Ko-Dalnev tablets 5 + 1.25 + 4 mg 30 pcs. pack (amlodipine, indapamide, Perindopril)

Latin name

Co-Dalneva

Release form

Tablets are white or almost white, round, slightly biconvex, with a bevel on both sides.



packaging 10 pcs - blister packs (3) - packs of cardboard.

Pharmacological action

Ko-Dalneva® is a combined preparation containing perindopril erbumin (an ACE inhibitor), indapamide (thiazide-like diuretic) and amlodipine (slow calcium channel blocker (BMCC)).

Ko-Dalneva® combines the properties of each of the active ingredients, which have a potentiating effect.

Amlodipine

Amlodipine - BMKK, a derivative of dihydropyridine. Amlodipine inhibits the transmembrane transition of calcium ions and cardiomyocytes and smooth muscle cells of the vascular wall. The antihypertensive effect of amlodipine is due to a direct relaxing effect on smooth muscle cells of the vascular wall. The mechanism of the antianginal action of amlodipine is not fully understood, it is presumably associated with the following effects:

- causes expansion of peripheral arterioles, decreasing OPSS - afterload, which reduces the oxygen demand of the myocardium

- causes the expansion of coronary arteries and arterioles in both intact and in ischemic areas of the myocardium, which increases the flow of oxygen into the myocardium, including in patients with Prinzmetal angina.

In patients with arterial hypertension (AH), taking amlodipine 1 time / day provides a clinically significant decrease in blood pressure (lying and standing) within 24 hours. The antihypertensive effect develops slowly, and therefore, the development of acute arterial hypotension is uncharacteristic. In patients with angina pectoris, taking amlodipine 1 time / day increases exercise tolerance, the time before the development of an attack of angina pectoris and to ischemic depression of the ST segment, reduces the frequency of angina attacks and the need for nitroglycerin (short-acting forms). Amlodipine does not affect the lipid profile and does not cause changes in lipid-lowering blood plasma parameters. The drug can be used in patients with bronchial asthma (AD), diabetes mellitus (DM) and gout.

indapamide

indapamide is a sulfonamide derivative. By pharmacological properties it is close to thiazide diuretics. Indapamide inhibits the reabsorption of sodium ions in the cortical segment of the Henle loop, which leads to increased kidney excretion of sodium and chlorine ions, and to a lesser extent potassium and magnesium ions, thereby increasing diuresis and lowering blood pressure.

In the monotherapy mode, the antihypertensive effect persists for 24 hours and is manifested when the drug is used in doses that have a minimal diuretic effect. The antihypertensive effect of indapamide is associated with an improvement in the elastic properties of large arteries and a decrease in OPSS. While taking indapamide, left ventricular hypertrophy (LVH) decreases. Indapamide does not affect the concentration of lipids in the blood plasma (triglycerides, total cholesterol, low and high density lipoproteins), carbohydrate metabolism (including in patients with diabetes).

Perindopril

Perindopril is an ACE inhibitor. ACE, or kinase II, is an exopeptidase that converts angiotensin I into a vasoconstrictor substance - angiotensin II, and also destroys bradykinin, which has vasodilating properties, to an inactive heptapeptide.

As a result, perindopril provides the following effects:

- reduces the secretion of aldosterone

- increases the activity of blood plasma renin by the principle of negative feedback

- with prolonged use it reduces OPSS - afterload of the heart, which is mainly due to the effect on muscle and kidney vessels. A decrease in OPSS is not accompanied by a delay in sodium and water and does not cause reflex

tachycardia.

A study of hemodynamic parameters in patients with chronic heart failure (CHF) revealed:

- decreased filling pressure in the left and right ventricles of the heart

- decreased OPSS

- increased cardiac output and cardiac index

- increased peripheral blood flow in the muscles.

In addition, an improvement in exercise results was noted.

The action of perindopril is carried out through the active metabolite - perindoprilat. Other metabolites do not have an inhibitory effect on ACE in vitro.

Perindopril is effective in the treatment of hypertension of any severity, reduces both systolic and diastolic blood pressure in the supine and standing position.

The antihypertensive effect reaches a maximum 4-6 hours after a single oral administration and persists for 24 hours.

The antihypertensive effect 24 hours after a single oral administration is about 87-100% of the maximum antihypertensive effect.

Perindopril has an antihypertensive effect in patients with both low and normal plasma renin activity.

The therapeutic effect occurs less than 1 month after the start of therapy and is not accompanied by tachyphylaxis. Discontinuation of therapy does not cause withdrawal syndrome.

Perindopril has vasodilating properties and helps to restore the elasticity of large arteries, the structure of the vascular stoics of small arteries, and also reduces LVH.

Concomitant use with a thiazide diuretic enhances the severity of the antihypertensive effect and reduces the risk of hypokalemia with diuretics.

Perindopril / Indapamide

The combination of perindopril / indapamide has a dose-dependent antihypertensive effect on both systolic and diastolic blood pressure (standing and lying), regardless of the patient's age. The antihypertensive effect persists for 24 hours. The therapeutic effect occurs less than 1 month after the start of therapy and is not accompanied by tachyphylaxis. Discontinuation of therapy does not cause withdrawal syndrome.

In clinical studies, the simultaneous use of perindopril and indapamide increased the severity of the antihypertensive effect compared with monotherapy with each drug. The combination of perindopril tertbutylamine (perindopril erbumin) / indapamide led to a significantly more pronounced decrease in LVH than enalapril monotherapy. The most significant effect on LVH is achieved with perindopril tertbutylamine (perindopril erbumin) 8 mg / indapamide 2.5 mg.

Indications

Arterial hypertension (if necessary, simultaneous therapy with amlodipine, indapamide and perindopril in doses used in monotherapy of individual components).

Contraindications

hypersensitivity to amlodipine and other derivatives of dihydropridine, indapamide and other derivatives of sulfonamide, perindopril and other ACE inhibitors, as well as to excipients that are part of the drug

angioedema, edema, and edema

hereditary / idiopathic angioneurotic edema

bilateral renal artery stenosis, stenosis of a single kidney artery

severe arterial hypotension (systolic Blood pressure less than 90 mmHg)

shock, in Vol. including cardiogenic shock

unstable angina (with the exception of Prinzmetal angina)

obstruction of the left ventricular outlet tract (for example, clinically significant aortic stenosis)

hemodynamically unstable heart failure after acute myocardial infarction

renal failure / min cc insufficiency, including hepatic encephalopathy

refractory hypokalemia

simultaneous use with drugs that can cause polymorphic ventricular arrhythmias such as pirouette (see section Interaction with other drugs)

simultaneous use with potassium-sparing diuretics, potassium and lithium preparations in patients with increased blood plasma

concomitant use of drugs, prolonging the QT interval

simultaneous use with aliskiren and aliskiren preparations in patients with diabetes

pregnancy and the period of breastfeeding (see section Pregnancy and the period of breastfeeding)

age up to 18 years (efficacy and safety have not been established).

Given the lack of sufficient clinical experience, should not be used in patients undergoing hemodialysis, as well as in patients with untreated heart failure stage decompensation.

Caution (see also sections Special instructions and Interactions with other drugs): mild to moderate hepatic failure, systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma), immunosuppressant therapy, allopurinol, procainamide (risk of developing neutropenia and agranulocytosis), inhibition of bone marrow hematopoiesis, decreased circulating blood volume (diuretics, diet with restriction of sodium chloride, vomiting, diarrhea, hemodialysis), coronary heart disease, atherosclerosis, cerebrovascular disease, renovascular hypertension, sugar, hypertension, sugar (IV NYHA functional class), hyperuricemia (especially in combination with gout and urate nephrolithiasis), simultaneous use of dantrolene, estramustine, surgical e intervention / general anesthesia, lability AD hemodialysis using vysokoprotochnyh membranes (eg. AN69®), before the procedure apheresis low density lipoproteins (LDL) using the dextran sulfate simultaneous desensitizing therapy allergens (e.g., Hymenoptera venom), condition after kidney transplantation, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy (GOKMP), use in elderly patients and in patients of the Negroid race.

Use during pregnancy and lactation

Pregnancy

Co-DalnevВ® is contraindicated in pregnancy (see Contraindications).

When planning a pregnancy or when it occurs while taking Co-DalnevВ®, you should immediately stop taking it and prescribe alternative antihypertensive therapy with a proven safety profile.

The safety of amlodipine during pregnancy has not been established. Limited data on the use of amlodipine and other BMCC during pregnancy indicate no adverse effects on the fetus. In animal experiments, signs of reproductive toxicity were observed with high doses of amlodipine. In some patients treated with BMKK therapy, a reversible decrease in sperm motility was noted. Clinical data regarding the potential effect of amlodipine on reproductive function are insufficient. Long-term use of thiazide diuretics in the III trimester of pregnancy can cause maternal hypovolemia and a decrease in uteroplacental blood flow, which leads to fetoplacental ischemia and fetal growth retardation. In rare cases, while taking diuretics shortly before birth, newborns develop hypoglycemia and thrombocytopenia.

The available data on the teratogenicity of ACE inhibitors in the first trimester of pregnancy are not convincing, but this risk cannot be completely ruled out. In the second and third trimesters of pregnancy, the effects of ACE inhibitors on the fetus can lead to impaired development (decreased renal function, oligohydramnios, delayed ossification of the bones of the skull) and the development of complications in newborns (renal failure, hypotension, hyperkalemia). If an ACE inhibitor was used in the II or ill trimester of pregnancy, it is recommended to conduct an ultrasound examination of the kidneys and bones of the fetal skull. Newborns whose mothers received ACE inhibitors during pregnancy need careful medical supervision, as there is a risk of developing arterial hypotension.

Breastfeeding period

There is no data on the excretion of amlodipine with breast milk. However, it is known that other BMCC - derivatives of dihydropyridine, are excreted in breast milk. Indapamide is excreted in breast milk. Reception of thiazide diuretics causes a decrease or suppression of lactation in the mother, in a newborn it is possible to develop increased sensitivity to sulfonamide derivatives, hypokalemia and nuclear jaundice. It is not known whether peridopril with breast milk is excreted.

Co-DalnevВ® is contraindicated in breastfeeding. If it is necessary to use the drug Co-DalnevВ® during lactation, breastfeeding should be discontinued.

Composition

1 tab. contains active substances: amlodipine besilate 6.935 mg, which corresponds to the content of amlodipine 5 mg

indapamide 1.25 mg

perindopril erbumin B substance-granules * 20.412 mg, which corresponds to the content of perindopril erbumin 4 mg.

Excipients: microcrystalline cellulose - 79.413 mg, pregelatinized starch - 21 mg, sodium carboxymethyl starch - 8.4 mg, sodium hydrogen carbonate - 0.76 mg, colloidal silicon dioxide - 0.43 mg, magnesium stearate - 1.4 mg.

* Excipients of the granule substance: microcrystalline cellulose 15.8 mg, calcium chloride hexahydrate 1.2 mg.

Dosage and administration of

Inside, 1 tab. 1 time / day, preferably in the morning, before meals.

The dose of the drug Ko-Dalneva® is selected after a previous titration of doses of the individual active components of the drug. The maximum daily dose of Co-Dalnev® is 10 mg of amlodipine + 2.5 indapamide + 8 mg of perindopril.

Elderly patients and patients with impaired renal function

Co-Dalneva® is contraindicated in patients with moderate and severe impaired renal function (CC less than 60 ml / min) (see section Contraindications). The drug Ko-Dalneva® can be used in patients with CC equal to and greater than 60 ml / min. Such patients are recommended an individual selection of doses of amlodipine, indapamide, perindopril.

Amlodipine, used in equivalent doses, is equally well tolerated by patients of both the elderly and younger ages. No changes in the dosage regimen are required in elderly patients, however, an increase in the dose should be carried out with caution, which is associated with age-related changes and T1 / 2 lengthening. A change in the concentration of amlodipine in blood plasma does not correlate with the severity of renal failure.

Elimination of perindoprilat in elderly patients and patients with renal failure is slowed down. Therefore, in such patients, it is necessary to regularly monitor the concentration of creatinine and the content of potassium in the blood plasma.

Patients with impaired liver function

Co-Dalnev® is contraindicated in patients with severe hepatic impairment {see section Contraindications).

Caution should be exercised when using the drug in patients with mild to moderate impaired liver function.

Side effects

Classification of the incidence of side effects of the World Health Organization (WHO): very often> 1/10, often from> 1/100 to1 / 1000 to1 / 10000 to

Classification of MedDRA Adverse Effects Frequency

Amlodipine Perindopril / Indapamide

Disorders of the blood and lymphatic system Leukopenia / neutropenia Very rare Very rarely

Agranulocytosis or pancytopenia Very rarely srtlcopenia Very rarely srdlcp Aplastic anemia - Very rarely

Hemolytic anemia Very rarely

During the treatment with ACE inhibitors in certain situations (after kidney transplantation, during dialysis) the development of anemia was observed - Very rarely

Disorders with aspects of the immune system Hypersensitivity reactions in patients anxiety) Infrequently Infrequently

Depression Infrequently -

Sleep disturbance - Infrequently

Confusion of consciousness Rarely

Disorders of the nervous system Drowsiness (especially at the beginning of treatment) Often

Dizziness (especially at the beginning of treatment) Often often

Headache

Hypesthesia Infrequently -

Paresthesia Infrequently Often

Muscular hypertension Very rare -

Peripheral neuropathy Very rare -

Vertigo - Often

Fainting Infrequently Frequency unknown

Visual impairment vision loss (including diplopia) Infrequently Often

Hearing impairment and labyrinth disturbances Noise (ringing) in the ears Infrequently Often

Disorders of the heart Sensation of palpitations Often -

Angina pectoris - Very rarely

Myocardial infarction, possibly due to an excessive decrease in blood pressure in high-risk patients Very rarely Very rarely

Heart rhythm disturbances (including bradycardia, ventricular tachycardia and atrial fibrillation) Very rarely Very rarely

Polymorphic ventricular tachycardia feasts by type (possibly fatal) - Frequency unknown

Violations from the side of blood vessels Sensation of flushing of the face skin Often

Pronounced decrease in blood pressure (including orthostatic hypotension) Infrequently Infrequent

Vasculitis (including hemorrhagic vasculitis) Very rare Infrequently

Disorders of the gastrointestinal tract gingival hyperplasia Very rare -

Abdominal pain, nausea Often Often

epigastric pain - often

Vomiting Uncommon Indigestion Uncommon

Often Often

change mode defecation (including diarrhea, constipation) Infrequently Often

Dryness of the oral mucosa Infrequently Often

Disorder of taste - Often

Pancreatitis Very rarely Very rarely

Gastritis Very rarely -

Decreased appetite - Often

Angioedema of the intestine - Very rarely * Very rare -

Jaundice * Very rare Very rarely

Hepatic encephalopathy in patients with hepatic impairment - Frequency unknown

Disorders of the skin and subcutaneous tissue Urticaria Infrequently N often

Angioedema of the face, limbs, lips, mucous membrane of the tongue, vocal folds and / or larynx (see section Special instructions) Very rarely Infrequent

Multiforme exudative erythema Very rarely Very rare

Exanthema Infrequent -

Alopecia Infrequently -

Skin color Change Frequently -

Increased sore skin dermatitis Very rarely -

Stevens-Johnson syndrome Very rarely Very rarely

Photosensitivity Very rarely Frequency unknown

Maculopapular rash - Often

Toxic epidermal necrolysis - Very rarely

Possible worsening of the acute form of systemic lupus erythematosus - Infrequently

Violations of the musculoskeletal system and connective tissue arthralgia, myalgia Infrequently -

Ankle swelling -

Muscle spasms Infrequent Often

Back pain Infrequently -

Disorders of the kidneys and urinary tract Painful urination, nocturia, frequent urination Very frequent - No sharp - No sharp - No sharp - No sharp

Violations of the genitals and mammary gland Impotence Infrequently Infrequently

Gynecomastia Infrequently -

General disorders and disorders together administration Peripheral edema Frequently -

Increased fatigue Infrequently -

Chest pain Infrequently -

Asthenia Infrequently Often

Pain of various localization Infrequently -

General malaise Infrequently -

Laboratory and instrumental data Increased serum bilirubin concentration, activity of liver enzymes ALT * and AST * Very rarely Frequency unknown

Increased QT interval on ECG - Frequency unknown

Increased creatinine concentration in urine and blood plasma after treatment withdrawal - Frequency unknown

Hypokalemia - Frequency unknown

Hyponatremia and hypovole dehydration and orthostatic hypotension - Frequency unknown

Increased plasma uric acid and glucose concentrations - Frequency unknown

Hyperkalemia - Frequency unknown

Hypercalcemia - P DKO

* In most cases, associated with cholestasis.

Drug Interaction

Amlodipine

Concomitant use not recommended

Dantrolen (in / into the introduction)

In laboratory animals, cases of ventricular fibrillation with lethal outcome and collapse were noted. Due to the risk of developing hyperkalemia, it is advisable to avoid the concomitant use of BMCC (amlodipine) and dantrolene in patients undergoing malignant hyperthermia as well as in the treatment of malignant hyperthermia.

Concomitant use with particular attention

CYP3A4 isoenzyme inducers

Data regarding the effect of CYP3A4 isoenzyme inducers on amlodipine, are missing. Concomitant use of CYP3A4 isoenzyme inducers (rifampicin, Hypericum perforatum preparations) may result in decreased plasma concentrations of amlodipine. Caution should be exercised when co-administering amlodipine with CYP3A4 isoenzyme inducers.

CYP3A4 isoenzyme inhibitors

Concurrent administration of amlodipine with potent or moderate CYP3A4 isoenzyme inhibitors (protease inhibitors, antifungal drugs of the azole group, macrolides, such as erythromycin or clarithromyldi amlvestycin, dielectin The clinical manifestations of these pharmacokinetic abnormalities may be more pronounced in elderly patients. In this regard, clinical monitoring and dose adjustment may be required.

Concomitant use requiring

Amlodipine enhances the antihypertensive effect of antihypertensive agents.

Other drug combinations

In clinical drug interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin, or cyclosporine.

The concomitant use of amlodipine and the use of grapefruit or grapefruit juice is not recommended due to the increased bioavailability of amlodipine in some patients, which may lead to an increased antihypertensive effect.

Indapamide

Concurrent use requiring special attention

Drugs capable of causing polymorphic ventricular tachycardia such as pruet

Given the risk of hypokalemia, the following should be followed when using indapamide with drugs capable of causing polymorphic tachycardia , trifluoroperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide), other drugs such as bepridil, cisapride, difemanil methylsulfate, erythromycin IV, halofantrine, misolastin, moxifloxacin, pentamidine, sparfloxacin, vincamine IV, methadone, astemizole, terfenadine. Concomitant use with the above drugs in the development of hypokalemia should be avoided, carry out its correction, monitor the ECG (QT interval).

Drugs that can cause hypokalemia

Concurrent administration with amphotericin B / I, systemic ACS and mineralocorticosteroids, tetracosactide, laxatives that stimulate gastrointestinal motility, increases the risk of developing hypokalemia. It is necessary to control the content of potassium in the blood plasma, if necessary - the correction of hypokalemia. Particular caution should be exercised when co-administered with cardiac glycosides. Laxatives that do not stimulate gastrointestinal motility should be used.

Cardiac glycosides

Hypokalemia enhances the toxic effect of cardiac glycosides. At simultaneous use it is necessary to control the content of potassium in blood plasma and ECG indicators and if necessary to decide the question of expediency of continuation of therapy.

Concomitant use that requires attention

Metformin

Functional renal failure, which may occur with diuretics, especially loopholes, with metformin increases the risk of lactic acidosis. Metformin should not be used if blood plasma QC exceeds 15 mg / l (135 μmol / l) in men and 12 mg / l (110 μmol / l) in women.

Iodine Contrast Substances

Dehydration of the body against diuretics increases the risk of acute renal failure, especially with high doses of iodine contrast media. Hypovolemia must be compensated for the use of iodine-containing contrast agents.

Calcium salts

Hypercalcaemia may occur with simultaneous administration due to decreased renal excretion of calcium.

Cyclosporine

It is possible to increase QC in blood plasma without changing the concentration of cyclosporine, even with normal water and sodium content.

Perindopril

Concomitant use not recommended

Aliskiren

Concomitant use of perindopril with aliskiren is contraindicated in patients with diabetes or moderate or severe renal impairment (CC less than 60 ml / min).

Potassium sparing diuretics, potassium preparations and potassium-containing salt substitutes

As a result of ACE inhibitor therapy, potassium content in the blood plasma usually remains within the normal range, but development of hyperkalemia is possible. Simultaneous intake of potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone), potassium preparations and potassium-containing substitutes for dietary salt can lead to a significant increase in the content of potassium in the blood plasma. If necessary, concomitant administration of ACE inhibitor with the above drugs (in the case of hypokalemia), caution should be exercised and regular monitoring of potassium in the blood plasma and ECG parameters.

Estramustine

The concomitant use of ACE inhibitors with estramustine is accompanied by the risk of angioneurotic edema.

Concomitant use requiring special attention

Double RAAS blockade in patients with atherosclerosis, CHF or diabetes mellitus, accompanying lesions of the target organs is associated with a higher frequency of development of arterial hypotension, fainting, hyperkalemia and impaired renal function (including, the development of TFD) compared with the use of the drug in one of these groups. Dual blockade of RAAS is only possible in some cases under careful monitoring of renal function.

NSAIDs, including high doses of acetylsalicylic acid (ASA) (more than 3 g / day)

Concurrent use of ACE inhibitors with NSAIDs (including ASAs at a dose that has anti-inflammatory effects, COX-2 inhibitors and non-inflammatory effects) , as well as impairment of renal function, including the development of ARF, and increased plasma potassium, especially in patients with impaired renal function. Caution should be exercised when administering this combination, especially in elderly patients. Patients should be compensated for fluid loss and regularly monitored for renal function, both at the beginning of treatment and during treatment.

Hypoglycemic agents (sulfonylureas and insulin derivatives)

ACE inhibitors may enhance the hypoglycemic effect of insulin and sulfonylureas in patients with diabetes mellitus. The development of hypoglycemia is very rare (probably due to an increase in glucose tolerance and a decrease in insulin requirement).

Concomitant use requiring

Diuretics (thiazide and loop)

In patients receiving diuretics, especially with excess fluid and / or electrolyte removal, at the beginning of ACE inhibitor therapy, a significant decrease in blood pressure may be observed. The risk of developing arterial hypotension can be reduced by eliminating diuretics, correcting hypovolemia and electrolyte balance, and prescribing perindopril in a low dose (2 mg / day), gradually increasing it.

Allopurinol, cytostatic and immunosuppressive drugs, glucocorticosteroids (with systemic use) and procainamide

Co-administration with ACE inhibitors may increase the risk of leukopenia.

General anesthesia drugs

The simultaneous use of ACE inhibitors and general anesthesia agents may increase the antihypertensive effect.

Gold preparations

When using ACE inhibitors, incl. perindopril, in patients receiving in / in the drug gold (sodium aurothiomalate), the symptom complex was described, including facial hyperemia, nausea, vomiting, hypotension.

Gliptins (lipagliptin, saxagliptin, sitagliptin, vitagliptin)

Concurrent administration with ACE inhibitors may increase the risk of angioneurotic edema due to suppression of dipeptidyl peptidase IV (DPP-IV) activity by glyptin.

Sympathomimetics

Sympathomimetics can attenuate the antihypertensive effect of ACE inhibitors.

Ko-Dalnev®

Concomitant use not recommended

Lithium preparations

When ACE inhibitors are co-administered with lithium preparations, a reversible increase in lithium plasma concentrations may occur with the development of intoxication.

Concomitant use with thiazide diuretics may further increase lithium concentrations and increase the risk of intoxication. Concomitant use of a combination of perindopril and indapamide with lithium preparations is not recommended. In the case of such therapy, regular monitoring of the concentration of lithium in the blood plasma is required.

Concomitant use requiring special attention

Baclofen

Antihypertensive effect may be increased. The blood pressure and function of the kidneys should be monitored and, if necessary, the dose of antihypertensive drugs should be adjusted.

Simultaneous use requiring attention

Hypotensive agents (eg beta blockers) and vasodilators

When used with antihypertensive drugs, antihypertensive effects may be enhanced. Caution should be exercised when co-administered with nitroglycerin, other nitrates or other vasodilators, as this may further reduce blood pressure.

Corticosteroids (mineral and glucocorticosteroids), tetracosactide

Reduced antihypertensive action (fluid and sodium retention due to corticosteroids).

Alpha-blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin)

Increased antihypertensive activity and increased risk of orthostatic hypotension.

Amifostine

The antihypertensive effect of amlodipine may be enhanced.

Tricyclic antidepressants / neuroleptics / general anesthesia drugs

Increased antihypertensive activity and increased risk of orthostatic hypotension (additive effect).

Overdose



symptoms The most likely symptoms of an overdose are a marked decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation (risk of severe and persistent arterial hypotension. Sometimes a pronounced decrease in blood pressure is accompanied by nausea, vomiting, convulsions, dizziness, drowsiness, confusion, oliguria, which can go into anuria (as a result of hypovolemia). Water-electrolyte balance disturbances (hyponatremia, hypokalemia) can also be observed.

Treatment

Emergency measures are aimed at removing the drug from the gastrointestinal tract: gastric lavage and / or intake of activated carbon followed by the restoration of the water-electrolyte balance. In case of a pronounced decrease in blood pressure, the patient should be placed with an elevated position of the lower extremities, if necessary to correct the hypovolemia (eg, infusion of 0.9% sodium chloride solution).

Perindoprilat, the active metabolite of perindopril, is removed by hemodialysis.

Amlodipine binds closely to blood plasma proteins, so hemodialysis is ineffective.

Indapamide is not removed by hemodialysis.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C, in the original packaging.

Expiration

2 years.

Deystvuyuschee substances

amlodipine, indapamide, Perindopril

pharmacy delivery terms

pharmacy

dosage form

dosage form

tablets

KRKA d.d. Novo mesto AO, Slovenia



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