Composition, form of production and packaging
Tablets are white or almost white, round, flat, with a facet, with a risk on one side and with engraving "A + L" - on the other.
1 tab.
amlodipine besylate 6.94 mg,
which corresponds to the content of amlodipine 5 mg
lisinopril dihydrate 10.88 mg,
which corresponds to the content of lisinopril 10 mg
Excipients: magnesium stearate - 1 mg, sodium carboxymethyl starch (type A) - 4 mg, microcrystalline cellulose (type 101) - 90.54 mg, microcrystalline cellulose (type 12) - 86.64 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (6) - packs of cardboard.
Tablets are white or almost white, round, biconcave, with engraved "CF2" on one side.
1 tab.
amlodipine besylate 6.94 mg,
which corresponds to the content of amlodipine 5 mg
lisinopril dihydrate 21.76 mg,
which corresponds to the content of lisinopril 20 mg
Excipients: microcrystalline cellulose (type 101) - 181.08 mg, microcrystalline cellulose (type 12) - 173.28 mg, sodium carboxymethyl starch (type A) - 8 mg, magnesium stearate - 2 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (6) - packs of cardboard.
Tablets are white or almost white, round, biconvex, with engraved "CF3" on one side.
1 tab.
amlodipine besylate 13.88 mg,
which corresponds to the content of amlodipine 10 mg
lisinopril dihydrate 21.76 mg,
which corresponds to the content of lisinopril 20 mg
Excipients: microcrystalline cellulose 101 - 181.08 mg, microcrystalline cellulose 12 - 173.28 mg, sodium carboxymethyl starch - 8 mg, magnesium stearate - 2 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Combined antihypertensive drug containing lisinopril and amlodipine.
Lizinopril - an ACE inhibitor, reduces the formation of angiotensin II from angiotensin I. Reduction of angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces OPSS, AD, preload, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and increased tolerance of the myocardium to loads in patients with chronic heart failure. Expands arteries more than veins. Some effects are explained by the effect on tissue RAAS.
With prolonged use, myocardial hypertrophy and the walls of arteries of resistive type decrease. Improves the blood supply of the ischemic myocardium.
ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients who underwent myocardial infarction without clinical manifestations of heart failure.
With a sharp withdrawal of the drug, there was no pronounced increase in blood pressure. Despite the primary effect, which manifests itself in the effect on RAAS, it is also effective in hypertension with low renin activity.
In addition to reducing blood pressure, lisinopril reduces albuminuria. Lizinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not increase the incidence of hypoglycemia.
The onset of action is 1 hour after ingestion. The maximum antihypertensive effect is determined after 6 hours and persists for 24 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, stable effect develops after 1-2 months.
Amlodipine is a blocker of slow calcium channels, a derivative of dihydropyridine. Has antianginal and antihypertensive effect. It blocks calcium channels, reduces the transmembrane transition of calcium ions into the cell (mostly in smooth muscle cells of blood vessels, rather than in cardiomyocytes).
Antianginal effect is due to the expansion of coronary and peripheral arteries and arterioles: with angina decreases the severity of myocardial ischemia; expanding peripheral arterioles, reduces OPSS, reduces afterload on the heart, reduces the need for myocardium in oxygen. Expanding coronary arteries and arterioles in unchanged and ischemic zones of the myocardium, increases the flow of oxygen into the myocardium (especially with vasospastic angina); prevents spasm of the coronary arteries (including caused by smoking).
In patients with stable angina, a single daily dose increases exercise tolerance, slows the development of angina pectoris and ischemic depression of the ST segment, reduces the incidence of angina attacks and the consumption of nitroglycerin and other nitrates.
Has a long-term dose-dependent antihypertensive effect. Antihypertensive action is due to direct vasodilating effect on smooth muscle vessels. With arterial hypertension, a single dose provides a clinically significant decrease in blood pressure over a period of 24 hours (in the position of the patient lying down and standing). Orthostatic hypotension in the appointment of amlodipine is rare. Does not cause a decrease in exercise tolerance, a fraction of the ejection of the left ventricle.
Reduces the degree of myocardial hypertrophy of the left ventricle. Has no effect on myocardial contractility and conductivity, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases the rate of glomerular filtration, has a weak natriuretic effect.
When diabetic nephropathy does not increase the severity of microalbuminuria.
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 and gout. A significant reduction in blood pressure is observed after 6-10 h, the duration of the effect is 24 h.
Amlodipine + Lysinopril
The combination of lisinopril with amlodipine in a single medicine can prevent the development of possible undesirable effects caused by one of the active substances. So, the calcium channel blocker, directly expanding the arterioles, can lead to a delay in sodium and fluid in the body, and, therefore, can activate RAAS.The ACE inhibitor blocks this process.
PHARMACOKINETICS
Lisinopril
Suction
After ingestion, lisinopril is absorbed from the digestive tract, its absorption can vary from 6 to 60%. Bioavailability - 29%. Eating does not affect the absorption of lisinopril. C max in blood plasma is 90 ng / ml and is achieved after 6 hours.
Distribution
Almost does not bind to blood plasma proteins. Permeability through the BBB and the placental barrier is low.
Metabolism
Lizinopril is not metabolized in the body.
Excretion
It is excreted unchanged in urine, T 1/2 - 12.6 hours.
Pharmacokinetics in special clinical cases
In elderly patients, the concentration of lisinopril in blood plasma and AUC is 2 times greater than in young patients.
In patients with chronic heart failure, the absorption and clearance of lisinopril are reduced.
In patients with renal insufficiency, the concentration of lisinopril is several times higher than the concentration in the blood plasma in healthy volunteers, with an increase in the time to reach C max in the blood plasma and an increase in T 1/2 .
Lizinopril is excreted from the body by hemodialysis.
Amlodipine
Suction
After ingestion, amlodipine is slowly and almost completely (90%) absorbed from the digestive tract. The bioavailability of amlodipine is 64% -80%. C max in the serum is observed after 6-10 hours. The intake of food does not affect the absorption of amlodipine.
Distribution
Most of the amlodipine, which is in the blood (95% -98%), binds to blood plasma proteins. C ss are achieved after 7-8 days of therapy. The average V d is 20 l / kg body weight, indicating that most of the amlodipine is in the tissues, and the smaller is in the blood. Amlodipine penetrates through the BBB.
Metabolism
Amlodipine undergoes a slow but active metabolism in the liver in the absence of a significant "first pass" effect. Metabolites do not have significant pharmacological activity.
Excretion
10% of amlodipine is excreted unchanged in urine, 60% in the form of metabolites; 20-25% - in the form of metabolites with bile through the intestine. Excretion has a two-phase character. T 1/2 of the final phase 30-50 h.
Pharmacokinetics in special clinical cases
In elderly patients (over 65 years), amlodipine excretion is slowed (T 1/2 - 65 h) compared to young patients, but this difference is not clinically significant.
In patients with hepatic insufficiency, the elongation of T 1/2 suggests that with prolonged use, amlodipine cumulation in the body will be higher (T 1/2 - up to 60 h).
Renal failure does not significantly affect the kinetics of amlodipine. When hemodialysis is not removed.
Amlodipine and lisinopril
Interaction between the active substances that make up the drug is unlikely. AUC, time to reach and C max values ​​in blood plasma, T 1/2 do not undergo changes in comparison with the indices of each individual active substance. Eating does not affect the absorption of active substances.
INDICATIONS
- Essential arterial hypertension (patients who are shown combined therapy).
DOSING MODE
The drug is taken orally, regardless of food intake, with a sufficient amount of liquid.
The recommended dose is 1 tab. 1 time / day. The maximum daily dose is 1 tablet.
At the beginning of therapy with Equator В® , symptomatic arterial hypotension may develop, which is more likely to occur in patients with impaired water-electrolyte balance due to previous diuretic therapy. Reception of diuretics should be discontinued 2-3 days before the start of therapy with Equator В® . In the case where the cancellation of diuretics is not possible, the initial dose of Equator В® is 1/2 table. 1 time / day, after taking it for several hours should be monitored for the patient because of the possible development of symptomatic arterial hypotension.
Patients with renal insufficiency
To determine the optimal initial and maintenance dose for patients with renal insufficiency, the dose should be titrated and determined individually, using separately lisinopril and amlodipine. Equator В® 5 mg / 10 mg is indicated only for those patients in whom the optimal maintenance dose of lisinopril and amlodipine is titrated to 10 mg and 5 mg, respectively. Equator В® 5 mg / 20 mg is indicated only for those patients in whom the optimal maintenance dose of lisinopril and amlodipine is titrated to 20 mg and 5 mg, respectively. Equator В® 10 mg / 20 mg is indicated only for those patients in whom the optimal maintenance dose of lisinopril and amlodipine is titrated to 20 mg and 10 mg, respectively. During treatment with Equator В®, it is necessary to monitor kidney function, potassium and sodium in the blood serum. In case of impaired renal function, the preparation of Equator В® should be discontinued and replaced with lisinopril and amlodipine in adequate doses.
Patients with hepatic insufficiency
Excretion of amlodipine may be delayed in patients with impaired hepatic function. Clear recommendations on the dosage regimen in such cases are not established, therefore the preparation Equator В® should be administered with caution to patients with hepatic insufficiency.
Elderly patients (over 65 years of age)
In clinical studies, age-related changes in efficacy or safety profile for amlodipine and lisinopril have not been observed. To determine the optimal maintenance dose, it is necessary to determine the dosage regimen individually, using separately lisinopril and amlodipine. Equator В® 5 mg / 10 mg is indicated only for those patients in whom the optimal maintenance dose of lisinopril and amlodipine is titrated to 10 mg and 5 mg, respectively. Equator В® 5 mg / 20 mg is indicated only for those patients in whom the optimal maintenance dose of lisinopril and amlodipine is titrated to 20 mg and 5 mg, respectively. Equator В® 10 mg / 20 mg is indicated only for those patients in whom the optimal maintenance dose of lisinopril and amlodipine is titrated to 20 mg and 10 mg, respectively.
SIDE EFFECT
The incidence of adverse reactions in patients receiving the combined drug was not higher than in patients receiving one of the active substances. Adverse reactions corresponded to the previously obtained data on amlodipine and / or lisinopril. Adverse reactions were mild, transient and rarely required the withdrawal of treatment.The most common adverse reactions with the combination of drugs were: headache (8%), cough (5%), dizziness (3%).
The frequency of adverse reactions is given separately for lisinopril and amlodipine.
The data are presented according to the system-organ classes according to the MedDRA classification and with the following frequency: very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from? 1/1000 to <1/100); rarely (from? 1/10 000 to <1/1000); very rarely (<1/10 000); frequency is unknown (can not be established based on available data).
Lisinopril
From the hemopoietic system: very rarely - oppression of bone marrow hematopoiesis, agranulocytosis, leukopenia, neutropenia, thrombocytopenia, hemolytic anemia, anemia, lymphadenopathy.
From the immune system: very rarely - vasculitis, a positive test for antinuclear antibodies.
From the side of metabolism and nutrition: very rarely - hypoglycemia.
Mental disorders: infrequent - mood changes, sleep disturbances; rarely - a violation of the psyche.
From the nervous system: often - dizziness, headache; infrequently - systemic dizziness, paresthesia, dysgeusia, convulsive twitching of the muscles of the extremities and lips; rarely confusion.
From the side of the cardiovascular system: often - a marked decrease in blood pressure, orthostatic hypotension; infrequently, myocardial infarction, AV conduction disorder, bradycardia, tachycardia, palpitations, worsening of the course of chronic heart failure, chest pain, cerebrovascular accident, Raynaud's syndrome.
From the respiratory system: often - dry cough; infrequently - rhinitis; rarely shortness of breath; very rarely - bronchospasm, allergic alveolitis / eosinophilic pneumonia, sinusitis.
From the digestive tract: often - diarrhea, vomiting; infrequently - abdominal pain, nausea, indigestion; rarely dry mouth; very rarely - pancreatitis, intestinal angioedema.
From the liver and bile ducts: very rarely - liver failure, cholestatic jaundice, hepatitis.
Allergic reactions: infrequently - allergic reactions / angioedema, swelling of the face, extremities, lips, tongue, vocal cords and / or larynx, skin rash, skin itch, photosensitivity; rarely - psoriasis, urticaria rash, alopecia; very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, vulgar pemphigus, increased sweating, pseudolymphoma of the skin *.
From the musculoskeletal system: rarely - arthralgia, myalgia, arthritis.
From the side of the kidneys and urinary tract: often - a violation of kidney function; rarely acute renal failure, uremia; very rarely - oliguria / anuria.
On the part of the reproductive system and mammary glands: infrequently - impotence; rarely - gynecomastia.
Common reactions: infrequent - increased fatigue, asthenia.
On the part of laboratory indicators: infrequently - increased concentration of urea and creatinine in the blood serum, hyperkalemia, increased activity of hepatic enzymes; rarely - reduction of hemoglobin and hematocrit, erythropenia, hyperbilirubinemia, hyponatremia.
Amlodipine
From the hemopoietic system: very rarely - thrombocytopenia.
From the immune system: very rarely - hypersensitivity.
From the side of metabolism and nutrition: very rarely - hyperglycemia.
Mental disorders: infrequent - insomnia, unusual dreams, mood changes, increased excitability, depression, anxiety; rarely - apathy, agitation.
From the nervous system: often - drowsiness, dizziness, headache; infrequently - syncope, tremor, paresthesia, dysgeusia, hypoesthesia; rarely migraine; very rarely - peripheral neuropathy, ataxia, amnesia, parosmia.
From the side of the organ of vision: infrequently - a vision disorder (diplopia, a violation of accommodation), xerophthalmia, conjunctivitis, pain in the eyes.
From the side of the organ of hearing: infrequently - noise in the ears.
From the cardiovascular system: often - heart palpitations, skin hyperemia; infrequent - marked decrease in blood pressure, orthostatic hypotension; rarely - exacerbation of chronic heart failure; very rarely - myocardial infarction, ventricular tachycardia, atrial fibrillation, arrhythmia, vasculitis.
From the respiratory system: infrequently - dyspnoea, rhinitis, nosebleeds; very rarely - cough.
From the side of the digestive tract: often - pain in the abdomen, nausea; infrequently - vomiting, indigestion, constipation or diarrhea, dry mouth, anorexia, thirst;rarely - increased appetite; very rarely - pancreatitis, gastritis, gingival hyperplasia.
From the liver and biliary tract: very rarely - cholestasis, jaundice, hepatitis.
Allergic reactions: infrequently - skin rash, skin itch, purpura, xeroderma; rarely - dermatitis; very rarely - angioedema, urticaria rash, erythema multiforme, increased sweating, cold sweat, alopecia, skin discoloration.
From the side of the kidneys and urinary tract: infrequent - urination disorder, nocturia, increased frequency of urination.
From the musculoskeletal system: infrequently - arthralgia, myalgia, muscle cramps, back pain, arthrosis; rarely - myasthenia gravis.
On the part of the reproductive system and mammary glands: infrequently - impotence, gynecomastia.
General reactions: often - peripheral edema, increased fatigue; infrequently - chest pain, pain, malaise, asthenia.
From the side of laboratory indicators: infrequently - increase or decrease in body weight; very rarely - increased activity of hepatic enzymes.
* A complex symptom complex has been reported that may include all or some of the following symptoms: fever, vasculitis, myalgia, arthralgia / arthritis, positive antinuclear antibody test, increased ESR, eosinophilia and leukocytosis, rash, photosensitization or other skin changes.
CONTRAINDICATIONS
- Quincke's edema in the anamnesis, incl. on the background of the use of ACE inhibitors;
- hereditary or idiopathic angioedema;
- hemodynamically significant stenosis of the aorta or mitral valve;
- hypertrophic obstructive cardiomyopathy;
- severe arterial hypotension (systolic blood pressure less than 90 mm Hg);
- cardiogenic shock;
- unstable angina (with the exception of Prinzmetal angina);
- heart failure after acute myocardial infarction (within the first 28 days);
- Pregnancy;
- lactation period;
- child and adolescence to 18 years (effectiveness and safety have not been established drug in this age group);
- hypersensitivity to the components of the drug;
- Hypersensitivity to lisinopril other ACE inhibitors;
- hypersensitivity to other dihydropyridine derivatives.
With cautionbe used in patients with bilateral renal artery stenosis or stenosis of the artery only kidneys with progressive azotemia, with azotemia, primary hyperaldosteronism, when expressed renal impairment, the condition after kidney transplantation, hyperkalemia, hepatic dysfunction, hypotension, cerebrovascular diseases (including. h. at cerebrovascular insufficiency), ischemic heart disease, during coronary insufficiency, SSS (bradycardia, tachycardia), chronic heart failure nonischemic etiology FC III-IV of NYHA classification, when aortic stenosis, mitral stenosis, acute myocardial infarction (and within 1 month after myocardial infarction), systemic autoimmune connective tissue diseases (including scleroderma, systemic lupus erythematosus)with inhibition of bone marrow hematopoiesis, diabetes, a diet restriction salt when hypovolemic states (in t. h. due to diarrhea, vomiting), elderly patients, hemodialysis vysokoprotochnyh using dialysis membranes with high permeability (AN69В® ).
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy.
When diagnosing pregnancy drug intake Equator В® should be discontinued immediately.
Lisinopril crosses the placental barrier. ACE inhibitors in the II and III trimester of pregnancy has adverse effects on the fetus (expressed may decrease blood pressure, renal failure, hyperkalemia, hypoplasia of bones of the skull, intrauterine fetal death). Information about the negative impact of the drug on the fetus in the case of use in the I trimester of pregnancy is not. For newborns and infants who have been exposed to intrauterine ACE inhibitor should be closely monitored for timely detection of significant decrease in blood pressure, oliguria and hyperkalemia.
Safety of amlodipine in pregnancy has not been established, therefore its use in this category of patients is contraindicated.
Lisinopril may be excreted in breast milk. There is no evidence of amlodipine allocation in breast milk. However it is known that other calcium channel blockers of the dihydropyridine derivatives are excreted in breast milk. Use of the drug Equator В® lactation is not recommended. If necessary, the drug Equator В® lactation discontinue breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
To determine the optimal maintenance dose is necessary to determine the dosing regimen individually using separate lisinopril and amlodipine, with simultaneous monitoring of renal function. In the case of reducing the renal function receiving Equator preparation В® should be discontinued and replaced by monotherapy drugs in adequate doses. Furthermore, it may require dose reduction or abolition of diuretics.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with impaired liver function T 1/2 amlodipine lengthened. At the moment, according to the dosing regimen recommendations are not designed so EquatorВ® should be administered with caution, being able to evaluate the expected benefits and potential risks of treatment.
APPLICATION FOR CHILDREN
Contraindications: childhood and adolescence to 18 years (effectiveness and safety have not been established drug in this age group);
APPLICATION IN ELDERLY PATIENTS
In clinical studies it found no age-related changes in efficacy or safety profile of amlodipine and lisinopril.
SPECIAL INSTRUCTIONS
Hypotension
Marked reduction in blood pressure with the development of clinical symptoms can be observed in patients with reduced BCC and / or the sodium content due diuretics, fluid loss, or for other reasons, such as excessive sweating, prolonged vomiting and / or diarrhea. In the case of hypotension patients, and should be put fill fluid loss (in / in infusion of 0.9% sodium chloride solution), if necessary. Preferably, the reconstitution fluid loss and / or sodium was conducted before treatment Equator. Blood pressure should be monitored after receiving the initial dose. This applies especially in patients with coronary artery disease or cerebrovascular disease when marked reduction in blood pressure can lead to myocardial infarction or stroke.
Aortic and mitral stenosis
As with all vasodilators, Equator В® should be administered with caution to patients with obstruction of the outflow tract of the left ventricle and mitral valve stenosis.
Impaired renal function
in some patients with hypertension without marked renovascular disease manifestations observed elevation of creatinine and urea in the blood serum, in most cases, minimal or transient more pronounced while receiving an ACE inhibitor and a diuretic. This is most common in patients with a history of renal diseases.
To determine the optimal maintenance dose is necessary to determine the dosing regimen individually using separate lisinopril and amlodipine, with simultaneous monitoring of renal function. In the case of reducing the renal function receiving Equator preparation В® should be discontinued and replaced by monotherapy drugs in adequate doses. Furthermore, it may require dose reduction or abolition of diuretics.
Angioneurotic edema
Angioneurotic edema of the face, extremities, lips, tongue, vocal cords and / or larynx reported in patients treated with ACE inhibitors, including lisinopril. In these cases, acceptance of the Equator should be discontinued immediately and the patient to conduct a thorough medical supervision until complete disappearance of symptoms.
Swelling of the face, lips and extremities are usually alone, however, should be used antihistamines to reduce the severity of symptoms.
Angioneurotic edema, laryngeal edema accompanied may lead to death. In identifying the swelling tongue, pharynx and larynx that cause airway obstruction, an urgent need to start the event emergency. By proper measures include: n / a 0.3-0.5 mg administering or slow / in a 0.1 mg 0.1% solution of epinephrine (adrenaline), followed by / in the introduction of corticosteroids and antihistamines and while monitoring the vital functions.
In patients treated with ACE inhibitors are rare intestinal angioedema bowel edema. These patients complained of abdominal pain (with or without nausea and vomiting them); in some cases, prior facial edema was observed, and the activity of the C-1 esterase was within normal limits. Intestinal bowel angioneurotic edema diagnosed according gastrointestinal computed tomography, ultrasound, or after, or during surgery, the symptoms disappeared after discontinuation of ACE inhibitor. When the differential diagnosis of abdominal pain in patients treated with ACE inhibitors, one should consider and intestinal bowel angioneurotic edema.
Anaphylactic reactions in patients on hemodialysis
Patients who carried through polyacrylonitrile dialysis membrane (e.g., AN69 В® ) and which are simultaneously obtained ACE inhibitors, cases of anaphylactic shock registered, therefore to avoid such a combination. Patients are advised to apply any other type of dialysis membrane, or other hypotensive drug pharmacotherapeutic group.
Anaphylactic reactions in patients during the apheresis LDL
rare in patients treated with ACE inhibitors during LDL apheresis dextran sulfate, developing life-threatening anaphylactic reactions. Such reactions are prevented by canceling the ACE inhibitor before each apheresis procedure.
Desensitization hornet or bee venom
Sometimes, patients treated with ACE inhibitors, desensitization with hymenoptera venom (e.g., bees and wasps) developed anaphylactic reactions. Such life-threatening situations can be avoided with the timely cancellation of ACE inhibitors.
Hepatotoxicity
In rare cases, ACE inhibitors accompanied syndrome who started with cholestatic jaundice or hepatitis and escalated in fulminant hepatic necrosis and in several cases led to death. The mechanism of this syndrome is unclear. Patients receiving Equator В® , the development of jaundice or increased activity of liver enzymes should be abolished Equator В® with follow-up of their condition.
Liver failure
In patients with impaired liver function T 1/2 amlodipine lengthened. At the moment, according to the dosing regimen recommendations are not designed so EquatorВ® should be administered with caution, being able to evaluate the expected benefits and potential risks of treatment.
Hematological toxicity
In rare cases, patients treated with ACE inhibitors, registered neutropenia, agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function and no other aggravating factors, neutropenia occurs rarely. Neutropenia and agranulocytosis are reversible and disappears after discontinuation of ACE inhibitor. EquatorВ® should be used with caution in patients with vascular collagenosis, during immunosuppressive therapy, during treatment with allopurinol or procainamide or a combination of these aggravating factors, especially when the preceding renal dysfunction. Some of these patients developed serious infections, which in some cases have not undergone correction in antibiotic therapy. During treatment EquatorВ® recommended to periodically monitor the level of white blood cells in these patients, and to warn them of the need to report the first signs of infectious disease.
Cough
during ACE inhibitors are often recorded cough. As a general rule, non-productive cough, constant, and stopped after discontinuation of the drug. When the differential diagnosis of cough should be considered and coughing, resulting from the use of ACE inhibitors.
Surgery / general anesthesia
In patients undergoing major surgery or during general anesthesia drugs, resulting in hypotension, lisinopril may block the formation of angiotensin II after compensatory renin release. If hypotension developed probably as a result of the above mechanism, it is possible to conduct correction of increasing BCC.
Elderly patients
Elderly patients with impaired renal function, carry out the correction of the drug dose Equator В® .
Hyperkalemia
in some patients treated with ACE inhibitors, observed an increase in serum potassium. Risk group for the development of hyperkalemia consists of patients with renal failure, diabetes, congestive heart failure, dehydration, metabolic acidosis or while receiving potassium-sparing diuretics, supplementation with potassium, potassium-based salt substitutes or any other medications, leading to an increase in potassium level in serum blood (e.g., heparin). If necessary, the simultaneous reception with the above preparations should monitor the concentration of potassium in blood serum.
Patients with decreased body weight, short stature patients and patients with severe hepatic dysfunction may require dose reduction.
Equator В® does not exert any adverse effect on metabolism and plasma lipids and can be used in the treatment of patients with bronchial asthma, diabetes and gout.
During treatment requires control of body weight and observing the dentist (to prevent pain, bleeding and gingival hyperplasia).
Impact on the ability to drive vehicles and manage mechanisms
Apply the drug Equator В® must be carefully (risk of pronounced reduction in blood pressure and dizziness). Therefore, early treatment is recommended to drive vehicles avoid using machinery and other work that requires high concentration of attention.
OVERDOSE
Amlodipine
Symptoms: marked reduction of blood pressure with possible development of reflex tachycardia and excessive peripheral vasodilation (the risk of severe and persistent hypotension, including the development of shock and death).
Treatment: gastric lavage, appointment of activated carbon, the maintenance function of the cardiovascular system, the control functions of the cardiovascular and respiratory systems, giving the patient a horizontal position with the raised feet, control BCC and diuresis. To restore the vascular tone - the use of vasoconstrictor (in the absence of contraindications to their use); with the purpose of elimination of consequences of blockade of calcium channels - in / in the introduction of calcium gluconate. Hemodialysis is ineffective.
Lisinopril
Symptoms: marked reduction of blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, irritability.
Treatment: gastric lavage, administration of activated charcoal, giving the patient a horizontal position with the raised feet, filling bcc - in / in a plasma-solutions, symptomatic therapy, control of the cardiovascular and respiratory functions
