Piristar - instructions for use, dose, side effects, contraindications

active substance: perindopril erbumine 4 mg or 8 mg; Excipients: lactose monohydrate 51 mg / 102 mg, microcrystalline cellulose 30 mg / 60 mg, magnesium stearate 1 mg / 2 mg, silicon dioxide 4 mg / 8 mg.

Description:

Dosage 4 mg:

White capsule capsules from white to almost white with a risk on one side of the tablet, with an engraving "4" on both sides of the risks on the other side of the tablet.

Dosage of 8 mg:

Round, biconvex tablets from white to almost white, smooth on one side and with engraving "8" on the other side.

Pharmacotherapeutic group:angiotensin-converting enzyme (AIF) inhibitor.

ATX: & nbsp

C.09.A.A.04 Perindopril

Pharmacodynamics:

The ACE inhibitor interacts with zinc ions (Zn ²⁺) in the ACE molecule and causes its inactivation. Perindopril acts through its active metabolite perindoprilata. Eliminates the vasoconstrictive effect of angiotensin II, increases the concentration of bradykinin and activates the system of prostaglandins (Pg) (ACE transfers inactive angiotensin I to active angiotensin II, which has a vasoconstrictive effect, and also causes degradation of bradykinin and Pg, having vasodilating activity); reduces the production and release of aldosterone, inhibits the release of norepinephrine from the endings of sympathetic nerve fibers and the formation of endothelin in the vessel wall. Reduction of the formation of angiotensin II is accompanied by an increase in the activity of renin of the blood plasma (due to the inhibition of negative feedback). The suppression of ACE is accompanied by an increase in the activity of both the circulating and tissue kallikrein-kinin system, as well as the system Pg. Helps restore the elasticity of large arteries (reducing the formation of excessive amounts of subendothelial collagen), reduces pressure in the pulmonary capillaries, with prolonged use reduces the severity of myocardial hypertrophy of the left ventricle and interstitial fibrosis, normalizes the isozyme profile of myosin; normalizes the work of the heart. Reduces preload and postnagruzku (reduces systolic and diastolic blood pressure (BP) in the "lying" and "standing"), the filling pressure of the left and right ventricles, the total peripheral vascular resistance (OPSS); increases the minute volume of circulation (IOC) and cardiac index,does not increase the heart rate (heart rate) (in patients with chronic heart failure (CHF) moderately reduces heart rate), increases regional blood flow in the muscles. Increases concentration high-density lipoprotein (HDL), in patients with hyperuricemia reduces the concentration of uric acid. Increases renal blood flow, does not change the rate of glomerular filtration.

In patients with CHF causes a significant decrease in the severity of clinical signs of heart failure, increases exercise tolerance (according to the bicycle ergometric test), does not significantly reduce blood pressure. After oral administration of the median single dose, the maximum antihypertensive effect is achieved after 4-6 hours and persists for 24 hours. Stabilization of the antihypertensive effect occurs after 1 month of therapy and persists for a long time. The termination of treatment is not accompanied by the development of the "withdrawal" syndrome.

It was found that with the use of perindopril at a dose of 8 mg / day, there was a significant reduction in the absolute risk of complications (mortality from cardiovascular disease, the incidence of non-fatal myocardial infarction and / or cardiac arrest followed by a successful resuscitation).

Pharmacokinetics:

Absorption is 25%, bioavailability is 65-70%. Eating slows the conversion of perindopril to perindoprilat, thus affecting bioavailability. Therefore, the drug should be taken orally 1 time per day, in the morning, before eating. The time to reach the maximum concentration (TC_max) - 1 h (perindopril), perindoprilata - 3-4 hours. Equilibrium concentration (C_ss) is created on the 4th day.

In the process of metabolism, 20% is transformed into an active metabolite - perindoprilat; the rest is in 5 metabolites that do not show pharmacological activity. The half-life (T1_/2) perindopril -1h.

The relationship between perindoprilat and plasma proteins is insignificant, with ACE -less than 30% (depends on concentration). The volume of distribution of free perindoprilata - 0.2 l / kg. Perindoprilat is excreted by the kidneys, T1 /₂free fraction of metabolite - 3-5 hours. Dissociation of perindopril associated with ACE is slow. As a consequence, the "effective" T_1/2is 25 hours. Repeated use of perindopril does not lead to its cumulation, and T_1/2 Perindoprilata with repeated admission corresponds to the period of its activity.

The excretion of perindoprilat slows in elderly patients,as well as in patients with CHF and chronic renal failure (CRF) (in the latter, dose adjustment should be carried out depending on the creatinine clearance (CC) .Dialytic clearance of perindopril is 70 ml / min.

In patients with liver cirrhosis, the liver clearance of perindopril is reduced by a factor of 2, while the total amount of perindoprilat formed does not change and correction of the dosing regimen is not required.

Indications:

- arterial hypertension;

- chronic heart failure;

- stable coronary heart disease (CHD): a reduced risk of developing cardiovascular complications in patients who had had previous myocardial infarction and / or coronary revascularization.

Contraindications:

- hypersensitivity to perindopril, as well as to any other components included in the formulation, or other ACE inhibitors;

- angioedema in a history as a result of previous therapy with ACE inhibitors, hereditary and / or idiopathic angioedema;

- simultaneous use with aliskiren and aliskirenoderzhaschimi drugs in patients with diabetes mellitus and / or renal dysfunction (creatinine clearance less than 60 ml / min);

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

- pregnancy, the period of breastfeeding;

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

Carefully:Caution should be exercised when using Piristar® in the following conditions: decreased circulating blood volume (bcc) diuretics, salt-free diet, vomiting, diarrhea, hemodialysis), hyponatremia, cerebrovascular diseases, angina pectoris - a risk of a sharp decrease in blood pressure; Renovascular hypertension, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney - the risk of severe arterial hypotension and renal failure; chronic renal failure; systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma) and immunosuppressant therapy - the risk of agranulocytosis and neutropenia; hyperkalemia; stenosis of the aortic valve, mitral stenosis, atherosclerosis, chronic heart failure (IV functional class by classification NYHA), hypertrophic obstructive cardiomyopathy; during the procedure of hemodialysis using high-flow polyacrylonitrile membranes; before the procedure for apheresis of LDL; in patientsafter kidney transplantation; simultaneously with the conduct of desensitizing therapy with allergens; surgical intervention (including general anesthesia); in patients with diabetes mellitus, receiving hypoglycemic agents for ingestion or insulin (it is recommended to control the concentration of glucose in the blood); intake of potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for edible salt and lithium, hyperkalemia, elderly age, and the use of a negroid race in patients.

Pregnancy and lactation:

Application of the drug during pregnancy is contraindicated. ACE inhibitors are able to penetrate the placenta and lead to an increase in the incidence and mortality of the fetus and newborn. The effect of ACE inhibitors on the fetus in the II and III trimesters of pregnancy can lead to fetal development of arterial hypotension, renal insufficiency, deformities of the bones of the skull and face, and even fatal. There are reports of the development in the mother of oligohydramnion (marked decrease in volume amniotic fluid); what is due to impaired renal function in the fetus.Oligohydramnios can be accompanied by the appearance of contractures of the upper and lower limbs; deformities of the bones of the skull and face, hypoplastic development of the lungs and retardation of intrauterine development. In case of pregnancy during treatment with the drug should immediately cancel the therapy and, if necessary, designate an alternative treatment with a proven safety profile during pregnancy. If perindopril therapy was performed in the II and / or III trimesters of pregnancy, ultrasound examination of the skull and fetal kidney function should be performed.

In newborns exposed to an ACE inhibitor in utero, a thorough examination should be performed to exclude arterial hypotension, oliguria, and hyperkalemia.

Currently, there are no data on the release of perindopril in breast milk. Women receiving the drug should be recommended to stop breastfeeding.

Dosing and Administration:

Inside, in the morning, before meals, once a day, at the same time.

With arterial hypertension - the initial dose is 4 mg 1 time per day, if the dose is ineffective, increase to a maximum daily dose of 8 mg once a day.

The drug Piristar ® can be used in monotherapy or in combination with other antihypertensive drugs.

In patients with a high activity of the renin-angiotensin-aldosterone system (especially in patients with renal vascular hypertension who follow a diet with reduced intake of table salt, reduced bcc, decompensated heart failure, or severe hypertension), after receiving the first dose of the drug, a marked decrease in blood pressure . In such patients, treatment should be started with a dose of 2 mg (Vi tablets of 4 mg), under medical supervision.

At the beginning of therapy with Piristar®, symptomatic arterial hypotension may occur, for the prevention of which it is recommended to stop taking diuretics 2-3 days before the expected initiation of therapy with Piristar® or to use the drug at lower doses of 2 mg (1/ 2 tablets of 4 mg) once a day (blood pressure, kidney function, potassium ion content in blood serum is necessary). In the future, if necessary, the reception of diuretics can be resumed.

In elderly patients, treatment should begin with a dose of 2 mg (1/2 tablets of 4 mg) per day for 1 week. Then the dose can be increased to 4 mg per day. A month after the start of treatment, the daily dose can be increased to 8 mg. The dose of the drug is increased depending on the clinical effect and function of the kidneys.

With chronic heart failure - treatment of patients in combination with a non-potassium-sparing diuretic and / or digoxin and / or beta-adrenergic blocker is recommended to begin under careful medical supervision, using the drug in an initial dose of 2 mg

(1/2 tablets of 4 mg) once a day, in the morning. In the future after 2 weeks treatment, depending on the clinical effect, the dose of the drug can be increased to 4 mg once a day.

In patients with severe chronic insufficiency (IV functional class by classification NYHA) or in patients with risk factors (including renal dysfunction and a tendency to disturb the electrolyte balance, patients receiving diuretics and / or vasodilators simultaneously), treatment should be carried out with extreme caution and under careful medical supervision.

With stable ischemic heart disease (CHD): a reduction in the risk of cardiovascular complications in patients who have had previous myocardial infarction and / or coronary revascularization - The initial dose is 4 mg for 2 weeks, then the daily dose should be increased to 8 mg (depending on kidney function and tolerability). Elderly patients should begin therapy with a dose of 2 mg (Vi tablets of 4 mg) once a day for one week, then 4 mg once a day for the next week. Then, taking into account the state of kidney function, the dose should be increased to 8 mg once a day. Increase the dose of the drug only if it is well tolerated in the previously recommended dose.

In case of impaired renal function - In case of renal insufficiency, dosing is determined by QC: for CC more than 60 ml / min - 4 mg / day, 30-60 ml / min - 2 mg / day. (1/2 tablets of 4 mg), 15-30 ml / min - 2 mg (1/2 tablets of 4 mg) every other day, below 15 ml / min - 2 mg (1/2 tablets of 4 mg) per day of dialysis (dialysal clearance perindoprilata - 70 ml / min).

If the liver function is impaired patients with a violation of liver function correction of the dosing regimen is not required.

Side effects:

The incidence of side effects is classified as follows way: very often (> 1/10), often (from> 1/100 to <1/10), infrequently (from> 1/1000 to <1/100), rarely (from> 1/10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown (the frequency of development can not be calculated from the available data)

From the nervous system: often - headache, fatigue, dizziness, decreased appetite, tinnitus, visual impairment, convulsions, paresthesia; infrequently - insomnia, mood lability, fainting; very rarely, including individual reports - confusion.

From the side of the cardiovascular system: often - excessive BP reduction and associated symptoms of vasodilation; infrequently - tachycardia, palpitation, vasculitis; very rarely - arrhythmia, angina pectoris, myocardial infarction, stroke (possibly a secondary mechanism of development as a result of a sharp decrease in blood pressure).

On the part of the respiratory system: often - "dry" cough, difficulty breathing, shortness of breath; infrequently bronchospasm; very rarely - eosinophilic pneumonia, rhinitis.

From the digestive system: often - nausea, vomiting, abdominal pain, taste disorder, diarrhea or constipation; infrequently - intestinal angioedema, dryness of the oral mucosa; very rarely - cholestatic jaundice, pancreatitis, cytolytic or cholestatic hepatitis.

From the sense organs: often - visual disturbances, noise in the ears.

From the musculoskeletal system: often - muscle spasms; infrequently - arthralgia, myalgia.

Allergic reactions: often - skin rashes, itching; infrequently - hives, angioedema, facial, upper and lower extremities, lips, mucous membranes, tongue, epiglottis and / or larynx, photosensitivity, pemphigus; very rarely - multiforme exudative erythema.

From the urinary system: infrequently - decreased kidney function, very rarely - acute renal failure.

Other: often - asthenia; infrequently - sexual dysfunction; rarely - increased sweating.

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

Are common: infrequently - pain in the chest, peripheral edema, weakness, fever, falls.

A symptom complex is described, which includes facial flushing, nausea, vomiting and arterial hypotension, and can develop with simultaneous use of ACE inhibitors and preparations of gold (sodium arotomalate) intravenously.

Overdose:

Symptoms: marked decrease in blood pressure, shock, stupor, bradycardia, water electrolyte disorders, renal failure, hyperventilation, tachycardia, palpitation, dizziness, agitation and cough.

Treatment: gastric lavage, restoration of water-electrolyte state, the reduction of reduced BCC. In the case of a pronounced reduction in blood pressure, the patient should take a horizontal position, the legs in an elevated position, an intravenous injection of 0.9% sodium chloride solution is required. Effective hemodialysis (do not use high permeability polyacrylnitrile membranes). Intravenous administration of catecholamines may be required. With the development of bradycardia - atropine, an artificial pacemaker may be required. Required constant monitoring of vital signs and indicators of water-electrolyte balance of blood.

Interaction:

Angiotensin II receptor antagonists (ARAP)

Simultaneous use of angiotensin II receptor antagonists (ARAII) with an ACE inhibitor leads to a significant increase in the incidence of adverse events such as hypotension, syncope, hyperkalemia, renal dysfunction, acute renal failure. The highest risk is in patients with established diagnosis of atherosclerosis, heart failure, diabetes mellitus (with any complication). The question of the application of a double blockade of RAAS (for example, by simultaneous administration of an ACE inhibitor and ARAN) should be addressed in each case individually, with careful monitoring of kidney function.

Aliskiren containing preparations

Simultaneous use with aliskiren and aliskirenoderzhaschimi drugs in patients with diabetes mellitus and / or impaired renal function (creatinine clearance less than 60 ml / min) is contraindicated.

Diuretics

In some patients receiving diuretic drugs, especially when excess fluid and / or salts are removed, at the very beginning of perindopril therapy, an excessive decrease in blood pressure may occur.The risk of developing this complication can be reduced by abolishing the diuretic 2-3 days before the start of perindopril therapy, by replenishing the BCC, and by applying an ACE inhibitor at lower doses. Further increase in dose should be done with caution.

Potassium-sparing diuretics, potassium preparations, potassium-sparing foods and nutritional supplements

It is not recommended simultaneous use of ACE inhibitors and potassium-sparing diuretics (spironolactone, eplerenone, triamterene and amiloride), as well as potassium preparations can lead to a significant increase in potassium in the serum. Use these drugs in combination should be only in the case of hypokalemia, while it is necessary to observe precautions and regularly monitor the potassium content in the blood serum.

Lithium

With simultaneous use with lithium preparations, it is possible to slow its elimination from the body and develop lithium intoxication. Simultaneous use of perindopril and lithium preparations is not recommended.

Non-steroidal anti-inflammatory drugs (NSAIDs), including high doses of acetylsalicylic acid (more than 3 g / day).

The use of NSAIDs may be accompanied by a weakening of the antihypertensive effect of ACE inhibitors. It has been established that NSAIDs and ACE inhibitors have an additive effect with respect to the increase in serum potassium, while kidney function is also possible. In some cases, acute renal failure may develop, especially with a decrease in BCC, in elderly patients and in renal impairment. As a rule, these effects are reversible and are usually observed in patients with impaired renal function.

Hypotensive drugs

The antihypertensive effect of perindopril may intensify against a background of simultaneous application with other hypotensive drugs, vasodilators, nitrates of short and prolonged action.

Insulin and hypoglycemic agents for oral administration The use of ACE inhibitors in patients with diabetes mellitus may exacerbate the hypoglycemic effect of insulin or hypoglycemic agents for ingestion, sulfonylurea derivatives (increased glucose tolerance leads to a decrease in the need for insulin or hypoglycemic agents for admissioninwards, derivatives of sulfonylurea).

Tricyclic antidepressants, agents for general anesthesia
At the same time, the use of ACE inhibitors and agents for general anesthesia can lead to an increased antihypertensive effect. Antipsychotic drugs (antipsychotics)

At the same time, the use of ACE inhibitors can lead to the development of postural hypotension.

Sympathomimetics

May weaken the antihypertensive effect of ACE inhibitors.

Acetylsalicylic acid as an antiplatelet agent, thrombolytics, beta-blockers, nitrates

Perindopril can be used simultaneously with acetylsalicylic acid, thrombolytic agents, beta-adrenoblockers and / or nitrates. Preparations of gold

At the same time, the use of ACE inhibitors and preparations of gold (sodium aurotomy malate for intravenous use) describes a symptom complex that includes facial flushing, nausea, vomiting and lowering blood pressure.

Baclofen enhances the antihypertensive effect of ACE inhibitors (it is necessary to monitor BP and, if necessary, adjust the dosage of antihypertensive drugs).

Joint application glyptins (linaglyptin, saxagliptin, sitagliptin, vitagliptin) with ACE inhibitors may increase the risk development of angioneurotic edema due to inhibition of dipeptidyl peptidase IV activity by glyptin.

Estramustine with simultaneous use increases the risk of developing adverse events, such as angioedema.

Special instructions:

In the event of an episode of unstable angina during the first month of therapy with Piristar® in patients with stable ischemic heart disease, the relationship between the benefit and the risk of continuing therapy with this drug should be evaluated.

ACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic arterial hypotension is observed rarely in patients without concomitant diseases. The risk of excessive reduction in blood pressure is higher in patients with reduced bcc (taking diuretics, with a diet with restricted intake of table salt, with hemodialysis, vomiting, diarrhea, as well as in patients with severe hypertension with high renin activity of blood plasma). This complication is most characteristic for patients from heavy chronic heart insufficiency both in the presence of concomitant renal insufficiency and in its absence (most often this side effect is noted in patients receiving "loop" diuretics in high doses, as well as in patients with hyponatremia or with renal dysfunction). In patients with an increased risk of symptomatic arterial hypotension, initiation of therapy should be carried out under careful medical supervision. In patients with IHD or with cerebrovascular disease, severe arterial hypotension can lead to the development of myocardial infarction or cerebrovascular complications. In connection with this, the treatment of such patients should be started medical supervision with a further titration dose depending on the clinical effect and tolerability.

Before starting therapy with Piristar®, and also during its administration, blood pressure, renal function and potassium ions in blood serum should be closely monitored.

In order to reduce the likelihood of developing symptomatic arterial hypotension in patients receiving diuretic therapy in high doses,they should be canceled 2-3 days before the use of Piristar®. In the future, if necessary, diuretic therapy can be resumed under the close supervision of blood pressure.

In case of development of arterial hypotension, the patient should take a horizontal position, if necessary, he should undergo an intravenous infusion with the use of 0.9% sodium chloride solution. The pronounced decrease in blood pressure during the first administration of Piristar® is not a contraindication for its further use. After the recovery of bcc and blood pressure, treatment can be continued provided that the dose of the drug is carefully selected.

In patients with symptomatic heart failure, arterial hypotension, which may develop in the initial period of therapy with ACE inhibitors, can lead to impaired renal function. In some cases, the development of acute renal deficiency, which is usually reversible.

In patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney (especially when availability renal

insufficiency) on the background of therapy with ACE inhibitors, the concentrations of urea and creatinine in the serum can increase. These changes return to normal after the drug is discontinued.In some patients with arterial hypertension, in the presence of previously unidentified renal failure, especially with the concomitant use of diuretic means, the concentration of urea and creatinine in the serum can increase.

These changes are usually not very pronounced and are reversible. In this case, it is recommended to reduce the dose of Piristar® and / or to cancel the diuretic.

The use of ACE inhibitors in patients with reninvascular hypertension is accompanied by an increased risk of severe arterial hypotension and renal failure. Treatment of such patients begins under careful medical supervision with the use of the drug in small doses and further adequate dose selection. During the first few weeks of therapy, it is necessary to temporarily stop treatment with diuretics and monitor kidney function. Anaphylactoid reactions can also develop with the use of ACE inhibitors in patients who have undergone apheresis of low-density lipoproteins by absorption with dextran sulfate or in patients on hemodialysis using high-flow membranes, such as polyacrylonitrile (for example, No. AN69). Therefore, similar combinations should be avoided, using either other antihypertensive drugs, or alternative membranes for hemodialysis. Data on the use of the drug Piristar after kidney transplantation are absent.

In the treatment of ACE inhibitors, cases of angioedema

face, lips, tongue, vocal folds and / or larynx. This complication

can occur at any stage of therapy. Edema of the tongue, vocal folds and

The larynx can lead to airway obstruction. When

laryngeal whistling or angioedema of the face, tongue,

Piristar® should be immediately discontinued. Emergency

therapy includes, in addition to other prescriptions, immediate

subcutaneous injection of a solution of epinephrine (adrenaline) 1: 1000 (1 mg / ml)

0.3-0.5 ml or slow intravenous administration (in accordance with instructions for preparing an infusion solution) under the control of ECG and blood pressure. The patient should be hospitalized for treatment and follow-up for at least 12-24 hours and until the symptoms regress completely.

In the treatment of ACE inhibitors, cases of angioedema of the intestine are also described.Patients noted abdominal pain (with / without nausea or vomiting); in some cases without a previous angioedema and the activity of the enzyme C-1 esterase. The diagnosis was established using computed tomography of the abdominal region, ultrasound examination or at the time of surgery.

Symptoms disappeared after discontinuation of ACE inhibitors. Therefore, in patients with abdominal pain taking ACE inhibitors, when establishing a differential diagnosis, it is necessary to consider the possibility of developing angioedema of the intestine.

Patients who have a history of angioedema, not associated with ACE inhibitors, may be at increased risk of developing it when treated with drugs of this group.

Patients receiving ACE inhibitors during desensitizing therapy with Hepaticoptera venom can develop life-threatening anaphylactoid reactions. By temporarily stopping the use of ACE inhibitors, these reactions could be avoided, but they arose again with the occasional administration of ACE inhibitors. Very rarely, with the administration of ACE inhibitors, there have been cases of the development of the syndrome,which began with the development of cholestatic jaundice, progressed to fulminant liver necrosis and in some cases resulted in death. The mechanism of development of this syndrome is not yet clear. The use of Piristar® in patients with signs of jaundice development or a significant increase in the activity of "liver" transaminases should be discarded and appropriate monitoring of laboratory parameters and patient condition should be carried out.

There have been cases of development of neutropenia / agranulocytosis, thrombocytopenia and anemia in patients receiving ACE inhibitors. Such cases are quite rare in patients with normal renal function. Neutropenia and agranulocytosis disappear after the withdrawal of ACE inhibitors. Piristar® should be used with extreme caution in patients with systemic vasculitis receiving immunosuppressive therapy, treatment with allopurinol or procainamide, or with a combination of these risk factors, especially in patients with impaired renal function. In such patients, in some cases, infectious diseases resistant to antibiotic therapy can develop.In the case of Piristar®, regular monitoring of blood leukocytes should be performed in these patients.

If any symptoms of infection (eg, sore throat, fever) appear, the patient should consult a doctor immediately, as they may be a manifestation of neutropenia.

It should be borne in mind that in patients of the Negroid race the risk of angioedema development is higher. Like other ACE inhibitors, perindopril is less effective as an antihypertensive drug in patients of the Negroid race. This effect is probably associated with a marked predominance of low-grade status in patients of the Negroid race with arterial hypertension.

Cough that occurs with the use of ACE inhibitors is unproductive, persistent and occurs after discontinuation of treatment. In the differential diagnosis of cough, its possible association with ACE inhibitors should be considered.

The use of ACE inhibitors in patients whose condition requires

surgical intervention and / or the need for general anesthesia,

may lead to the development of arterial hypotension or collapse, that

is caused by a sharp increase in antihypertensive activity. Should

to warn the surgeon / anesthesiologist about the use of ACE inhibitors and stop taking Piristar 24 hours before surgery (including dentistry). With the development of arterial hypotension, it is necessary to maintain blood pressure by replenishing the BCC.

With the use of ACE inhibitors, it is possible to develop hyperkalemia. Risk factors for hyperkalemia include renal failure, elderly age (over 70 years), diabetes mellitus, concomitant pathological conditions (in particular, a decrease in BCC, acute cardiac decompensation, metabolic acidosis). Giperculosis may cause severe, sometimes fatal cardiac rhythm disturbances. It is recommended to periodically monitor the content of potassium ions in the blood plasma.

It is usually not recommended to use both Piristar® and potassium preparations, salt substitutes containing potassium ions, potassium-sparing diuretics (spironolactone, eplerenone, triamterene or amiloride) or other drugs associated with a risk of increasing potassium levels (eg, heparin) because of the possibility of severe hyperkalemia.If joint intake of these drugs is necessary, then therapy should be accompanied by regular monitoring of potassium in the blood serum.

Patients with diabetes may need more careful observation and correction of a dose of hypoglycemic agents for oral and insulin intake, especially during the first month of therapy with ACE inhibitors. It is not recommended to use lithium preparations with Piristar® at the same time. Perindopril, like other ACE inhibitors, should be used with caution in patients with obstruction of the left ventricular outflow tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as in patients with mitral stenosis.

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

During the treatment period, care must be taken when driving vehicles and engaging in potentially hazardous activities requiring concentration of attention and speed of psychomotor reactions, especially at the beginning of treatment, due to the danger of developing arterial hypotension and dizziness.

Form release / dosage:

Tablets 4 mg, 8 mg.

Packaging:Tablets 4 mg:

For 30 tablets in a blister of PVC / Aklar / aluminum foil.1 blister is placed at airtight sealed envelopes of laminated aluminum foil together with a bag containing 3 g of silica gel. The envelope together with the instruction for use is placed in a cardboard box.

Tablets 8 mg:

For 15 tablets in a blister of PVC / Aklar / aluminum foil. 2 blisters place at airtight sealed envelopes of laminated aluminum foil together with a bag containing 3 g of silica gel. The envelope together with the instruction for use is placed in a cardboard box.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002209

Date of registration:30.08.2013

The owner of the registration certificate:Lupine Co., Ltd.Lupine Co., Ltd. India

Manufacturer: & nbsp

LUPIN, Ltd. India

Representation: & nbspLUPIN LIMITEDLUPIN LIMITED

Information update date: & nbsp28.08.2015

Illustrated instructions

Instructions

Piristar (Piristar)