Enalozide 12.5 mg tablets number 30
Author Ольга Кияница
|Amount in a package||30|
|Manufacturer||Farmak OJSC (Ukraine, Kiev)|
|The main medicament||Enaloside|
Enalozid (Enalapril and Diuretics) Instructions for use
Basic physical and chemical properties.
White or white tablets with a cream color, with a flat surface, a facet and a risk, or without risk.
Combined angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors and diuretics. Code ATX C09B A02.
Enalozide 12.5 is a combination of an angiotensin converting enzyme (enalapril maleate) inhibitor and a diuretic (hydrochlorothiazide).
The angiotensin converting enzyme (ACE) is peptidyl dipeptidase, which catalyzes the conversion of angiotensin I into the press substance angiotensin II. After absorption, enalapril is hydrolysed to enalaprilat, which inhibits ACE.Contravention of ACE leads to a decrease in the level of angiotensin II in blood plasma, which leads to an increase in the plasma renin activity (through the inhibition of negative feedback in the release of renin) and a decrease in the secretion of aldosterone.
APF is identical to Kininase II. Enalapril can also block the breakdown of bradykinin, which is a powerful vasodilator peptide. However, the role of this fact in the therapeutic effects of enalapril remains unknown. While the mechanism by which enalapril reduces arterial pressure is primarily associated with the depression of the activity of the renin-angiotensin-aldosterone system, which plays a major role in regulating blood pressure, enalapril may exhibit antihypertensive effects even in patients with low-coronary hypertension.
Hydrochlorothiazide is a diuretic and antihypertensive agent that increases the plasma renin activity of the blood. The antihypertensive effects of the two components are additive and usually last for 24 hours. Although one enalapril exhibits hypotensive effects even in patients with low-coronary hypertension, co-administration with hydrochlorothiazide in such patients leads to a greater reduction in blood pressure. The enalapril component in the drug, as a rule, weakens the decrease in potassium induced by hydrochlorothiazide.
Enalaprila maleate. After oral administration, enalapril is rapidly absorbed, reaching maximum concentrations in serum for 1 hour. Based on the urinary excretion rate, oral absorption of enalapril is approximately 60-70%.
After absorption, enalapril is rapidly and extensively hydrolysed to enalaprilat, a potent inhibitor of angiotensin converting enzyme. The maximum concentration of enalaprilat in the serum is achieved 3-4 hours after the oral administration of enalapril maleate. Enalapril is mainly excreted by the kidneys. The main components in the urine are enalaprilat, which is approximately 40% of the dose, and enalapril in the unmodified form. Except for conversion to enalapilat, there are no signs of significant metabolism of enalapril. The enalaprilat concentration profile in the serum is characterized by a prolonged terminal phase, which is probably due to ACE binding. In individuals with normal kidney function, the equilibrium state of concentrations of enalaprilat in serum is achieved on the 4th day of oral use of enalapril. The effective half-life of enalaprilat cumulative use after repeated oral administration of enalapril is 11 hours.The intake of food does not affect the absorption of enalapril in the gastrointestinal tract. The volume of absorption and hydrolysis of enalapril are similar when taking different doses within the recommended therapeutic range.
Hydrochlorothiazide. When monitoring blood plasma levels for at least 24 hours, the half-life of the blood plasma was 5.6-14.8 hours. Hydrochlorothiazide is not metabolized, but is rapidly released by the kidneys. At oral administration, at least 61% of the dose is withdrawn unchanged for 24 hours. Hydrochlorothiazide penetrates through the placental and does not penetrate the blood-brain barrier.
Enalapril / hydrochlorothiazide. Simultaneous multiple use of enalapril and hydrochlorothiazide has little or no effect on the bioavailability of these drugs. The combined tablet is bioequivalent to its individual components, which are applied at the same time.
Treatment of arterial hypertension in patients who are shown with combined therapy.
Hypersensitivity to the components of the drug. Angioedema in the history associated with previous treatment with angiotensin converting enzyme (ACE) inhibitors, as well as hereditary or idiopathic angioneurotic edema. Severe renal (creatinine clearance <30 ml / min) or hepatic insufficiency. Anuria Symptomatic hyperuricemia (gout). Hypersensitivity to other drugs that are sulfonamide derivatives. Stenosis of the renal arteries. Resistant to hypokalaemia or hypercalcemia. Refractory hyponatremia. When conducting hemodialysis.
Pregnant women or women planning pregnancy (see section "Use during pregnancy or breast-feeding").
Do not use with preparations containing aliskiren, patients with diabetes mellitus or with renal impairment (SCF ˂60 ml / min / 1.73 m2).
Interaction with other drugs and other types of interactions
Enalapril maleate and hydrochlorothiazide
Other antihypertensive drugs. Simultaneous use of these drugs can increase the hypotensive effect of enalapril and hydrochlorothiazide. Simultaneous administration with nitroglycerin, other nitrates or other vasodilators can further reduce arterial pressure.
Lithium Reversible increases in lithium concentration in serum and toxicity were reported with the simultaneous use of lithium with ACE inhibitors. Simultaneous use of thiazide diuretics may further increase lithium levels and increase the risk of lithium toxicity if an ACE inhibitor is used.
The use of Enalozide 12.5 is not recommended at the same time as lithium preparations, but if such a combination is necessary, blood serum lithium levels should be closely monitored.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, may reduce the antihypertensive effects of ACE inhibitors, the effects of diuretics and / or other antihypertensive drugs. For this reason, the antihypertensive effect of angiotensin II receptor antagonists, ACE inhibitors or diuretics may be attenuated with NSAIDs, including selective COX-2 inhibitors.
Concomitant use of NSAIDs (including COX-2 inhibitors) and angiotensin II receptor antagonists or ACE inhibitors has an additional effect on serum potassium levels and may impair renal function. These effects are usually reversible.
Renal insufficiency, in particular, in patients with impaired renal function (eg, elderly patients or dehydrated patients, including patients treated with diuretics), can rarely develop. Therefore, such a combination of drugs should be used with caution in patients with impaired renal function.
Double block of renin-angiotensin-aldosterone system (RAAS). The double blockade of RAAS with angiotensin receptor blockers, ACE inhibitors or direct renin inhibitors (e.g., aliskiren) is associated with an increased risk of arterial hypotension, fainting, hyperkalaemia, and altered kidney function (including acute renal failure) in patients with atherosclerotic vascular disease, cardiac insufficiency or defeat of target organs with diabetes mellitus in comparison with monotherapy. Care should be taken to monitor blood pressure, renal function and electrolyte levels in patients receiving Enalozide 12.5 and other drugs that affect RAAS. Patients with diabetes mellitus can not be prescribed concomitantly with the aliskirenic preparation Enalozide 12.5. Aliskiren should be avoided concurrently with Enalozide in 12.5 patients with impaired renal function (SCF ˂60 ml / min / 1.73 m2).
Potassium-sparing diuretics or potassium supplements. ACE inhibitors reduce potassium losses induced by the use of diuretics. Potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes can lead to a significant increase in serum potassium levels. If simultaneous use of such drugs is indicated due to hypokalemia, treatment should be carried out with caution and often monitor the level of potassium in the serum.
Diuretics (thiazide or loop diuretics). Pre-treatment with diuretics in high doses can lead to dehydration and the risk of developing hypotension at the onset of enalapril treatment. Hypotensive effects can be relaxed by abolishing the diuretic, increasing the volume of fluid in the body or increasing salt intake.
Tricyclic antidepressants / antipsychotics / anesthetics / hypnotics. Simultaneous application of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors can lead to an additional reduction in blood pressure.
Preparations of gold. Nitroid reactions (facial redness, nausea, vomiting, and arterial hypotension) have been reported in patients treated with injectable preparations of gold (sodium aurotiomalate) at the same time as ACE inhibitors, including enalapril.
Sympathomimetics. Sympathomimetics can reduce the antihypertensive effect of ACE inhibitors.
Alcohol. Alcohol potentiates the hypotensive effect of ACE inhibitors.
Antidiabetic drugs. Epidemiological studies show that the simultaneous use of ACE inhibitors and antidiabetic agents (insulin, oral hypoglycaemic agents) can lead to a reduction in blood glucose levels with a risk of hypoglycaemia. Such an effect is likely to occur during the first weeks of concomitant treatment and in patients with impaired renal function.Acetylsalicylic acid, thrombolytic drugs and β-blockers. Enalapril can be used with caution with acetylsalicylic acid (in cardiac doses), thrombolytic agents and β-blockers.
Non-depolarizing muscle relaxants. Thiazides can increase susceptibility to tubocurarine and enhance the muscle relaxant effect.
When used with the following drugs, interaction with thiazide diuretics may occur.
Alcohol, barbiturates, or narcotic analgesics. They can potentiate the development of orthostatic hypotension.
Antidiabetic drugs (oral and insulin). Correction of the dose of an antidiabetic drug may be necessary, since co-administration of ACE inhibitors and anti-diabetic drugs may lead to lower blood glucose levels.
On the background of treatment with thiazides it is possible to decrease glucose tolerance. There may be a need for a change in dosage. Metformin should be used with caution given the risk of lactic acidosis due to possible functional renal dysfunction induced by hydrochlorothiazide.
Other antihypertensive drugs. Additive effect.
Lithium Diuretics reduce renal clearance of lithium and significantly increase the risk of toxicity due to lithium.Simultaneous administration of these drugs is not recommended.
Antipodagrical agents (probenecid, sulfinpyrazone and allopurinol). There may be a need for dose adjustment of uricosuric drugs, since hydrochlorothiazide may increase uric acid levels in serum. The probable occurrence of the need for an increase in the dose of probenecid or sulfinpyrazone. With the simultaneous use of thiazides, an increase in the incidence of hypersensitivity reactions to allopurinol is possible.
Anticholinergics (eg, atropine, biperidine). Because of the weakening of the motility of the gastrointestinal tract and the reduction of the evacuation rate from the stomach, the bioavailability of the diuretics of the thiazide type increases.
Resins of colestiramina and colestipol. The absorption of hydrochlorothiazide is reduced in the presence of anion exchange resins. A single dose of the drug colestiramine or colestipol resin binds to hydrochlorothiazide and reduces its absorption from the gastrointestinal tract by 85% and 43%, respectively.
Increase QT interval (quinidine, procaineamide, amiodarone, sotalol). The risk of developing a polymorphic ventricular tachycardia of the "pyruet" type is increased.
Salicylates When using high doses of salicylates hydrochlorothiazide can increase their toxic effects on the central nervous system.
Methyldopa Reported individual cases of hemolytic anemia with the simultaneous use of hydrochlorothiazide and methyldopa.
Ciclosporin At simultaneous application of cyclosporine hyperuricemia may increase and the risk of complications in gout similarity may increase.
Glycosides of digitalis. Thiazide-induced hypokalemia or hypomagnesaemia may contribute to arthritis caused by digitalis.
Drugs that affect the effects of changes in serum potassium levels. Periodic monitoring of serum potassium levels and ECG testing are recommended if hydrochlorothiazide is taken concurrently with drugs whose effects are affected by changes in serum potassium levels (eg, digitalis glycosides and antiarrhythmic drugs), and the following drugs that cause polymorphic pyretic type tachycardia (ventricular tachycardia) (including some antiarrhythmic drugs), since hypokalemia is a factor contributing to the development of piroate tachycardia:
- antiarrhythmic drugs of Class Ia (for example, quinidine, hydroquinidine, disopyramide);
- Antiarrhythmic drugs of Class III (for example, amiodarone, sotalol, dopetilid, ibutylid);
- some neuroleptics (e.g., tioridazine, chlorpromazine, levomepromazine, trifluoroperazine, ciamemazine, sulpiride, sulfopride, amiluspiridide, thiapride, pimozide, haloperidol, droperidol);
- other drugs (for example, bepridil, cisapride, dipemanil, erythromycin for intravenous administration, halofantrine, miolastine, pentamidine, terfenadine, vincamine for intravenous administration).
Calcium salts. Thiazide diuretics raise the level of calcium in the serum by reducing its withdrawal. If calcium-containing dietary supplements are to be prescribed, serum calcium monitoring should be monitored and the dose of calcium adjusted accordingly.
Influence of drugs on the results of laboratory tests. Because of the effect on the exchange of calcium, thiazides can influence the results of the evaluation of parathyroid glands (see section "Peculiarities of use").
Carbamazepine Given the risk of symptomatic hyponatremia, clinical and biological monitoring is required.
Iodine-containing contrast media. In the case of dehydration-induced diuretics, the risk of developing acute renal failure is increased, mainly with the use of high doses of iodine-containing contrast agents. Patients need rehydration before the introduction of iodine-containing drugs.
Amphotericin B (for parenteral administration), corticosteroids, ACTH and stimulating laxatives. Hydrochlorothiazide enhances electrolyte imbalance, predominantly hypokalemia.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2), acetylsalicylic acid> 3 g / day and non-selective NSAIDs. Concomitant administration of NSAIDs may weaken the antihypertensive effect of hydrochlorothiazide and increase its effect on potassium levels in serum.
Beta-blockers and diazoxide. Simultaneous use of thiazide diuretics, including hydrochlorothiazide, with beta-blockers may increase the risk of hyperglycemia. Thiazide diuretics, including hydrochlorothiazide, may increase the hyperglycaemic effect of diaxoside.
Amantadine Thiazides, including hydrochlorothiazide, can increase the risk of side effects caused by amantadine.
Potassium-urea diuretics (eg furosemide), carbenoxolone. Hydrochlorothiazide can increase potassium and / or magnesium losses.
Pressor Amines (for example, adrenaline). Thiazides can lower the response in response to pressor amines, but not enough to exclude the concomitant intake.
Cytotoxic drugs (eg, cyclophosphamide, methotrexate). Thiazides, including hydrochlorothiazide, can reduce the release of cytotoxic drugs in the kidneys and increase their myelosuppressive effects.
Ynhybytorы prostaglandin synthase. In nekotorыh patsyentov s Application Can umenshat dyuretycheskye, natryyuretycheskye diuretics and antihypertensive эffektы.
Enalapril maleate and hydrohlorotyazyd
Hypotension and electrolyte / Vodny imbalance. Symptomatycheskaya rarely hypotension is observed in patsyentov neoslozhnennoy arteryalnoy with hypertension. Symptomatycheskaya hypotension chashche arises in patsyentov with violation of water balance, prynymayuschyh 12.5 Эnalozyd for example, as a result of therapy diuretics, dyetы ohranychennыm upotreblenyem with salt, diarrhea and rvotы. For those tired patsyentov regularly, because opredelennыe yntervalы of time, opredelyat эlektrolytov Levels in blood whey. Particular WARNING It should be the destiny of treatment with patsyentov yshemycheskoy illness or heart disease tserebrovaskulyarnыmy, because the Significant Reduction arterial pressure Can lead for stroke or myocardial ynfarktu.
Symptomatycheskaya hypotension nablyudalas in patsyentov with cardiac insufficiency, kotoraja soprovozhdalas or not soprovozhdalas renal insufficiency. Chashche symptomatycheskaya hypotension razvyvalas in patsyentov with more than tyazhelыmy forms of cardiac insufficiency, kotorыm prymenyaly vыsshye dozы petlevыh diuretics, with Hyponatremia abuse or kidney function. This patsyentam Treatment sleduet the Start observation pod doctor, as well as for tschatelno nablyudat STATUS patsyenta dozы Changes in the preparation and / or diuretics. This also kasaetsya patsyentov of treatment with yshemycheskoy illness and heart disease tserebrovaskulyarnыmy, because the Significant Reduction arterial pressure Can lead for stroke or myocardial ynfarktu.
If hypotension DEVELOPMENT arteryalnoy Nuzhny patsyenta hath put on his back and, If neobhodimo, enter vnutryvenno infusion Solution physiological sodium chloride solution. Temporary hypotension not javljaetsja Contraindications for dalneyshemu Application drug. If after tsyrkulyruyuschey Normalize Volume Increase arterial blood pressure arises, Can bыt therapy restored in obыchnыh doses.
In nekotorыh patsyentov with cardiac insufficiency and with normalnыm or ponyzhennыm pressure Can snyzytsya Advanced Level arterial pressure. Prohnozyruemыy such effect and no grounds for javljaetsja prekraschenyya treatment. In cases, when symptomatic hypotension stanovytsya, sleduet snyzyt dose and / or prekratyt Treatment diuretics and / or medication.
Violations kidney function. Was reported at DEVELOPMENT renal failure, svyazannoy primeneniem with enalapril, something preymuschestvenno was observed in patsyentov with severe cardiac insufficiency or renal osnovnыm disease, renal artery stenosis vkljuchaja. In svoevremennoy Diagnosis and Treatment sootvetstvuyuschem Renal failure, svyazannaya primeneniem with enalapril, As a rule, reversible. Эnalozyd 12.5 It should not assign patsyentam with violation of the kidney function (creatinine ride height ˂80 ml / min ˃30 ml / min), the dose of enalapril yet at tytratsyy not dostyhnet dozyrovanyya a data preparate.
If enalapril therapy with a diuretic The combination of nekotorыh patsyentov with no kakyh arteryalnoy hypertension, kidney disease Liboje pryznakov to the beginning of treatment voznykalo Increase CONTENT mochevynы and creatinine in the blood. In such cases Treatment Эnalozydom 12.5 Nuzhny prekratyt, as well rassmotret question of renal artery stenosis Perhaps.
Hyperkalemia. Kombynatsyya enalapril and diuretic in a series of doses Can vыzvat emergence of hyperkalemia.
Cast. Pryem concomitant enalapril and cast Usually not recommended .
Aortalnыy stenosis / hypertrophic cardiomyopathy. Ynhybytorы ACE (as all others and vazodylatatorы) sleduet Apply with caution patsyentam with obstruktsyey valve and tracks ottoka IZ levoho ventricle. Application ynhybytorov ACE neobhodimo yzbehat in cardiogenic shock and sluchae in sluchae hemodynamically znachymoy obstruktsyy.
Renovaskulyarnaya hypertension. Treatment In patients with ACE inhibitors bylateralnыm pochechnыh arteries stenosis or artery stenosis edynstvennoy kidney povыshennыy risk exists occurrence of hypotension and kidney function violations. Violation kidney function Can voznykat Even when neznachytelnыh Changes urovnja whey creatinine in the blood. In such patsyentov Treatment sleduet Start in a series of doses and observation pod doctor, with a dose of caution uvelychyvat kontrolyrovat kidney function.
Patsyentы, kotorыm provodjat hemodialysis. Application enalapril contraindicated patients, kotorыm neobhodimo Conducting dyalyza with renal failure. Anafylaktoydnыe reaction nablyudalys in patsyentov, nahodyvshyhsya on dyalyze s Using membranes with Peak propusknoy sposobnostju (such As AN 69) and simultaneously poluchaly Treatment with ACE inhibitors . In эtyh patsyentov neobhodimo Require dyalyznыe second type membranes or hypotensive Preparations second classes .
Kidney transplantation. No Experience Application drug patients, kotoryya recently underwent surgery for kidney transplantation. Therefore, this is not recommended patsyentam Treatment preparation.
Pechenochnaya failure. Application rarely ynhybytorov ACE soprovozhdalos syndrome kotoryya nachynaetsya with cholestatic jaundice or hepatitis and prohressyruet to fulmynantnoho necrotic hepatitis Sometimes with letalnыm outcomes. Mechanism эtoho neyzvesten syndrome. Patients, kotoryya lechatsya ACE inhibitors and in kotorыh voznykla Jaundice or Significant Increase liver enzyme level, sleduet to cancel ACE inhibitors and establish sootvetstvuyuschee medytsynskoe observation.
Neutropenia / agranulocytosis. Among patsyentov, prynymavshyh ynhybytorы ACE was reported appearance of neutropenia / agranulocytosis, thrombocytopenia and anemia. In patsyentov with normal renal function and in the absence of second oslozhnyayuschyh factors neutropenia poyavlyalas rare. It should assign enalapril Very cautious with patsyentam kollagenozah vessels, transmitted ymmunosupressantnuyu therapy, Treatment Allopurinol or prokaynamydom or at kombynatsyy эtyh oslozhnyayuschyh factors, especially If already exist violation kidney function. In nekotorыh patsyentov razvyvalys sereznыe infection, kotoryya nekotorыh in cases not otvechaly on yntensyvnuyu antibiotic therapy. With this appointment enalapril patsyentam recommended MONITORING Periodically Quantity leykotsytov and patsyentы dolzhnы Report lyubыh manifestations infection.
Hyperkalemia. In nekotorыh patsyentov, kotoryya poluchaly Treatment with ACE inhibitor, enalapril vkljuchaja, was observed urovnja Increase potassium in blood whey.
K factors of development hyperkalemia otnosjatsja Renal failure, saharnыy diabetes, patsyentы in age> 70 years, ynterkurrentnыe STATUS, in particular dehydration, Acute serdechnaya dekompensatsyya, metabolic acidosis and simultaneous Application kaliysberegayuschimi diuretics (for example, spironolactone, triamterene or amiloride) pyschevыh additives or solevыh substitute, soderzhaschyh potassium, as well as others Application preparations, assotsyyrovannыh with urovnja Increase potassium in blood whey (for example, heparin).
Application of potassium supplements, diuretics and kaliysberegayuschimi salt substitute, potassium soderzhaschyh, in particular in patsyentov with abuse kidney function, can lead Significantly Increase urovnja for potassium in blood whey. Can sex hyperkalemia prychynoy sereznoy Even letalnoy and arrhythmia.
If the simultaneous appointment of the drug Эnalozyd 12.5 and Above ukazannыh assets is believed neobhodymыm, s sleduet Apply with caution and control pod chastыm urovnja potassium in blood whey.
Hypoglycemia. Patsyentam with saharnыm diabetes, prynymayuschym oral antydyabetycheskye Preparations or insulin and beginner prynymat ACE inhibitors, sleduet recommend tschatelno kontrolyrovat Level Sahara in the blood, especially in techenye First Several months kombynyrovannoy therapy (see. Section "Interaction with the second lekarstvennыmy funds and others types vzaymodeystvyy") .
Hypersensitivity / anhyonevrotycheskyy edema. In Treatment ACE inhibitor, enalapril maleate vkljuchaja, bыly opysanы Separate cases anhyonevrotycheskoho edema Faces, limbs, lips, language, Voice schely and / or the larynx. In such cases neobhodimo nemedlenno prekratyt Treatment of drug and establish tschatelnoe for observation with a view STATUS patsyenta control Clinical symptoms. Only after yscheznovenyya medytsynskoe s observation can be prekratyt. When edema Faces rasprostranyaetsya the area and lips, antihistamine therapy obespechyvaet funds blahopryyatnыy effect. Even in technical cases, when observed Only language edema without respiratory distress, it is necessary dlytelnoe STATUS observation for patients, Treatment As well antihistamine drugs and corticosteroids Can bыt nedostatochnыm.
Anhyonevrotycheskyy edema, laryngeal edema accompanied kotoryya or language, can result in lethal outcomes for. In technical cases, when lokalyzuetsya edema in the field of language, Voice schely or throat, can u bring something for obstruktsyy dыhatelnыh tracks, sleduet nemedlenno enter Solution subcutaneous epinephrine 1: 1000 (0.3-0.5 mL) and others osuschestvyt sootvetstvuyuschye lechebnыe measures.
Patsyentы in kotorыh earlier voznykal anhyonevrotycheskyy edema not related pryemom ynhybytorov ACE mogut bыt in bolshej degrees sklonnы occurrence anhyonevrotycheskoho for edema on the background therapy of ACE inhibitors.
In nehroydnoy rasы representatives, kotoryya prymenyaly ACE chashche voznykal anhyonevrotycheskyy edema compared with patsyentamy second races.
Anafylaktoydnыe reactions IN TIME conducting desensitization yadom pereponchatokrыlыh.
Yzredka in patsyentov, poluchayuschyh ynhybytorы ACE razvyvalys Heavy anafylaktoydnыe reactions IN TIME conducting hyposensybylyzatsyy Allergen IZ Jada pereponchatokrыlыh. Podobnыh reactions can be avoided, to the beginning If conducting hyposensybylyzatsyy temporarily prekratyt pryem ACE inhibitors.
Anafylaktoydnыe reactions IN TIME LDL apheresis conducting. In patsyentov, prynymavshyh ynhybytorы ACE IN TIME conducting apheresis LDL with dextran sulphate, life rarely voznykaly uhrozhayuschye anafylaktoydnыe reaction. Podobnыh reactions can be avoided, temporarily prekratyv Application ACE inhibitors before conducting kazhdogo apheresis sessions.
Cough. Nablyudalys cough cases on the background therapy of ACE inhibitors. Usually wear neproduktyvnыy cough, Standing nature and prekraschaetsya after otmenы drug. Cough, as a result voznykayuschyy Application ynhybytorov ACE sleduet uchytыvat with the differential diagnosis of cough.
Surgery / anesthesia. Vaud large-TIME hyrurhycheskyh interventions or during anesthesia with primeneniem funds, vыzыvayuschyh arteryalnuyu hypotension, эnalaprylat blokyruet Education angiotensin II vtorychno vыsvobozhdenyyu for compensatory renin. If at this razvyvaetsya hypotension, obъyasnyaemaya podobnыm mechanism, uh possible to korrektyrovat Volume Increase fluid.
Эtnycheskye differences. As and when the second ynhybytorov Application ACE enalapril javljaetsja less than эffektyvnыm Reduction in arterial pressure in patsyentov nehroydnoy rasы compared to patsyentamy second races. Perhaps more than the High obъyasnyaetsya This pokazatelem prevalyrovanyya nyzkoaktyvnoy system renynovoy Among patsyentov nehroydnoy rasы, hypertonyey patients.
hypotension and violations of water-solevoho balance. As and when the second antyhypertenzyvnыh Application lekarstvennыh funds in nekotorыh patsyentov Can voznykat symptomnaya hypotension. For patsyentamy neobhodimo osuschestvlyat observation, Avto Vovremya vыyavyt Clinical signs of violations of water-solevoho balance (for example, hypovolemia, Hyponatremia, hypohloremycheskyy alkalosis, or hypokalemia hypomahnyemyyu) kotoryya mogut razvyvatsya in sluchae simultaneous diarrhea or rvotы. In such patsyentov neobhodimo Periodically kontrolyrovat Level elektrolytov in blood whey.
Violation kidney function. Tyazydы mogut okazatsya not enough эffektyvnыmy diuretics for patsyentov of treatment with violation of the kidney function, as well as ride height creatinine at 30 ml / min and below (ie at a moderate renal insufficiency or vыrazhennoy).
It should assign Эnalozyd 12.5 patsyentam with renal insufficiency (creatinine ride height <80 ml / min), yet tytrovanye otdelnыh components of the drug did not dostyhnet of the given dose of the drug.
Violation liver function. It should Tyazydы with caution Apply patsyentam abuse with liver function or liver disease prohressyruyuschym, because the deviations Even if neznachytelnыh water and electrolyte balance voznyknut Can pechenochnaya coma.
Metabolic and эndokrynnыe эffektы. Therapy tyazydamy Can Change tolerance for glucose. Can potrebovatsya antydyabetycheskyh correction doses of drugs, vkljuchaja insulin. In the background therapy tyazydamy Can manyfestyrovat latentnыy saharnыy diabetes.
Tyazydы mogut snyzhat Level sodium, magnesium and potassium in blood whey.
Increase level cholesterol and triglycerides Can assotsyyrovatsya therapy with diuretics tyazydnыmy, but the protyazhenyy Application malыh doses (12.5 mg) was reported at mynymalnom эffekte or absence of ego. At 6 mg Application hydrohlorotyazyda not meaningful Clinical Effect was observed at the level of glucose, cholesterol, triglycerides, sodium, magnesium and potassium.
Tyazydы mogut umenshyt Allocation calcium with urine and vыzvat peryodycheskoe neznachytelnoe Increase of calcium in blood whey.
Vыrazhennaya hypercalcemia Can Hide hyperparatyreoydyzma bыt manifestations. Application tyazydov It should prekratyt before conducting a test on the function of parathyroid glands.
Can therapy tyazydnыmy vыzыvat giperurikemii diuretics and / or exacerbations of podahrы nekotorыh patients. However enalapril Can povыshat Level mochevoj acid in urine and in this way can u weaken hyperurykemycheskyy hydrohlorotyazyda effect.
For patsyentov, poluchayuschyh therapy diuretics, sleduet regularly yzmeryat эlektrolytov Levels in blood whey through sootvetstvuyuschye yntervalы time.
Thiazides (including hydrochlorothiazide) can cause an imbalance of fluid and electrolytes (hypokalemia, hyponatremia, and hypochloremic alkalosis). Dyspnoea, thirst, weakness, lethargic sleep, drowsiness, fatigability, muscle aches or convulsions, muscle weakness, arterial hypotension, oliguria, tachycardia, gastrointestinal disturbances (nausea, vomiting) are dangerous signs of disturbance of water-electrolyte balance.
Although hypocalemia may occur during the use of thiazide diuretics, co-therapy with enalapril may reduce hypokalemia induced by diuretic therapy. The risk of hypokalemia may be increased in patients with cirrhosis of the liver, in patients with elevated diuresis, with inadequate oral electrolyte use, and in patients who receive corticosteroids or adrenocorticotropic hormone (ACTH) at the same time.
In hot weather, patients who are prone to edema may have hyponatremia due to liquefaction of blood. Chloride deficiency is usually mild and does not require treatment.
Thiazides increase magnesium excretion with urine, which can lead to hypomagnesaemia.
Antidoping test. The drug contains hydrochlorothiazide, which can give a positive result in an anti-doping test.
Hypersensitivity. Hypersensitivity reactions to hydrochlorothiazide may occur in patients who are prone to allergy, or in patients with bronchial asthma, and also if patients have not previously had these diseases.
When using thiazide diuretics, exacerbation or activation of systemic lupus erythematosus was observed.
The drug may affect the results of the following laboratory tests:
- the drug may lower the level of iodine-bound ions in the plasma;
- the treatment should be discontinued prior to a laboratory examination to evaluate the function of parathyroid glands;
- the drug is able to increase the concentration of free bilirubin in serum.
Special warnings about inactive components of the drug. Patients with rare hereditary disorders of galactose malnutrition, lactase deficiency of the Lapp, or glucose-galactose malabsorption syndrome should not use this medication.
Older patients. The efficacy and tolerability of enalapril maleate and hydrochlorothiazide with concurrent administration are similar in elderly and younger patients.
You should not drink alcohol during treatment with Enalozide 12.5.
Use during pregnancy or breastfeeding.
The Enalozide 12.5 drug should not be used by pregnant women or women who are planning a pregnancy. If during the treatment of this drug the pregnancy is confirmed, its use should be discontinued immediately and replaced with another medication authorized for use in pregnant women.
It is known that the use of ACE inhibitors during the II and III trimesters of pregnancy can cause fetotoxicity (decreased renal function, oligohydramniosis, retardation of skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
If in the second trimester of pregnancy the ACE inhibitors were used, ultrasound examination is recommended for checking the function of the kidneys and the condition of the skull bones. Infants, mothers who have been using an ACE inhibitor, often have to be screened for the onset of arterial hypotension.
There is limited experience with the use of hydrochlorothiazide during pregnancy, especially during the first trimester.Studies in animals are not enough.
Hydrochlorothiazide penetrates through the placental barrier. Given the pharmacological mechanism of action of hydrochlorothiazide, its use in II and III trimesters of pregnancy can damage the blood supply between the placenta and the fetus and cause jaundice, electrolyte imbalance and thrombocytopenia in the fetus and newborn.
The use of Enalozide 12.5 during breastfeeding is not recommended. Enalapril and thiazide diuretics penetrate breast milk. If the use of the drug is considered necessary, breastfeeding should be discontinued.
Ability to influence the speed of reaction when driving motor vehicles or other mechanisms.
When driving motor vehicles and vehicles, you should be aware of the possibility of dizziness or fatigue.
Method of administration and dose
With arterial hypertension.
The initial dose of the drug is 1 tablet once a day. If the desired effect is not achieved, the daily dose should be increased to 2 tablets once a day. The maximum dose is 2 tablets per day.
With renal failure.
For patients with impaired renal function, with moderate or severe renal insufficiency (at a creatinine clearance level of 30 ml / min and below), thiazides may not be effective.
If the creatinine is in the range of> 30 to <80 ml / min, Enalozide 12.5 should be used only after a pre-selection of the dose of each component.
The recommended initial dose of enalapril maleate, which is taken separately, with mild impairment of renal function is 5 to 10 mg.
Pre-treatment with diuretics.
If a patient already receives diuretics, it is recommended to discontinue treatment or reduce the dose of diuretic at least 2-3 days before starting Enalozide 12.5 therapy in order to avoid a sharp decrease in blood pressure. Symptomatic arterial hypotension may occur at the start of Enalozide therapy at 12.5, it is more common in patients whose previous diuretic therapy has caused a water-electrolyte imbalance.
Where are you.
The safety and efficacy of the drug for children have not been established.
Symptoms: arterial hypotension, nausea, weakness, dizziness due to violations of electrolyte balance. Treatment is symptomatic and supportive. The use of the drug should be discontinued and thoroughly examined by the patient.
In case of accidental overdose, if the drug was taken recently, it is necessary: to rinse the stomach, cause vomiting, take activated charcoal and laxatives, and also correct the water and electrolyte imbalance and arterial hypotension with the help of commonly accepted measures.
Enalaprila maleate. Signs of overdose of enalapril, according to available data, include pronounced arterial hypotension due to blockade of the renin-angiotensin system, which begins approximately 6 hours after taking the drug and is accompanied by a blockade of the renin-angiotensin system and stupor.
Symptoms associated with an overdose of ACE inhibitors may include circulatory shock, electrolyte imbalance, renal failure, hyperventilation, tachycardia, palpitation, bradycardia, dizziness, anxiety and coughing.
Enalaprilat levels in blood plasma exceeding 100 and 200 times the maximum levels were recorded after receiving, respectively, 300 mg and 440 mg of enalapril maleate.
For the treatment of overdose, intravenous infusion of saline solution is recommended.
If arterial hypotension arises, the patient should be placed horizontally with his feet up. If necessary, consideration may be given to infusion of angiotensin II and / or intravenous administration of catecholamines. If the drug was recently adopted, measures should be taken to eliminate enalapril maleate from the body (provoking vomiting, gastric lavage, use of absorbents and sodium sulfate). Enalapril can be removed from the systemic blood flow by hemodialysis. With bradycardia, resistant to ongoing therapy, the use of a pacemaker is indicated. It is necessary to constantly monitor the main indicators of the vital activity of the body, the levels of electrolytes and creatinine in the serum.
Hydrochlorothiazide. The symptoms associated with the loss of electrolytes (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive diuresis are more commonly observed.
Cardiovascular symptoms: tachycardia, arterial hypotension, shock.
Neurological symptoms: weakness, confusion, dizziness, muscle cramps, paresthesia, exhaustion, disorders of consciousness.
Gastrointestinal symptoms: nausea, vomiting, thirst.
Renal symptoms: polyuria, oliguria, anuria.
Abnormalities in laboratory parameters: hypokalemia, hyponatremia, hypochloremia, alkalosis, elevated levels of urea nitrogen in the blood (mainly renal insufficiency).
Treatment: There is no specific antidote. To remove the drug from the stomach, it is recommended to induce vomiting, gastric lavage and to reduce absorption - the use of activated charcoal. In the case of arterial hypotension and shock, the introduction of fluids and electrolytes (potassium, sodium, magnesium) is recommended. Until the normalization of the patient's condition, it is necessary to control the balance of fluid and electrolytes and the function of the kidneys.
If earlier preparations of digitalis have been prescribed, hypokalemia can increase the manifestations of arrhythmias.Symptomatic treatment.
From the heart: arterial hypotension, orthostatic hypotension, tachycardia, palpitation, arrhythmia, angina pectoris.
On the vessel side: Raynaud's phenomenon, fluctuations, myocardial infarction / stroke (possibly due to excessive arterial hypotension in patients at high risk), vasculitis, necrotizing angiitis.
On the gastrointestinal tract: anorexia, dry mouth, thirst, sialadenitis (inflammation of the salivary glands), stomatitis / aphthous stomatitis, glossitis, nausea, vomiting, pancreatitis, diarrhea, dyspepsia, abdominal pain, flatulence, constipation, angioedema, intestinal edema , ileus, irritation of the stomach, peptic ulcers.
On the nervous system / mental disorders: headache, syncope, changes in taste sensations, insomnia, nervousness, anxiety, drowsiness, paresthesia, vertigo, dizziness, convulsions, confusion, sleep disorders, abnormal dreams, paresis (due to hypokalemia), decreased libido , depression, disorientation, mood changes.
On the part of the musculoskeletal system and connective tissue: myalgia, muscle cramps, arthralgia.
On the part of the respiratory system, thoracic and mediastinal organs: sore throat and voiced voiding, rhinitis, rhinorrhea, cough, dyspnea, pulmonary infiltrates, allergic alveolitis / eosinophilic pneumonia, bronchospasm / asthma, respiratory distress (including pneumonitis and pulmonary edema).
On the hepatobiliary system: hepatic insufficiency, liver necrosis (may be fatal), hepatitis (hepatocellular or cholestatic), jaundice, cholecystitis (in particular, in patients with already existing gallstone disease).
Endocrine disorders: antidiabetic hormone secretion syndrome. Metabolic violations, hypokalemia, hyperkalemia, Hyponatremia, Increase urovnja cholesterol and triglyceride blood, hypoglycemia, giperurikemija, kotoraja Can provotsyrovat podahrycheskye prystupы in patsyentov with asymptomnыm techenyem disease, hypomahnyemyya, hyperglycemia, Reduction hlyukozotolerantnosty, kotoroe Can obuslovyt manyfestatsyyu latent diabetes diabetes, hypercalcemia, hypohloremycheskyy alkalosis, which can induce hepatic encephalopathy or hepatic coma, with the use of high doses, it is possible Increasing the levels of lipids in the blood.
From the kidneys and the urinary system: renal dysfunction, renal failure, proteinuria, oliguria, interstitial nephritis, glucosuria.
From the organs of the hearing: noises in the ears.
From the organs of vision: blurred vision, transient visual impairment, xanthopsis.
From the reproductive system: gynecomastia, impotence, sexual disorders.
Skin and subcutaneous fat: rash (exanthema), purpura, itching, increased sweating, alopecia, urticaria, multiformal erythema (Stevens-Johnson syndrome), red lupus erythematosus, erythroderma, toxic epidermal necrolysis, exfoliative dermatitis, pemphigus.
A symptom has been reported that may include several or all of the following symptoms: fever, serositis, vasculitis, myalgia / myositis and arthralgia / arthritis, positive antinuclear antibody test (ANA), increased ESR, eosinophilia, leukocytosis. Rash, photosensitivity or other dermatological reactions may occur.
Blood and lymphatic system: decreased hemoglobin and hematocrit, thrombocytopenia, neutropenia, leukopenia, pancytopenia, agranulocytosis, anemia (including aplastic and hemolytic anemia), lymphadenopathy, oppression of bone marrow function, autoimmune diseases.
On the immune system: hypersensitivity, anaphylactic reaction, angioedema, including angioneurotic edema of the face, limbs, lips, tongue, vocal cavity and / or larynx, anaphylactic shock.
Laboratory data: Increased blood urea, elevated blood urea nitrogen, increased serum creatinine, elevated liver enzymes and / or serum bilirubin.
Disorders of the general condition and from the place of introduction: asthenia, chest pain, fever, increased fatigability, malaise, exhaustion.
2 years Do not apply after the expiry date stated on the packaging.
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
10 tablets in a blister. 2 or 3 blister packs.