Eclamise
Eclamiz: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Eklamiz
ATX code: C09BB03
Active ingredient: lisinopril (lisinopril), amlodipine (amlodipine)
Manufacturer: Ozone, LLC (Russia)
Description and photo updated: 2018-23-11
Prices in pharmacies: from 412 rubles.
Buy
Eclamisis is a combined antihypertensive drug, slow calcium channel blocker and angiotensin-converting enzyme (ACE) inhibitor.
Release form and composition
Eclamise is available in the form of tablets: almost white or white, round, flat-cylindrical, beveled on both sides, on one side there is a dividing line (10 or 30 pcs. In blisters, in a cardboard box 1, 2, 3, 4, 5, 6, 8 or 10 packs; 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 pcs. In polyethylene cans, in a cardboard box 1 can).
1 tablet contains:
- active ingredients: amlodipine besylate - 6.94 mg or 13.88 mg, which is equivalent to 5 mg or 10 mg of amlodipine; lisinopril dihydrate - 10.88 mg or 21.76 mg, which is equivalent to 10 mg or 20 mg of lisinopril;
- auxiliary components: sodium carboxymethyl starch, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide.
Pharmacological properties
Pharmacodynamics
Eclamysis is an antihypertensive drug, the action of which is due to the combination of two active substances - lisinopril and amlodipine.
Lisinopril is an ACE inhibitor. By reducing the formation of angiotensin II, lisinopril helps to reduce the release of aldosterone. Increases the synthesis of prostaglandins, reduces the degradation of bradykinin. Its action causes a decrease in the total peripheral vascular resistance (OPSS), blood pressure (BP), preload, pressure in the pulmonary capillaries, and an increase in the minute blood volume. In patients with chronic heart failure, it increases myocardial tolerance to stress. Expands veins to a lesser extent than arteries. Affects the tissue renin-angiotensin-aldosterone system (RAAS), long-term drug therapy leads to a decrease in myocardial hypertrophy and the walls of resistive arteries. Lisinopril helps to improve the blood supply to the ischemic myocardium.
The use of ACE inhibitors in patients with chronic heart failure lengthens life expectancy, in patients without clinical manifestations of heart failure after myocardial infarction - slows down the progression of left ventricular dysfunction.
After oral administration, the antihypertensive effect appears after 1 hour, the maximum effect is achieved after 6-7 hours and lasts for 24 hours. The stable effect of lisinopril develops with regular administration of the drug (usually after 1–2 months). Abrupt withdrawal of the drug does not cause a pronounced increase in blood pressure.
Along with the hypotensive effect, Eclamise reduces albuminuria. In diabetes mellitus, it does not affect the level of glucose concentration in the blood and the incidence of hypoglycemia.
Amlodipine is a dihydropyridine derivative, a slow calcium channel blocker. It has antihypertensive and antianginal effects. By blocking calcium channels, it lowers the transmembrane transition of calcium ions into the cell, while acting to a greater extent on vascular smooth muscle cells.
The mechanism of the antianginal action of amlodipine is due to its ability to dilate the coronary and peripheral arteries and arterioles. With angina pectoris, this leads to a decrease in the severity of myocardial ischemia, reduces the systemic vascular resistance, afterload on the heart, and myocardial oxygen demand. Due to the expansion of the coronary arteries and arterioles in the ischemic or unchanged areas of the myocardium, the supply of oxygen to the myocardium increases. Prevents spasm of the coronary arteries.
With stable angina pectoris, the daily dose of Eclamise can increase exercise tolerance, slow down the development of angina pectoris and ischemic ST-segment depression, and reduce the frequency of angina attacks.
A direct vasodilating effect on vascular smooth muscle provides amlodipine with a long-term dose-dependent hypotensive effect. Against the background of the drug, the development of orthostatic hypotension is quite rare. Amlodipine does not reduce the left ventricular ejection fraction, does not affect myocardial contractility and conductivity, heart rate (HR). Has a weak natriuretic effect, helps to reduce the rate of platelet aggregation and increase the rate of glomerular filtration.
Eclamisis is indicated for use in patients with diabetic nephropathy, diabetes mellitus, bronchial asthma, gout.
A decrease in blood pressure occurs after 6-10 hours and lasts for 24 hours.
The combination of lisinopril and amlodipine helps to achieve comparable blood pressure control. Their combination allows you to prevent the appearance of undesirable effects that may occur against the background of monotherapy with each of the active substances. Slow calcium channel blockers cause sodium and fluid retention in the body, and an ACE inhibitor blocks the RAAS activation process.
Pharmacokinetics
After oral administration, absorption from the gastrointestinal tract (GIT) of lisinopril averages 25%, amlodipine (slowly) - 90%. Bioavailability of lisinopril - 25%, amlodipine - 64-80%. Food intake does not affect their absorption.
Binding to blood plasma proteins: lisinopril - almost does not bind, amlodipine - 95%. The maximum concentration in blood plasma (C max) of lisinopril is achieved after 6-7 hours, amlodipine - after 6-10 hours.
Lisinopril has a low ability to overcome the blood-brain and placental barriers. Amlodipine crosses the blood-brain barrier. There is a small amount of amlodipine in the blood, most of the dose taken is distributed in the tissues, it is not removed during hemodialysis.
Biotransformation of lisinopril in the body does not occur. Metabolism of amlodipine occurs in the liver slowly, but actively, with the formation of pharmacologically inactive metabolites.
The half-life (T 1/2) of lisinopril - 12 hours, amlodipine - up to 45 hours.
The drug is excreted through the kidneys: lisinopril - unchanged, amlodipine - unchanged 10%, in the form of metabolites - about 60%.
Through the intestine, 20-25% of the dose of amlodipine taken is excreted.
In studies of the pharmacokinetics of the drug in elderly patients, no clinically significant changes in the efficacy and safety of amlodipine and lisinopril were found.
In chronic heart failure, absorption, bioavailability and clearance of lisinopril are reduced. It can be excreted from the body by hemodialysis.
In renal failure, T 1/2 of the active substances is lengthened.
The interaction of active substances is unlikely, the combination does not affect their pharmacokinetic parameters.
Long-term circulation of active substances in the body allows the use of Eclamise 1 time in 24 hours.
Indications for use
According to the instructions, Eclamise is indicated for the treatment of essential hypertension in patients who require combination therapy with a slow calcium channel blocker and an ACE inhibitor.
Contraindications
- hemodynamically significant aortic stenosis, mitral stenosis;
- hypertrophic obstructive cardiomyopathy;
- severe arterial hypotension with systolic blood pressure less than 90 mm Hg;
- unstable angina, except for Prinzmetal's angina;
- cardiogenic shock;
- heart failure during the first 28 days after acute myocardial infarction;
- a combination with aliskiren or preparations containing aliskiren for renal failure with a glomerular filtration rate of less than 60 ml / min per 1.73 m 2 or diabetes mellitus;
- an indication in the history of angioedema, including while taking ACE inhibitors;
- idiopathic angioedema, hereditary Quincke's edema;
- established hypersensitivity to dihydropyridine derivatives or ACE inhibitors;
- period of pregnancy;
- breast-feeding;
- age up to 18 years;
- individual intolerance to the components of the drug.
Eclamysis should be used with caution after kidney transplantation, with severe renal dysfunction, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney with progressive azotemia, impaired liver function, hyperkalemia, azotemia, primary hyperaldosteronism, cerebrovascular diseases (including cerebrovascular insufficiency), cerebral circulation hematopoiesis, arterial hypotension, coronary insufficiency, ischemic heart disease, sick sinus syndrome (severe bradycardia, tachycardia), chronic heart failure of non-ischemic etiology III-IV functional class according to NYHA classification (New York Heart Association), mitral stenosis, aortic stenosis, acute myocardial infarction and within 30 days after myocardial infarction,autoimmune systemic diseases of the connective tissue (including scleroderma, systemic lupus erythematosus), adherence to a diet with limited salt intake, hypovolemic conditions (including a decrease in the volume of fluid in the body as a result of vomiting, diarrhea), treatment of elderly patients, hemodialysis using high-flow dialysis membranes with high permeability.
Instructions for the use of Eclamiz: method and dosage
Eclamiz tablets are taken orally, regardless of food intake, with a sufficient amount of liquid, 1 time per day.
Recommended dosage: the initial dose is 5 mg / 10 mg (amlodipine / lisinopril), then, if the clinical effect is insufficient, in order to further lower blood pressure, the dose can be gradually increased. The maximum daily dose is 10 mg / 20 mg.
To reduce the risk of developing symptomatic arterial hypotension, which may occur at the beginning of drug therapy or, which happens more often, if the water-electrolyte balance is disturbed due to the previous intake of diuretics, the use of diuretics should be discontinued 2-3 days before starting therapy with Eclamis. If diuretics cannot be canceled, then treatment with the combined drug should be started with ½ tablet at a dose of 5 mg / 10 mg once a day. During this period, the patient should be monitored for several hours after taking Eclamise, since symptomatic arterial hypotension may develop.
In case of impaired renal function, it is recommended to start taking with ½ tablet at a dose of 5 mg / 10 mg. The maintenance dose is selected individually, taking into account the tolerability of therapy, and the state of renal function, the level of potassium and sodium in the blood plasma are constantly monitored.
In case of impaired liver function, the initial and maintenance doses should not exceed ½ tablet (5 mg amlodipine + 10 mg lisinopril).
Determination of the optimal maintenance dose of Eclamise in patients over the age of 65 is made individually, based on the results of a separate intake of each of the active components - lisinopril and amlodipine.
Side effects
- on the part of the lymphatic and hematopoietic systems: very rarely - leukopenia, neutropenia, inhibition of bone marrow hematopoiesis, thrombocytopenia, agranulocytosis, anemia, hemolytic anemia, lymphadenopathy;
- from the side of the heart: often - palpitations; infrequently - chest pain, tachycardia, bradycardia, violation of atrioventricular conduction, exacerbation of symptoms of chronic heart failure, myocardial infarction; very rarely - ventricular tachycardia, arrhythmia, atrial fibrillation;
- mental disorders: infrequently - anxiety, mood changes, anxiety, insomnia, sleep disturbances, unusual dreams, depression; rarely - agitation, apathy, mental disorders;
- from the nervous system: often - drowsiness, headache, dizziness; infrequently - paresthesia, systemic dizziness, dysgeusia, convulsive twitching of the lips and muscles of the extremities, syncope, tremor, hypesthesia; rarely - migraine, confusion; very rarely - ataxia, peripheral neuropathy, parosmia, amnesia;
- from the vascular system: often - a significant decrease in blood pressure, hyperemia, orthostatic hypotension; infrequently - Raynaud's syndrome, impaired cerebral circulation; very rarely - vasculitis;
- on the part of the organ of vision: infrequently - pain in the eyes, violation of accommodation, diplopia, xerophthalmia;
- from the organ of hearing and the labyrinth: infrequently - tinnitus;
- from the respiratory system, chest and mediastinal organs: often - cough; infrequently - nosebleeds, rhinitis, dyspnea; rarely - shortness of breath; very rarely - sinusitis, bronchospasm, eosinophilic pneumonia, allergic alveolitis;
- dermatological reactions: infrequently - skin rash, pruritus, allergic reactions, angioedema (including tongue, vocal folds, larynx, face, lips, limbs), photosensitivity, purpura, xeroderma; rarely - urticaria rash, dermatitis, alopecia, psoriasis; very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus vulgaris, cold sweat, increased sweating, pseudolymphoma of the skin (including some or all of the following: rash, vasculitis, myalgia, fever, arthralgia or arthritis, eosinophilia and leukocytosis, increased titer of antinuclear antibodies and erythrocyte sedimentation rate, photosensitization, other changes on the part of the skin), skin discoloration;
- from the digestive system: often - nausea, vomiting, diarrhea, abdominal pain; infrequently - thirst, dryness of the oral mucosa, indigestion, constipation, dyspepsia, anorexia; rarely - increased appetite; very rarely - gastritis, pancreatitis, gingival hyperplasia, angioedema of the intestine;
- on the part of nutrition and metabolism: very rarely - hypoglycemia, hyperglycemia;
- on the part of the hepatobiliary system: very rarely - cholestatic jaundice, jaundice, hepatitis, cholestasis, liver failure;
- from the immune system: very rarely - hypersensitivity, vasculitis, increased titer of antinuclear antibodies;
- on the part of the skeletal system and connective tissues: infrequently - back pain, myalgia, arthralgia, arthrosis, muscle cramps; rarely - arthritis, myasthenia gravis;
- from the urinary system: often - impaired renal function; infrequently - nocturia, disorder and / or increased frequency of urination; rarely - uremia, acute renal failure; very rarely - anuria, oliguria;
- from the reproductive system and mammary glands: infrequently - gynecomastia, impotence;
- systemic and local reactions: often - peripheral edema, increased fatigue; infrequently - asthenia, chest pain, malaise;
- laboratory indicators: infrequently - an increase or decrease in body weight, hyperkalemia, an increase in the concentration of creatinine and urea in the blood serum, the activity of liver enzymes; rarely - hyperbilirubinemia, decreased hemoglobin and hematocrit, erythropenia, hyponatremia.
Overdose
Symptoms characteristic of an overdose of the active substances of Eclamysis: amlodipine - a pronounced decrease in blood pressure, in which the development of reflex tachycardia and excessive peripheral vasodilation is possible (the risk of severe and persistent arterial hypotension is increased, including with the development of shock and death); lisinopril - a marked decrease in blood pressure, drowsiness, anxiety, dryness of the oral mucosa, urinary retention, constipation, increased irritability.
Treatment: immediate gastric lavage, intake of activated charcoal. The patient should be placed on a flat surface with his legs raised. Hospitalization is required, as well as monitoring and maintaining the function of the cardiovascular and respiratory systems, determining the volume of circulating blood, the concentration of creatinine, urea, the content of electrolytes in the blood serum, diuresis, the appointment of intravenous (iv) administration of plasma-substituting solutions, to eliminate the consequences of calcium blockade. channels - in / in the introduction of calcium gluconate. To restore vascular tone, if there are no contraindications, the appointment of vasoconstrictors is indicated.
The use of hemodialysis is ineffective, since Eclamise consists of two active substances.
special instructions
The appointment of Eclamiz should be made taking into account the results of laboratory studies of the BCC and the sodium content in the blood plasma, especially in patients who have previously taken diuretics. If the BCC is reduced, it is recommended to take measures to restore it before starting drug therapy. This will reduce the risk of a pronounced decrease in blood pressure, and in case of ischemic heart disease or cerebrovascular diseases - the risk of myocardial infarction or stroke.
Eclamisis causes vasodilation, so it should be used with caution in obstruction of the left ventricular outflow tract and mitral stenosis.
It is necessary to take into account the possible transient increase in the level of creatinine and urea in the blood serum, especially in patients with a history of kidney disease.
When determining the optimal maintenance dose, it is recommended to take lisinopril and amlodipine separately, monitoring renal function. Eclamisis is indicated for use only if the optimal maintenance dose of amlodipine is titrated up to 5 mg and 10 mg, lisinopril - up to 10 mg and 20 mg.
In patients with reduced renal function, the use of the combined drug should be replaced with monotherapy with each of the components in adequate doses. At the same time, it is necessary to consider whether it is advisable to take diuretics at the same time or to reduce their dose.
If symptoms of angioedema appear, you should stop taking Eclamise and consult a doctor immediately.
Anaphylactic reactions occur during hemodialysis using polyacrylonitrile membranes and during apheresis of low density lipoprotein (LDL) with dextran sulfate in patients taking ACE inhibitors. Therefore, during the period of taking the drug, it is recommended to use a different type of dialysis membrane for hemodialysis and to cancel taking the pills before each apheresis procedure.
Before desensitization from wasp / bee venom, the ACE inhibitor should be discontinued.
In case of development of jaundice or increased activity of liver enzymes, treatment with Eclamis should be canceled.
In case of impaired liver function, T 1/2 of amlodipine is lengthened, there are no special recommendations on the dosage regimen for patients with hepatic insufficiency. In such cases, when prescribing the drug, one should first assess the benefits and potential risks of therapy.
When prescribing Eclamiz to patients with connective tissue diseases, during the period of immunosuppressive therapy and / or the use of allopurinol or procainamide, it is recommended to periodically monitor the number of leukocytes in the blood. Patients should be informed about the need for immediate medical attention if symptoms of an infectious disease appear.
When making a differential diagnosis of cough, it should be borne in mind that a non-productive, persistent cough can be caused by lisinopril.
Eclamysis is indicated for use in patients with diabetes mellitus, bronchial asthma and gout.
To reduce the risk of hyperkalemia in renal failure, diabetes mellitus, acute heart failure, dehydration, metabolic acidosis, concomitant use of potassium-sparing diuretics or other drugs that lead to an increase in serum potassium levels, potassium-containing dietary supplements and salt substitutes, it is necessary to use tablets regularly control of potassium content in blood serum.
When prescribing Eclamise to patients with short stature and / or body weight, severe liver dysfunction, it is necessary to consider lowering the initial dose.
Influence on the ability to drive vehicles and complex mechanisms
The doctor should give recommendations on the possibility of driving vehicles individually, both at the beginning of therapy and after establishing a maintenance dose.
Application during pregnancy and lactation
The appointment of Eclamiz is contraindicated in the period of gestation and breastfeeding.
If conception occurred during the period of use of the drug, it should be stopped immediately.
If necessary, taking Eclamise during lactation, breastfeeding should be discontinued.
Pediatric use
Due to the lack of safety and efficacy data, the use of Eclamise is contraindicated under the age of 18 years.
With impaired renal function
In case of impaired renal function, it is recommended to start taking with ½ tablet at a dose of 5 mg / 10 mg. The maintenance dose is selected individually, taking into account the tolerability of therapy. Treatment should be accompanied by regular monitoring of renal function, sodium and potassium levels in blood plasma.
For violations of liver function
When treating patients with impaired liver function, the initial and maintenance doses of Eclamise should not exceed ½ tablet 5 mg / 10 mg (amlodipine / lisinopril).
Use in the elderly
For patients over the age of 65, the maintenance dose of Eclamise must be determined individually, based on the optimal doses of lisinopril and amlodipine, established during the separate administration of each of the active components.
Drug interactions
With the simultaneous use of Eclamise:
- eplerenone, spironolactone, amiloride, triamterene and other potassium-sparing diuretics, potassium-containing dietary supplements and salt substitutes, drugs that increase serum potassium levels (including heparin): increase the risk of hyperkalemia, especially in case of renal failure and other renal dysfunction in history patients;
- diuretics, other antihypertensive drugs: can significantly enhance the antihypertensive effect of Eclamiz;
- tricyclic antidepressants, drugs for general anesthesia, antipsychotics, narcotic analgesics: can cause a significant decrease in blood pressure, increase the risk of orthostatic hypotension;
- ethanol: enhances the hypotensive effect of Eclamise;
- cytostatics, allopurinol, procainamide, systemic glucocorticosteroids (immunosuppressants): increase the risk of developing leukopenia;
- antacids, cholestyramine: reduce the bioavailability of lisinopril;
- sympathomimetics: it is possible to reduce the antihypertensive effect of ACE inhibitors;
- insulin, oral hypoglycemic agents: the risk of hypoglycemia increases, more often in patients with renal insufficiency during the first week of therapy;
- non-steroidal anti-inflammatory drugs, including selective inhibitors of cyclooxygenase-2: their long-term use in high doses can cause a decrease in the hypotensive effect of Eclamise, an increase in serum potassium and a deterioration in renal function;
- lithium preparations: can slow down their elimination time, increasing the risk of increased neurotoxicity;
- gold preparations (sodium aurothiomalate): can cause the development of a complex of symptoms, including nausea, vomiting, arterial hypotension, facial flushing;
- drugs that affect the RAAS: increase the risk of arterial hypotension, hyperkalemia, renal dysfunction;
- dantrolene: its use should be avoided;
- rifampicin, anticonvulsants (including carbamazepine, phenobarbital, phenytoin, phosphenytoin, primidone), St. John's wort preparations (inducers of cytochrome CYP3A4 isoenzymes): can increase the metabolism of amlodipine in the liver, reducing the level of its concentration in blood plasma;
- itraconazole, ketoconazole (inhibitors of cytochrome CYP3A4 isoenzymes): increase the risk of side effects due to a possible increase in the plasma concentration of amlodipine;
- beta-blockers - bisoprolol, metoprolol, carvedilol: may increase the risk of arterial hypotension, cause a worsening of the course of chronic heart failure;
- baclofen, amifostine, isoflurane, antipsychotics: may enhance the hypotensive effect of Eclamise;
- tetracosactide, corticosteroids (gluco- and mineralocorticosteroids): cause a decrease in the hypotensive effect of the drug;
- alpha-blockers (alfuzosin, prazosin, doxazosin, terazosin, tamsulosin): increase the antihypertensive effect of amlodipine and increase the risk of orthostatic hypotension;
- QT interval lengthening agents (including procainamide, quinidine): a significant lengthening of the QT interval is possible.
Analogs
Eclamiz analogs are: Amlodipine + Lisinopril, Tenliza, Equator, Ekvakard.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C in a dark place.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Eklamize
Reviews about Eclamise are positive. Patients with the second degree of arterial hypertension indicate that after several weeks of using the drug, blood pressure began to normalize, headaches and a feeling of lack of air disappeared. Regular intake of Eclamise completely stabilizes the pressure for 10-15 weeks, reduces the influence of external factors on the patient's well-being.
Also, patients note good tolerance, no side effects.
Price for Eclamise in pharmacies
The price of Eclamiz for a package containing 30 tablets at a dose of 5 mg amlodipine / 10 mg lisinopril can be 484 rubles, at a dose of 10 mg / 20 mg - 621 rubles.
Eclamiz: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Eclamiz 5 mg + 10 mg tablets 30 pcs. 412 RUB Buy |
|
Eclamiz 5 mg + 10 mg tablets combi-pack 1 + 1 30 pcs. 433 r Buy |
|
Eclamiz tab. 10mg + 20mg No. 30 521 RUB Buy |
|
Eclamiz 10 mg + 20 mg tablets 30 pcs. 521 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
