Active substanceIndapamide + PerindoprilIndapamide + Perindopril
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active ingredients: perindopril erbumina 2 mg, indapamide 0.625 mg or perindopril erbumine 4 mg, indapamide 1.25 mg;

    Excipients: lactose monohydrate, microcrystalline cellulose, sodium bicarbonate, silicon dioxide colloidal, anhydrous, magnesium stearate.

    Description:

    Tablets white or almost white, oval, slightly biconcave, with a bevel.

    Pharmacotherapeutic group:antihypertensive agent combined (diuretic + ACE inhibitor)
    ATX: & nbsp

    C.09.B.A.04   Perindopril in combination with diuretics

    Pharmacodynamics:

    Co-Prensa® - a combined preparation containing an ACE inhibitor - perindopril and diuretic - indapamide, has an antihypertensive, diuretic and vasodilating effect.

    Perindopril - Angiotensin converting enzyme (ACE) inhibitor, whose mechanism of action is associated with inhibition of angiotensin-converting enzyme activity, which leads to a decrease in the formation of angiotensin II, eliminates the vasoconstrictive effect of angiotensin II, reduces the secretion of aldosterone. Promotes restoration of elasticity of large arterial vessels, reduces hypertrophy of the left ventricle, pressure in the pulmonary capillaries. Reduces myocardial hypertrophy. Reduces preload and afterload, filling pressure of the left and right ventricles,general peripheral vascular resistance (OPSS), moderately reduces the heart rate (heart rate), increases the regional blood flow in the muscles.

    Indapamide refers to derivatives of sulfonamide and by pharmacological properties is close to thiazide diuretics. Indapamide inhibits the reabsorption of sodium in the cortical segment of the renal tubules, which increases the urinary excretion of sodium and chlorine ions, and leads to increased diuresis. To a lesser extent, the drug increases the excretion of potassium and magnesium ions. Possessing the ability to selectively block "slow" calcium channels, increases the elasticity of the walls of the arteries and reduces the overall peripheral resistance of the vessels (OPSS). Indapamide has hypotensive effect in doses that do not have a pronounced diuretic effect. In high doses does not affect the degree of lowering blood pressure (BP), despite an increase in diuresis.

    Indapamide, like other thiazide diuretics, reduces hypertrophy of the left ventricle.

    Co-Prensa® has a pronounced dose-dependent hypotensive effect, independent of the age and position of the patient's body and not accompanied by reflex tachycardia.Does not affect the metabolism of lipids (total cholesterol, low density lipoproteins (LDL), very low density lipoproteins (VLDL), high density lipoproteins (HDL), triglycerides (TG)) and carbohydrates, including those with diabetes.

    Pharmacokinetics:

    The pharmacokinetic parameters of a fixed combination of perindopril and indapamide are not different compared to their separate use.

    Perindopril after oral intake quickly absorbed from the gastrointestinal tract. Bioavailability of perindopril is 65-70%. 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 the active metabolite perindoprilata. The maximum concentrations of perindoprilat in the blood serum are observed after 3-4 hours. Communication with plasma proteins is dose-dependent and is less than 30%. Taking perindopril Once a day, stable concentrations are achieved within 4 days. Perindoprilat easily passes through the histohematetic barriers, excluding the blood-brain barrier,a small amount penetrates through the placenta and into breast milk. It is excreted by the kidneys, the half-life of perindoprilata is about 24 hours. Do not cumulate. In elderly patients, in patients with renal and cardiac failure, excretion of perindoprilate is slowed.

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

    Indapamide quickly and almost completely absorbed in the gastrointestinal tract. Eating somewhat slows down absorption, but does not significantly affect the amount of the adsorbed drug. The maximum concentration in the blood plasma is reached after 1 hour after taking a single dose. At repeated receptions of fluctuation of concentration of a preparation in a blood plasma in an interval between two doses are smoothed out. Indapamide binds to plasma proteins by 79%. The half-life period is from 14 to 24 hours (an average of 18 hours). Do not cumulate.

    Metabolised in the liver. 70% of indapamide is excreted by the kidneys mainly in the form of metabolites (the fraction of unchanged drug is about 5%). About 22% is excreted by bile in the form of inactive metabolites.In patients with insufficient renal function, the pharmacokinetic parameters of the preparation do not change significantly.

    Indications:Arterial hypertension (patients who are shown combined therapy).
    Contraindications:

    - Hypersensitivity to any component of the drug;

    - hypersensitivity to perindopril or other ACE inhibitors;

    - hypersensitivity to sulfonamides;

    - angioedema in the anamnesis (hereditary, idiopathic or angioedema due to the administration of ACE inhibitors);

    - hypokalemia;

    - marked renal failure (creatinine clearance less than 30 ml / min);

    - severe hepatic impairment (including encephalopathy);

    - simultaneous reception of drugs that extend the interval QT;

    - pregnancy and lactation;

    - age to 18 years (efficacy and safety not established).

    Carefully:

    Two-sided stenosis of the renal arteries, stenosis of the artery of a single kidney, renal failure (creatinine clearance more than 30 ml / min), systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma), immunodeficiency therapy(risk of developing neutropeniaand agranulocytosis), oppression of bone marrow hematopoiesis. Reduced circulating blood volume (diuretics, salt-free diet, diarrhea, vomiting, hemodialysis), stenocardia, cerebrovascular diseases, renovascular hypertension, diabetes mellitus, severe heart failure, hyperuricemia (especially accompanied by gout or urate nephrolithiasis), intake of potassium-sparing diuretics, potassium and lithium, labile blood pressure (BP), elderly, hemodialysis using high membrane or desensitization state after Transplan ation renal, aortic valve stenosis / hypertrophic cardiomyopathy, the presence of lactase deficiency galactosemia or malabsorption syndrome glucose / galactose.

    Pregnancy and lactation:

    Admission Co-Prenes® in pregnancy is not recommended. The use of the drug may cause fetoplacental ischemia with the risk of slowing the development of the fetus.

    It is not recommended to use the drug during lactation (indapamide penetrates into breast milk).

    Dosing and Administration:

    Inside, 1 tablet, once a day, preferably in the morning before breakfast, with plenty of liquid.

    Patients with renal insufficiency (creatinine clearance 30 ml / min or more) dose adjustment is not required.

    Side effects:

    From the cardiovascular system: infrequent: a marked decrease in blood pressure (BP) (including orthostatic hypotension), changes in the ECG (due to hypokalemia), arrhythmia, palpitations.

    From the central nervous system: infrequently: headache, dizziness, nervousness, asthenia, mood lability, sleep disturbances.

    From the digestive system: often: dry mouth, constipation or diarrhea, dyspepsia, nausea, abdominal pain, taste distortion, anorexia, very rare: development of hepatic encephalopathy, pancreatitis.

    From the genitourinary system: frequent infections, nocturia, polyuria.

    Allergic reactions: skin itch, patchy-papular rash, hives, hemorrhagic vasculitis, very rarely: angioedema (Quincke's edema).

    From the respiratory system: often: dry cough, pharyngitis, rhinitis, sinusitis.

    From the hematopoietic system: Hypercreatininemia, proteinuria, hypercalcemia, hyperuricemia, chloropenia, hyponatremia, hyperglycemia, very rare: thrombocytopenia, neutropenia, leukopenia, agranulocytosis, aplastic and haemolytic anemia (patients on hemodialysis or peritoneal dialysis).

    From the musculoskeletal system: convulsions, paresthesia.

    Other: possibly exacerbation of systemic lupus erythematosus.

    Overdose:

    Symptoms: marked decrease in blood pressure (BP), nausea, vomiting, cramps, dizziness, insomnia, polyuria or oliguria, anuria, bradycardia, disruption of water-electrolyte balance.

    Treatment: gastric lavage and / or the administration of activated charcoal. With a significant reduction in blood pressure (BP), the patient should be transferred to a horizontal position with a low headboard. Follow-up activities in the medical institution, should be directed to restore the water-electrolyte balance, symptomatic therapy. There is no specific antidote.

    Interaction:

    With simultaneous application drugs lithiI and indapamide need careful monitoring of the concentration of lithium in blood plasma and correctiondosage, it is possible to increase the concentration of lithium in blood plasma with symptoms of an overdose, as well as with a salt-free diet (decrease in the release of lithium in the urine).

    FROM astemizole, bepderin, erythromycin (with intravenous administration), halofantrine, pentamidine, sultopride, terfenadine and vincamine, antiarrhythmics IA class (quinidine, disopyramide, amiodarone, brethylium, sotalol) - the probability of occurrence of disturbances of a warm rhythm of type "pirouette" raises. Risk factors are hypokalemia, bradycardia, and previous lengthening of the interval QT.

    FROM nonsteroidal anti-inflammatory drugs (with systemic administration), high doses of salicylates - there is a risk of acute renal failure in dehydrated patients (decreased glomerular filtration rate). It is necessary to compensate for the loss of fluid and, at the beginning of the treatment, monitor the function of the kidneys.

    FROM amfothericin B (w / w), gluco- and mineralocorticosteroids (with a system assignment), tetrakozaktidom, laxatives, stimulating intestinal motility, cardiac glycosides - increases the risk of hypokalemia (additive effect).It is necessary to control the level of potassium in the blood plasma, ECG, if necessary - the appointment of appropriate treatment.

    FROM baclofen - increased hypotensive effect.

    FROM cyclosporin - an increase in the concentration of creatinine in the blood plasma, with an unchanged concentration of circulating cyclosporine.

    FROM tricyclic antidepressants, antipsychotics - increases the hypotensive effect of indapamide and the risk of developing orthostatic hypotension increases (additive effect).

    FROM antihypertensive drugs - increased risk of severe arterial hypotension.

    FROM iodine-containing radiopaque agents (in high doses) - dehydration of the body and an increased risk of developing acute renal failure. Before using iodine-containing contrast agents, patients should compensate for fluid loss.

    FROM calcium salts - an increase in the concentration of calcium ions in the blood plasma due to a decrease in their excretion in the urine.

    FROM potassium-sparing diuretics (amiloride, spironolactone, triamterene) - risk of hypokalemia or hyperkalemia, especially in patients with diabetes mellitus and patients with impaired renal function.

    FROM hypoglycemic drugs (insulin, sulfonamides) - ACE inhibitors can increase the hypoglycemic effect in patients with diabetes mellitus.

    FROM anesthetics - strengthening of the hypotensive effect of angiotensin converting enzyme (ACE) inhibitors.

    FROM allopurinol, cytostatics or immunosuppressants, corticosteroids administered systemically, or procainamide - risk of developing leukopenia.

    Special instructions:

    Use of Co-Prenex® can cause a sharp drop in blood pressure (BP), especially when taking the drug for the first time and during the first 2 weeks of therapy. The risk of developing hypotension is increased in patients with reduced circulating blood volume, with severe heart failure, with initially lowered arterial pressure (BP), renal artery stenosis or arterial stenosis of a single kidney, cirrhosis accompanied by edema and ascites.

    When taking the drug, it is necessary to systematically monitor the concentration of electrolytes (potassium, sodium, magnesium), glucose, uric acid and creatinine in the blood plasma.

    It is necessary to stop taking the drug before the forthcoming surgical treatment (for 12 hours).

    In case of application by sportsmen it is necessary to know: false positive reactions during "doping control" are possible.

    Effect on the ability to drive transp. cf. and fur:

    In some cases, individual reactions associated with changes in blood pressure are possible, especially at the beginning of treatment or with the addition of another antihypertensive agent. As a result, the ability to drive and work with mechanisms that require increased attention and speed of psychomotor reactions can be reduced.

    Form release / dosage:Tablets, 2 mg + 0.625 mg and 4 mg + 1.25 mg .
    Packaging:

    For 7, 10, 14, 15 or 30 tablets in a contour cell or cell-free packaging.

    2 contour packs (7 tablets each) or 3, 6 or 9 contour packs (10 tablets each), or 1 (14 tablets), or 2, 4 or 6 outline packages (15 tablets each), or 1, 2 or 3 contour packs (30 tablets each) along with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 of the year.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005188/07
    Date of registration:24.12.2007
    Date of cancellation:2017-04-28
    The owner of the registration certificate:KRKA-RUS, LLC KRKA-RUS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspKRKA KRKA Slovenia
    Information update date: & nbsp28.04.2017
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