Eklamiz pills 5mg+10mg, 30pcs

Composition

Active ingredients: amlodipine bezylate – 6.94 mg in terms of amlodipine-5.00 mg, lisinopril dihydrate-10.88 mg, in terms of lisinopril-10.00 mg. Auxiliary substances: microcrystalline cellulose-173.00 mg, sodium carboxymethyl starch-6.18 mg, colloidal silicon dioxide-1.00 mg, magnesium stearate-2.00 mg

Pharmacological action

Pharmacotherapy group: combined antihypertensive agent (slow calcium channel blocker + angiotensin converting enzyme (ACE) inhibitor) ATX code: C 09 BB 03 Pharmacological properties

Pharmacodynamics

Combined preparation containing active ingredients: lisinopril and amlodipine.

Lisinopril

Angiotensin-converting enzyme (ACE) inhibitor, reduces the formation of angiotensin II from angiotensin I. A decrease in angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins.

Reduces total peripheral vascular resistance (OPSS), blood pressure (BP), preload, pressure in the pulmonary capillaries, causes an increase in minute blood volume and increased myocardial tolerance to loads in patients with chronic heart failure (CHF). Dilates the arteries to a greater extent than the veins. Some of the effects are attributed to effects on the tissue renin-angiotensin-aldosterone system (RAAS). With prolonged use, hypertrophy of the myocardium and arterial walls of the resistive type decreases. Improves blood supply to the ischemic myocardium.

ACE inhibitors prolong life expectancy in patients with CHF, slow the progression of left ventricular dysfunction in patients who have had a myocardial infarction without clinical manifestations of heart failure.

The onset of action is 1 hour after ingestion. The maximum antihypertensive effect is determined after 6-7 hours and persists for 24 hours. With arterial hypertension, the antihypertensive effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months. When the drug was abruptly discontinued, there was no marked increase in blood pressure.

In addition to lowering blood pressure, lisinopril reduces albuminuria. Lisinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not lead to an increase in hypoglycemia.

Amlodipine

Dihydropyridine derivative-a blocker of “slow” calcium channels, has an antianginal and antihypertensive effect. Blocks calcium channels, reduces the transmembrane transfer of calcium ions into the cell (more to vascular smooth muscle cells than to cardiomyocytes).

Antianginal action is caused by the expansion of coronary and peripheral arteries and arterioles: with angina, it reduces the severity of myocardial ischemia; expanding peripheral arterioles, reduces OPSS, reduces afterload on the heart, reduces the need for myocardial oxygen. Dilating the coronary arteries and arterioles in unchanged and ischemic areas of the myocardium, increases oxygen supply to the myocardium (especially in vasospastic angina); prevents spasm of the coronary arteries (including those caused by smoking). In patients with stable angina, a single daily dose increases exercise tolerance, slows down the development of angina and “ischemic” ST-segment depression, reduces the frequency of angina attacks and consumption of nitroglycerin and other nitrates.

It has a long-term dose-dependent antihypertensive effect. The antihypertensive effect is due to the direct vasodilating effect on vascular smooth muscles. In patients with arterial hypertension, a single dose provides a clinically significant reduction in blood pressure (BP) for 24 hours (in the patient’s “lying” and “standing”positions). Orthostatic hypotension with the appointment of amlodipine is quite rare. It does not cause a decrease in exercise tolerance, left ventricular ejection fraction. Reduces the degree of left ventricular myocardial hypertrophy.

It does not affect the contractility and conduction of the myocardium, does not cause a reflex increase in heart rate (HR), inhibits platelet aggregation, increases the glomerular filtration rate, and has a weak natriuretic effect. In diabetic nephropathy, it does not increase the severity of microalbuminuria. It 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 mellitus and gout. A significant decrease in blood pressure is observed after 6-10 hours, the duration of the effect is 24 hours.

Lisinopril+amlodipine

The combination of lisinopril and amlodipine in one drug allows achieving comparable blood pressure control and preventing the development of possible undesirable effects caused by one of the active substances. Thus, BMCC, by directly dilating the arterioles, can lead to sodium and fluid retention in the body, and, therefore, can activate the RAAS. An ACE inhibitor blocks this process.

Pharmacokinetics

Lisinopril

Suction. After oral use, lisinopril is absorbed from the gastrointestinal tract (GI) by an average of 25%, but absorption can vary from 6 to 60%. Bioavailability is 25%. Food intake does not affect the absorption of lisinopril.

Distribution. Almost does not bind to plasma proteins. The maximum concentration in blood plasma (Cmax) of 90 ng / ml is reached in 6-7 hours. Blood-brain and placental barrier permeability is low.

Metabolism. Lisinopril is not biotransformed in the body.

Output. It is excreted unchanged by the kidneys. The half-life (T 1/2) is 12 hours

. Pharmacokinetics in selected groups of patients

In elderly patients, the concentration of lisinopril in blood plasma and the area under the concentration-time curve (AUC) are twice as large as in young patients.

In patients with CHF, lisinopril absorption and clearance are reduced, and bioavailability is 16%.

In patients with renal insufficiency, the concentration of lisinopril is several times higher than the concentration in blood plasma in healthy volunteers, and there is an increase in the time to reach Cmax and an increase in T 1/2.

Lisinopril is eliminated from the body by hemodialysis.

Amlodipine

Suction. After oral use, amlodipine is slowly and almost completely (90%) absorbed from the gastrointestinal tract. Bioavailability is 64-80%. Food intake does not affect the absorption of amlodipine.

Distribution. Most of the amlodipine in the blood (95%) binds to plasma proteins. Cmax is observed after 6-10 hours. Steady-state concentrations are reached after 7-8 days of therapy. The average volume of distribution is 20 liters / kg of body weight, which indicates that most of amlodipine is in the tissues, and less in the blood.

Metabolism. Amlodipine undergoes slow but active metabolism in the liver in the absence of a significant “primary passage” effect. The metabolites do not have significant pharmacological activity.

Output. After a single dose, T 1/2-varies from 31 to 48 hours, with repeated use, T 1/2 is approximately 45 hours. About 60% of the oral dose is excreted by the kidneys mainly in the form of metabolites,10% – unchanged, and 20-25% – through the intestines with bile. The total clearance of amlodipine is 0.116 ml / s / kg (7 ml / min / kg,0.42 l / h / kg).

Pharmacokinetics in selected groups of patients

In elderly patients (over 65 years of age), the elimination of amlodipine is slowed (T 1/2 – 65 h) compared to young patients, but this difference is not clinically significant. Prolongation of T 1/2 in patients with hepatic insufficiency suggests that with prolonged use, the accumulation of the drug in the body will be higher (T 1/2-up to 60 hours). Renal failure does not significantly affect the kinetics of amlodipine. Amlodipine penetrates the blood-brain barrier. It is not removed during hemodialysis.

Lisinopril+Amlodipine

Interaction between the active substances that make up the drug is unlikely.

AUC, time to reach and values of Cmax, T 1/2 do not change in comparison with the indicators of each individual Active ingredient. Food intake does not affect the absorption of active substances. Long-term circulation of both active substances in the body makes it possible to take the drug 1 time a day.

Indications

Essential hypertension (patients who are indicated for combination therapy).

Use during pregnancy and lactation

The use of Eclamiz is not recommended during pregnancy. When diagnosing pregnancy, the drug should be discontinued as early as possible. Taking ACE inhibitors in the second and third trimester of pregnancy led to the development of fetotoxic effects (impaired renal function, delayed ossification of fetal skull bones, oligohydramnios) and neonatal toxic effects (renal failure, hypotension, hyperkalemia) and death of the developing fetus. According to a retrospective analysis, the use of ACE inhibitors during the first trimester of pregnancy was accompanied by the development of fetal and newborn pathology. For newborns and infants who have been exposed to intrauterine ACE inhibitors, it is recommended to conduct careful monitoring for the timely detection of a pronounced decrease in blood pressure, oliguria, hyperkalemia. The safety of using amlodipine during pregnancy has not been established. In some patients treated with slow calcium channel blockers, a reversible decrease in sperm motility was observed. Lisinopril passes through the placenta. There are no data on the excretion of lisinopril in breast milk. There are no data indicating the excretion of amlodipine in breast milk.However, other BMCC derivatives of dihydropyridine are known to be excreted in breast milk. The use of Eklamiz during breast-feeding is not recommended. If the use of the drug is necessary during lactation, then breastfeeding should be discontinued.

Contraindications

• Hypersensitivity to lisinopril or other ACE inhibitors, amlodipine, other derivatives of dihydropyridine and other components of the drug;
• a history of angioedema, including on the background of the use of ACE inhibitors, hereditary angioedema, or idiopathic angioedema, hemodynamically significant aortic stenosis or mitral stenosis, hypertrophic obstructive cardiomyopathy, severe hypotension (systolic BP less than 90 mm Hg. St. ), unstable angina (with the exception of prinzmetals angina), cardiogenic shock;
• heart failure after acute myocardial infarction (during the first 28 days), concomitant use with aliskiren or iliskilendirmesi drugs in patients with diabetes mellitus or renal impairment (glomerular filtration rate less than 60 ml/min/1.73 m2);
• pregnancy and breastfeeding, age to 18 years (efficacy and safety not established).

With caution

• Severe renal dysfunction, bilateral renal artery stenosis or stenosis of the artery to a solitary kidney with progressive azotemia, condition after kidney transplantation, azotemia, hyperkalemia, primary aldosteronism, hypotension, cerebrovascular disease (including cerebrovascular insufficiency), ischemic heart disease, coronary insufficiency, autoimmune systemic diseases of connective tissue (including scleroderma, systemic lupus erythematosus);
• oppression of bone marrow hematopoiesis;
• a diet with restriction of salt;
• hypovolemic state (including due to diarrhoea, vomiting);
• use in elderly patients, hemodialysis using a high-flow dialysis membranes with high permeability (e. g., AN69®);
• the liver, the syndrome of weakness of the sinus node (bradycardia, tachycardia), non-ischemic etiology of CHF III-IV functional class NYHA classification, aortic stenosis, mitral stenosis, acute myocardial infarction (within 1 month after myocardial infarction).

Side effects

Side effects caused by the combined drug Eklamiz do not occur more often than in cases of taking each component separately.

The most common adverse reactions when taking a combination of medications: headache (8%), dry cough (5%) and dizziness (3%).

The frequency of adverse reactions is given separately for lisinopril and amlodipine.

Data are presented by organ-system classes according to the MedDRA dictionary and with the following frequency: very common (≥1/10); common (≥1/100 to <1/10); infrequent (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (

Isolated cases of extrapyramidal syndrome have been reported when taking “slow” calcium channel blockers.

*A complex symptom complex has been reported, which may include all or some of the following symptoms: fever, vasculitis, myalgia, arthralgia/arthritis, increased antinuclear antibody titer, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis, rash, photosensitization, or other skin changes.

Interaction

Lisinopril drugs that affect the potassium content: potassium-sparing diuretics (for example, spironolactone, eplerenone, amiloride and triamterene), potassium-containing dietary supplements, potassium-containing salt substitutes and other drugs that lead to an increase in serum potassium (for example, heparin) can lead to hyperkalemia when used concomitantly with ACE inhibitors, especially in patients with renal insufficiency and other kidney diseases. medical history. When prescribing a drug that affects the potassium content, simultaneously with lisinopril, the potassium content in the blood serum should be monitored. Therefore, concomitant use should be carefully justified and performed with extreme caution and regular monitoring of both serum potassium and renal function. Potassium-sparing diuretics can be taken together with the drug Eklamiz only under medical supervision. Diuretics: if a diuretic is used by a patient receiving Eklamiz, the antihypertensive effect is usually enhanced, it is necessary to take Eklamiz in combination with diuretics with extreme caution. Lisinopril softens the kaliyuretic effect of diuretics. Other antihypertensive medications: concomitant use of these medications may increase the antihypertensive effect of Eklamiz. Concomitant use with nitroglycerin, other nitrates, or vasodilators may result in a greater reduction in blood pressure. Tricyclic antidepressants/antipsychotics/general anaesthetics/ narcotic analgesics: Concomitant use with ACE inhibitors may result in a greater reduction in blood pressure. Ethanol enhances the antihypertensive effect. Allopurinol, procainamide, cytostatics or immunosuppressants (systemic glucocorticosteroids) may lead to an increased risk of leukopenia when co-administered with ACE inhibitors. Antacids and colestyramine, when taken concomitantly with ACE inhibitors, reduce the bioavailability of the latter. Sympathomimetics may reduce the antihypertensive effect of ACE inhibitors; careful monitoring should be performed to achieve the desired effect. Hypoglycemic drugs: concomitant use of ACE inhibitors and hypoglycemic drugs (insulin and oral hypoglycemic agents) may increase the likelihood of a decrease in blood glucose concentration and the risk of hypoglycemia. Most often, this phenomenon is observed during the first week of combined treatment and in patients with renal insufficiency. Nonsteroidal anti-inflammatory drugs (NSAIDs) (including selective cyclooxygenase-2 (COX-2) inhibitors): long-term use of NSAIDs, including high doses of acetylsalicylic acid greater than 3 g / day, may reduce the antihypertensive effect of ACE inhibitors. The additive effect of taking NSAIDs and ACE inhibitors is manifested in an increase in serum potassium and may lead to deterioration of renal function. These effects are usually reversible. Acute renal failure is very rare, especially in elderly and dehydrated patients. Lithium: The elimination of lithium may be slowed down during concomitant use with ACE inhibitors and therefore the concentration of lithium in the blood serum should be monitored during this period. When combined with lithium preparations, it is possible to increase the manifestation of their neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus). Gold preparations: with the simultaneous use of ACE inhibitors and a gold preparation (sodium aurothiomalate) intravenously, a symptom complex is described, including facial hyperemia, nausea, vomiting and arterial hypotension. Dual blockade Simultaneous use of ACE inhibitors with other drugs that affect the RAAS leads to an increase in the frequency of cases of arterial hypotension, hyperkalemia, and impaired renal function. It is necessary to monitor blood pressure, renal function, and blood plasma electrolyte levels when using the drug with other drugs that affect the RAAS. Concomitant use of the drug with aliskiren or aliskiren-containing drugs is contraindicated in patients with diabetes mellitus and renal insufficiency (GFR less than 60 ml / min/1.73 m2) (see the section “Contraindications”). Amlodipine Non-recommended drug combinations Dantrolen (intravenous): in laboratory animals, cases of ventricular fibrillation with a fatal outcome were noted against the background of verapamil and intravenous dantrolene use. Extrapolating from the available data, the concomitant use of dantrolene and amlodipine should be avoided. Drug combinations requiring special attention Inducers of cytochrome CYP3A4 isoenzymes (rifampicin, St. John’s wort preparations, anticonvulsants such as carbamazepine, phenobarbital, phenytoin, phosphenytoin, primidone): it is possible to reduce the plasma concentration of amlodipine due to increased metabolism in the liver. Caution should be exercised when concomitantly using amlodipine and inducers of microsomal oxidation and, if necessary, adjust the dose of amlodipine. Inhibitors of cytochrome CYP3A4 isoenzymes (itraconazole, ketoconazole): it is possible to increase the plasma concentration of amlodipine and increase the risk of side effects. Caution should be exercised when concomitantly using amlodipine and itraconazole or ketoconazole, if necessary, adjust the dose of amlodipine.Drug combinations requiring attention Beta-blockers used in chronic heart failure (CHF) (bisoprolol, carvedilol, metoprolol): the risk of hypotension and worsening of the course of CHF in patients with uncontrolled or latent CHF (increased negative inotropic effect). Beta-blockers can also reduce excessive reflex cardiac sympathetic activation in the presence of concomitant CHF. Other drug combinations:The safety of using amlodipine in combination with thiazide diuretics, beta-blockers, ACE inhibitors, prolonged-acting nitrates, nitroglycerin (for sublingual use), digoxin, warfarin, atorvastatin, sildenafil, antacids (algeldrate, magnesium hydroxide), simethicone, cimetidine, NSAIDs, antibiotics and hypoglycemic agents for oral use was noted. In addition, special studies have shown that the following drugs do not interact with amlodipine::- concomitant use of amlodipine and cimetidine did not change the pharmacokinetic parameters of amlodipine;- with the simultaneous use of amlodipine and sildenafil, there was no increase in the antihypertensive effect of each of the drugs;- grapefruit juice: a study in 20 healthy volunteers showed that taking 240 ml of grapefruit juice together with a single dose of amlodipine (10 mg orally) did not significantly affect the pharmacokinetics of amlodipine. Amlodipine does not affect the pharmacokinetics of the following drugs:- atorvastatin: repeated doses of amlodipine 10 mg in combination with atorvastatin 80 mg do not significantly change the steady – state pharmacokinetic parameters of atorvastatin; – digoxin: simultaneous use of amlodipine and digoxin is not accompanied by changes in the concentration of digoxin in the blood serum and renal clearance of digoxin in healthy volunteers; – warfarin: in healthy male volunteers treated with warfarin, the addition of amlodipine did not significantly affect the change in the value of prothrombin time due to warfarin;- cyclosporine: amlodipine does not significantly affect the pharmacokinetic parameters of cyclosporine. Drug combinations that require special attention:Baclofen: may increase the antihypertensive effect. Blood pressure and renal function should be monitored, and dose adjustment of amlodipine is required if necessary. A combination of medications that requires attention:Antihypertensive agents (e. g. beta-blockers) and vasodilators: the antihypertensive effect of amlodipine may be enhanced. Caution should be exercised when prescribing concomitantly with nitroglycerin, other nitrates or other vasodilators, as this may lead to an additional decrease in blood pressure. Corticosteroids (mineral and glucocorticosteroids), tetracosactide: reduced antihypertensive effect (fluid retention and sodium ions as a result of the action of corticosteroids). Alpha-blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin): increased antihypertensive effect and increased risk of orthostatic hypotension. Amifostine: the antihypertensive effect of amlodipine may be enhanced. Tricyclic antidepressants/ general anaesthetics: increased antihypertensive effect and increased risk of orthostatic hypotension. Erythromycin with simultaneous use increases the Cmax of amlodipine in young patients by 22%, and in the elderly-by 50%. Ethanol (beverages containing alcohol): amlodipine with a single and repeated use in a dose of 10 mg does not affect the pharmacokinetics of ethanol. Neuroleptics and isoflurane-enhancing the antihypertensive effect of dihydropyridine derivatives. Calcium supplements can reduce the effect of BMCC. When amlodipine is used concomitantly with lithium preparations, it is possible to increase the manifestation of neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus). Procainamide, quinidine, and other drugs that prolong the QT interval may contribute to its significant prolongation.

How to take, course of use and dosage

Tablets of the drug are taken orally once a day, regardless of the time of meal, with a sufficient amount of liquid. The recommended starting dose of Eklamiz is 5 mg of amlodipine + 10 mg of lisinopril once a day. If an additional reduction in blood pressure is necessary, the dose of Eklamiz can be increased to a maximum daily dose of 10 mg of amlodipine + 20 mg of lisinopril once a day. At the beginning of therapy with the drug, symptomatic hypotension may develop, which more often occurs in patients with impaired water-electrolyte balance due to previous diuretic therapy. Diuretics should be discontinued 2-3 days before the start of Eklamiz therapy. In cases where the withdrawal of diuretics is not possible, the initial dose of Eklamiz is ½ tablet (5 mg of amlodipine+10 mg of lisinopril) 1 time per day, after which the patient should be monitored for several hours due to the possible development of symptomatic arterial hypotension. Impaired renal function patients with impaired renal function are recommended to use ½ tablet (5 mg amlodipine+10 mg lisinopril) of the drug (increasing the half-life of lisinopril). The maintenance dose is selected depending on the tolerability of the therapy, monitoring of renal function, potassium and sodium levels in blood plasma is required. Impaired liver functionin patients with impaired liver function, it is recommended to use ½ tablet (5 mg amlodipine+10 mg lisinopril) of the drug (increasing the half-life of amlodipine). Use in elderly patients (over 65 years of age)No age-related changes in the efficacy or safety profile of amlodipine and lisinopril were found in clinical trials. To determine the optimal maintenance dose, it is necessary to determine the dosage regimen individually, using lisinopril and amlodipine separately.

Overdose

Amlodipine symptoms: a marked decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation (risk of severe and persistent hypotension, including shock and death). Treatment: gastric lavage, taking activated charcoal, maintaining the function of the cardiovascular and respiratory systems, giving the patient a horizontal position with raised legs, monitoring the volume of circulating blood (BCC) and diuresis. To restore vascular tone – the use of vasoconstrictors (in the absence of contraindications to their use), in order to eliminate the consequences of calcium channel blockade – intravenous use of calcium gluconate. Hemodialysis is ineffective. Lisinopril symptoms: marked decrease in blood pressure, dryness of the oral mucosa, drowsiness, urinary retention, constipation, anxiety, increased irritability. Treatment: gastric lavage, taking activated charcoal, giving the patient a horizontal position with raised legs, filling the BCC-intravenous use of plasma-substituting solutions, symptomatic therapy, monitoring the functions of the cardiovascular and respiratory systems, BCC, urea concentration, creatinine and electrolyte content in the blood serum, as well as diuresis. Lisinopril can be removed from the body by hemodialysis.

Special instructions

Arterial hypotension

A marked decrease in blood pressure with the development of clinical symptoms can be observed in patients with a decrease in BCC and/or sodium content due to diuretics, fluid loss, or other reasons, such as increased sweating, prolonged vomiting, and / or diarrhea. In case of arterial hypotension, the patient should be laid down, his legs raised and the loss of fluid should be replenished (intravenous infusion of 0.9% sodium chloride solution) if necessary. Preferably, recovery of fluid and/or sodium loss should be performed prior to initiation of Eklamiz therapy. Blood pressure should be monitored after the initial dose. Similar conditions apply to patients with coronary heart disease or cerebrovascular diseases, in which a pronounced decrease in blood pressure can lead to a myocardial infarction or stroke.

Aortic and mitral stenosis

As with all vasodilators, Eklamiz should be used with caution in patients with left ventricular outlet obstruction and mitral valve stenosis.

Impaired renal function

In some patients with arterial hypertension without pronounced manifestations of renovascular diseases, an increase in serum creatinine and urea concentrations was observed, in most cases minimal or transient, more pronounced with simultaneous use of ACE inhibitors and a diuretic. This is most common in patients with a history of kidney disease.

To determine the optimal maintenance dose, the dosage regimen should be determined individually, using lisinopril and amlodipine separately, with simultaneous monitoring of renal function. The combination drug Eklamiz is indicated only in patients whose optimal maintenance dose of amlodipine and lisinopril is titrated to 5 mg and 10 mg or 10 mg and 20 mg, respectively.

In case of decreased renal function, the drug Eklamiz should be discontinued and replaced with monotherapy with drugs in adequate doses. In addition, it may be necessary to reduce the dose or discontinue diuretics.

Angioedema

Angioedema of the face, extremities, lips, tongue, vocal folds, and / or larynx has been reported in patients treated with ACE inhibitors, including lisinopril. In these cases, Eklamiz should be discontinued immediately and the patient should be closely monitored until symptoms disappear completely.Swelling of the face, lips, and extremities usually resolves on its own, but antihistamines should be used to reduce the severity of symptoms.

Angioedema accompanied by laryngeal edema can be fatal. If edema of the tongue, pharynx or larynx is detected, which is the cause of airway obstruction, it is necessary to urgently start emergency measures. Appropriate measures include: the use of 0.1% epinephrine (epinephrine) subcutaneously at a dose of 0.3-0.5 mg or 0.1 mg intravenously slowly, followed by intravenous use of glucocorticosteroids and antihistamines and simultaneous monitoring of vital functions.

Patients taking ACE inhibitors rarely experienced intestinal edema. These patients complained of abdominal pain (with or without nausea and vomiting); in some cases, no previous facial edema was observed and C-1 esterase activity was within the normal range.

Angioedema is diagnosed by computed tomography of the gastrointestinal tract, or after ultrasound examination, or during surgery. Symptoms disappeared after discontinuation of the ACE inhibitor. Intestinal edema should be included in the differential diagnosis of abdominal pain in patients taking ACE inhibitors.

Anaphylactic reactions in patients with hemodialysis

Cases of anaphylactic shock have been reported in patients undergoing polyacrylonitrile membrane hemodialysis (e. g., AN69*) and receiving concomitant ACE inhibitors, so this combination should be avoided. Patients are recommended to use either a different type of dialysis membrane, or a hypotensive drug of a different pharmacotherapeutic group.

Anaphylactic reactions in patients with low-density lipoprotein (LDL)apheresis

Rarely, patients treated with ACE inhibitors during LDL apheresis with dextran sulfate developed life-threatening anaphylactic reactions. Such reactions were prevented by discontinuing ACE inhibitors before each apheresis procedure.

Desensitization from wasp or bee venom

Sometimes patients treated with ACE inhibitors developed anaphylactic reactions when desensitized by hymenopteran venom (for example, wasps or bees). Such life-threatening situations can be avoided by timely withdrawal of the ACE inhibitor prior to the desensitization procedure.

Hepatotoxicity

In rare cases, the use of ACE inhibitors was accompanied by a syndrome that began with cholestatic jaundice or hepatitis and developed into fulminant liver necrosis and in several cases led to death. The mechanism of this syndrome is unclear. Patients receiving the drug Eklamiz, and who develop jaundice or have an increase in the activity of “liver” enzymes, should cancel the drug with subsequent monitoring of their condition.

Liver failure

In patients with impaired liver function, the T 1/2 of amlodipine is prolonged. Currently, recommendations on the dosage regimen have not been developed, and therefore, this drug should be prescribed with caution, having previously determined the expected benefit and potential risk of treatment.

Neutropenia/agranulocytosis

Neutropenia, agranulocytosis, thrombocytopenia, and anemia have been reported in rare cases in patients treated with ACE inhibitors. Neutropenia is rare in patients with normal renal function and in the absence of other aggravating factors. Neutropenia and agranulocytosis are reversible and disappear after discontinuation of the ACE inhibitor.

The combination drug Eklamiz should be used with extreme caution in patients with connective tissue diseases, during immunosuppressive therapy, during treatment with allopurinol or procainamide, or with a combination of these aggravating factors, especially in the presence of previous renal dysfunction. Some of these patients developed severe infectious diseases, which in several cases were not corrected by antibiotic therapy.

When prescribing the drug Eklamiz, it is recommended to periodically monitor the number of white blood cells in such patients, as well as warn them about the need to report the appearance of the first signs of an infectious disease.

Cough

Cough was frequently reported during the use of ACE inhibitors. As a rule, the cough is unproductive, permanent and stopped after discontinuation of the drug. In the differential diagnosis of cough, it is necessary to take into account the cough caused by the use of ACE inhibitors.

Surgical intervention/general anesthesia

In patients undergoing extensive surgery or during general anesthesia with drugs that lead to hypotension, lisinopril may block the formation of angiotensin II after a compensatory release of renin. If arterial hypotension develops, probably as a result of the above mechanism, correction can be made by increasing the BCC.

Elderly patients

Elderly patients with impaired renal function should adjust the dose of the combined drug amlodipine and lisinopril.

Hyperkalemia

In some patients treated with ACE inhibitors, an increase in serum potassium was observed. Patients with renal insufficiency, diabetes mellitus, acute heart failure, dehydration, metabolic acidosis, or concomitant use of potassium-sparing diuretics, potassium-containing dietary supplements, potassium-containing salt substitutes, or any other medications that lead to an increase in serum potassium (for example, heparin) are at risk for hyperkalemia.

If it is necessary to simultaneously take with the above drugs, it is necessary to monitor the content of potassium in the blood serum.

Patients with low body weight, short stature and patients with severe hepatic impairment may need to reduce the dose.

The combined preparation Eklamiz does not have any adverse effect on the metabolism and plasma lipids and can be used in the treatment of patients with bronchial asthma, diabetes mellitus and gout.

During treatment, it is necessary to monitor body weight and follow up with a dentist (to prevent soreness, bleeding and gum hyperplasia).

In Vitro fertilization (IVF)

In isolated cases, during IVF with the use of BMCC, reversible biochemical changes in the sperm head were noted, which led to a violation of their functions.

If IVF attempts are unsuccessful and other causes of infertility are excluded, consideration should be given to the likelihood that BMCC may affect sperm cells if used.

Impact on the ability to drive vehicles:

It may affect the ability to drive vehicles and work with mechanisms, especially at the beginning of treatment, when the risk of hypotension is more likely. The dose and dosage regimen at which you can drive vehicles and perform work associated with an increased risk of injury is set individually.

Storage conditions

In a dark place at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Amlodipine, Lisinopril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets