Perindopril tabs 4mg #30

Instruction for Perindopril

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Perindopril is a drug with an antihypertensive effect.

Release form and composition

Dosage forms of release of Perindopril:
    tablets: white or white with a creamy / yellowish tinge, slight marbling is permissible, flat-cylindrical, with a bevel (10, 15, 20, 30, 50 or 100 pieces each in glass or polymer jars or bottles, in a cardboard box 1 can / bottle; 10 pcs. in blister packs, in a cardboard bundle 1–5 packs; 7 pcs. in a blister strip, in a cardboard bundle 2–4 packs);
    film-coated tablets: round, biconvex, the core on the cross section is almost white or white; 2 mg each - almost white or white; 4 mg each - from green to light green; 8 mg - from green with a grayish tinge to gray-green (10 pcs. in blisters, in a cardboard box 1-3, 5, 6 or 9 packs).
Composition of 1 tablet:
    active substance: perindopril erbumine - 2, 4 or 8 mg (perindopril - 1.669; 3.338 or 6.675 mg);
    additional components (2/4/8 mg): magnesium stearate - 1/1 / 1.5 mg; partially pregelatinized corn starch - 43.1 / 42.2 / 62.3 mg; talc - 2/2/3 mg; microcrystalline cellulose - 13 / 12.7 / 18.8 mg; croscarmellose sodium - 5/5 / 7.5 mg; lactose monohydrate (milk sugar) - 33.9 / 33.1 / 48.9 mg.
Composition of 1 coated tablet:
    active substance: perindopril erbumine - 2, 4 or 8 mg;
    additional components (2/4/8 mg): pregelatinized corn starch - 15/15/15 mg; microcrystalline cellulose - 71/69/65 mg; crospovidone - 10/10/10 mg; colloidal silicon dioxide - 1/1/1 mg; magnesium stearate - 1/1/1 mg;
    shell (2/4/8 mg): Opadry II white 85F18422 (talc - 14.8%, macrogol-3350 - 20.2%, polyvinyl alcohol - 40%, titanium dioxide - 25%) / Opadry II green 85F21738 (dioxide titanium - 24.345%, talc - 14.8%, indigo carmine - 0.54%, polyvinyl alcohol - 40%, macrogol-3350 - 20.2%, yellow aluminum varnish - 0.115%) / Opadry II green 85F21867 (titanium dioxide - 21%, polyvinyl alcohol - 40%, talc - 14.8%, macrogol - 3350 - 20.2%, indigo carmine - 2.5%, dye iron oxide yellow - 1.5%) - 3/3/3 mg.

Pharmacodynamics

Perindopril is an ACE (angiotensin converting enzyme) inhibitor. ACE is an exopeptidase that converts angiotensin I into the vasoconstrictor angiotensin II and destroys bradykinin, which has a vasodilating effect, to an inactive heptapeptide. Due to this, the plasma content of angiotensin II in the blood decreases, as a result of which the activity of plasma renin increases and the secretion of aldosterone decreases. The suppression of ACE promotes an increase in the activity of the circulating and tissue kallikrein-kinin system, while the activation of the prostaglandin system is observed. The therapeutic effect of perindopril is due to the active metabolite - perindoprilat. Other metabolites have no inhibitory effect on ACE.
Perindopril helps to reduce systolic and diastolic blood pressure (blood pressure). Due to the use of the drug, a decrease in the total peripheral vascular resistance is observed, which leads to a decrease in blood pressure, while an improvement in peripheral circulation occurs without a change in heart rate (heart rate).
The maximum hypotensive effect develops 4-6 hours after taking the drug and lasts for 24 hours. The normalization of blood pressure in patients with a positive response to therapy occurs within a month of daily intake of perindopril, while there is no addictive effect. With a sharp withdrawal of the drug, the withdrawal syndrome does not appear.
The drug helps to restore the elasticity of large arteries and the structure of the vascular walls of small arteries, has a vasodilator effect, and also reduces left ventricular myocardial hypertrophy.
With concomitant use with thiazide diuretics, the severity of the hypotensive effect increases. There is also a decrease in the likelihood of hypokalemia associated with diuretic therapy.
In cases of use in patients with chronic heart failure (heart failure), there is a decrease in pre- and afterload on the heart. Perindopril reduces the filling pressure of the right and left ventricles, total peripheral vascular resistance, increases regional muscle blood flow and cardiac output with an improvement in the cardiac index.
Also, when using the drug, there is a decrease in the risk of cardiovascular complications (the frequency of non-fatal myocardial infarction, mortality from cardiovascular diseases, etc.).

Pharmacokinetics

Absorption: after oral administration, it is rapidly absorbed from the gastrointestinal tract. TCmax (time to reach maximum concentration) in blood plasma of perindopril - 1 hour, perindoprilat - from 3 to 4 hours. Approximately 27% of the total absorbed perindopril is converted to the active metabolite, perindoprilat. In addition to it, in the process of metabolism, 5 more metabolites are formed, which are inactive substances. T1 / 2 (half-life) of perindopril from blood plasma - 1 hour, perindoprilat - from 3 to 4 hours. Taking the drug with food leads to a decrease in the conversion of perindopril to perindoprilat, which accordingly reduces the bioavailability of the drug.
Distribution: binding of perindoprilat to blood plasma proteins - 20%, is dose-dependent. The volume of distribution of the free substance is approximately 0.2 l / kg.
Excretion: excreted by the kidneys, the total period T1 / 2 of the unbound fraction is 17 hours, which ensures an equilibrium concentration for 4 days.
In old age, as well as in the presence of renal and heart failure, the excretion of perindoprilat is slowed down. The dialysis clearance of perindoprilat is 70 ml / min. With cirrhosis of the liver, the hepatic clearance of perindopril is reduced by 50%. Nevertheless, the amount of perindoprilat formed does not decrease, as a result of which dose adjustment is not carried out.

Indications for use

    arterial hypertension;
    chronic heart failure;
    stable coronary artery disease (ischemic heart disease) (reducing the likelihood of cardiovascular complications in patients with previous myocardial infarction and / or coronary revascularization);
    conditions after a stroke or transient ischemic cerebrovascular accident (prevention of recurrent stroke; in combination with indapamide).

Contraindications

Absolute:
    idiopathic and / or hereditary angioedema, a history of angioedema associated with previous therapy with ACE inhibitors;
    lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (for tablets);
    pregnancy and breastfeeding period;
    age under 18;
    old age (for pills);
    individual intolerance to the components of the drug or other ACE inhibitors.
Relative (diseases / conditions in the presence of which the appointment of the drug requires caution):
    cerebrovascular diseases, hyponatremia, a decrease in the volume of circulating blood (associated with diarrhea, vomiting, hemodialysis, adherence to a salt-free diet, the use of diuretics, potassium-containing drugs and dietary supplements), coronary heart disease (due to the risk of a sharp decrease in blood pressure);
    chronic renal failure;
    renovascular hypertension, chronic heart failure in the stage of decompensation, arterial hypotension, bilateral stenosis of the renal arteries or stenosis of an artery of a single kidney (due to the risk of renal failure and severe arterial hypotension);
    systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma) and the use of immunosuppressants, including after kidney transplantation (due to the risk of neutropenia and agranulocytosis);
    hyperkalemia;
    hypertrophic obstructive cardiomyopathy, mitral or aortic valve stenosis;
    conditions before the procedure of apheresis of low density lipoprotein (LDL);
    use in patients after kidney transplantation (due to lack of clinical experience);
    surgical interventions under general anesthesia;
    congenital deficiency of glucose-6-phosphate dehydrogenase (due to the likelihood of hemolytic anemia, which was recorded in isolated cases);
    simultaneous desensitizing therapy with allergens;
    combined use with oral hypoglycemic agents or insulin in patients with diabetes mellitus (it is recommended to control the concentration of glucose in the blood);
    simultaneous use with potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for table salt and lithium;
    hemodialysis using high-flow polyacrylonitrile membranes;
    belonging to the Negroid race;
    old age (for coated tablets).

Instructions for use: method and dosage

Perindopril is taken orally, preferably in the morning before meals, in 1 dose.
The doctor sets the dosage regimen individually, based on the severity of the course of the disease and the response to the therapy. An increase in the dose is carried out only in cases of good tolerance to therapy.

Arterial hypertension

It is possible to use the drug as a monopreparation or in combination with other drugs.
The recommended starting dose is 4 mg.
With pronounced activation of the RAAS (renin-angiotensin-aldosterone system), in particular with hyponatremia and / or hypovolemia, renovascular hypertension, chronic heart failure in the stage of decompensation or severe arterial hypertension, it is recommended to take Perindopril in a reduced initial dose of 2 mg. If therapy is ineffective for 30 days, the dose can be increased to 8 mg.
The addition of Perindopril to patients taking diuretics can lead to the development of arterial hypotension. For this reason, therapy is recommended with caution. Diuretics should be discontinued 2-3 days before starting the drug. You can also start using Perindopril with 2 mg. Monitoring of the following indicators is required: blood pressure, renal function, serum potassium in the blood. In the future, depending on the dynamics of blood pressure, the dose may be increased. If necessary, it is possible to resume diuretic therapy.
The recommended initial daily dose in elderly patients is 2 mg, if necessary, it can be gradually increased, first to 4 mg, and then to 8 mg per day.

Chronic HF

Perindopril is prescribed under medical supervision at an initial dose of 2 mg. After 2 weeks, the dose can be doubled (under the control of blood pressure). Therapy for symptomatic chronic HF is usually combined with digoxin, potassium-sparing diuretics, and / or beta-blockers.
In chronic heart failure, renal failure and a tendency to electrolyte disturbances (hyponatremia), as well as in patients taking vasodilators and / or diuretics at the same time, Perindopril should be prescribed under strict medical supervision.
In cases where there is a high risk of clinically pronounced arterial hypotension (for example, while taking high doses of diuretics), if possible, hypovolemia and electrolyte disturbances should be eliminated before prescribing the drug. Before and during treatment, it is recommended to carefully monitor blood pressure, the functional state of the kidneys and the serum potassium content in the blood.
Prevention of recurrent stroke in patients with a burdened history of cerebrovascular diseases
During the first 2 weeks before taking indapamide, the drug is prescribed at 2 mg, then the dose may be doubled. After a stroke, you can start therapy at any time (from 14 days to several years).

Ischemic heart disease

In case of stable coronary artery disease, it is recommended to start taking the drug with 4 mg. After 2 weeks, under the control of renal function, the dose can be increased by 2 times.
For elderly patients, the drug is prescribed in a reduced dose - 2 mg. After 7 days, the dose can be doubled. In the future, if necessary, after 7 days (with mandatory preliminary monitoring of renal function), it is possible to increase the dose to a maximum of 8 mg.
In kidney disease, the dose of the drug is set depending on the degree of renal dysfunction. Monitoring the patient's condition, as a rule, includes regular determination of the content of creatinine and potassium in the blood serum.
Recommended doses depending on creatinine clearance:
    from 60 ml / min: 4 mg per day;
    30-60 ml / min: 2 mg daily;
    15 to 30 ml / min: 2 mg every other day;
    up to 15 ml / min (hemodialysis patients): 2 mg per day of dialysis.

Side effects

Possible adverse reactions (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 0.01% and <0.1% - rarely; <0, 01%, taking into account individual messages - very rarely; with an unspecified frequency - if it is impossible to determine the frequency of occurrence of violations):
    cardiovascular system: often - a pronounced decrease in blood pressure; very rarely - arrhythmias, angina pectoris, stroke or myocardial infarction; with an unknown frequency - vasculitis;
    nervous system: often - dizziness, headache, paresthesia; infrequently - mood / sleep disorders; very rarely - confusion of consciousness;
    digestive system: often - diarrhea, nausea, constipation, vomiting, abdominal pain, dyspepsia, dysgeusia; infrequently - xerostomia; rarely - pancreatitis; very rarely - angioedema of the intestine, cholestatic / cytolytic hepatitis;
    musculoskeletal system: often - muscle cramps;
    genitourinary system: infrequently - impotence, renal failure; very rarely - acute renal failure;
    lymphatic system / hematopoietic organs: very rarely (with long-term administration of high doses) - decrease in hematocrit and hemoglobin, leukopenia / neutropenia, thrombocytopenia, pancytopenia, agranulocytosis; very rarely - hemolytic anemia (in the presence of congenital glucose-6-phosphate dehydrogenase deficiency);
    respiratory organs: often - shortness of breath, cough; infrequently - bronchospasm; very rarely - rhinitis, eosinophilic pneumonia;
    organ of sight and hearing: often - tinnitus, visual impairment;
    skin: often - skin rash, itching; infrequently - angioedema of the extremities / face, urticaria; very rarely - erythema multiforme;
    laboratory parameters: increased serum urea concentration in the blood and plasma creatinine concentration, hyperkalemia; rarely - increased serum activity of liver enzymes and bilirubin in the blood, hypoglycemia;
    general disorders: often - asthenia; infrequently - increased sweating.

Overdose

The main symptoms: cough, anxiety, marked lowering of blood pressure, shock, hyperventilation, disturbances in water and electrolyte balance (hyponatremia, hyperkalemia), renal failure, tachycardia, palpitations, dizziness, bradycardia.
Therapy: with a pronounced decrease in blood pressure, the patient is recommended to take a lying position and raise his legs, measures should be taken to replenish the volume of circulating blood, if possible, a solution of catecholamines is injected intravenously. In cases of severe bradycardia that does not respond to drug therapy (including atropine), an artificial pacemaker is usually installed. It is necessary to monitor vital functions and the concentration of creatinine and electrolytes in the blood serum. Perindopril can be removed from the systemic circulation by hemodialysis.

Special instructions

In cases of development during the first month of therapy, a significant / minor episode of unstable angina pectoris, it is necessary to assess the ratio of benefits with the possible risk of further use of the drug.
Taking the drug can lead to a sharp decrease in blood pressure. Symptomatic hypotension rarely occurs in patients with uncomplicated arterial hypertension after taking the first dose. The risk of an excessive decrease in blood pressure is increased in patients with a reduced volume of circulating blood during therapy with diuretics, with hemodialysis, adherence to a strict salt-free diet, as well as with vomiting, diarrhea, and severe renin-dependent hypertension. Severe arterial hypotension is observed in severe chronic heart failure with / without concomitant renal failure. Most often, severe arterial hypotension can occur in patients with more severe chronic heart failure who take high doses of loop diuretics, as well as in the presence of renal failure or hyponatremia. Such patients are recommended to carry out careful medical supervision at the beginning of therapy and during titration of doses of Perindopril. The same recommendations apply to patients with coronary artery disease or cerebrovascular diseases, in whom a pronounced decrease in blood pressure can cause myocardial infarction or cerebrovascular complications.
In some patients with chronic heart failure and low / normal blood pressure, an additional decrease in blood pressure may be observed during the use of the drug. This is the expected effect, which in normal cases does not lead to the cancellation of therapy. If clinical manifestations occur against the background of arterial hypotension, dose reduction / drug withdrawal may be required.
In symptomatic HF, arterial hypotension, which develops at the beginning of the drug administration, can lead to deterioration of renal function. In such patients, cases of acute renal failure are sometimes noted, usually of a reversible nature.
There are isolated reports of prolonged, life-threatening anaphylactoid reactions in patients taking ACE inhibitors during desensitizing therapy with hymenoptera (wasp, bee) venoms. Such reactions can be prevented by temporarily discontinuing the drug at least 24 hours before each desensitization procedure.
In rare cases, patients taking the drug develop angioedema of the extremities, face, tongue, mucous membranes, lips, larynx and / or vocal folds. Such conditions can develop at any time of taking the drug. If angioedema occurs, therapy is immediately canceled, until the symptoms disappear completely, the patient should be under medical supervision. Angioneurotic edema of the face and lips in most cases does not require treatment; to reduce the severity of symptoms, it is possible to use antihistamines.
Angioedema of the tongue, larynx, or vocal folds can be fatal. When it occurs, immediate subcutaneous administration of epinephrine (adrenaline) and airway management is required.
In patients of the black race, ACE inhibitors cause angioedema more often. With a burdened history of angioedema, not associated with the use of an ACE inhibitor, when taking the drug, there is an increased risk of its development.
There is information about rare cases of angioedema of the intestine. At the same time, patients have abdominal pain, possibly in combination with vomiting and nausea. For diagnosis, computed tomography or ultrasound examination of the abdominal organs should be used. Also, the diagnosis can be confirmed during surgery. Symptoms disappear after discontinuation of therapy.
During the use of the drug, the development of a persistent, unproductive dry cough may occur, which stops after the drug is discontinued. This must be taken into account when conducting a differential diagnosis of cough.
It should be taken into account that the hypotensive effect of the drug in elderly patients may be more pronounced in comparison with young patients. In this regard, the course of treatment is recommended to start with lower doses. At the beginning of taking the drug, the functional state of the kidneys should be assessed.
In some cases, there may be an increase in the level of potassium in the blood. The likelihood of hyperkalemia is higher in patients with heart / renal failure, decompensated diabetes mellitus and in patients using potassium-sparing diuretics, potassium supplements or other drugs that can lead to hyperkalemia (in particular, heparin). Combination therapy should be carried out under regular monitoring of serum potassium in the blood.
24 hours before surgery, the drug must be discontinued. If this is not possible, arterial hypotension can be corrected by increasing the volume of circulating blood.
In patients with normal renal function in the absence of other complications, neutropenia develops in rare cases. Very great care must be taken in patients with one or more of the following risk factors: systemic connective tissue diseases (in particular, systemic lupus erythematosus, scleroderma), combination therapy with immunosuppressants, allopurinol or procainamide (especially with existing impaired renal function). This is due to the likelihood of severe infections that are not amenable to intensive therapy with antibacterial drugs. Patients belonging to this group, periodically during treatment, need to control the number of leukocytes. If any symptoms of infection appear, medical advice is required.
There is information about isolated cases of hemolytic anemia in patients with congenital deficiency of glucose-6-phosphate dehydrogenase.
With diabetes mellitus, patients using oral hypoglycemic agents or insulin, in the first few months of taking the drug, need to carefully monitor the concentration of glucose in the blood.
In the presence of impaired renal function, as well as during the use of high doses of the drug, the development of proteinuria is possible.
If jaundice appears while taking Perindopril, or the activity of hepatic transaminases increases, therapy is immediately canceled. The patient's condition should be monitored. This is due to the fact that during the period of treatment, a syndrome can be observed that begins with cholestatic jaundice, after which it progresses to fulminant necrosis of the liver, in some cases with a fatal outcome. The mechanism behind this syndrome is unclear.

Influence on the ability to drive vehicles and complex mechanisms

When driving motor vehicles, care must be taken, which is associated with the likelihood of arterial hypotension or dizziness.

Application during pregnancy and lactation

Perindopril is contraindicated during pregnancy. When pregnancy is confirmed, the drug is immediately canceled. Its use in the II-III trimesters can lead to fetotoxic effects (decreased renal function, oligohydramnios, slowing of ossification of the fetal skull bones) and neonatal toxic effects (renal failure, arterial hypotension, hyperkalemia). If, nevertheless, the drug was used during this period, it is necessary to conduct an ultrasound examination of the bones of the skull and kidneys of the fetus.
During lactation, the drug is not prescribed, which is due to the lack of necessary data confirming its effectiveness / safety.

Childhood use

According to the instructions, the drug is not prescribed to patients under 18 years of age, which is due to the lack of the necessary data confirming its effectiveness / safety.

With impaired renal function

In chronic renal failure, as well as in patients after kidney transplantation and with bilateral renal artery stenosis or stenosis of an artery of a single kidney, the drug should be used with caution.

Use in the elderly

    tablets: therapy is contraindicated;
    film-coated tablets: the drug should be used with caution.

Drug interactions

Combinations not recommended:
    potassium preparations, potassium-sparing diuretics, potassium-containing food additives / products: development of hyperkalemia (the combination is possible only in cases of hypokalemia, subject to precautions under regular monitoring of serum potassium in the blood);
    angiotensin II receptor antagonists, ACE inhibitors or aliskiren: an increase in the likelihood of hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy with these drugs (requires careful monitoring of blood pressure, renal function and electrolyte balance in patients receiving drugs, which influence the RAAS);
    aliskiren: the combination in patients with diabetes mellitus and renal failure (with creatinine clearance less than 60 ml / min) is not recommended;
    gold preparations (sodium aurothiomalate intravenously): the development of a symptom complex, including a decrease in blood pressure, nausea, facial flushing, vomiting.
Combinations requiring caution:
    diuretics, especially with excessive sodium and / or fluid excretion: the development of excessive arterial hypotension at the beginning of therapy (diuretic withdrawal is indicated, intravenous administration of 0.9% sodium chloride solution, as well as the appointment of perindopril in lower doses; the dose of the drug should be increased with caution );
    lithium preparations: the appearance of a reversible increase in the serum lithium content in the blood and lithium toxicity; combined use with thiazide diuretics can further increase the serum lithium content and the likelihood of its toxic effects (combination with lithium is not recommended; in cases of the need for combined use, regular monitoring of serum lithium levels in the blood is required);
    non-steroidal anti-inflammatory drugs, including acetylsalicylic acid in doses of 3000 mg per day: weakening the hypotensive effect of perindopril; an additive effect on an increase in serum potassium, which can cause deterioration of renal function (usually reversible); in rare cases, the development of acute renal failure is observed, especially with existing disorders of renal function, for example, against the background of dehydration or in elderly patients;
    hypoglycemic agents: increased hypoglycemic effect up to the development of hypoglycemia (usually observed in the first weeks of combined treatment in patients with renal failure);
    ethanol, other antihypertensive drugs, antipsychotic drugs, tricyclic antidepressants, agents for general anesthesia: increased antihypertensive effect of perindopril;
    nitroglycerin and other nitrates or vasodilators: the likelihood of an additional hypotensive effect;
    procainamide, allopurinol, systemic glucocorticosteroids, immunosuppressants, cytostatic agents: increased risk of leukopenia;
    sympathomimetics: weakening the hypotensive effect of perindopril (with combined use, a regular assessment of the effectiveness of therapy is required).

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 or 30 ° C (film-coated tablets / tablets). Keep out of the reach of children.
Shelf life is 2 years.

Reviews about Perindopril

According to reviews, Perindopril is an affordable and effective drug. In addition to the main effect, it also contributes to the improvement of trophism and has a positive effect on overall well-being. The development of side effects is possible, which in most cases are easily stopped.

Terms of sell

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