Amlodipine + Lisinopril - Instructions For Use Of Tablets, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Amlodipine + Lisinopril

Latin name: Amlodipine + Lisinopril

ATX code: C09BB03

Active ingredient: amlodipine (Amlodipine) + lisinopril (Lisinopril)

Manufacturer: CJSC Severnaya Zvezda (Russia)

Description and photo update: 2019-10-07

Amlodipine + Lisinopril is a combined antihypertensive drug containing a slow calcium channel blocker and an angiotensin-converting enzyme (ACE) inhibitor.

Release form and composition

The drug is available in the form of tablets: round, flat-cylindrical, almost white or white, with a chamfer and a dividing line (10 pcs. In blister strip packs, in a cardboard box of 3, 5 or 6 packages; 30 pcs. In cans or bottles, in a cardboard box 1 can or bottle Each pack also contains instructions for the use of Amlodipine + Lisinopril).

1 tablet contains:

• active ingredients: amlodipine (in the form of amlodipine besylate) + lisinopril (in the form of lisinopril dihydrate) - 5 mg (6.95 mg) + 10 mg (10.93 mg), 10 mg (13.9 mg) + 20 mg (21, 86 mg) or 5 mg (6.95 mg) + 20 mg (21.86 mg);
• auxiliary components: sodium carboxymethyl starch, aerosil anhydrous (colloidal anhydrous silicon dioxide), microcrystalline cellulose, magnesium stearate.

Pharmacological properties

Pharmacodynamics

Amlodipine + Lisinopril is a combined antihypertensive drug, the mechanism of action of which is due to the properties of its active components - amlodipine and lisinopril.

Amlodipine is a calcium channel blocker derived from dihydropyridine. Has hypotensive and antianginal effects. Its antihypertensive activity is due to the relaxing effect exerted directly on the smooth muscle cells of the vascular wall. The substance blocks the transmembrane transition of calcium ions into the smooth muscle cells of the vascular wall and cardiomyocytes. The antianginal effect of amlodipine determines the expansion of the coronary and peripheral arteries and arterioles. With angina pectoris, this helps to reduce the severity of myocardial ischemia. Expansion of peripheral arterioles leads to a decrease in OPSS (total peripheral vascular resistance), a decrease in afterload on the heart and myocardial oxygen demand. The expansion of the coronary arteries and arterioles in the ischemic and unchanged areas of the myocardium provides an increase in oxygen entering the myocardium (especially with vasospastic angina). Amlodipine prevents coronary artery spasm, which can be caused by, including smoking.

Long-term antihypertensive effect is dose-dependent. With arterial hypertension, taking amlodipine 1 time per day provides a clinically significant decrease in blood pressure (BP) within 24 hours in the standing and lying position.

For amlodipine, the occurrence of acute arterial hypotension is uncommon due to the slow onset of the antihypertensive effect. With stable angina pectoris, a single daily dose increases exercise tolerance, helps to slow the development of angina attacks and ischemic ST segment depression, and reduces the frequency of angina attacks and the need for nitroglycerin or other nitrates.

Amlodipine has no effect on myocardial contractility and conductivity, reduces the degree of left ventricular myocardial hypertrophy. It inhibits platelet aggregation, does not cause a reflex increase in heart rate (HR), increases the glomerular filtration rate (GFR), has a weak natriuretic effect.

A clinically significant decrease in blood pressure occurs within 6-10 hours, the effect lasts 24 hours. In patients with diabetic nephropathy, taking the drug does not increase the severity of microalbuminuria. There was no marked adverse effect of amlodipine on metabolism or plasma lipid concentration. Its use is indicated for patients with comorbidities such as bronchial asthma, diabetes mellitus, gout.

The use of amlodipine for angina pectoris, atherosclerosis of the carotid arteries, coronary atherosclerosis (from damage to one vessel to stenosis of three or more arteries) and other diseases of the cardiovascular system, as well as in patients who have had myocardial infarction or percutaneous transluminal coronary angioplasty, prevents an increase in the thickness of the complex intima-media of the carotid arteries, helps to reduce the number of deaths from myocardial infarction, stroke, coronary artery bypass grafting or percutaneous transluminal coronary angioplasty. In addition, the number of hospitalizations for the progression of chronic heart failure and unstable angina pectoris decreases, and the frequency of interventions to restore coronary blood flow decreases.

In patients with chronic heart failure of III-IV functional class according to NYHA classification (New York Heart Association), the simultaneous use of amlodipine with digoxin, ACE inhibitors or diuretics does not increase the risk of complications and deaths.

With non-ischemic etiology of chronic heart failure (NYHA functional class III – IV), taking amlodipine increases the risk of pulmonary edema.

Lisinopril, being an ACE inhibitor, reduces the formation of angiotensin II from angiotensin I, which leads to a decrease in the concentration of angiotensin II and a direct decrease in the secretion of aldosterone. Under the action of lisinopril, the degradation of bradykinin decreases, and the synthesis of prostaglandins increases. By reducing the OPSS, preload, blood pressure and pressure in the pulmonary capillaries, the substance helps to increase the minute blood volume and increase myocardial tolerance to physical activity in chronic heart failure. Arteries dilate to a greater extent than veins. Part of the effects of lisinopril is due to the effect on the tissue renin-angiotensin system. Against the background of long-term treatment, there is a decrease in myocardial hypertrophy and the walls of resistive arteries.

Lisinopril improves the blood supply to the ischemic myocardium.

The use of ACE inhibitors in patients with chronic heart failure prolongs life expectancy, and in patients who have had myocardial infarction without clinical manifestations of heart failure, it slows down the progression of left ventricular dysfunction.

After oral administration, lisinopril begins to act in 1 hour, the maximum hypotensive effect occurs after 6-7 hours and lasts for 24 hours. In patients with arterial hypertension, the clinical effect is noted within a few days after the start of treatment, and in order to achieve a stable effect of the drug, regular intake is required for 30-60 days. Abrupt withdrawal does not cause a pronounced increase in blood pressure. In addition to the antihypertensive effect, lisinopril helps to reduce albuminuria, with hyperglycemia - to normalize the function of the damaged glomerular endothelium. In patients with diabetes mellitus, it does not affect the level of glucose concentration in the blood and the increase in the incidence of hypoglycemia.

Due to the combination of the properties of the two active components Amlodipine + Lisinopril in one preparation, it allows achieving comparable blood pressure control and preventing the occurrence of possible side effects.

Pharmacokinetics

After taking Amlodipine + Lisinopril, the absorption of active substances occurs inside the gastrointestinal tract (GIT): amlodipine is absorbed slowly and almost completely, lisinopril - in an amount of ~ 25% of the dose taken. The simultaneous intake of food does not affect their absorption. The maximum concentration (C _max) in the blood plasma of amlodipine is achieved after 6-12 hours, lisinopril - 6-8 hours after administration. Average absolute bioavailability: amlodipine - 64-80%, lisinopril - 25-29%.

The volume of distribution (V _d) of amlodipine averages 21 liters per 1 kg of body weight, which indicates its significant distribution in tissues.

The binding of amlodipine to blood plasma proteins is 97.5% of the part in the blood. Its equilibrium concentration (C _ss) in blood plasma is reached after 7–8 days of regular intake.

Lisinopril weakly binds to blood plasma proteins.

Both active substances cross the blood-brain and placental barriers.

Amlodipine is slowly but actively metabolized in the liver to form metabolites that do not have significant pharmacological activity. The "first pass" effect through the liver is negligible.

Lisinopril is not biotransformed in the body, it is excreted through the kidneys unchanged. The half-life (T _1/2) of lisinopril is 12 hours.

T _{1/2 of} amlodipine after a single dose can be from 35 to 50 hours, against the background of repeated use - about 45 hours. Up to 60% of the dose taken is excreted through the kidneys: 10% - unchanged, the rest - in the form of metabolites. Through the intestines, 20–25% of the drug is excreted in the bile. The total clearance of amlodipine is 0.116 ml / s / kg, or 7 ml / min / kg. Amlodipine is not removed during hemodialysis.

In liver failure, T _{1/2 of} amlodipine is extended to 60 hours, with prolonged drug therapy, an increase in its cumulation in the body is expected.

In chronic heart failure, there is a decrease in absorption and clearance of lisinopril, its bioavailability does not exceed 16%.

In renal failure with creatinine clearance (CC) less than 30 ml / min, the level of lisinopril in blood plasma is several times higher than in patients with normal renal function. This increases the time to reach C _max in blood plasma and T _1/2.

In elderly patients, the level of lisinopril concentration in blood plasma is on average increased by 60%, AUC (area under the concentration-time curve) is 2 times higher than in young patients.

The bioavailability of lisinopril in cirrhosis of the liver is reduced by 30%, and clearance is reduced by 50% of those in patients with normal liver function.

The interaction between amlodipine and lisinopril has not been established, the pharmacokinetics and pharmacodynamics of the active substances of the drug are not disturbed in comparison with the indicators of each substance separately.

Long-term circulation of the drug in the body allows to achieve the desired clinical effect with a dosage regimen once a day.

Indications for use

The use of the drug Amlodipine + Lisinopril is indicated for the treatment of essential hypertension in patients who require combination therapy.

Contraindications

Absolute:

• a history of angioedema, including cases associated with the use of ACE inhibitors;
• hereditary or idiopathic angioedema;
• shock, including cardiogenic;
• unstable angina (except for Prinzmetal's angina);
• severe arterial hypotension (systolic blood pressure less than 90 mm Hg);
• hemodynamically significant mitral stenosis, hypertrophic obstructive cardiomyopathy, severe aortic stenosis and other hemodynamically significant obstruction of the left ventricular outflow tract;
• hemodynamically unstable heart failure after acute myocardial infarction;
• combination with drugs that are angiotensin II receptor antagonists in patients with diabetic nephropathy;
• concomitant therapy with aliskiren or aliskiren-containing agents in patients with diabetes mellitus and / or with moderate or severe renal impairment (CC less than 60 ml / min);
• period of pregnancy;
• breast-feeding;
• age up to 18 years;
• hypersensitivity to other ACE inhibitors or dihydropyridine derivatives;
• individual intolerance to the components of the drug.

It is recommended to use Amlodipine + Lisinopril tablets with caution in case of severe renal impairment, condition after kidney transplantation, bilateral renal artery stenosis or renal artery stenosis of a single kidney, liver dysfunction, azotemia, hyperkalemia, primary aldosteronism, cerebrovascular diseases (including cerebral circulation insufficiency), arterial hypotension, ischemic heart disease, sick sinus syndrome (tachycardia, severe bradycardia), coronary insufficiency, chronic heart failure of non-ischemic genesis (III-IV functional class according to NYHA classification), aortic or mitral stenosis, acute myocardial infarction and within 30 days after him, oppression of bone marrow hematopoiesis,autoimmune diseases of the connective tissue (including systemic lupus erythematosus, scleroderma), adherence to a diet restricted to table salt, hemodialysis using high-flow dialysis membranes (such as AN69), vomiting, diarrhea and other conditions that cause a decrease in BCC (circulating blood volume) in the elderly the patient's age.

Amlodipine + Lisinopril, instructions for use: method and dosage

Tablets Amlodipine + Lisinopril are taken orally with a sufficient amount of liquid, regardless of food intake, at the same time every day.

The dose of the drug is selected by titration of individual active components, taking amlodipine and lisinopril as monotherapy.

Taking Amlodipine + Lisinopril is indicated only in cases where the optimal maintenance dose of amlodipine and lisinopril for the patient corresponds to the following fixed doses (respectively): 5 mg and 10 mg, 5 mg and 20 mg, 10 mg and 20 mg.

The selection of the optimal dose should be carried out under the supervision of a physician.

Recommended dosage: 1 tablet at a dose of 5 mg + 10 mg, 5 mg + 20 mg or 10 mg + 20 mg once a day. The maximum daily dose is 1 tablet.

In case of impaired renal function, treatment should be accompanied by monitoring of the functional state of the kidneys, sodium and potassium content in the blood plasma. If during therapy there is a deterioration in renal function, the use of the drug Amlodipine + Lisinopril should be discontinued and treated with separate dosage forms of active ingredients.

When prescribing the drug to patients with impaired liver function, it is necessary to take into account the possible delayed excretion of amlodipine.

Side effects

Criteria for assessing the occurrence: very often - ≥ 10%; often - from ≥ 1% to <10%; infrequently - from ≥ 0.1% to <1%; rarely - from ≥ 0.01% to <0.1%; very rarely - <0.01%; frequency not established - it is not possible to establish the frequency of occurrence of adverse reactions based on the available data:

• allergic reactions: rarely - urticaria, angioedema (including swelling of the face, lips, tongue, epiglottis and / or larynx, extremities); very rarely - intestinal angioedema;
• mental disorders: often - sleep disturbance; infrequently - mood lability, insomnia, unusual dreams, hyperexcitability, depression, anxiety; very rarely - agitation, apathy, confusion, amnesia; frequency not established - confusion, depression;
• from the nervous system: often - increased fatigue, headache, drowsiness, dizziness; infrequently - taste perversion, malaise, insomnia, asthenia, hypesthesia, dysgeusia, paresthesia, peripheral neuropathy, muscle rigidity, tremor; rarely - convulsions, asthenic syndrome; very rarely - migraine, ataxia, parosmia, peripheral neuropathy; frequency not established - convulsive twitching of the muscles of the face and limbs, syncope;
• on the part of the hematopoietic system: rarely - a decrease in the level of hemoglobin and hematocrit; very rarely - neutropenia, agranulocytosis, leukopenia, thrombocytopenia, thrombocytopenic purpura, bone marrow suppression, lymphadenopathy, anemia, hemolytic anemia; frequency not established - erythropenia;
• from the cardiovascular system: often - hot flashes, an excessive decrease in blood pressure, increased heart rate, swelling of the ankles and feet; infrequently - orthostatic hypotension, marked decrease in blood pressure, myocardial infarction and / or cerebrovascular accident (in patients who, due to a pronounced decrease in blood pressure, are in the increased risk category), chest pain, Raynaud's syndrome; rarely - tachycardia, bradycardia, heart palpitations, the appearance or aggravation of chronic heart failure, violation of atrioventricular conduction; very rarely - cardiac arrhythmias (including bradycardia, atrial fibrillation, ventricular tachycardia), myocardial infarction, syncope, vasculitis;
• from the respiratory system: often - sinusitis, dry cough, allergic alveolitis or eosinophilic pneumonia; infrequently - nosebleeds, shortness of breath, rhinitis; very rarely - bronchospasm;
• from the side of metabolism: very rarely - hyperglycemia, hypoglycemia;
• from the digestive system: often - abdominal pain, nausea, liver failure; infrequently - thirst, dryness of the oral mucosa, taste perversion, flatulence, constipation, diarrhea, dyspepsia, vomiting, anorexia; rarely - increased appetite, gingival hyperplasia; very rarely - pancreatitis, gastritis, hepatocellular and cholestatic jaundice, hyperbilirubinemia, hepatitis;
• from the urinary system: often - impaired renal function; infrequently - frequent urination, pain during urination, nocturia; rarely - acute renal failure, uremia; very rarely - dysuria, oliguria, anuria, polyuria; frequency not established - proteinuria;
• on the part of the organ of vision: infrequently - eye pain, diplopia, conjunctivitis, impaired accommodation, visual impairment, xerophthalmia;
• on the part of the organ of hearing: infrequently - tinnitus;
• from the genitals and mammary gland: infrequently - decreased potency, erectile dysfunction, gynecomastia;
• on the part of the skin and subcutaneous tissue: infrequently - itching, rash (including erythematous, maculopapular rash); rarely - urticarial rash, photosensitivity, dermatitis, alopecia, psoriasis; very rarely - increased sweating, pemphigus, cold sweat, erythema multiforme, skin pigmentation disorders, Stevens-Johnson syndrome, skin pseudolymphoma, toxic epidermal necrolysis, xeroderma, exudative erythema multiforme;
• from the musculoskeletal system: infrequently - muscle cramps, back pain, arthralgia, arthritis, myalgia, arthrosis; rarely - myasthenia gravis;
• from the endocrine system: the frequency has not been established - syndrome of inappropriate antidiuretic hormone secretion;
• laboratory parameters: infrequently - hyponatremia, increased serum urea and creatinine concentrations, hyperkalemia; rarely - an increase in the activity of liver enzymes; very rarely - increased ESR (erythrocyte sedimentation rate), increased titer of antinuclear antibodies; frequency not established - leukocytosis, eosinophilia;
• others: infrequently - increased fatigue, pain of unspecified localization, peripheral edema, changes in body weight; very rarely - autoimmune diseases; the frequency has not been established - fever (the development of lupus-like syndrome, accompanied by fever, myalgia, arthralgia or arthritis, an increase in the titer of antinuclear antibodies, eosinophilia, leukocytosis, an increase in ESR, the appearance of a rash, photosensitivity reactions and other skin manifestations).

Overdose

Symptoms

In case of an overdose of the drug Amlodipine + Lisinopril, the symptoms of the negative effect of each of the active components should be taken into account.

Amlodipine: exceeding the recommended dosage regimen causes a significant decrease in blood pressure. The development of reflex tachycardia and significant peripheral vasodilation is possible, accompanied by an increased risk of severe and persistent arterial hypotension, including shock and death.

Lisinopril: a high dose can cause anxiety and increased irritability of the patient, dry mouth, drowsiness, urinary retention, constipation.

Treatment

As a treatment for an overdose, immediate gastric lavage is indicated, and the intake of activated charcoal. Then the patient should be laid on a horizontal surface, slightly lifting his legs. It is necessary to ensure the maintenance and control of the function of the cardiovascular and respiratory systems, control of creatinine, urea and electrolytes in the blood serum, BCC, diuresis. In order to restore vascular tone, the appointment of vasoconstrictors is indicated, provided that the patient has no contraindications to their use. To eliminate the consequences of the blockade of calcium channels, calcium gluconate is administered intravenously (iv), and plasma-substituting solutions are used to replenish the BCC.

The use of hemodialysis is effective only for removing lisinopril.

special instructions

When treating with the drug Amlodipine + Lisinopril, it is necessary to follow the recommendations for the use of each of the active ingredients.

Amlodipine

In order to prevent such phenomena as soreness, bleeding or gingival hyperplasia caused by the presence of amlodipine in the composition of the drug, it is necessary to maintain dental hygiene and regular observation by the dentist.

Despite the fact that there is no withdrawal syndrome in calcium channel blockers, it is advisable to discontinue treatment with amlodipine by gradually reducing the daily dose of the drug.

It should be borne in mind that the use of amlodipine in chronic heart failure of non-ischemic genesis III – IV functional class according to NYHA classification increases the incidence of pulmonary edema in the absence of signs of worsening heart failure in the patient.

Currently, there is no sufficient clinical data indicating the potential effect of amlodipine on fertility. However, it should be borne in mind that in some patients, the intake of slow calcium channel blockers caused reversible biochemical changes in the sperm head.

Lisinopril

With lisinopril monotherapy, the most common cause of an excessive decrease in blood pressure is a decrease in BCC, which can be caused by the simultaneous intake of diuretics, reduced intake of table salt with food, diarrhea and / or vomiting, or dialysis. In chronic heart failure, the development of symptomatic arterial hypotension is possible both in patients with concomitant renal failure, and in its absence. In patients with severe heart failure, arterial hypotension often occurs with the use of high doses of diuretics, impaired renal function, or hyponatremia. In this category of patients, the selection of the dose of lisinopril and a diuretic should be carried out under the strict supervision of a physician. Besides,careful supervision of a specialist is required when prescribing lisinopril to patients with cerebrovascular insufficiency and ischemic heart disease, since with a sharp decrease in blood pressure in this category of patients, myocardial infarction or stroke may occur.

With a pronounced decrease in blood pressure, the patient should take a horizontal position. If necessary, it is shown in / in the introduction of 0.9% sodium chloride solution to replenish fluid loss. Such reactions are transient in nature and are not grounds for canceling the next dose of lisinopril.

Before starting treatment in patients with an increased risk of developing symptomatic arterial hypotension, it is necessary to replenish the loss of fluid and salts; after taking the initial dose of lisinopril, control of the antihypertensive effect is required.

In connection with the existing risk of thrombocytopenia, anemia, neutropenia or agranulocytosis, it is recommended to take special care if it is necessary to prescribe lisinopril against the background of concomitant therapy with immunosuppressants, allopurinol or procainamide in patients with systemic connective tissue diseases, especially with impaired renal function. It is recommended to periodically conduct studies for the number of leukocytes in the blood plasma. If you have a sore throat, fever or other symptoms of infectious diseases, you should see a doctor, as this category of patients can develop severe infections that are resistant to intensive antibiotic therapy. In the absence of these aggravating factors and impaired renal function, neutropenia occurs rarely.

The combined use of lisinopril with nitroglycerin (IV or transdermal) is allowed.

In acute myocardial infarction in patients at risk of further serious hemodynamic deterioration after the use of vasodilators (systolic blood pressure 100 mm Hg or lower, cardiogenic shock), lisinopril therapy should not be initiated. During the first three days after myocardial infarction, it is recommended to reduce the dose of lisinopril if the systolic blood pressure is 120 mm Hg or below. With systolic blood pressure of 100 mm Hg or below, the maintenance dose of lisinopril should be 5 mg, or it should be temporarily reduced to 2.5 mg.

If arterial hypotension persists for more than 1 hour, you should not continue using lisinopril.

In chronic heart failure, an excessive decrease in blood pressure while taking lisinopril can contribute to a further deterioration in renal function, up to the appearance of acute renal failure.

The use of ACE inhibitors in patients with bilateral renal artery stenosis or stenosis of a solitary kidney artery causes a reversible increase in serum urea and creatinine levels.

If renal dysfunction develops against the background of the use of lisinopril, then the need to continue therapy should be assessed.

With the development of angioedema of the face, lips, tongue, epiglottis, larynx and / or extremities, lisinopril therapy should be discontinued as soon as possible and measures should be taken to immediately conduct appropriate therapy.

Due to the fact that when taking ACE inhibitors in rare cases, angioedema of the intestine may occur, in the differential diagnosis of abdominal pain in patients taking lisinopril, the likelihood of developing angioedema of the intestine should be taken into account. To clarify the diagnosis, a computed tomography of the gastrointestinal tract or ultrasound (ultrasound) is required.

To prevent the development of life-threatening anaphylactic reactions, it is necessary to temporarily stop taking the drug before starting each desensitization procedure (including hymenoptera venom).

With an increase in the activity of hepatic transaminases and the appearance of symptoms of cholestasis, lisinopril should be discontinued.

During hemodialysis, the use of high-flow membranes should not be allowed, this will avoid the development of anaphylactic reactions in the patient.

When identifying the causes of cough in patients taking an ACE inhibitor, it should be borne in mind that the cough may be caused by taking the drug.

Before any surgical intervention (including dental surgery), the patient should inform the doctor or anesthesiologist about the treatment with lisinopril. This is due to the fact that lisinopril can block the formation of angiotensin II during the compensatory release of renin when combined with general anesthetic drugs that can cause arterial hypotension. To prevent an excessive decrease in blood pressure, it is necessary to increase the BCC.

It should be borne in mind that risk factors for the development of hyperkalemia include renal failure, diabetes mellitus, the simultaneous use of potassium-sparing diuretics such as triamterene, amiloride, spironolactone, eplerenone (a derivative of spironolactone), potassium-containing salt substitutes or potassium preparations, especially with impaired renal function. Therefore, if it is necessary to use lisinopril in combination with these agents, it is recommended to regularly monitor the level of potassium in the blood serum.

Patients with diabetes who are taking oral hypoglycemic drugs or receiving insulin require careful monitoring of plasma glucose concentrations during the first 30 days of treatment with an ACE inhibitor.

Influence on the ability to drive vehicles and complex mechanisms

During the period of use of the drug Amlodipine + Lisinopril, it is recommended to be careful when driving vehicles and performing other potentially hazardous activities associated with increased concentration of attention and speed of psychomotor reactions, especially for those patients who noticed a significant decrease in blood pressure or the occurrence of dizziness, drowsiness and other similar phenomena caused by taking the drug.

Application during pregnancy and lactation

The use of Amlodipine + Lisinopril is contraindicated during gestation and breastfeeding.

Pediatric use

The safety and efficacy of the drug Amlodipine + Lisinopril in children and adolescents have not been established, therefore, its appointment to patients under 18 years of age is contraindicated.

With impaired renal function

Care should be taken to prescribe Amlodipine + Lisinopril to patients with severe renal impairment, bilateral renal artery stenosis or renal artery stenosis of a single kidney, as well as in the period after kidney transplantation.

For violations of liver function

It is recommended to use Amlodipine + Lisinopril with caution in case of liver dysfunction.

Use in the elderly

In elderly patients, taking standard doses of lisinopril causes an increase in the concentration of this substance in the blood. Therefore, despite the fact that the patient's age does not affect the antihypertensive effect of the drug, special care is required when selecting a dose in elderly patients.

Drug interactions

With the simultaneous use of the drug Amlodipine + Lisinopril with other drugs, it is necessary to take into account the interaction of each of the active components of the drug.

Amlodipine

In the treatment of arterial hypertension, amlodipine can be combined with ACE inhibitors, thiazide diuretics, alpha- and beta-blockers, in patients with stable angina pectoris - with other antianginal agents, including short-acting or prolonged-acting nitrates, beta-blockers.

There is no clinically significant interaction of amlodipine with NSAIDs (non-steroidal anti-inflammatory drugs), including indomethacin, as well as with antibiotics and hypoglycemic agents for oral administration.

Patients undergoing therapy for malignant hyperthermia, or predisposed to this disease, are contraindicated in amlodipine due to the increased risk of hyperkalemia.

The simultaneous use of amlodipine with rifampicin, St. John's wort preparations and other inducers of the CYP3A4 isoenzyme can lead to a decrease in the concentration of amlodipine in plasma.

It should be borne in mind that ketoconazole, itraconazole and other potent inhibitors of the CYP3A4 isoenzyme contribute to a more significant increase in the level of amlodipine in the blood plasma compared with diltiazem. Plasma concentrations of amlodipine increase ritonavir and other antiviral agents.

An increase in the antianginal and antihypertensive effect of amlodipine can occur when combined with ACE inhibitors, loop and thiazide diuretics, beta-blockers or nitrates. The antihypertensive effect of calcium channel blockers is enhanced with concomitant therapy with alpha-blockers or antipsychotics.

Against the background of treatment with amlodipine at a dose of 10 mg, the exposure of simvastatin, taken at a dose of 80 mg, increases by 77%. Therefore, with a combination of drugs, the dose of simvastatin should not exceed 20 mg.

It has been established that the hypotensive effect of dihydropyridine derivatives can be enhanced with the simultaneous use of neuroleptics, isoflurane, baclofen, therefore, renal function and blood pressure should be carefully monitored in order to timely adjust the dose of amlodipine.

The antihypertensive effect of calcium channel blockers may decrease when combined with calcium supplements.

With concomitant therapy with lithium drugs, the manifestations of their neurotoxicity (tinnitus, nausea, vomiting, ataxia, tremor, diarrhea) may be aggravated.

Concomitant use of grapefruit juice can enhance the hypotensive effect of amlodipine.

In patients after kidney transplantation, with the combined use of amlodipine and cyclosporine, it is necessary to control the concentration of the latter in the blood, since in some cases this combination led to an increase in C _{max of} cyclosporine up to 40%.

It should be borne in mind that in patients with arterial hypertension aged 69 to 87 years, the simultaneous administration of diltiazem at a dose of 180 mg and amlodipine at a dose of 5 mg increases the systemic exposure of amlodipine by 57%. In addition, this category of patients is recommended to use amlodipine with caution in combination with erythromycin.

A decrease in the antihypertensive effect of amlodipine may be facilitated by concomitantly taken glucocorticoids or tetracosactide.

General anesthetics, tricyclic antidepressants increase the hypotensive effect and increase the risk of orthostatic hypotension.

Lisinopril

Simultaneous use of potassium-sparing diuretics with lisinopril (spironolactone, eplerenone, amiloride, triamterene), potassium preparations or potassium-containing salt substitutes increases the risk of hyperkalemia. In addition, taking lisinopril with diuretics can cause an excessive decrease in blood pressure.

The severity of the hypotensive effect of lisinopril increases when combined with beta-blockers, diuretics, slow calcium channel blockers, tricyclic antidepressants or neuroleptics.

When combined with ACE inhibitors, the hypoglycemic effect of insulin or hypoglycemic agents for oral administration may increase, increasing the risk of hypoglycemia. This effect can more often occur during the first weeks of therapy and with impaired renal function.

The hypotensive effect of lisinopril may decrease with the simultaneous administration of sympathomimetics, NSAIDs, anti-inflammatory doses (3000 mg per day or more) of acetylsalicylic acid, estrogens, adrenomimetics.

Lisinopril can be taken in combination with acetylsalicylic acid (as an antiplatelet agent), beta-blockers, thrombolytics and / or nitrates.

With concomitant therapy with aliskiren, the risk of arterial hypotension, hyperkalemia, renal dysfunction (including renal failure), insulin and oral hypoglycemic agents - hypoglycemia, selective serotonin reuptake inhibitors - severe hyponatremia increases.

When combined with lisinopril, the elimination of lithium preparations from the body slows down.

Antacids and cholestyramine slow down the absorption of lisinopril from the gastrointestinal tract.

The effect of lisinopril is enhanced by the simultaneous administration of ethanol.

The interaction of ACE inhibitors with a gold preparation (sodium aurothiomalate) can cause the following symptom complex: facial flushing, nausea, vomiting, and a decrease in blood pressure.

With the simultaneous use of lisinopril with cytostatics, allopurinol, procainamide, the risk of developing leukopenia increases, muscle relaxants - a pronounced decrease in blood pressure, co-trimoxazole (trimethoprim, sulfamethoxazole) - hyperkalemia, selective serotonin reuptake inhibitors (paroxetine, serocyonate).

When treating with ACE inhibitors, it should be borne in mind that the combination with estramustine, sirolimus, everolimus, temsirolimus, omapatrilat, ilepatril, daglutril, sacubitril, linagliptin, vildagliptin, saxitagliptin, contributes to an increase in the risk of developing angioedema. In addition, angioedema can occur against the background of the interaction of lisinopril with racecadotril, used to treat acute diarrhea, and tissue plasminogen activators (reteplase, tenecteplase, alteplase).

Analogs

Analogues of Amlodipine + Lisinopril are: De-Kriz, Tenliza, Ekvakard, Equator, Eklamiz.

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.

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, 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!