Ramikardia - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspcapsules

Composition:

Capsules of 2.5 mg

Active ingredient: ramipril 2.5 mg;

Excipients: pregelatinized starch 97.50 mg;

Capsule shell accessories (ACG Associated Capsules "Pvt. Ltd., India): gelatin 37.857 mg, dye sunset sunset yellow 0.051 mg, crimson dye [Ponso 4R] 0.012 mg, azorubin dye 0.0072 mg, titanium dioxide 1.432 mg, methyl parahydroxybenzoate 0.512 mg, propyl parahydroxybenzoate 0.128 mg.

Capsules of 5 mg:

Active substance: ramipril 5 mg;

Auxiliary substances: pregelatinized starch 95.00 mg;

Capsule shell accessories (ACG Associated Capsules Pvt. Ltd., India): gelatin 37.709 mg, dye crimson [Ponso 4R] 0.068 mg, azorubin dye 0.348 mg, brilliant blue dye 0.00064 mg, titanium dioxide 1.232, mg, methyl parahydroxybenzoate 0.512 mg, propyl parahydroxybenzoate 0.128 mg .;

'Capsules of 10 mg:

Active ingredient: ramipril 10 mg;

Auxiliary substances: pregelatinized starch 90.00 mg;

Capsule shell accessories (ACG Associated Capsules Pvt. Ltd., India): gelatin 37.907 mg, diamond brilliant blue 0.140 mg, titanium dioxide 1.313 mg, methyl parahydroxybenzoate 0.512 mg, propyl parahydroxybenzoate 0.128 mg. ,

Description:

Capsules of 2.5 mg: hard gelatin capsules of size 4, with an orange lid 1 color and body white color, containing powder from white to almost white. , 5 mg capsules: size 4 hard gelatin capsules, with a red-brown lid and a white body containing powder from white to almost white.

Capsules of 10 mg: hard gelatin capsules of size 4, with a blue lid and a white body containing powder from white to almost white

Pharmacotherapeutic group:angiotensin-converting enzyme inhibitor

Pharmacodynamics:

The active metabolite-ramipril-ramiprylate, formed under the influence of "liver" enzymes, is a long-acting inhibitor of the angiotensin-converting enzyme (ACE), which is, peptidyl dipeptidase. ACE in the blood plasma and tissues catalyzes, the conversion of angiotensin I into angiotensin II and the breakdown of bradykinin. Therefore, when taking ramipril, the formation of angiotensin II decreases and the accumulation of .bradykinin occurs, which leads to vasodilation and a decrease in arterial pressure (BP). The increased activity of kallikrein-kinin system in blood and tissues causes cardioprotective and endothelioprotective action of ramipril due to activation of the prostaglandin system and, accordingly, an increase in the synthesis of prostaglandins stimulating the formation of nitric oxide in endotheliocytes. Angiotensin II stimulates the production of aldosterone, therefore, taking ramipril leads to a decrease in the secretion of aldosterone and an increase in the potassium content.

With a decrease in the concentration of angiotensin II in the blood, its inhibiting effect on renin secretion by negative feedback is eliminated, which leads to an increase in renin activity of the blood plasma. It is assumed that the development of some undesirable phenomena (in particular, "dry" cough) is also associated with an increase in bradykinin activity.

In patients with arterial hypertension, taking ramipril inside leads to a decrease in blood pressure in the "lying" and "standing" positions, without compensatory increase in frequency. heart rate (HR). Ramipril significantly reduces the overall peripheral vascular resistance (OPSS), virtually without causing changes in the renal blood flow and the rate of klubochkovogo filtration. Antihypertensive action begins to develop 1-2 hours after ingestion of a single dose of the drug, reaching the highest value in 3-9 hours, and persists for 24 hours. At the course of treatment, the antihypertensive effect can gradually increase, usually stabilizing by 3-4 weeks of regular intake drug and then persisting for a long time.

Sudden discontinuation of the drug does not lead to a rapid and significant increase in blood pressure (the absence of the "withdrawal" syndrome).

. In patients with hypertension ramipril slows down, development and progression of myocardial hypertrophy and vascular wall.

In patients with chronic heart failure ramipril reduces. OPSS (decrease in postload on the heart), increases the capacity of the venous bed and reduces the filling pressure of the left ventricle, which, accordingly, leads to a decrease in preload in the heart. In these patients, when taking ramipril, there is an increase in cardiac output, ejection fraction and improvement of exercise tolerance. In diabetic and nondiabetic nephropathy, ramipril slows the rate of progression of renal failure and the time of onset of terminal failure. stage of renal failure and, as a result, reduces the need for hemodialysis or kidney transplantation procedures. At the initial stages of diabetic or nondiabetic nephropathy ramipril reduces the severity of albuminuria.

In patients with a high risk of developing cardiovascular diseases

due to or vascular lesions (diagnosed coronary heart disease, obliterating diseases of the peripheral arteries in the anamnesis, a stroke in the anamnesis),or diabetes mellitus with at least one additional risk factor (microalbuminuria, hypertension, increase in total cholesterol concentration, and a decrease in high-density lipoprotein cholesterol), the addition of ramipril to standard therapy significantly reduces the incidence of myocardial infarction, stroke, and mortality from cardiovascular causes. Besides, ramipril reduces the overall mortality rate, as well as the need for revascularization procedures, and - slows the onset or progression of chronic heart failure.

In the general population of patients, as well as in patients with diabetes mellitus, both with arterial hypertension, and with normal BP ramipril significantly reduces the risk of developing nephropathy and the occurrence of microalbuminuria.

Pharmacokinetics:

After oral administration ramipril quickly absorbed from the gastrointestinal tract (50-60%). Eating slows down its absorption, but does not affect the degree of absorption.Ramipril is subjected to intensive presystemic metabolism / activation (mainly in the liver by hydrolysis),which results in the formation of its only active metabolite, ramiprilate, whose activity for inhibition of ACE is about 6 times that of ramipril. In addition, as a result of the metabolism of ramipril, diketopiperazine, which does not possess pharmacological activity, is formed, which then undergoes conjugation with glucuronic acid, ramiprilate also glucuronizes and. is metabolized to diketopiperazic acid. All metabolites formed, with the exception of ramiprilate, have no pharmacological activity.

. Bioavailability - for ramipril after oral administration .2.5-5 mg / - 15-28%; for ramiprilate - 45%.

After taking ramipril inside, the maximum plasma concentrations of ramipril and ramiprilata are reached, after 1 h and 2-4 h, respectively. The decrease in plasma concentration of ramiprilata occurs in several stages: the distribution and elimination phase with a half-life (T1 / 2) of ramiprilata of about 3 hours, then an intermediate phase with T1 / 2 ramiprilata of about 15 hours, and: a final phase with a very low concentration ramiprilate in blood plasma and T1 / 2 ramiprilata, which is about 4-5 days. This final phase is due. slow release of ramiprilate from a strong bond with ACE receptors. Despite a long final phase with a single daily ramipril, inside at a dose of 2.5 mg or more, the equilibrium plasma concentration of ramiprilate is reached after approximately 4 days of treatment. With the prescription of the drug "effective" T1 / 2 depending on the dose is 13-17 hours. The relationship with blood plasma proteins is approximately 73% for ramipril, and for ramiprilate - 56%.

'After intravenous administration, the volume of the distribution of ramipril and ramiprilate is approximately 90 liters and about 500 liters, respectively.

It is excreted by the kidneys - 60%, through the intestines - 40% (mainly in the form of metabolites). If renal function is impaired, excretion of ramipril and its metabolites slows in proportion to the decrease in creatinine clearance (CC), which leads to. , an increase in the plasma concentration of ramiprilate, which decreases more slowly than in patients with normal renal function.

. When the liver function is slowed down, transformation into ramiprilate; atchronic heart failure, the concentration of ramiprilate and the area under the pharmacokinetic curve "concentration-time" - increased by 1.5-1.8 times.

In healthy elderly volunteers (65-76 years old), the pharmacokinetics of ramipril and ramiprilat are not significantly different. is different from that of young healthy volunteers.

In animal studies, it has been shown that ramipril excreted in breast milk.

Indications:

Essential hypertension.
Chronic heart failure (as part of combination therapy, in particular in combination with diuretics).
Diabetic or nondiabetic nephropathy: preclinical and clinically expressed stages, incl. with pronounced proteinuria in particular, when combined with arterial hypertension.

Contraindications:

Hypersensitivity to ramipril, other ACE inhibitors, or to any of the components of the drug.
Angioedema (hereditary or idiopathic,: and also after the administration of ACE inhibitors) in the anamnesis - the risk of rapid development of angioedema.
Hemodynamically significant renal stenosis. arteries (bilateral, or one-sided in the case of a single kidney).
Severe arterial hypotension (systolic blood pressure less than 90 mm Hg) or, with unstable hemodynamics.
Hemodynamically significant stenosis of the aortic or mitral valve or hypertrophic obstructive cardiomyopathy.
Primary hyperaldosteronism.
Severe renal failure (CC less than 20 ml / min with body surface area 1.73 m2).
Hemodialysis (clinical experience is not enough).
Pregnancy.
Lactation period.
Nephropathy, - treatment. which is carried out by glucocorticosteroids, nonsteroidal anti-inflammatory drugs, immunomodulators and / or other cytotoxic agents (see Interactions with other medicinal products).
Chronic heart failure in the stage of decompensation;
Age to 18 years.
Hemodialysis or hemofiltration using some membranes with a negatively charged surface, such as high-flux membranes from polyacrylnitrin (the risk of developing hypersensitivity reactions) (see,1 sections Interactions with other medicinal products, Special instructions).
Lysis of low density lipoproteins using dextrin sulfate (the risk of developing hypersensitivity reactions) (see section Special instructions).
Typosensitizing. therapy for reactions of hypersensitivity to poisonous insects, such as bees, wasps (see section Special instructions).

Carefully:

Conditions in which excessive reduction in blood pressure is particularly dangerous (with atherosclerotic lesions of the coronary and cerebral arteries).
Conditions accompanied by increased activity of the renin-angiotensin-aldosterone system (RAAS), in which, with ACE inhibition, there is a risk of a sharp decrease in blood pressure with impaired renal function:

- severe arterial hypertension, especially malignant hypertension;

- chronic heart failure, 'especially severe or about which other medications with hypotensive effect are taken;

- hemodynamically significant unilateral stenosis of the renal artery (in the presence of both kidneys);

- previous intake of diuretics;

- Violation of the water-electrolyte balance as a result of insufficient intake of liquid and table salt, diarrhea, vomiting, excessive sweating.

Dysfunction of the liver (insufficiency of the experience of application: it is possible to strengthen and weaken the effects of ramipril, in the presence of cirrhosis of the liver with ascites and edema, a significant activation of RAAS is possible, see above the states accompanied by increased activity of RAAS).
Dysfunction of the kidneys (QC more than 20 ml / min at the surface area
body 1.73 m2) because of the risk of developing hyperkalemia and leukopenia).
Condition after kidney transplantation.
Systemic diseases of connective tissue, including systemic lupus erythematosus, scleroderma; concomitant therapy with drugs that can cause changes in the picture of peripheral blood, (possibly oppression, bone marrow, the development of neutropenia or agranulocytosis, see the section Interactions with Other Drugs).
Diabetes mellitus (risk of hyperkalemia)
Elderly age (risk of increased antihypertensive action)
Hyperkalemia.

Pregnancy and lactation:

The drug Ramicardium is contraindicated for use during pregnancy, because it can have an adverse effect on the fetus: a violation of the development of the kidneys of the fetus,reduction of fetal and newborn infants, impaired renal function; hyperkalemia, hypoplasia of the skull bones, oligohydramnion, limb contracture, deformation of bones. skull, hypoplasia of the lungs. Therefore, before starting the drug in women of childbearing age, pregnancy should be excluded. If a woman is planning a pregnancy, then treatment with ACE inhibitors should be discontinued. In case of onset, pregnancy during treatment with the drug, Ramicardia should, as soon as possible, stop taking it and transfer the patient to taking other drugs, in which application the risk for the child will be the least. If treatment with Ramikardia is necessary during breastfeeding, then breastfeeding should be discontinued.

Dosing and Administration:

Inside. Capsules must be swallowed whole, and washed down with enough (1/2 cup) water, regardless of intake, food. The dose is selected depending on the therapeutic effect and tolerability of the drug to patients.

Treatment with Ramicardia usually is long, and it. the duration in each case is determined by the doctor.

With normal kidney and liver function, the following dosing regimens are recommended.

With essential hypertension

Usually the initial dose is 2.5 mg 1 time, per day in the morning. If, when taking the drug at this dose for 3 weeks or more, you can not normalize blood pressure, then the dose can be increased to 5 mg. a drug of Ramicardium per day. When insufficient. the effectiveness of the dose of 5 mg in 2-3 weeks, it can be doubled again to the maximum recommended daily dose - 10 mg per day.

As an alternative to increasing the "dose to 10 mg per day with insufficient hypotensive efficacy of a daily dose of 5 mg, it is possible to add to the treatment of other antihypertensive drugs, in particular diuretics or blockers of" slow "calcium channels.

With chronic heart failure

The recommended initial dose: 1.25 mg once a day (in this case, it is necessary to apply ramipril in another dosage form: 2.5 mg tablets with a risk).

Depending on the reaction to the patient's therapy, the dose may increase. - It is recommended to double the dose at intervals of 1-2 weeks. If a daily dose of 2.5 mg or more is required, it can be given as a single dose per day, or divided into 2 doses.The maximum recommended daily dose is 10 mg.

With diabetic or non-diabetic nephropathy

The recommended initial dose: 1.25 mg-1 time per day (in this case, it is necessary to apply ramipril in another dosage form: 2.5 mg tablets with a risk). The dose can be increased only to 5 mg once a day.

Patients with impaired renal function

With SC from 50 to 20 ml / min. at 1.73 m2 body surface, the initial daily dose is usually 1.25 mg (in this case it is necessary to apply ramipril in another dosage form: 2.5 mg tablets, with a risk). The maximum daily dose is 5 mg.

Patients with incompletely adjusted loss of fluid and electrolytes, patients with severe arterial hypertension and patients for whom excessive BP reduction represents a certain risk (for example, in severe, atherosclerotic lesions of the coronary and cerebral arteries)

The initial dose is reduced to 1.25 mg / day (in this case it is necessary to apply ramipril in another dosage form: 2.5 mg tablets with a risk).

Patients with prior diuretic therapy

It is necessary to cancel if possible, diuretics, for 2-3 days (depending on the duration of the action of diuretics) before starting treatment with the drug Ramicardia or,at least reduce the dose of diuretics taken. Treatment of such patients should start with the lowest dose equal to 1.25 mg of ramipril (in this case, it is necessary to apply ramipril in another dosage form: 2.5 tablets1 mg with a risk), taken once a day, in the morning. After taking the first dose and every time after increasing the dose of ramipril and (or) "loop" diuretics, patients should be under medical supervision not. less - 8 hours to avoid an uncontrolled hypotensive reaction.

Patients of advanced age (over 65 years)

The initial dose is reduced to 1.25 mg per day (in this case, it is necessary to apply ramipril in another dosage form: 2.5 mg tablets with a risk).

Patients with hepatic impairment

The response of blood pressure to the reception of the drug Ramicardium can be increased (by delaying the excretion, ramiprilata) and decrease (due to the slowing down of the conversion of low-active ramipril into active ramiprilate). Therefore, careful medical supervision is required at the beginning of treatment. The maximum allowable daily dose is 2.5 mg.

Side effects:

The undesirable effects listed below are given in accordance with the following gradations of their occurrence frequency:

very often: (> 10%);

often: (> 1% - <10%);

infrequently: (> 0.1% - <1%);

rarely: (0.01% -0.1%);

very rarely: (<0.01%, including individual messages)

the frequency is unknown: according to the available data, it is not possible to establish the frequency of occurrence.

Heart Disease

Infrequently: myocardial ischemia, including the development of an attack of angina or. '

myocardial infarction, tachycardia, arrhythmias (appearance or gain), palpitations, peripheral edema. Violations from the vessels.

Often: excessive decrease in blood pressure, orthostatic hypotension, syncopal conditions. '

Infrequently: the "tides" of blood to the skin of the face.

Rarely: the occurrence or intensification of circulatory disorders - against a background of stenosing vascular lesions, vasculitis.

The frequency is unknown: Raynaud's syndrome.

Disorders from the central nervous system Often: headache, a sense of "lightness" in the head.

Infrequently: dizziness, agevzia, dysgeusia.

Rarely: tremor, imbalance.

The frequency is unknown: cerebral ischemia, including ischemic stroke and transient ischemic stroke; violation of psychomotor reactions, paresthesia, parosmia

Disturbances on the part of the organ of sight

Infrequent: visual disturbances, including blurred image.

Rarely: conjunctivitis.

Hearing disorders

Rarely: hearing impairment, ringing in the ears.

Disorders from the psyche -

Infrequent: depressed mood, anxiety, nervousness, motor anxiety, sleep disturbances, including drowsiness.

Rarely: confusion ..

The frequency is unknown: attention violation.

Disturbances from the respiratory system

Often: "dry" cough (worse at night and in the "lying" position), bronchitis, sinusitis, dyspnea.

Infrequently: bronchospasm, including weighting of the course of bronchial asthma, nasal congestion.

Disturbances from the digestive tract

Often: inflammatory reactions in the stomach and intestines, digestive disorders, abdominal discomfort, dyspepsia, diarrhea, nausea, vomiting.

Infrequently: (pancreatitis, including fatal cases (cases of pancreatitis with a lethal outcome with the intake of ACE inhibitors were very rare), increased activity of pancreatic enzymes in the blood plasma, intestinal angioedema, pain in the stomach, gastritis, constipation , dryness of the oral mucosa.

Rarely: glossitis.

Frequency unknown: aphthous stomatitis.

Disorders from the side of the liver

Infrequently: increased activity of "liver" transaminases and bilirubin concentration in the blood plasma.

Rarely: cholestatic jaundice, hepatocellular lesions.

The frequency is unknown: acute, hepatic insufficiency, cholestatic or cytolytic hepatitis (lethal outcome was observed extremely rarely).

Disorders from the kidneys and urinary tract

Infrequent: renal dysfunction, including acute renal disease

insufficiency, decreased urinary output, increased pre-existing proteinuria, increased urea and creatinine levels in the blood.

Disorders from the reproductive system and mammary glands

Infrequently: transient impotence due to erectile dysfunction, decreased libido.

The frequency is unknown: gynecomastia.

Violations of the blood and lymphatic system

Infrequently: eosinophilia.

Rarely: leukopenia, including neutropenia and agranulocytosis, a decrease in the number of erythrocytes in the peripheral blood, a decrease in hemoglobin, thrombocytopenia.

Frequency is unknown: oppression of bone marrow hematopoiesis, pancytopenia, hemolytic anemia.

Disturbances from the skin

. Often: skin rash, in particular maculopapular.

Infrequently: angioedema, including fatal outcome (swelling of the larynx can cause, obstruction of the respiratory passages leading to death), skin itching, hyperhidrosis.

Rarely: exfoliativedermatitis, urticaria, onycholysis.

Very rarely: photosensitization reactions.

Frequency, unknown. toxic epidermal; necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, weighting of psoriasis; psoriasis-like dermatitis, pemphigoid or lichenoid (lichen-like) exanthema or enanthema, alopecia.

Disturbances on the part of the musculoskeletal system and connective tissue

Often: muscle cramps, myalgia

Infrequently: - arthralgia

Disorders from the metabolism, nutrition and laboratory indicators Often: hyperkalaemia

Infrequent: anorexia, decreased appetite

Unknown frequency: hyponatremia.,

Immune system disorders

The frequency is unknown: anaphylactic or anaphylactoid reactions, (With the inhibition of ACE, the amount of anaphylactic or anaphylactoid reactions to insect venoms increases),increase in the concentration of antinuclear antibodies.

Common violations

Often: chest pain, fatigue.

. Infrequent: 'fever.

. . Rare: asthenia.

Overdose:

Symptoms: excessive peripheral vasodilation with the development of a pronounced decrease in blood pressure, shock; bradycardia, water-electrolyte disorders, acute renal failure, stupor.

Treatment: washing, stomach, intake of adsorbents. In the case of a pronounced decrease in blood pressure to therapy for replenishing the volume of circulating blood and restoring the electro-electrolyte balance, the introduction of alpha-adrenergic agonistsnorepinephrine, dopamine) and angiotensin-H (angiotensinamide). In the case of refractory to drug treatment. bradycardia may require the installation of a temporary - artificial.-driver rhythm. - In case of overdose, serum creatinine and electrolyte concentrations should be monitored.

Interaction:

Contraindicated combinations

Use of some high-permeability membranes with a negatively charged surface (for example, polyacrynitrile membranes) during hemodialysis or hemofiltration; usingDextran sulfate in the apheresis of low-density lipoproteins

Risk of development of severe anaphylactic reactions.

Not recommended combinations

With potassium salts, potassium-sparing diuretics (for example, amiloride, triamterene, spironolactone)

Perhaps more pronounced increase in potassium in the blood serum (with the simultaneous use requires regular monitoring of potassium in the blood serum).

. Combinations; which should be used with caution

With antihypertensive drugs (especially diuretics) and other drugs that reduce blood pressure (nitrates, tricyclic antidepressants) '

Potentiation of antihypertensive effect; when combined. with diuretics' should monitor the sodium content in the serum. With sleeping pills, narcotic and anesthetics.

Perhaps a more pronounced decrease in blood pressure;

With vasopressor sympathomimetics (epinephrine)

Reduction of the antihypertensive effect of ramipril requires careful monitoring of blood pressure.

With allopurinol, procainamide, cytostatics, immunosuppressants, systemic glucocorticosteroids and other agents,which can affect hematologic indices'

Joint application increases the risk of developing leukopenia

With lithium salts

Increase serum, concentration - lithium - and enhance the cardio- and neurotoxic action of lithium.

With hypoglycemic agents for. reception, inside (derivatives - sulfonylurea, biguanides), insulin '

In connection with a decrease in insulin resistance under the influence of ramipril, it is possible to increase the hypoglycemic effect of these drugs right up to the development of hypoglycemia.

Combinations that should be taken into account '

With non-steroidal anti-inflammatory drugs (indomethacin, acetylsalicylic acid) , .

It is possible to weaken the action of ramipril, increase the risk of impaired renal function and increase the potassium content in the serum.

With heparin

It is possible to increase the potassium content in the blood serum.

With sodium chloride

Weakening of antihypertensive action of ramipril and less effective treatment of symptoms of chronic heart failure

With ethanol

Strengthening of vasodilation. Ramipril can enhance the adverse effects of ethanol on the body.

With estrogens

Weakening of antihypertensive action of ramipril (fluid retention). '

Desensitizing therapy with hypersensitivity to poisons insects

'ACE inhibitors, including ramipril, increase the likelihood of anaphylactic or anaphylactoid reactions to insect venoms.

Special instructions:

Before starting treatment with Ramicardia, it is necessary to eliminate hyponatremia and hypovolemia. In patients previously treated with diuretics, it is necessary to cancel them or at least reduce their dose for 2-3 days before you start taking Ramikardiya drug (in this case, .tschatelno monitor the status of patients with chronic heart failure, in connection with vozmozhnostyu- development - they have decompensation due to an increase in the volume of circulating blood).

After the first dose of the drug, as well as by increasing the dose and / or dose of diuretics (particularly "loop") necessary to provide a thorough medical observation of the patient for at least 8 hours for timely appropriate action in the event of excessive reduction in blood pressure.

If Ramikardiya drug is used for the first time or at high doses in patients with an increased activity of the RAAS, then they should carefully monitor blood pressure, especially at the beginning of treatment,because these patients have an increased risk of excessive blood pressure lowering.

With malignant arterial hypertension and heart failure, especially in the acute stage - myocardial infarction, 'drug treatment, Ramicardia - it is necessary to start only in a hospital.

In patients with chronic heart disease; Insufficiency of taking the drug may lead to the development of a marked decrease in blood pressure, which in some cases is accompanied by: oliguria or azotemia and rarely 7 development of acute renal failure.

Care should be taken when treating elderly patients, since they can be particularly sensitive to ACE inhibitors, in the initial phase of treatment it is recommended to monitor the indicators of kidney function.

In patients for whom a decrease in blood pressure may represent a certain risk-for example, in patients with atherosclerotic-narrowing of the coronary or cerebral arteries-treatment should begin under strict medical supervision.

. Care should be taken with physical activity and / or hot weather due to the risk of increased sweating and dehydration,1 with the development of arterial hypotension, due to a decrease in the volume of circulating blood and a decrease in the sodium content in the blood.

During treatment with Ramicardia it is not recommended to drink alcohol.

Transient arterial hypotension is not a contraindication - to continue treatment, after, stabilization of blood pressure. In the case of repeated occurrence of severe arterial hypotension, the dose should be reduced or the drug should be withdrawn.

In patients treated with inhibitors, ACE, angioedema of the face, limbs, lips, tongue, throat or larynx was observed. If there is swelling in the face (lips, eyelids) or tongue, or a violation of swallowing or breathing. The patient should immediately stop taking the medication. Angioedema, localized in the area of the tongue, pharynx, or larynx (possible symptoms: violation of swallowing or breathing) can be life threatening and requires urgent measures for its reduction: subcutaneous administration of 0.3- 0.5 mg or intravenously drip 0.1 mg epinephrine (under the control of blood pressure, heart rate and ECG) followed by the use of glucocorticosteroids 1 (in / in, in / m, or inside); also "recommended intravenous administration of antihistamines (antagonists H1- and H2-histamine receptors), and in the case of inactivation of enzyme inactivators C1- esterase may consider the need to introduce in addition to epinephrine (adrenaline) inhibitors of the enzyme C1-esterase. The patient should be hospitalized, and follow-up should be performed until symptoms come to a complete relief, but not less than 24 hours.

In patients receiving ACE inhibitors, there were cases of intestinal angioedema, which manifested itself in abdominal pain with nausea and vomiting or, without them; in some cases, angioneurotic edema of the face was simultaneously observed. When a patient appears on the background of treatment with ACE inhibitors * the above symptoms should be considered in the differential diagnosis and the possibility of developing their intestinal angioedema.

Treatment aimed at desensitization to insect venoms (bees, wasps), and simultaneous intake of ACE inhibitors can initiate anaphylactic and anaphylactoid reactions (eg, lowering blood pressure, dyspnea, vomiting, allergic skin reactions), which can sometimes be life threatening.Against the background of treatment with ACE inhibitors, hypersensitivity reactions to insect venom (for example, bees, wasps) develop faster and take more severe course. If desensitization to insect venom is required, the ACE inhibitor must be temporarily replaced with a corresponding drug of another class.

. With the use of 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 membrane manufacturers' instructions). It is necessary to avoid the joint use of the 'Ramicardium preparation and such membranes, for example, for urgent hemodialysis or hemofiltration. In this case, it is preferable to use other membranes, or to stop taking ACE inhibitors. . Similar reactions were observed in the apheresis of low-density lipoproteins using dextran sulfate. Therefore. This method should not be used in patients receiving ACE inhibitors.

U'patsientov with violations of liver function reaction to, treatment with the drug - Ramicardia can be either strengthened or weakened. In addition, in patients with severe cirrhosis of the liver with-edema and / or ascites, significant activation of RAAS is possible, therefore, care should be taken in the treatment of these patients.

Before - surgical intervention (including dentistry) is necessary

to warn the surgeon / anesthesiologist about the use of ACE inhibitors.

Control of kidney function (determination of creatinine concentration).

In the treatment of ACE inhibitors in the first weeks of treatment and in the following it is recommended to monitor the function of the kidneys. Particularly careful monitoring is required for patients with acute and chronic heart failure, renal dysfunction, after transplantation, kidney, patients with renovascular disease, including patients with hemodynamically significant unilateral renal artery stenosis in the presence of two kidneys (in such patients, even a slight increase in creatinine concentration may be an indicator of decreased renal function).

'Control of the concentration of electrolytes

Regular monitoring of potassium content in serum is recommended.Particularly careful monitoring of potassium content in blood serum requires patients with impairments. kidney function, significant violations of water-electrolyte balance, chronic heart failure.

Control of hematological parameters

It is recommended to monitor the parameters of the general blood test, to identify possible leukopenia. More regular monitoring is recommended at the beginning of treatment and in patients with impaired renal function, as well as in patients with connective tissue diseases or in patients receiving concomitantly other drugs capable of altering the pattern of peripheral blood (see Interactions with Other Drugs ). Controlling the number of leukocytes is necessary for the early detection of leukopenia, which is especially important in patients with an increased risk of developing it, as well as at the first signs of infection. In detecting neutrobenia, (the number of neutrophils is less than 2000 / μl), discontinuation of treatment with ACE inhibitors is required.

When symptoms appear due to leukopenia "(eg, fever, - enlarged lymph nodes, tonsillitis), urgent monitoring of the picture of peripheral blood is needed.In case of signs of Bleeding (the smallest petechiae, red-brown rashes on the skin and mucous membranes), it is also necessary to control the number of platelets in the peripheral blood.

When jaundice occurs or a significant increase in activity. "hepatic" transaminases treatment with Ramicardia should be discontinued and medical supervision of the patient should be ensured.

Effect on the ability to drive transp. cf. and fur:

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions. (possibly dizziness, especially after the initial dose of an ACE inhibitor in patients taking diuretic drugs).

Form release / dosage:

Capsules 2.5 mg, 5 mg, 10 mg.

Primary packaging: 14 capsules in a blister of Al / PVC.

Secondary packaging: 2 blisters together with instructions for use in a cardboard box.

Packaging:

Primary packaging: 14 capsules in a blister of Al / PVC.

Secondary packaging: 2 blisters together with instructions for use in a cardboard box.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C.Keep out of the reach of children

Shelf life:

2 years. '

Do not use after expiration date

Terms of leave from pharmacies:On prescription

Registration number:LP-001268

Date of registration:24.11.2011

The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India

Manufacturer: & nbsp

IPCA LABORATORIES, Ltd. India

Information update date: & nbsp24.11.2011

Illustrated instructions

Instructions

Ramycardia ® (Ramikardiya ®)