Perineva - Instructions For The Use Of 4 Mg, 2 And 8 Mg Tablets, Drug Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Perineva

Perineva: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Perineva

ATX code: C09AA04

Active ingredient: Perindopril

Manufacturer: LLC "KRKA PHARMA", Russia

Description and photo update: 19.10.2018

Prices in pharmacies: from 265 rubles.

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Perineva is an ACE (angiotensin converting enzyme) inhibitor.

Release form and composition

Dosage form - tablets: almost white or white, slightly biconvex, with a chamfer: round shape at a dosage of 2 and 8 mg or oval shape at a dosage of 4 mg, on one side of the 4 and 8 mg tablets there is a dividing risk (in blisters 10 pcs., in a cardboard box 3, 6 or 9 packs; in blister packs of 14 pcs., in a cardboard box 1, 2, 4 or 7 packs; in blister packs of 30 pcs., in a cardboard box 1, 2 or 3 packs).

Composition of 1 tablet:

• perindopril erbumin, semi-finished product-granules - 38.39 / 76.78 / 153.56 mg;
• the active substance of semi-finished granules - perindopril erbumin - 2/4/8 mg;
• auxiliary components of semi-finished granules: calcium chloride hexahydrate, lactose monohydrate, crospovidone;
• excipients of tablets: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate.

Pharmacological properties

Pharmacodynamics

Perindopril or kinase II is an angiotensin-converting enzyme (ACE) inhibitor, belongs to exopeptidases and is a prodrug from which the active metabolite perindoprilat is formed. Converts angiotensin I to angiotensin II (vasoconstrictor) and breaks down the vasodilator bradykinin to an inactive hectapeptide. Due to the suppression of ACE activity, the level of angiotensin II decreases, the activity of renin in the plasma increases (the negative feedback of renin release is inhibited) and the secretion of aldosterone decreases. ACE destroys bradykinin, therefore suppression of this enzyme also leads to an increase in the activity of the circulating and tissue kallikrein-kinin system, while activating the prostaglandin system.

The therapeutic effect of the drug is due to the effect of the active metabolite - perindoprilat.

Perindopril lowers blood pressure (both diastolic and systolic) while lying and standing. It reduces total peripheral vascular resistance (OPSR), resulting in a decrease in blood pressure (BP). This accelerates peripheral blood flow, but the heart rate (HR) does not increase. As a rule, renal blood flow also accelerates, but the glomerular filtration rate does not change. The development of the maximum hypotensive effect after a single oral pill intake requires 4–6 hours, the effect lasts for 24 hours, but even after a day, 87–100% of the maximum effect is still provided. Blood pressure decreases rapidly. Stabilization of the hypotensive effect is observed after 1 month of regular intake of Perineva and lasts a long time. Discontinuation of therapy does not cause withdrawal symptoms.

The active substance reduces left ventricular myocardial hypertrophy. Increases the concentration of high density lipoprotein (HDL), in patients with hyperuricemia, reduces the concentration of uric acid. With prolonged use, it normalizes the isozyme profile of myosin, reduces the severity of interstitial fibrosis.

The drug eliminates structural changes in small arteries and improves the elasticity of large arteries. By reducing pre- and post-load, it normalizes heart function. In chronic heart failure (CHF), it decreases the OPSS, filling pressure in the right and left ventricles, increases cardiac output and cardiac index. When taking the drug in an initial daily dose of 2 mg in patients with CHF I and II functional classes according to the NYHA classification, there is no statistically significant decrease in blood pressure compared with placebo.

Pharmacokinetics

Perindopril in tablet form is rapidly absorbed from the gastrointestinal tract, it takes 1 hour to reach the maximum plasma concentration. Bioavailability is about 65-70%.

About 20% of the absorbed substance is converted into the active metabolite perindoprilat. The maximum content in plasma is observed after 3-4 hours. The half-life (T _1/2) is 1 hour. The volume of distribution of unbound perindoprilat is 0.2 l / kg. The connection with blood plasma proteins is insignificant, the connection with ACE is less than 30%, but depends on its concentration. It is excreted by the kidneys. Does not accumulate. T _{1/2 of the} unbound fraction is 3-5 hours, in patients with chronic heart and renal failure and the elderly, excretion is slowed down.

In patients with cirrhosis of the liver, the hepatic clearance of perindopril changes, but the total amount of the resulting metabolite remains unchanged, therefore, dose adjustment of Perineva is not required.

Food reduces the conversion of perindopril to perindoprilat, thereby reducing the bioavailability of the drug.

Perindoprilat is removed during peritoneal dialysis and hemodialysis (rate 70 ml / min., 1.17 ml / sec.).

Indications for use

According to the instructions, Perineva is intended for the treatment of arterial hypertension and chronic heart failure.

The drug is used (as part of a combination therapy with indapamide) for the prevention of recurrent stroke in patients with cerebrovascular diseases in the history of the disease.

Also, an ACE inhibitor is prescribed for stable coronary heart disease (IHD) to reduce the risk of cardiovascular complications in patients after coronary revascularization and / or myocardial infarction.

Contraindications

Absolute contraindications (conditions / diseases for which the drug is prohibited from taking):

• age up to 18 years;
• Lapp lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption syndrome;
• idiopathic, hereditary, or developed as a result of taking ACE inhibitors, angioedema in history;
• increased individual sensitivity to any component of the drug or other ACE inhibitors.

Relative contraindications (conditions / diseases in which the use of the drug is possible, but only after assessing the benefits and risks, with extreme caution and under special medical supervision):

• CHF in the stage of decompensation;
• arterial hypotension;
• hypertrophic obstructive cardiomyopathy;
• stenosis of the aortic or mitral valve;
• renovascular hypertension;
• cerebrovascular diseases (including ischemic heart disease, cerebrovascular insufficiency, coronary insufficiency);
• chronic renal failure (creatinine clearance less than 60 ml / min);
• bilateral stenosis of the renal arteries or stenosis of an artery of a solitary kidney;
• condition after kidney transplantation;
• hemodialysis using high-flow polyacrylonitrile membranes;
• the period before the procedure for apheresis of low density lipoprotein (LDL);
• severe hypovolemia and hyponatremia (eg, due to vomiting, diarrhea, salt-free diet, dialysis, prior diuretic therapy);
• hyperkalemia;
• congenital deficiency of glucose-6-phosphate dehydrogenase;
• connective tissue diseases such as systemic lupus erythematosus or scleroderma;
• diabetes;
• inhibition of bone marrow hematopoiesis while taking immunosuppressants, procainamide, allopurinol;
• surgical intervention;
• elderly age;
• belonging to the Negroid race;
• simultaneous desensitizing therapy with allergens (for example, hymenoptera venom).

Instructions for use of Perineva: method and dosage

It is advisable to take Perinev tablets before meals, once a day - in the morning.

The doctor selects the dose for the patient personally, based on the indication and the individual effectiveness of the treatment.

Regardless of the indications, it is possible to increase the dosage only if the drug is well tolerated in the previous dose used.

Arterial hypertension

The drug is used either as monotherapy or as part of a combination treatment, in combination with other antihypertensive drugs.

The recommended starting dose of Perineva is 4 mg. For patients with severe activation of the RAAS (renin-angiotensin-aldosterone system), for example, with severe arterial hypertension, renovascular hypertension, CHF in the stage of decompensation, hyponatremia, hypovolemia, 2 mg. In case of insufficient effect, after a month of treatment, the daily dose can be increased to 8 mg.

If Perineva is prescribed to patients receiving diuretics, in order to avoid the development of arterial hypotension, it is recommended to start taking perindopril 2-3 days after stopping the diuretic, or prescribe it in a minimum dose of 2 mg. In this case, the concentration of potassium ions in the blood serum, blood pressure and renal function should be monitored. Depending on the dynamics of the blood pressure indicator, the dose can be increased. Diuretic therapy is resumed if necessary.

Elderly patients are prescribed perindopril 2 mg at the beginning of therapy. Further, according to indications, it is increased to 4 mg and, if the effect is still insufficient, up to 8 mg.

Prevention of recurrent stroke in patients with a history of cerebrovascular disease

The drug Perinev is taken in a dose of 2 mg 2 weeks before the appointment of indapamide.

You can start prophylactic therapy after a stroke at any time, even after several years, but not earlier than 2 weeks later.

Chronic heart failure

The optimal starting dose is 2 mg. After 2 weeks, if necessary, under the control of blood pressure, it is increased to 4 mg. If the disease is accompanied by clinical manifestations, β-blockers, potassium-sparing diuretics and / or digoxin are additionally prescribed.

With CHF, renal failure, a tendency to electrolyte disturbances (hyponatremia) or the simultaneous use of diuretics and / or vasodilators, treatment should be started under the strict supervision of a physician.

In the case of a high risk of developing clinically pronounced arterial hypotension (for example, with the concomitant intake of a diuretic in high doses), before the appointment of Perineva, it is recommended to eliminate electrolyte disturbances and hypovolemia if possible. Before and during therapy, blood pressure, the concentration of potassium ions in the serum and the state of renal function should be constantly monitored.

Stable ischemic heart disease

The initial recommended daily dose of Perineva is 4 mg. After 2 weeks, under the control of renal function, the dose is increased to 8 mg.

Elderly patients begin treatment with a dose of 2 mg. If the effect is insufficient, after obligatory preliminary control of renal function, it can be increased to 4 mg after a week, and up to 8 mg after another week.

In renal insufficiency, the dose is determined based on the results of the study of renal function, namely, the creatinine clearance (CC) indicator:

• CC> 60 ml / min - 4 mg / day;
• CC 30-60 ml / min - 2 mg / day;
• CC 15-30 ml / min - 2 mg every other day;
• CC <15 ml / min (hemodialysis) - 2 mg per day of dialysis.

During treatment, control of the concentration of creatinine and potassium ions in the blood serum is required.

Side effects

Separation of side effects by prevalence: very often -> 1/10, often - from> 1/100 to 1/1000 to 1/10000 to <1/1000, very rarely - <1/10000, including individual reports.

Side effects that may occur during therapy with perindopril:

• from the organ of hearing: often - tinnitus;
• on the part of the organ of vision: often - visual impairment;
• from the central and peripheral nervous system: often - paresthesia, headache, dizziness; infrequently - mood changes, sleep disturbances; very rarely - confusion of consciousness;
• from the respiratory system: often - shortness of breath, cough; infrequently - bronchospasm; very rarely - rhinitis, eosinophilic pneumonia;
• on the part of the musculoskeletal system: often - muscle cramps;
• from the genitourinary system: infrequently - impotence, renal failure; very rarely - acute renal failure;
• from the digestive tract: often - diarrhea, constipation, dyspepsia, abdominal pain, nausea, vomiting, dysgeusia; infrequently - dryness of the oral mucosa; rarely - pancreatitis; very rarely - hepatitis (cholestatic or cytolytic);
• on the part of the cardiovascular system: often - a pronounced decrease in blood pressure; very rarely - angina pectoris, arrhythmias, as well as stroke and myocardial infarction (in high-risk patients, possibly secondary, due to severe arterial hypotension); frequency unknown - vasculitis;
• on the part of the hematopoietic and lymphatic system: very rarely in patients with congenital glucose-6-phosphate dehydrogenase deficiency - hemolytic anemia; very rarely with prolonged use of the drug in high doses - agranulocytosis, thrombocytopenia, pancytopenia, leukopenia / neutropenia, decreased hemoglobin concentration and hematocrit;
• on the part of the skin: often - skin rashes, itching; infrequently - urticaria, angioedema of the face and extremities; very rarely - erythema multiforme;
• laboratory tests: hyperkalemia, increased concentration of plasma creatinine and urea in the blood serum, especially in patients with severe CHF, renovascular hypertension and renal failure (reversible after drug withdrawal); rarely - hypoglycemia, increased serum bilirubin and hepatic enzyme activity;
• other reactions: often - asthenia; infrequently - increased sweating.

Overdose

Signs of an overdose: a pronounced decrease in blood pressure, bradycardia, palpitations, tachycardia, imbalance in water and electrolyte balance (hyperkalemia, hyponatremia), hyperventilation, cough, anxiety, dizziness, renal failure, shock.

With a pronounced decrease in blood pressure, it is necessary to put the patient down and raise his legs, replenish the circulating blood volume (BCC), if possible, intravenously inject angiotensin II and / or a solution of catecholamines. If bradycardia develops, which does not respond to drug therapy (including atropine), a pacemaker is installed (an artificial pacemaker). Overdose treatment should be carried out under the control of vital body functions, the concentration of creatinine and electrolytes in the blood serum. It is possible to remove the drug from the systemic circulation by hemodialysis, only the use of high-flow polyacrylonitrile membranes should be avoided.

special instructions

Perinev's drug is not recommended to be used simultaneously with such agents as lithium preparations, potassium preparations, potassium-sparing diuretics, potassium-containing food additives / products.

Like other ACE inhibitors, perindopril can cause a sharp decrease in blood pressure. Symptomatic hypotension after taking the first dose in patients with uncomplicated arterial hypertension is rare. An excessive decrease in blood pressure is likely in people with a reduced BCC on the background of a strict salt-free diet, hemodialysis, diuretic therapy, with vomiting and diarrhea, as well as with renin-dependent hypertension, severe CHF, including with the concomitant presence of renal failure. More often, a pronounced decrease in blood pressure is observed in patients with severe CHF receiving high doses of loop diuretics, as well as in renal failure and hyponatremia. These categories of patients are shown to be closely monitored at the beginning of treatment and during the selection of the optimal dose. The same applies to patients with ischemic heart disease and cerebrovascular disease,since an excessive decrease in blood pressure in them is fraught with myocardial infarction and cerebrovascular complications.

If the patient has arterial hypotension, it is necessary to give him a horizontal position and raise his legs, if necessary, intravenously inject sodium chloride solution to increase the BCC. Transient (passing) arterial hypotension is not a contraindication to continue treatment. After the restoration of blood pressure and BCC, therapy can be resumed, only it is necessary to choose the correct dose of Perineva.

In some patients with CHF, including those with a low blood pressure, the drug can cause an additional decrease in blood pressure. This effect is expected and is often not a reason for stopping therapy. In cases where arterial hypotension is accompanied by clinical symptoms, reduce the dose of the drug or cancel it completely.

In the event of an episode (even minor) of unstable angina pectoris in patients with stable coronary artery disease during the first month of using Perineva, the balance of benefits and risks should be assessed for further treatment.

Patients with a history of angioedema not associated with ACE inhibitors are at high risk of angioedema as a reaction to perindopril.

In the event of the development of angioedema, Perineva should be canceled immediately. With swelling of the lips and face, special treatment is not required; it is enough to take antihistamines to reduce the severity of symptoms. Swelling of the tongue, larynx, or glottis can be fatal. If such a reaction occurs, adrenaline (epinephrine) must be injected subcutaneously and the airway must be maintained. More often, angioedema during therapy with ACE inhibitors occurs in patients of the Negroid race.

In rare cases, anaphylactic reactions develop in patients who, during the treatment of Perineva, undergo LDL apheresis using dextran sulfate absorption, because of this, it is recommended to cancel the ACE inhibitor before each procedure. The same applies to patients who are prescribed a course of desensitization - the drug should be temporarily discontinued before each procedure.

If during treatment there is an increase in the activity of liver enzymes or jaundice appears, the drug should be discontinued and an appropriate examination should be carried out, since Perineva can cause the development of a syndrome that begins with cholestatic jaundice and progresses to a fulminant course of hepatitis with extensive liver necrosis, up to death.

ACE inhibitors can contribute to the development of renal failure and severe arterial hypotension in patients with renovascular hypertension, therefore, treatment should be started with low doses, under close medical supervision, and with further adequate titration of the dose of the drug. During the first weeks of taking Perineva, it is necessary to cancel diuretics and constantly monitor renal function.

In some cases, in patients with arterial hypertension and previously undetected renal failure, especially with concomitant use of diuretics, a slight and temporary increase in creatinine and serum urea concentration is possible, which requires a decrease in the dose of the drug and / or withdrawal of the diuretic.

Patients on hemodialysis should not use high-strength membranes for a session, otherwise persistent, life-threatening anaphylactic reactions may develop.

In patients with diabetes mellitus, receiving insulin or taking oral hypoglycemic agents, at the beginning of Perineva therapy, it is necessary to control the blood glucose level.

Patients awaiting planned surgery or other measures with the use of anesthesia with drugs that can cause arterial hypotension should cancel the ACE inhibitor one day before. If this is not possible, arterial hypotension can be corrected by increasing the BCC.

Perindopril may increase the concentration of potassium ions in the blood. The likelihood of developing hyperkalemia increases with renal and / or heart failure, decompensated diabetes mellitus, in the case of the simultaneous use of potassium-sparing diuretics, potassium preparations or other agents that can cause hyperkalemia (for example, heparin). If the combined use of these drugs is justified, you should constantly monitor the level of potassium in the blood serum.

When carrying out a differential diagnosis of cough in a patient, it should be borne in mind that perindopril can cause a persistent, unproductive cough - it stops after the drug is discontinued.

Influence on the ability to drive vehicles and complex mechanisms

The drug can cause dizziness and arterial hypotension, which can affect the reaction speed and concentration of attention, which should be taken into account by drivers and persons employed in potentially hazardous industries.

Application during pregnancy and lactation

Perineva is contraindicated during pregnancy. In case of pregnancy during treatment, the drug should be urgently canceled. When used late, perindopril can cause fetotoxic (oligohydramnios, decreased renal function, slowed down ossification of the skull bones) and neonatal toxic (renal failure, hyperkalemia, arterial hypotension) effects. If the drug for some reason was used in the II-III trimesters, it is necessary to conduct an ultrasound examination of the kidneys and bones of the fetal skull.

There is no data on the penetration of perindopril into breast milk, therefore, if it is necessary to use Perineva, women are advised to stop breastfeeding.

Pediatric use

The safety and efficacy of the drug in children and adolescents under 18 years old have not been confirmed, therefore Perineva is not used in pediatric practice.

With impaired renal function

For patients with kidney disease, the drug is used with caution, the dose is determined individually, depending on the degree of renal dysfunction and the therapeutic response. Treatment should be carried out under regular monitoring of serum creatinine and potassium ions.

For violations of liver function

In case of diseases and abnormal liver function, dose adjustment of Perineva is not required.

Use in the elderly

Perineva is used with caution. Treatment in old age should be started with a dose of 2 mg / day. If the effect is insufficient, but only if the drug is well tolerated, it can be increased to 4 mg after a week, and up to 8 mg after another week.

Drug interactions

• sympathomimetics: may decrease the effectiveness of perindopril. If the use of such a combination is necessary, the effectiveness of Perineva should be regularly evaluated;
• diuretics: possible development of excessive arterial hypotension. The risk can be reduced by intravenous administration of 0.9% sodium chloride solution, by using lower doses of perindopril, or by stopping the diuretic;
• potassium preparations, potassium-sparing diuretics, potassium-containing foods and food supplements: the risk of developing hyperkalemia increases. Such combinations are undesirable except in cases of hypokalemia;
• lithium preparations: a reversible increase in the concentration of lithium in the blood serum and the development of toxicity are possible. This combination is not recommended. If the combined administration of drugs is necessary, the serum lithium should be monitored;
• hypoglycemic agents: it is possible to increase their effect and develop hypoglycemia, the risk is especially high in patients with renal failure in the first weeks of combination therapy;
• tricyclic antidepressants, antipsychotics (neuroleptics), agents for general anesthesia (general anesthetics): it is possible to increase the hypotensive effect of the drug;
• nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid in a daily dose of 3000 mg or more: the effect of perindopril may be weakened, the risk of an increase in the level of potassium ions in the blood serum increases, as a result of which renal function may deteriorate (reversible effect), in rare cases up to the development of acute renal failure, especially in patients with concomitant impaired renal function, for example, with dehydration and in the elderly;
• other antihypertensive agents and vasodilators: an increase in the antihypertensive effect is possible.

If necessary, Perineva can be prescribed in combination with drugs such as nitrates, β-blockers, thrombolytic drugs, acetylsalicylic acid in doses that have an antiplatelet effect.

Analogs

The analogues of Perineva are: Coverex, Arentopres, Perindopril, Perindopril-Teva, Perindopril-Richter, Perindopril-TAD, Perindopril-C3, Parnavel, Hypernik, Prestarium, Perinpress, Perineva, Perineva Ku-tab, Pyristar, Prenessa, Stopress.

Terms and conditions of storage

Keep out of the reach of children.

Storage conditions - temperature not higher than 30 ° С.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Perinev

Reviews about Perinev are mostly good: the drug effectively normalizes blood pressure, while it is much cheaper than a similar drug Prestarium, which is especially important if you need a lifelong intake.

Some patients note the development of side effects, however, in comparison with the benefits, doctors most often do not consider them a disadvantage.

Price for Perineva in pharmacies

The price for Perineva depends on the dosage and the number of tablets in the package:

• 30 tablets 4 mg - 200-265 rubles;
• 90 tablets 4 mg - 490-710 rubles;
• 30 tablets 8 mg - 320-417 rubles;
• 90 tablets 8 mg - 780-970 rubles.

The cost of Perinev 2 mg tablets is unknown, because at this dose, the drug is not currently sold in pharmacies.

Perineva: prices in online pharmacies

Drug name Price Pharmacy

Perineva 4 mg tablets 30 pcs. 265 RUB Buy

Perineva 8 mg tablets 30 pcs. 282 r Buy

Perineva tablets 4mg 30 pcs. RUB 290 Buy

Perineva 4 mg tablets 90 pcs. 476 r Buy

Perineva tablets 8mg 30 pcs. 504 RUB Buy

Perineva tablets 4mg 90 pcs. 586 r Buy

Perineva 8 mg tablets 90 pcs. 753 r Buy

Perineva tablets 8mg 90 pcs. 1101 RUB Buy

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!