Universal reference book for medicines
Product name: DALNEVA ® (DALNEVA ® )

Active substance: amlodipine, perindopril

Type: Combined antihypertensive and antianginal drug

Manufacturer: KRKA-RUS (Russia) manufactured by KRKA-RUS (Russia)
Composition, form of production and packaging
Tablets
white or almost white, round, slightly biconcave, with a bevel.

1 tab.

amlodipine besylate 6.935 mg,

which corresponds to the content of amlodipine 5 mg

perindopril erbumine A substance-granules 21 mg,

which corresponds to the content of perindopril erbumine 4 mg

Excipients: microcrystalline cellulose - 80.075 mg, pregelatinized starch - 21 mg, sodium carboxymethyl starch - 8.4 mg, sodium hydrogencarbonate - 0.76 mg, silicon colloidal dioxide - 0.43 mg, magnesium stearate - 1.4 mg.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (9) - packs cardboard.
Tablets are white or almost white in color, capsular, biconvex, with a risk on one side.

1 tab.

amlodipine besylate 13.87 mg,

which corresponds to the content of amlodipine 10 mg

perindopril erbumine A substance-granules 21 mg,

which corresponds to the content of perindopril erbumine 4 mg

Excipients: microcrystalline cellulose - 181.91 mg, pregelatinized starch 42 mg, sodium carboxymethyl starch 16.8 mg, sodium bicarbonate 0.76 mg, colloidal colloidal silicon 0.86 mg, magnesium stearate 2.8 mg.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (9) - packs cardboard.
Tablets are white or almost white, round, biconvex, with a bevel.

1 tab.

amlodipine besylate 6.935 mg,

which corresponds to the content of amlodipine 5 mg

perindopril erbumin A substance-granules 42 mg,

which corresponds to the content of perindopril erbumine 8 mg

Excipients: microcrystalline cellulose - 167.085 mg, pregelatinized starch - 42 mg, sodium carboxymethyl starch - 16.8 mg, sodium hydrogen carbonate - 1.52 mg, silicon dioxide colloid - 0.86 mg, magnesium stearate - 2.8 mg.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (9) - packs cardboard.
Tablets are white or almost white, round, biconvex, with a facet and a risk on one side.

1 tab.

amlodipine besylate 13.87 mg,

which corresponds to the content of amlodipine 10 mg

perindopril erbumin A substance-granules 42 mg,

which corresponds to the content of perindopril erbumine 8 mg

Excipients: microcrystalline cellulose - 160.15 mg, pregelatinized starch 42 mg, sodium carboxymethyl starch 16.8 mg, sodium hydrogen carbonate 1.52 mg, silicon colloidal dioxide 0.86 mg, magnesium stearate 2.8 mg.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (9) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Combined antihypertensive drug.

Perindopril

Perindopril is an ACE inhibitor.
ACE or kininase II is an exopeptidase that converts angiotensin I into a vasoconstrictor substance, angiotensin II, in addition, ACE destroys bradykinin, which has a vasodilating effect, to an inactive heptapeptide. Suppression of ACE activity leads to a decrease in angiotensin II, an increase in renin activity in the blood plasma and a decrease in the secretion of aldosterone. Since ACE also destroys bradykinin, suppression of ACE leads to an increase in the activity of the kallikrein-kinin system.
Perindopril acts via its active metabolite, perindoprilat.
Other metabolites have no inhibitory effect on ACE in vitro. Perindopril has a therapeutic effect at any degree of arterial hypertension, reducing systolic and diastolic blood pressure in a supine and standing position.
Reduces OPSS, resulting in increased peripheral blood flow without changes in heart rate.

Renal blood flow, as a rule, increases, while GFR does not change.

The hypotensive effect reaches its maximum after 4-6 hours after a single dose of perindopril inside and persists for 24 hours. The hypotensive effect after 24 hours after a single oral intake is about 87-100% of the maximum hypotensive effect.

Reduction of blood pressure develops rapidly.
The therapeutic effect occurs less than 1 month after the start of therapy and is not accompanied by tachycardia.
Termination of therapy does not lead to the development of withdrawal syndrome.

Perindopril has a vasodilating effect, helps restore the elasticity of large arteries and the structure of the vascular wall of small arteries, and also reduces left ventricular hypertrophy.

Amlodipine

The dihydropyridine derivative, a blocker of slow calcium channels, has an antianginal and hypotensive effect.
It blocks calcium channels, reduces the transmembrane transition of calcium ions into the cell (mostly in smooth muscle cells of blood vessels, rather than in cardiomyocytes).
Antianginal effect is due to the expansion of coronary and peripheral arteries and arterioles: with angina decreases the severity of myocardial ischemia;
expanding peripheral arterioles, reduces OPSS, reduces afterload on the myocardium, reduces the need for myocardium in oxygen, expanding coronary arteries and arterioles in unchanged and ischemic zones of the myocardium, increases the flow of oxygen into the myocardium (especially with vasospastic angina); prevents spasm of the coronary arteries (including caused by smoking). In patients with stable angina, a single daily dose increases exercise tolerance, increases the time until the onset of an attack of angina and ischemic depression of the ST segment on the ECG, reduces the incidence of angina attacks and the consumption of nitroglycerin and other nitrates.
Has a long-term dose-dependent hypotensive effect.
The hypotensive effect is due to a direct vasodilatory effect on smooth muscle vessels. With arterial hypertension, a single dose provides a clinically significant decrease in blood pressure over a period of 24 hours (in the position of the patient lying down and standing). Orthostatic hypotension in the appointment of amlodipine is rare. Does not cause a decrease in the fraction of the ejection of the left ventricle.
Reduces the degree of myocardial hypertrophy of the left ventricle.
Does not affect the contractility and conductance of the myocardium, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases GFR, has a weak natriuretic effect. When diabetic nephropathy does not increase the severity of microalbuminuria. Does not have any adverse effect on the metabolism and concentration of plasma lipids and can be used in the treatment of patients with bronchial asthma, diabetes and gout. A significant reduction in blood pressure is observed after 6-10 h, the duration of the effect is 24 h.
PHARMACOKINETICS

The amount of absorption of amlodipine and perindopril in the application of the Dal'nev ® preparation does not differ significantly from that of monopreparations.

Perindopril

Suction

After ingestion, perindopril is rapidly absorbed and reaches C max in blood plasma for 1 hour. Food intake decreases the bioavailability of perindopril, so the drug should be taken 1 time / day, in the morning, before eating.

There is a linear dependence of the concentration of perindopril in the blood plasma on the magnitude of its dose.

Distribution

The binding of perindoprilat to plasma proteins (mainly with ACE) is 20%, and depends on its concentration.
V d of free perindoprilate is approximately 0.2 l / kg.
Metabolism

Perindopril does not have pharmacological activity, it is a prodrug.
Approximately 27% of the total amount of perindopril ingested enters the bloodstream as an active metabolite, perindoprilate. In addition to perindoprilata, another 5 metabolites are formed that do not have pharmacological activity. C max perindoprilata in blood plasma is achieved 3-4 hours after ingestion.
Excretion

T 1/2 perindopril from blood plasma is approximately 1 hour.

Perindoprilat is excreted by the kidneys, T 1/2 of the unbound fraction is approximately 17 hours, so C ss is reached within 4 days after ingestion.

Pharmacokinetics in special clinical cases

The excretion of perindoprilat is delayed in elderly patients and in patients with cardiac and renal insufficiency, therefore monitoring such patients should include regular monitoring of creatinine and potassium concentrations in the blood plasma.

The dialysed clearance of perindoprilat is 70 ml / min.

The pharmacokinetics of perindopril has been changed in patients with liver cirrhosis: liver clearance decreases by a factor of 2, but the amount of perindoprilat formed does not decrease, so dose adjustment is not required.

Amlodipine

Suction

Amlodipine is well absorbed when ingested at therapeutic doses.
C max in blood plasma is achieved after 6-12 hours. Absolute bioavailability is 64-80%. Eating food does not affect the bioavailability of amlodipine.
Distribution

V d is approximately 21 l / kg.
In vitro studies have shown that approximately 97.5% of circulating amlodipine is associated with plasma proteins.
Metabolism and excretion

Amlodipine is metabolized in the liver with the formation of inactive metabolites.
The final T 1/2 from the blood plasma is 35-50 h, which allows taking the drug 1 time / day.
Approximately 60% of the accepted dose is excreted by the kidneys, 10% - unchanged.

Pharmacokinetics in special clinical cases

The time to reach C max in blood plasma is the same in elderly patients and young adults.
There is a tendency to decrease the clearance of amlodipine in elderly patients, which is accompanied by an increase in AUC. The recommended dosing regimen for elderly patients is the same as for younger patients, although dose increases should be carried out with caution.
T 1/2 amlodipine is prolonged in patients with impaired hepatic function.

INDICATIONS

- arterial hypertension and / or IHD: stable angina in patients requiring perindopril and amlodipine therapy.

DOSING MODE

The drug is taken orally, 1 tablet.
1 time / day, preferably in the morning before eating.
The dose of the drug Dalnev ® is selected after previous titration of the doses of individual components of the drug: perindopril and amlodipine in patients with arterial hypertension and stable angina.

If necessary, the dose of the drug Dalnev ® can be changed on the basis of individual selection of the doses of individual components: (amlodipine 5 mg + perindopril 4 mg) or (amlodipine 10 mg + perindopril 4 mg) or (amlodipine 5 mg + perindopril 8 mg) or ( Amlodipine 10 mg + perindopril 8 mg).

The maximum daily dose: amlodipine 10 mg + perindopril 8 mg.

The drug Dalneva ® can be prescribed to patients with CC greater than 60 ml / min .
The drug Dalneva ® is contraindicated for use in patients with SC less than 60 ml / min . Such patients are recommended individual selection of doses of perindopril and amlodipine. The change in the concentration of amlodipine in the blood plasma does not correlate with the degree of renal insufficiency.
Care should be taken with the use of the Dal'nev ® preparation in patients with hepatic insufficiency , t.
There are no recommendations on the doses of the drug in such patients.
When using the drug Dalnev ® in elderly patients, dose adjustment is not required.

The drug Dalneva ® should not be given to children and adolescents under the age of 18,
there are no data on the efficacy and safety of perindopril and amlodipine in these groups of patients, both in monotherapy and in combination therapy.
SIDE EFFECT

Classification of the incidence of adverse events (WHO): 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 (can not be estimated from available data).
In each group, undesirable effects are presented in order of decreasing severity.

From the hemopoietic system: very rarely - leukopenia / neutropenia, agranulocytosis, pancytopenia, thrombocytopenia, hemolytic anemia in patients with congenital glucose-6-phosphate dehydrogenase deficiency, decrease in hemoglobin and hematocrit concentration.

From the immune system: infrequently - hives.

Metabolic disorders: infrequently - weight gain, weight loss;
very rarely - hyperglycemia, the frequency is unknown - hypoglycemia.
From the nervous system: often - drowsiness, dizziness, headache, paresthesia, vertigo;
infrequently - insomnia, mood lability, sleep disturbance, tremor, hypoesthesia;very rarely - peripheral neuropathy, confusion.
From the sense organs: often - visual disturbances, noise in the ears.

From the cardiovascular system: often - a feeling of palpitations, flushes of blood to the skin of the face, a pronounced decrease in blood pressure;
rarely - a syncope;rarely - chest pain; very rarely - angina pectoris, myocardial infarction, possibly due to excess BP reduction in patients at high risk, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), stroke, possibly due to excess BP reduction in patients from the high-risk group risk, vasculitis.
On the part of the respiratory system: often - shortness of breath, cough;
infrequently - rhinitis, bronchospasm; very rarely - eosinophilic pneumonia.
On the part of the digestive system: often - abdominal pain, nausea, vomiting, indigestion, diarrhea, constipation;
infrequent - dryness of the oral mucosa, a violation of taste perception, a change in the rhythm of defecation; very rarely - pancreatitis, gingival hyperplasia, gastritis, hepatitis, cholestatic jaundice, cytolytic or cholestatic hepatitis.
From the skin: often - skin itching, skin rash;
infrequently - angioedema, swelling of the face, extremities, lips, mucous membranes, tongue, vocal cords and / or larynx, alopecia, hemorrhagic rash, photosensitivity, increased sweating; very rarely - Quincke's edema, erythema multiforme, Stevens-Johnson syndrome.
From the musculoskeletal system: often - muscle spasms;
infrequently - arthralgia, myalgia, back pain.
On the part of the urinary system: infrequently - a violation of urination, nocturia, frequent urination, renal failure;
very rarely acute renal failure.
From the side of the reproductive system: infrequently - impotence, gynecomastia.

Other: often - peripheral edema, asthenia, fatigue;
infrequently - pain in the chest, malaise.
Laboratory indicators: rarely - increased bilirubin concentration;
very rarely - increased activity of ACT, ALT (most often - in combination with cholestasis); the frequency is unknown - an increase in the concentration of urea and creatinine in the blood serum.
Additional data on amlodipine: individual cases of extrapyramidal syndrome have been reported with the use of slow calcium channel blockers.

CONTRAINDICATIONS

Perindopril

- angioedema (angioedema) in the anamnesis (including against the background of taking other ACE inhibitors);

- hereditary / idiopathic angioedema;

- age under 18 years (effectiveness and safety not established);

- hypersensitivity to perindopril or other ACE inhibitors.

Amlodipine

- severe arterial hypotension (systolic blood pressure less than 90 mm Hg);

- shock, including cardiogenic shock;

- Obstruction of the left ventricular outflow tract (eg, severe aortic stenosis);

- unstable angina (with the exception of Prinzmetal angina);

- age under 18 years (effectiveness and safety not established);

- hemodynamically unstable heart failure after acute myocardial infarction;

- Hypersensitivity to amlodipine or other dihydropyridine derivatives.

Dalnev ®

- renal failure (CC less than 60 ml / min);

- age under 18 years (effectiveness and safety not established);

- Hypersensitivity to the components of the drug.

With caution: liver failure;
chronic heart failure; aortic and / or mitral stenosis; hypertrophic obstructive cardiomyopathy; bilateral stenosis of the renal arteries, stenosis of the artery of a single functioning kidney; renal failure (CC <60 mL / min); systemic diseases of connective tissue (including systemic lupus erythematosus, scleroderma); therapy with immunosuppressants, allopurinol, procainamide (risk of neutropenia, agranulocytosis); reduced bcc (reception of diuretics, diet with restriction of table salt, vomiting, diarrhea); atherosclerosis; cerebrovascular diseases; Renovascular hypertension; diabetes; application of dantrolene, estramustine, potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for edible salt and lithium preparations; hyperkalemia; surgical intervention / general anesthesia; hemodialysis using high-flow polyacrylonitrile membranes (risk of anaphylactoid reactions); conduction of apheresis of LDL with dextran sulfate;simultaneous conduct of desensitizing therapy with allergens (for example, Hymenoptera venom); condition after kidney transplantation (lack of clinical data); elderly age; the use of Negroid race in patients.
PREGNANCY AND LACTATION

The use of the drug Dalnev ® is contraindicated in pregnancy.

The drug Dalneva ® should not be used in the first trimester of pregnancy.
When planning a pregnancy or when it comes on the background of the use of the drug, it is necessary to stop taking it as soon as possible and to prescribe another hypotensive therapy that has been approved for use during pregnancy. Appropriate controlled trials of the use of ACE inhibitors in pregnant women have not been conducted. Available limited data on the effect of the drug on the fetus in the first trimester of pregnancy suggest that the use of ACE inhibitors does not lead to fetal malformations, but the increase in risk can not be ruled out. It is known that the effect of ACE inhibitors on the fetus in the II and III trimesters of pregnancy can lead to disruption of its development (decreased kidney function, oligohydramnion, delayed ossification of the skull bones) and development of complications in the newborn (kidney failure, arterial hypotension, hyperkalemia). If the patient has received an ACE inhibitor in the II or III trimester of pregnancy, it is recommended to conduct ultrasound to assess the status of the skull bone and fetal kidney function.
Newborns whose mothers received ACE inhibitors during pregnancy, should be under close medical supervision because of the risk of hypotension, oliguria and hyperkalemia.
It is not recommended to apply the preparation Dalnevost ® lactation, as there is no corresponding clinical experience with amlodipine and perindopril in monotherapy and in combination therapy. If necessary, use Dalnevost ® lactation discontinue breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER

Preparation Dalnevost ® may be administered to patients with CC more than 60 ml / min . Preparation Dalnevost ® is contraindicated in CS patients less than 60 ml / min . Such patients recommended selection of individual doses of amlodipine and perindopril. Change amlodipine plasma concentrations are not correlated with the severity of renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Care must be taken when applying Dalnevost preparation ® y with hepatic failure patients , since There are no recommendations on the doses of the drug in these patients.
APPLICATION FOR CHILDREN

The drug Dalnevost ® should not be administered to children and adolescents younger than 18 years, since There are no data on the efficacy and safety of perindopril and amlodipine in these groups of patients both in monotherapy and in combination therapy.
APPLICATION IN ELDERLY PATIENTS

In applying the drug Dalnevost ® in elderly patients a dose adjustment is required.
SPECIAL INSTRUCTIONS

Specific guidance related to amlodipine and perindopril, applicable to the preparation Dalnevost ® .
Perindopril
Hypersensitivity / angioedema (Quincke's edema)
When used ACE inhibitors, including perindopril, in rare cases, can be observed the development of facial angioedema, lips, tongue, vocal cords, and / or the larynx. When these symptoms application Dalnevost preparation ® should stop immediately; the patient should be monitored as long as the edema symptoms do not disappear completely.
If angioedema affects only the face and lips, its manifestations are usually alone or antihistamines may be used to treat its symptoms. Angioneurotic edema, accompanied by edema of the larynx or tongue may cause airway obstruction and death. When these symptoms should immediately enter p / epinephrine (adrenaline), diluted 1: 1000 (0.3 or 0.5 ml) and / or to ensure airway patency. The patient should be under medical supervision until complete and persistent symptoms disappear.
In patients with a history of angioedema observed, not associated with the use of ACE inhibitors, the risk of its development can be increased by treatment with drugs in this group.
In rare cases during treatment with ACE inhibitors develop angioedema bowel edema. Thus, patients have a pain in the abdomen as an isolated symptom or in combination with nausea and vomiting in some cases without prior angioneurotic edema of the face and under the normal C-1 esterase. Diagnosis is established via CT abdomen, ultrasound or during surgery. Symptoms disappear after cessation of ACE inhibitors. In patients with abdominal pain who receive ACE inhibitors in the differential diagnosis should consider the possibility of angioneurotic edema of the intestine.
Anaphylactoid reactions during desensitizing treatments
There are some reports about the development of long-term, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing treatment with poison Hymenoptera (Hymenoptera). ACE inhibitors should be used with caution in patients prone to allergic reactions, undergoing desensitization procedure. Avoid destination ACE inhibitor to patients receiving immunotherapy Hymenoptera venom. Nevertheless, development of anaphylactoid reactions can be avoided by temporary discontinuation of ACE inhibitor at least 24 hours prior to the desensitization treatment.
Anaphylactic reactions during LDL apheresis using a dextran sulfate
In rare cases, patients receiving ACE inhibitors during LDL apheresis using a dextran sulfate can develop life-threatening anaphylactoid reactions. To prevent anaphylactoid reactions should discontinue therapy with an ACE inhibitor before every LDL apheresis procedure using vysokoprotochnyh membranes.
Hemodialysis
Patients receiving ACE inhibitors during hemodialysis using vysokoprotochnyh membranes (e.g., AN69 ® ) anafilaktodnye reactions were noted. It is therefore desirable to use a different type of membrane used and other hypotensive drug pharmacotherapeutic group.
Neutropenia / agranulocytosis, thrombocytopenia and anemia
Patients taking ACE inhibitors, there may be cases of neutropenia / agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function, in the absence of other complications of neutropenia is rare and takes place spontaneously after discontinuation of ACE inhibitors.
Perindopril is necessary with great caution in patients with connective tissue diseases and at the same time receiving immunosuppressive therapy, allopurinol or procainamide, especially when existing renal impairment. Some patients may develop severe infections that can not be intensive antibiotic therapy. In the case of the appointment of perindopril it is recommended to control the number of white blood cells in the blood plasma. Patients should be warned that in case of any signs of infection (sore throat, fever) should consult a doctor.
The risk of hypotension and / or kidney disease (including patients with chronic heart failure, disturbance of water-electrolyte balance)
In liver cirrhosis, accompanied by edema and ascites, hypotension, chronic heart failure, there may be a significant RAAS activation, especially in severe hypovolemia and reducing the content of electrolytes in plasma (compared to diet restriction of salt long diuretics).
The use of an ACE inhibitor causes a blockade of the RAAS, in connection with the possible sharp decline in blood pressure and / or increasing the concentration of creatinine in the blood plasma, indicating the development of acute renal failure that often occurs when taking the first dose or during the first 2 weeks of therapy with Dalnevost ® .
ACE inhibitors may cause a sharp decrease in blood pressure. Symptomatic hypotension is rarely occurs in patients without comorbidities. The risk of excessive reduction of blood pressure is elevated in patients with reduced BCC that can be observed during therapy with diuretics, subject to a strict diet with restriction of salt, dialysis, diarrhea or vomiting, or in patients with severe hypertension with high renin activity. In patients at high risk of symptomatic hypotension should be carefully monitored blood pressure, renal function and potassium content in blood serum during therapy with Dalnevost ® .
The same precautions apply to patients with angina pectoris or cerebrovascular disease, in whom a marked reduction in blood pressure can lead to myocardial infarction or cerebral circulation disorders.
In case of hypotension the patient should be transferred to a horizontal position in a low headboard. If necessary - to fill the bcc / in the introduction of 0.9% sodium chloride solution. Transient hypotension is not a contraindication for further use Dalnevost preparation ® . After restoring the bcc and BP treatment with Dalnevost ®can be continued.
Aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyopathy
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.
Potassium-sparing diuretics and potassium supplements
simultaneous use of perindopril and potassium-sparing diuretics, and potassium-containing preparations and potassium salt substitutes is not recommended.
Cough

The therapy of ACE inhibitor may occur dry unproductive cough, which disappears after drug withdrawal in this group. When dry cough should be mindful of possible association of this symptom by using an ACE inhibitor.
Renal function
If the kidney function (creatinine clearance less than 60 mL / min) individual selection recommended doses of amlodipine and perindopril. Regular monitoring of potassium content and creatinine in blood plasma are essential in the treatment of such patients. In some patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, who took ACE inhibitors, there was an increase in plasma concentrations of urea and creatinine, reversible after discontinuation of therapy. These changes are more likely in patients with renal insufficiency. Patients with renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency. Some hypertensive patients with no apparent signs of existing kidney disease who received perindopril together with a diuretic,It noted a slight and temporary increase in the concentration of urea and creatinine in serum. These changes are more likely to develop in patients with prior renal impairment.
Abnormal liver function
Rarely ACE inhibitors is accompanied by the syndrome, the development of which begins with cholestatic jaundice and which then progresses to fulminant hepatic necrosis, sometimes with fatal consequences. The mechanism of this syndrome is unclear. If during the use of an ACE inhibitor appears jaundice or increased activity of hepatic transaminases, an ACE inhibitor should be lifted immediately and the patient should remain under appropriate medical supervision.
ethnic features
Patients blacks are more likely than people of other races on a background of ACE inhibitors develop angioedema. Perindopril as other ACE inhibitors, may provide a less pronounced hypotensive effect in blacks compared to patients with other races. Perhaps this difference is due to the fact that in patients with hypertension blacks often marked low activity of renin in blood plasma.
Surgery / general anesthesia
The use of ACE inhibitors in patients undergoing major surgery and / or general anesthesia may lead to a marked decrease in blood pressure, if used for general anesthesia agents with hypotensive action. This is due to blockade of angiotensin II on the background of a compensatory increase in renin activity. If the development of arterial hypotension associated with the described mechanism, increase the BCC. It is recommended to stop using the product for 24 hours prior to surgery.
Hyperkalemia

Against the background of therapy with ACE inhibitors, including perindopril, the content of potassium in the blood plasma can rise in some patients. Risk factors for the development of hyperkalemia is renal failure, renal impairment, advanced age (over 70 years), diabetes mellitus, intercurrent conditions such as dehydration, acute cardiac decompensation, metabolic acidosis, the simultaneous use of potassium-sparing diuretics (eg, spironolactone, eplerenone, triamterene or amiloride), drugs or additives in potassium kalisodergaszczye edible salt substitutes or concurrent use of other drugs, promoting their plasma potassium content (e.g., heparin). Hyperkalemia can cause serious, sometimes life-threatening arrhythmias.If necessary, the simultaneous use of perindopril and one of the above means, be careful and regular monitoring the potassium content in the blood plasma.
Patients with diabetes mellitus
in patients with diabetes mellitus, host hypoglycemic agents for oral and / or insulin, in the first few months of ACE inhibitor therapy requires strict control of blood glucose concentration.
Amlodipine
Impaired Hepatic Function
In patients with impaired liver function T 1/2 of amlodipine is prolonged. In appointing the drug to such patients should be careful and regular monitoring of liver enzymes.
Patients with heart failure
in patients with chronic heart failure (III and IV NYHA functional class classification) treatment should be done with care, because of the possibility of pulmonary edema.
Use in Pediatrics

The drug Dalnevost ® is contraindicated in children and adolescents under the age of 18 years due to a lack of data on efficacy and safety of the drug in this age group.
Impact on the ability to drive vehicles and manage mechanisms

Due to the possibility of dizziness and other side effects during treatment with the drug Dalnevost ® care must be taken when driving and operating other technical devices, require high concentration and psychomotor speed reactions.
OVERDOSE

Information about drug overdose Dalnevost ® absent.
Perindopril
information perindopril overdose is limited.
Symptoms: marked reduction of blood pressure, shock, disorders of water and electrolyte balance, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.
Treatment: emergency measures to reduce elimination of the drug from the body: gastric lavage and / or destination of activated charcoal, followed by reduction BCC. In marked decrease in blood pressure should be transferred to the patient in the horizontal position with a low headboard, arrange for the recovery bcc if necessary (e.g., in / in infusion of 0.9% sodium chloride solution). also
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