Equacard, pills 5mg+10mg, 30pcs

Composition

1 tablet contains amlodipine 5 mg,

lisinopril 10 mg

Pharmacological action

Equacard is a combination drug 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, preload, pressure in the pulmonary capillaries, causes an increase in minute blood volume and increased myocardial load tolerance in patients with chronic heart failure. Dilates the arteries to a greater extent than the veins. Some of the effects are attributed to effects on the renin-angiotensin-aldosterone system (RALS). 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 chronic heart failure, slow the progression of left ventricular dysfunction in patients who have suffered an acute myocardial infarction without clinical manifestations of heart failure.

The onset of action of the drug in 1 hour, the maximum antihypertensive effect is achieved in 6-7 hours and persists for 24 hours. The duration of the effect also depends on the amount of the dose taken. With arterial hypertension, the effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months of therapy. When lisinopril was abruptly discontinued, there was no significant increase in blood pressure. Lisinopril reduces albuminuria. It does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not lead to an increase in cases of hypoglycemia.

Amlodipine

Slow calcium channel blocker, dihydropyridine derivative slow calcium channel blocker (BMCC), has an antianginal and antihypertensive effect, blocks calcium channels, reduces the granemembrane transition of calcium ions into the cell (to a greater extent in vascular smooth muscle cells than in 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 pectoris); prevents spasm of the coronary arteries (including those caused by smoking). In patients with stable angina, a single daily dose increases exercise tolerance, increases the time to angina attack 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 arterial hypertension, a single dose provides a clinically significant reduction in blood pressure 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 the 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, inhibits platelet aggregation, increases the glomerular filtration rate, and has a weak natriuretic effect.

In diabetic nephropathy, it does not increase the severity of microalbumiuria. 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.

Indications

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

Use during pregnancy and lactation

The use of Equacard is not recommended during pregnancy.

When diagnosing pregnancy, Equacard should be discontinued as soon as possible.

Taking ACE inhibitors in the second and third trimester of pregnancy has an adverse effect on the fetus (there may be a pronounced decrease in blood pressure, renal failure, hyperkalemia, hypoplasia of the skull bones, intrauterine death). There are no data on the negative effects of the drug on the fetus when used during the first trimester. For newborns and children 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, so use during pregnancy is possible only if the benefit to the mother exceeds the potential risk to the fetus.

Lisinopril passes through the placenta. There are no data on the penetration of lisinopril into 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 Equacard® during breast-feeding is not recommended.

If the use of the drug is necessary during lactation, then breastfeeding should be discontinued.

Contraindications

• hypersensitivity to any component of the drug or to other dihydropyridine derivatives, other ACE inhibitors;
• a history of angioedema, including that caused by the use of other ACE inhibitors;
• hereditary and/or idiopathic angioedema;
• hemodynamically significant stenosis of the aortic or mitral valve disease or hypertrophic obstructive cardiomyopathy;
• severe arterial hypotension (systolic BP less than 90 mm Hg. St. )
• cardiogenic shock;
• pregnancy, lactation;
• age to 18 years;
• acute myocardial infarction (during the first 28 days), unstable angina (with the exception of prinzmetals angina);
• lactose intolerance, lactase deficiency and glucose-galactose malabsorption.

Side effects

the Frequency of adverse reactions listed below were determined according to the following (classification of the world health organization): very often – at least 10%; often – not less than 1% but < 10%; infrequently – at least 0.1% but < 1%; rarely – not less than 0.01%, but less than 0.1%; very rarely – less than 0.01%, including individual messages.

Lisinopril

From the cardiovascular system:  often-marked decrease in blood pressure, orthostatic hypotension; infrequently-acute myocardial infarction, tachycardia, palpitation sensation; Raynaud’s syndrome; rarely-bradycardia, tachycardia, worsening of symptoms of chronic heart failure, atrioventricular conduction disorders, chest pain.

From the central nervous system:  often – dizziness, headache; infrequently-mood lability, paresthesia, sleep disorders, stroke; rarely-confusion, asthenic syndrome, convulsive twitching of the muscles of the limbs and lips, drowsiness.

Hematopoietic and lymphatic system disorders:  rarely-decreased hemoglobin, hematocrit; very rarely-leukopenia, neutropenia, agranulocytosis, thrombocytopenia, eosinophilia, erythropenia, hemolytic anemia, lymphadenopathy, autoimmune diseases.

Respiratory system disorders:  often – cough; infrequently-rhinitis; very rarely-sinusitis, bronchospasm, allergic alveolitis/eosinophilic pneumonia, shortness of breath.

From the digestive system:  often – diarrhea, vomiting; infrequently-dyspepsia, taste changes, abdominal pain; rarely-dryness of the oral mucosa; very rarely-pancreatitis, jaundice (hepatocellular or cholestatic), hepatitis, liver failure, interstitial edema, anorexia.

From the side of the skin:  Infrequently-pruritus, rash; rarely-angioedema of the face, extremities, lips, tongue, larynx, urticaria, alopecia, psoriasis; very rarely-increased sweating, vasculitis, pemphigus, photosensitization, toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme, Stevens-Johnson syndrome.

From the urinary system:  often-impaired renal function; infrequently-uremia, acute renal failure; very rarely-anuria, oliguria, proteinuria.

From the side of the reproductive system:  infrequently-impotence, rarely-gynecomastia.

From the side of metabolism:  very rarely – hypoglycemia.

From the side of laboratory parameters:  infrequently-increased urea concentration in the blood, hypercreatininemia, hyperkalemia, increased activity of “hepatic” transaminases, rarely-hyperbilirubinemia, hyponatremia, increased erythrocyte sedimentation rate, false positive results of the antinuclear antibody test.

From the musculoskeletal system:  rarely-arthralgia/arthritis, myalgia.

Amlodipine

From the central nervous system:  often-headache (especially at the beginning of treatment), dizziness, increased fatigue, snot; infrequently-general malaise, hypesthesia, asthenia, paresthesia, peripheral neuropathy, tremor, insomnia, emotional lability, unusual dreams, nervousness, increased excitability, depression, anxiety, increased sweating; rarely-convulsions, apathy, agitation; very rarely-ataxia, amnesia.

From the digestive system: often – nausea, abdominal pain; infrequently-vomiting, changes in bowel movements (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dry oral mucosa, thirst; rarely – gum hyperplasia, increased appetite; very rarely – pancreatitis, gastritis, jaundice (usually cholestatic), hyperbilirubinemia, increased activity of “liver” transaminases, hepatitis.

From the cardiovascular system: often – peripheral edema (ankles and feet), palpitations, “flushes” of blood to the skin of the face; infrequently – excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely – development or aggravation of the course of chronic heart failure; very rarely – fainting, shortness of breath, cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, pulmonary edema, migraine.

From the hematopoietic and lymphatic systems: very rarely – thrombocytopenic purpura, leukopenia, thrombocytopenia.

From the urinary system: infrequently-pollakiuria, painful urination, nocturia; very rarely-dysuria, polyuria.

From the side of the reproductive system and mammary glands: infrequently-gynecomastia, impotence.

Respiratory system disorders: infrequently-shortness of breath, rhinitis; very rarely – cough.

From the musculoskeletal system: infrequently-muscle cramps, myalgia. arthralgia, back pain, osteoarthritis; rarely-myasthenia gravis.

From the side of cutaneous coverings: infrequently – alopecia: rarely-dermatitis; very rarely-alopecia, xeroderma, cold sticky sweat, skin pigmentation disorder.

Allergic reactions: rarely-pruritus of the skin, rash (including erythematous, maculopapular rash); very rarely-urticaria, angioedema, erythema multiforme.

From the side of the senses: infrequently-tinnitus, visual impairment, diplopia, accommodation disorders, xerophthalmia, conjunctivitis, eye pain; very rarely-parosmia.

From the side of metabolism: very rarely – hyperglycemia.

Other services: infrequently – weight loss, weight gain, taste distortion, nosebleeds, chills.

Interaction

Lisinopril should be used with caution simultaneously with potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone), potassium preparations, salt substitutes containing potassium, cyclosporine – the risk of hyperkalemia increases, especially in patients with impaired renal function. Therefore, these combinations should be used only on the basis of an individual doctor’s decision, with regular monitoring of serum potassium and renal function. When used concomitantly with diuretics and other antihypertensive agents, the antihypertensive effect of lisinopril is enhanced.

When used concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs) (including selective cyclooxygenase-2 (COX-2) inhibitors), estrogens, and sympathomimetics, the antihypertensive effect of lisinopril decreases. NSAIDs, including COX-2, and ACE inhibitors increase serum potassium and may impair kidney function. This effect is usually reversible.

Lisinopril slows down the elimination of lithium preparations, so when used simultaneously, there is a reversible increase in its concentration in blood plasma, which can increase the likelihood of adverse events, so you should regularly monitor the concentration of lithium in the blood serum.

When used concomitantly with antacids and other tyramines, the absorption of lisinopril from the gastrointestinal tract decreases. Ethanol enhances the effect of lisinopril.

When used concomitantly with insulin and hypoglycemic agents for oral use, the risk of hypoglycemia increases.

When lisinopril is used concomitantly with vasodilators, barbiturates, antipsychotics( neuroleptics), tricyclic antidepressants.

BMCC, beta-blockers may enhance the antihypertensive effect. With the simultaneous use of ACE inhibitors and intravenous gold preparations (sodium aurothiamalate), a symptom complex has been described, including facial hyperemia, nausea, vomiting, and a decrease in blood pressure.

Combined use with allopurinol, procainamide, cytostatics can lead to leukopenia.

Amlodipine can be safely used for the treatment of hypertension together with thiazide diuretics, alpha-blockers or ACE inhibitors.

Unlike other BMCs, no clinically significant interaction of amlodipine was found when co-administered with NSAIDs, including Indometacin.

It is possible to enhance the antianginal and antihypertensive effects of BMCC when combined with thiazide and loop diuretics, ACE inhibitors and nitrates, as well as to enhance their antihypertensive effect when used simultaneously with alpha-1-blockers.

Erythromycin, when co-administered, increases the Cmax of amlodipine in young patients by 22%, and in elderly patients-by 50%.

Beta-blockers when used concomitantly with amlodipine may cause an exacerbation of the course of chronic heart failure.

Although no negative inotropic effects have usually been observed in studies of amlodipine, however, some BMCs may increase the severity of the negative inotropic effects of antiarrhythmic agents that cause prolongation of the QT interval (for example, amiodarone and quinidine).

A single dose of 100 mg of sildenafil in patients with arterial hypertension does not affect the pharmacokinetics of amlodipine. Repeated use of amlodipine at a dose of 10 mg and atorvastatin at a dose of 80 mg is not accompanied by significant changes in the pharmacokinetics of atorvastatin.

Ethanol (beverages containing alcohol): amlodipine with a single and repeated use in a dose of 10 mg does not affect the pharmacokinetics of ethanol.

Antiretroviral drugs (ritonavir) increase the plasma concentrations of BMCC, including amlodipine. Neuroleptics and isoflurane enhance the antihypertensive effect of dihydropyridine derivatives. Calcium supplements can reduce the effect of BMCC.

When amlodipine is co-administered with lithium preparations, it is possible to increase the manifestation of neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

Amlodipine does not alter the pharmacokinetics of cyclosporine.

It does not affect the serum concentration of digoxin and its renal clearance.

It does not significantly affect the effect of warfarin (prothrombin time).

Cimetidine does not affect the pharmacokinetics of amlodipine.

In vitro studies, amlodipine did not affect the binding to plasma proteins of digoxin, phenytoin, warfarin, and Indometacin.

Grapefruit juice: concomitant single oral use of 240 mg grapefruit juice and 10 mg amlodipine is not accompanied by a significant change in the pharmacokinetics of amlodipine.

Aluminum-or magnesium-containing antacids: their single use does not significantly affect the pharmacokinetics of amlodipine.

How to take, course of use and dosage

Tablets of the drug Equacard are taken orally once a day, regardless of the time of meal, with a sufficient amount of liquid.

AdultsThe recommended dose is 1 tablet of Equacard 1 time/day. At the beginning of therapy with Equacard, symptomatic hypotension may develop, which more often occurs in patients with impaired water-electrolyte balance due to previous diuretic therapy. The use of diuretics should be discontinued 2-3 days before the start of therapy with Equacard.

In cases where the withdrawal of diuretics is impossible, the initial dose of Equacard is 1/2 tablet (5 mg+5 mg) 1 time/day. after taking it, the patient should be monitored for several hours due to the possible development of symptomatic arterial hypotension.

Overdose

Lisinopril

Symptoms: marked decrease in blood pressure, dryness of the oral mucosa, impaired water-electrolyte balance, renal failure, rapid breathing, tachycardia, palpitation, bradycardia, dizziness, anxiety, increased irritability, cough, drowsiness, urinary retention, constipation.

Treatment: there is no specific antidote. Gastric lavage, use of enterosorbents and laxatives. Intravenous use of 0.9% sodium chloride solution is indicated. In the case of treatment-resistant bradycardia, an artificial pacemaker should be used. It is necessary to monitor blood pressure, water and electrolyte balance indicators. Hemodialysis is effective.

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, use of activated charcoal (especially in the first 2 hours after overdose), maintenance of cardiovascular function, elevated position of the lower extremities, monitoring of heart and lung function, control of circulating blood volume (BCC) and diuresis.

To restore vascular tone, use vasoconstrictors (in the absence of contraindications to their use); to eliminate the consequences of calcium channel blockade, intravenous use of calcium gluconate. Hemodialysis is not effective.

Special instructions

Treatment with Equacard can be started only after correcting hyponatremia and restoring the volume of circulating blood.

After taking the first dose of the drug, careful monitoring of blood pressure is recommended, a significant decrease in blood pressure is possible with the development of symptomatic arterial hypotension.Most often, a pronounced decrease in blood pressure occurs with a decrease in BCC caused by diuretic therapy, a decrease in the content of table salt in food, dialysis, diarrhea or vomiting. With arterial hypotension, the patient is placed in a horizontal position and, if necessary, a solution that replenishes the volume of circulating fluid (infusion of 0.9% sodium chloride solution) is administered intravenously.

Similar rules should be followed when using Equacard in patients with coronary heart disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke.

In aortic stenosis, hypertrophic obstructive cardiomyopathy, the appointment of a vasodilator requires caution. During therapy with Equacard®, it is necessary to monitor body weight and consumption of table salt, and the appointment of an appropriate diet is indicated.

It is necessary to maintain oral hygiene and follow up with a dentist (to prevent soreness, bleeding and gum hyperplasia).

During the period of therapy, periodic monitoring of peripheral blood is necessary, since the potential risk of agranulocytosis cannot be excluded, periodic monitoring of peripheral blood is required.

In cases of impaired renal function, for example, with renal artery stenosis (especially bilateral or with stenosis of the arteries of a single kidney), hyponatremia, dehydration, circulatory insufficiency, taking the drug can provoke deterioration of renal function and acute renal failure, reversible after discontinuation of treatment. Patients with impaired renal function should be monitored.

In elderly patients, the T1/2 of amlodipine may increase and the clearance of the drug may decrease. More careful monitoring of patients in this category is necessary.

If hepatic function is impaired, the half-life of amlodipine increases, and such patients should be prescribed the drug with caution, after evaluating the benefits and risks. Angioedema of the face, extremities, lips, tongue, epiglottis or larynx may develop when ACE inhibitors are used, requiring immediate discontinuation of treatment with the drug and the establishment of medical supervision until complete regression of symptoms. Angioedema with laryngeal edema can be fatal. Edema of the tongue, epiglottis, or larynx can cause airway obstruction, so appropriate therapy (0.3-0.5 ml of 1:1000 epinephrine (epinephrine) subcutaneous solution) and/or measures to ensure airway patency should be performed immediately. In cases where edema is localized only on the face and lips, the condition most often passes without treatment, but antihistamines can be used.

The risk of developing angioedema is increased in patients who have a history of angioedema due to the use of ACE inhibitors.

Patients taking ACE inhibitors during the hymenopteran venom desensitization procedure are extremely rare and may develop life-threatening anaphylactoid reactions. This can be avoided by temporarily discontinuing treatment with an ACE inhibitor before each hymenopter desensitization procedure.

Surgical intervention/general anesthesia: lisinopril inhibits the formation of angiotensin-II in response to compensatory renin release when using general anesthesia products with antihypertensive effects and during extensive surgical procedures. With such arterial hypotension, blood pressure is normalized by increasing the volume of circulating blood.

Before surgery (including dental surgery), the surgeon/anesthesiologist should be informed about the use of an ACE inhibitor.

Anaphylactoid reactions are also observed in patients undergoing hemodialysis using high-flow dialysis membranes (AN69), who are simultaneously taking ACE inhibitors. In such cases, the possibility of using a different type of dialysis membrane or other antihypertensive agent should be considered. When selecting the dose, it should be taken into account that in elderly patients, both active substances are detected in the blood in a higher concentration, while the effectiveness does not change.

Coughing has been reported with ACE inhibitors. The cough is dry and prolonged, which disappears after discontinuation of treatment with an ACE inhibitor. In the differential diagnosis of cough, it is necessary to take into account the cough caused by the use of an ACE inhibitor.

Storage conditions

In a dark place, at a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Amlodipine, Lisinopril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension