Amlodipine, Ramipril
Egis
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2019-09-19
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Clinical Pharmacology
Antihypertensive combined agent (ACE inhibitor + BMCK)
Indications
Arterial hypertension (patients who have been shown combination therapy with amlodipine and ramipril in doses, as in combination).
Composition
| 1 caps | |
| amlodipine besylate | 6.95 mg, |
| which corresponds to the content of amlodipine | 5 mg |
| ramipril | 5 mg |
Excipients: crospovidone - 20 mg, hypromellose - 1.18 mg, microcrystalline cellulose - 114.82 mg, glyceryl dibehenate - 2.05 mg.
The composition of the hard gelatin capsule (CONI-SNAP 3), the color code of the cover and base 51072: brilliant blue dye (E133), charming red dye (E129), titanium dioxide, gelatin.
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Dosage and Administration
Orally, 1 capsule 1 time per day, at the same time, regardless of the meal.
The dose of Agipres is selected after a previously performed titration of doses of individual components of the drug: ramipril and amlodipine in patients with hypertension. The drug Egipres with fixed doses of active ingredients cannot be used for initial therapy. If patients need a dose adjustment, then it should be carried out only by titrating the doses of active ingredients in monotherapy. Only after that, it is possible to use the drug Egipres with fixed doses of the active components in the combinations below.
With therapeutic necessity, the dose of Egipres can be changed based on individual titration of the doses of individual components: 5 mg of amlodipine + 5 mg of ramipril or 5 mg of amlodipine + 10 mg of ramipril or 10 mg of amlodipine + 5 mg of ramipril or 10 mg of amlodipine + 10 mg of ramipril.
Egipres in a dose of 10 mg of amlodipine + 10 mg of ramipril is the maximum daily dose of the drug, which is not recommended to exceed. Dosages of 10 mg of amlodipine + 5 mg of ramipril (for amlodipine) and 5 mg of amlodipine + 10 mg of ramipril (for ramipril) are the maximum daily doses.
Adult patients
In patients taking diuretics, the drug should be prescribed with caution, due to the risk of impaired water and electrolyte balance. In these patients, kidney function and potassium should be monitored.
Patients of advanced age and patients with a renal failure. Withdrawal of amlodipine and ramipril and its metabolites in elderly patients and patients with renal insufficiency is slowed down. Therefore, in these patients it is necessary to regularly monitor the content of creatinine and potassium in the blood plasma. Egipres can be prescribed to patients with Cl creatinine equal to or greater than 60 ml / min. With Cl creatinine less than 60 ml / min, as well as in patients with hypertension who are on hemodialysis, Egipres is recommended only for patients who received 5 mg of ramipril, as the optimal maintenance dose during the individual dose titration process. There is no need to titrate an individual dose of amlodipine in patients with impaired renal function. Egipres is contraindicated in patients with Cl creatinine less than 20 ml / min / 1.73 m2. Changes in the concentration of amlodipine in the blood plasma do not correlate with the severity of renal failure.
Patients with liver failure. Care should be taken when prescribing Egipres in patients with hepatic insufficiency due to the lack of recommendations on the dosing of the drug in these patients. Egipres is recommended only for patients who received 2.5 mg of ramipril as the optimal maintenance dose during the individual dose titration process.
Kids and teens
Egipres should not be prescribed to children and adolescents under 18 years of age due to the lack of data on the efficacy and safety of the use of ramipril and amlodipine in these groups of patients, both as monotherapy and as combination therapy.
Adverse reactions
The undesirable effects listed below are given in accordance with the following gradations of the frequency of their occurrence according to the WHO classification: very often - more than 1/10 (more than 10%); often - more than 1/100, but less than 1/10 (more than 1%, but less than 10%); infrequently - more than 1/1000, but less than 1/100 (more than 0.1%, but less than 1%); rarely, more than 1/10000, but less than 1/1000 (more than 0.01%, but less than 0.1%); very rarely - less than 1/10000 (less than 0.01%).
Amlodipine
On the part of the cardiovascular system: often - peripheral edema (ankles and feet), a heartbeat; infrequently - excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely - development or exacerbation of HF; very rarely - cardiac arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), MI, chest pain, migraine.
From the musculoskeletal system and connective tissue: rarely - arthralgia, muscle cramps, myalgia, back pain, arthrosis; rarely - myasthenia.
From the side of the central nervous system and peripheral nervous system: often - a sensation of heat and flushing to the skin of the face, increased fatigue, dizziness, headache, drowsiness; infrequently - indisposition, fainting, increased sweating, asthenia, hypesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, mood lability, unusual dreams, nervousness, depression, anxiety; rarely - convulsions, apathy; very rarely - ataxia, amnesia, isolated cases of extrapyramidal syndrome.
On the part of the digestive system: often - abdominal pain, nausea; infrequently - vomiting, changes in the mode of bowel movement (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dryness of the oral mucosa, thirst; rarely - gingival hyperplasia, increased appetite; very rarely - gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of hepatic transaminases, hepatitis.
From the side of blood: very rarely - thrombocytopenic purpura, thrombocytopenia, leukopenia.
Metabolic disorders: very rarely - hyperglycemia.
On the part of the respiratory system: infrequently - shortness of breath, rhinitis; very rarely - cough.
On the part of the kidneys and urinary tract: infrequently - frequent urination, painful urination, nocturia, impotence; very rarely - dysuria, polyuria.
Allergic reactions: rarely - pruritus, rash; very rarely - angioedema, erythema multiforme, urticaria.
Other: infrequently - alopecia, tinnitus, gynecomastia, weight gain / loss, visual impairment, diplopia, accommodation disturbance, xerophthalmia, conjunctivitis, eye pain, taste perversion, chills, nose bleeding; rarely - dermatitis; very rarely - parosmia, xerodermia, cold sweat, impaired skin pigmentation.
Ramipril
From the side of the heart: infrequently - myocardial ischemia, including the development of an attack of angina or myocardial infarction, tachycardia, arrhythmias (appearance or intensification), palpitations, peripheral edema.
On the part of the vessels: often - an excessive decrease in blood pressure, impaired orthostatic regulation of vascular tone (orthostatic hypotension), syncopal states; infrequently - flushing to the skin of the face; rarely - the occurrence or enhancement of circulatory disorders on the background of stenotic vascular lesions, vasculitis; frequency is unknown - Raynaud's syndrome.
From the side of the central nervous system: often - headache, a feeling of lightness in the head; infrequently - dizziness, agevziya (loss of taste sensitivity), dysgeusia (violation of taste sensitivity), paresthesia (burning sensation); rarely - tremor, imbalance; frequency unknown - cerebral ischemia, including ischemic stroke and transient disturbance of cerebral circulation, disturbance of psychomotor reactions, parosmia (disturbance of perception of smells).
On the part of the organ of vision: infrequently - visual impairment, including blurred vision; rarely - conjunctivitis.
On the part of the organ of hearing: rarely - hearing loss, ringing in the ears.
On the part of the psyche: infrequently - depressed mood, anxiety, nervousness, restlessness, sleep disturbances, including drowsiness; rarely - confusion; frequency unknown - impaired concentration.
On the part of the respiratory system: often - dry cough (worse at night and when lying down), bronchitis, sinusitis, shortness of breath; infrequently - bronchospasm, including the worsening of the course of bronchial asthma, nasal congestion.
On the part of the digestive system: often - inflammatory reactions in the stomach and intestines, digestive disorders, discomfort in the abdomen, dyspepsia, diarrhea, nausea, vomiting; Infrequently - pancreatitis, incl. and fatal (cases of pancreatitis with a fatal outcome when taking ACE inhibitors were extremely rare), increased activity of pancreatic enzymes in the blood plasma, intestinal angioedema, edema, gastritis, constipation, dry oral mucosa; rarely - glossitis; unknown frequency - aphthous stomatitis (inflammatory reaction of the oral mucosa).
On the part of the hepatobiliary system: infrequently - increased activity of liver enzymes and the content of conjugated bilirubin in the blood plasma; rarely - cholestatic jaundice, hepatocellular lesions; frequency is unknown - acute liver failure, cholestatic or cytolytic hepatitis (death was rarely observed).
On the part of the kidneys and urinary tract: infrequently - impaired renal function, including the development of acute renal failure, an increase in urine excretion, an increase in pre-existing proteinuria, an increase in the concentration of urea and creatinine in the blood.
On the part of the reproductive system and mammary glands: infrequently - transient impotence due to erectile dysfunction, decreased libido; frequency unknown - gynecomastia.
From the side of blood and lymphatic system: infrequently - eosinophilia; rarely - leukopenia, including neutropenia and agranulocytosis, a decrease in the number of red blood cells in peripheral blood, a decrease in hemoglobin, thrombocytopenia; frequency is unknown - oppression of bone marrow hematopoiesis, pancytopenia, hemolytic anemia.
On the part of the skin and mucous membranes: often - skin rash, in particular maculopapular; infrequently - angioedema, incl. and fatal (laryngeal edema can cause airway obstruction, leading to death), pruritus, hyperhidrosis (sweating); rarely - exfoliative dermatitis, urticaria, onycholysis; very rarely - photosensitivity reactions; unknown frequency - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, worsening of the course of psoriasis, psoriasis-like dermatitis, pemphigoid or lichenoid (desiccous) exanthema or enanthema, alopecia.
On the part of the musculoskeletal system and connective tissue: often - muscle cramps, myalgia; infrequently - arthralgia.
On the part of metabolism, nutrition and laboratory parameters: often - an increase in the content of potassium in the blood; infrequently - anorexia, loss of appetite; frequency is unknown - decrease in sodium concentration in the blood, syndrome of inadequate secretion of ADH.
On the part of the immune system: the frequency is unknown - anaphylactic or anaphylactoid reactions (with the inhibition of ACE, the number of anaphylactic or anaphylactoid reactions to insect poisons increases), an increase in the titer of antinuclear antibodies.
General disorders: often - chest pain, feeling tired; infrequently - fever; rarely - asthenia (weakness).
Amlodipine
- hypersensitivity to amlodipine and other dihydropyridine derivatives;
- severe hypotension (SAD less than 90 mmHg), shock (including cardiogenic);
- an obstructive process that impedes the release of blood from the left ventricle (for example, clinically significant aortic stenosis);
- hemodynamically unstable heart failure after myocardial infarction;
- pregnancy;
- breastfeeding period;
- age up to 18 years (safety and efficacy not determined).
Ramipril
- hypersensitivity to ramipril and other ACE inhibitors;
- history of angioedema (hereditary or idiopathic, as well as associated with previous therapy with ACE inhibitors);
- hemodynamically significant renal artery stenosis (bilateral or unilateral, in the case of a single kidney);
- arterial hypotension (SAD less than 90 mmHg) or conditions with unstable hemodynamic parameters;
- hemodynamically significant aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy;
- primary hyper aldosteronism;
- severe renal impairment (Cl creatinine 2);
- hemodialysis (experience with clinical use is insufficient);
- nephropathy, the treatment of which is carried out by the SCS, NSAIDs, immunomodulators and / or other cytotoxic agents (clinical experience is insufficient);
- decompensated chronic heart failure (experience with clinical use is insufficient);
- hemodialysis or hemofiltration using certain types of membranes with a negatively charged surface, such as high-flow polyacrylonitrile membranes (risk of hypersensitivity reactions);
- LDL apheresis with dextran sulfate (risk of hypersensitivity reactions);
- desensitization therapy in case of hypersensitivity reactions to the poisons of insects - bees, wasps;
- acute stage of myocardial infarction in patients with diseases such as severe heart failure (NYHA functional class IV); life-threatening ventricular arrhythmias; pulmonary heart;
- the simultaneous use of drugs containing aliskiren in patients with impaired renal function (Cl creatinine less than 60 ml / min) and patients with diabetes mellitus;
- pregnancy;
- breastfeeding period;
- age up to 18 years (experience of clinical use is insufficient).
Amlodipine + Ramipril
- hypersensitivity to excipients that are part of the drug;
- renal failure (creatinine Cl);
- pregnancy;
- breastfeeding period;
- age up to 18 years (experience of clinical use is insufficient).
With caution for the combination of amlodipine + ramipril: atherosclerotic lesions of the coronary and cerebral arteries (the danger of an excessive decrease in blood pressure); increased activity of the RAAS, in which with the inhibition of ACE there is a risk of a sharp decrease in blood pressure with deterioration of renal function; severe, especially malignant hypertension; CHF, especially severe or about which other drugs with antihypertensive action are taken; hemodynamically significant unilateral renal artery stenosis (in the presence of both kidneys); prior diuretic use; violations of water and electrolyte balance, reduction of bcc (including during the intake of diuretics, salt-free diet, diarrhea, vomiting, excessive sweating); simultaneous use with drugs containing aliskiren (with double blockade of RAAS increases the risk of a sharp decrease in blood pressure, hyperkalemia and deterioration of renal function); dysfunction of the liver (lack of experience with the application: both strengthening and weakening of the effects of ramipril are possible; in patients with cirrhosis of the liver with ascites and edema, significant activation of the RAAS is possible); impaired renal function (Cl creatinine more than 20 ml / min); condition after kidney transplantation; Systemic diseases of the connective tissue, incl. systemic lupus erythematosus, scleroderma, concomitant therapy with drugs that can cause changes in the pattern of peripheral blood (including allopurinol, procainamide) - possibly inhibition of bone marrow hematopoiesis, development of neutropenia or agranulocytosis; diabetes mellitus (risk of developing hyperkalemia); advanced age (risk of increased antihypertensive effect); hyperkalemia; hyponatremia; CHF is a non-ischemic etiology of functional class III – IV according to the NYHA classification; aortic stenosis; sick sinus syndrome; mitral stenosis; hypotension; the only functioning kidney; renovascular hypertension; simultaneous use of dantrolene, estramustine, potassium-saving diuretics and potassium preparations, potassium-containing food salt substitutes, lithium preparations; surgery / general anesthesia; hemodialysis using high-flow membranes (for example AN69).
Drug interactions
Amlodipine
Inhibitors of microsomal liver oxidation enzymes (erythromycin in young people, diltiazem in the elderly, ketoconazole, itraconazole, ritonavir) can be expected to increase plasma concentration of amlodipine, increasing the risk of side effects, and inductors of liver microsomal oxidation enzymes decrease. With simultaneous use of amlodipine with cimetidine pharmacokinetics of amlodipine does not change.
The simultaneous single dose of 240 ml of grapefruit juice and 10 mg of amlodipine orally is not accompanied by a significant change in the pharmacokinetics of amlodipine.In contrast to other BPCs, the clinically significant interaction of amlodipine (III generation BPC) was not found when used together with NSAIDs, especially indomethacin.
It is possible to enhance the antianginal and antihypertensive effects of BPC when used together with thiazide and loop diuretics, verapamil, ACE inhibitors, beta-blockers and nitrates, as well as increase their antihypertensive action when used together with alpha1-adrenergic neuroleptics. Although in the study of amlodipine negative inotropic effect is usually not observed, however, some CCBs can increase the severity of the negative inotropic effect of antiarrhythmic drugs causing prolongation of the QT interval (for example, amiodarone and quinidine).
The combined use of BPC with lithium preparations (data for amlodipine is not available) may enhance the manifestation of their neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).
Amlodipine does not affect in vitro the degree of binding to plasma proteins of digoxin, phenytoin, warfarin and indomethacin.
A single dose of aluminum / magnesium-containing antacids has no significant effect on the pharmacokinetics of amlodipine.
A single dose of 100 mg of sildenafil in patients with essential hypertension does not affect the parameters of amlodipine pharmacokinetics.
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. With simultaneous use of amlodipine with digoxin in healthy volunteers, the content of digoxin in serum and its renal clearance do not change. With a single and repeated use at a dose of 10 mg, amlodipine does not significantly affect the pharmacokinetics of ethanol.
Amlodipine does not affect the change in PV caused by warfarin. Amlodipine does not cause significant changes in the pharmacokinetics of cyclosporine.
Combinations not recommended
Simultaneous use of dantrolene (on / in the introduction), cytochrome CYP3A4 isoenzyme inducers (for example rifampicin, Hypericum perforatum drugs) and inhibitors of cytochrome CYP3A4 isoenzymes (protease inhibitors, antifungal drugs of the azole group, macrolides (for example, erythromycin glyphs) or anti-glyphs that have been added to them and they are ancryls or macrosides or ants or anti-fungal groups using macrosides or using anti-fungal fluids or anti-fungal fluids or anti-fungal fluids (anti-fungal fluids). .
Ramipril
Contraindications
The use of some high-flow membranes with a negatively charged surface (for example, polyacrylonitrile membranes) during hemodialysis or hemofiltration; The use of dextran sulfate in LDL apheresis is the risk of developing severe anaphylactic reactions.
Combinations not recommended
With potassium salts, potassium-sparing diuretics (for example amiloride, triamterene, spironolactone) and other drugs, including with antagonists of angiotensin II receptors (APA II), trimethoprim, tacrolimus, cyclosporine — hyperkalemia may develop (if used simultaneously, regular monitoring of serum potassium is required).
Combinations that should be used with caution
With antihypertensive drugs (especially diuretics) and other drugs that reduce blood pressure (nitrates, tricyclic antidepressants, general and local anesthesia, ethanol, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin) - potentiation of the antihypertensive effect. When combined with diuretics, serum sodium should be monitored.
With sleeping pills, narcotic and other painkillers - perhaps a more pronounced decrease in blood pressure.
With vasopressor sympathomimetics (epinephrine, isoproterenol, dobutamine, dopamine) - reducing the antihypertensive effect of ramipril, requires regular monitoring of blood pressure.
With allopurinol, procainamide, cytostatics, immunosuppressants, systemic corticosteroids and other means that may affect hematological parameters, combined use increases the risk of leukopenia.
With lithium salts, an increase in serum lithium content and an increase in the cardio and neurotoxic effect of lithium.
With hypoglycemic agents for oral administration (sulfonylurea derivatives, biguanides), insulin - due to a decrease in insulin resistance under the influence of ramipril, the hypoglycemic effect of these drugs may increase, up to the development of hypoglycemia.
The simultaneous use of drugs containing aliskiren in patients with diabetes mellitus and renal insufficiency (Cl creatinine less than 60 ml / min), as well as vildagliptin - due to an increase in the incidence of angioedema and simultaneous use with ACE inhibitors.
Combinations to be taken into account
With NSAIDs (indomethacin, acetylsalicylic acid) - it is possible to weaken the effect of ramipril, increase the risk of renal dysfunction and increase the content of potassium in the blood serum.
With heparin, an increase in serum potassium is possible.
With sodium chloride, a weakening of the antihypertensive effect of ramipril and a less effective treatment of the symptoms of CHF.
With ethanol - increased vasodilation symptoms. Ramipril may increase the adverse effects of ethanol on the body.
With estrogen - a weakening of the antihypertensive effect of ramipril (fluid retention).
Desensitizing therapy for hypersensitivity to the poisons of insects - ACE inhibitors, including ramipril, increase the likelihood of severe anaphylactic or anaphylactoid reactions to insect poisons.
Pregnancy and Lactation
The drug Egipres contraindicated for use, because ramipril can have an adverse effect on the fetus: impaired development of the kidneys of the fetus, lowering blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, hypoplasia of the skull bones, oligohydramnios, contracture of the extremities, deformation of the bones of the skull, hypoplasia of the lungs. Before starting the drug in women of childbearing age, pregnancy should be excluded.
If a woman is planning a pregnancy, treatment with the drug should be discontinued. If pregnancy occurs during drug treatment, it should be discontinued as soon as possible and the patient transferred to other drugs, the application of which will have the lowest risk for the child.
If drug treatment is necessary during breastfeeding, it should be discontinued (data on the elimination of amlodipine and ramipril with breast milk of women are not available).
Fertility
Amlodipine. Reversible biochemical changes in sperm heads were observed in some patients who received BPC. Clinical data are insufficient to assess the potential effect of amlodipine on fertility.
Special instructions
The information relating to ramipril and amlodipine is applicable to the drug Egipres.
Amlodipine
In the treatment of hypertension, amlodipine can be combined with the administration of thiazide diuretics, alpha- and beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, NSAIDs, antibiotics and hypoglycemic agents for oral administration.
In the treatment of angina, amlodipine can be prescribed in combination with other antianginal agents, including patients refractory to treatment with nitrates and / or beta-blockers in adequate doses.
Amlodipine does not have any adverse effect on the metabolism and plasma lipids and can be used in the treatment of patients with bronchial asthma, diabetes and gout.
Amlodipine can also be used in cases where the patient is prone to vasospasm / vasoconstriction.
Patients with low body weight, short stature and patients with severe liver dysfunction may require a lower dosage.
During treatment, body weight control and monitoring by a dentist is necessary (to prevent soreness, bleeding and gingival hyperplasia).
Ramipril
Before starting treatment with ramipril, it is necessary to eliminate hyponatremia and hypovolemia. Patients who have previously taken diuretics need to cancel them or at least reduce their dose 2–3 days before starting ramipril (in this case, you should regularly monitor the condition of patients with CHF due to the possibility of their decompensation with an increase in BCC).
After taking the first dose of the drug, as well as increasing its dose and / or diuretic dose (especially loop), it is necessary to ensure regular medical observation of the patient for at least 8 hours in order to take appropriate measures in the event of an excessive decrease in blood pressure.
If ramipril is used for the first time or in a high dose in patients with increased RAAS activity, they should regularly monitor their blood pressure, especially at the beginning of treatment, because these patients have an increased risk of excessive blood pressure reduction. In case of malignant hypertension and HF, especially in the acute stage of myocardial infarction, treatment with ramipril should be initiated only in a hospital setting.
In patients with CHF, the drug may lead to the development of a pronounced decrease in blood pressure, which in some cases is accompanied by oliguria or azotemia and rarely by the development of acute renal failure.
Care should be taken when treating elderly patients, since they may be particularly sensitive to ACE inhibitors; In the initial phase of treatment, it is recommended to monitor indicators of renal function.
In patients for whom a decrease in blood pressure may pose a certain risk (for example, patients with atherosclerotic narrowing of the coronary or cerebral arteries), treatment should begin under strict medical supervision.
Caution should be exercised during physical exertion and / or hot weather due to the risk of sweating and dehydration with the development of arterial hypotension due to a decrease in the BCC and a decrease in the sodium content in the blood.
Alcohol is not recommended during treatment.
Transient hypotension is not a contraindication to continue treatment after stabilization of blood pressure. In the case of recurrence of severe hypotension, reduce the dose or discontinue the drug. In patients treated with ACE inhibitors, there were cases of angioedema of the face, limbs, lips, tongue, pharynx, or larynx. In the event of swelling in the face (lips, eyelids) or tongue, or a violation of swallowing or breathing, the patient should immediately stop taking the drug. Angioedema, localized in the area of the tongue, pharynx or larynx (possible symptoms: impaired swallowing or breathing), can be life-threatening and requires urgent measures for its relief: s / w introduction 0.3-0.5 mg or IV the introduction of 0.1 mg of epinephrine (under the control of blood pressure, heart rate and ECG), followed by the use of corticosteroids (intravenously, intramuscularly or orally); It is also recommended in / in the introduction of antihistamines (antagonists of N1- and H2- histamine receptors), and in case of insufficiency of inactivators of the enzyme C1-esterase can consider the need to introduce in addition to epinephrine inhibitors of the enzyme C1esterase. The patient should be hospitalized and should be monitored until the symptoms are relieved, but not less than 24 hours.
In patients treated with ACE inhibitors, there were cases of intestinal angioedema, which was manifested by abdominal pains with nausea and vomiting or without them; in some cases, angioedema of the face was observed simultaneously.When a patient with the above described symptoms appears to have treated with an ACE inhibitor, the possibility of developing intestinal angioedema in them should also be considered when conducting a differential diagnosis.
Treatment aimed at desensitization to the poison of insects (bees, wasps) and the simultaneous use of ACE inhibitors can initiate anaphylactic and anaphylactoid reactions (for example, reduction of blood pressure, shortness of breath, vomiting, allergic skin reactions), which can sometimes be life-threatening. During treatment with ACE inhibitors, hypersensitivity reactions to insect venom (for example, bees, wasps) develop faster and are more difficult. If it is necessary to conduct desensitization to the poison of insects, then the ACE inhibitor should be temporarily replaced by the corresponding drugs of another class.
When using ACE inhibitors, life-threatening, rapidly developing anaphylactoid reactions have been described, sometimes up to the development of shock during hemodialysis or plasma filtration using certain high-flow membranes (for example, polyacrylonitrile membranes) (see also the instructions of the membrane manufacturers). It is necessary to avoid the joint use of ramipril and such membranes (for example, for urgent hemodialysis or hemofiltration). In this case, it is preferable to use other membranes or exclude the use of an ACE inhibitor. Similar reactions were observed in LDL apheresis using dextran sulfate. Therefore, this method should not be used in patients receiving an ACE inhibitor. In patients with impaired liver function, the response to ramipril treatment can be either enhanced or weakened. In addition, in patients with severe liver cirrhosis with edema and / or ascites, significant activation of the RAAS is possible, therefore, special care should be taken in treating these patients.
Before surgery (including dental) it is necessary to warn the surgeon / anesthesiologist about the use of an ACE inhibitor.
The use of an ACE inhibitor in patients undergoing extensive surgery and / or general anesthesia can lead to a pronounced decrease in blood pressure if agents are used for general anesthesia with hypotensive action. This is due to the blocking of the formation of angiotensin II against the background of a compensatory increase in renin activity. In this case, increase the volume of circulating fluid. It is recommended to stop taking an ACE inhibitor 24 hours before surgery. Based on the results of epidemiological studies, it is assumed that the simultaneous intake of ACE inhibitors and insulin, as well as hypoglycemic agents for oral administration can lead to the development of hypoglycemia. The greatest risk of development is observed during the first weeks of combination therapy, as well as in patients with impaired renal function.
Patients with diabetes require regular glycemic control, especially during the first month of treatment with ACE inhibitors.
It is recommended to conduct careful monitoring of newborns who were exposed to prenatal exposure to ACE inhibitors to detect arterial hypotension, oliguria and hyperkalemia.
When oliguria, it is necessary to maintain blood pressure and renal perfusion by injecting appropriate fluids and vasoconstrictor agents.
These newborns are at risk of developing oliguria and neurological disorders, possibly due to a decrease in renal and cerebral blood flow due to a decrease in blood pressure caused by ACE inhibitors.
During therapy with ACE inhibitors, a dry cough may occur. Coughing persists while taking this group of drugs and disappears after they are canceled. When a patient has a dry cough, you should be aware of the possible iatrogenic nature of this symptom.
Patients of the Negroid race are more likely to develop angioedema than on other races while taking ACE inhibitors. Ramipril, like other ACE inhibitors, may have a less pronounced antihypertensive effect in patients of the Negroid race compared to other races. Perhaps this difference is due to the fact that in patients of the Negroid race with AH, low renin activity is more often observed.
Monitoring of laboratory paramete
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