2017-04-28
    The owner of the registration certificate:KRKA-RUS, LLC KRKA-RUS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.04.2017
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