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

50 mg tablets: round plano-cylindrical tablets from white to white with a creamy shade of color with a characteristic smell, with a risk on one side and with a bevel. A slight "marbling" of the surface is permissible.

Tablets 100 mg: round flat-cylindrical tablets from white to white with a creamy shade of color with a characteristic smell, with a cross-shaped risk on one side and with a bevel. A slight "marbling" of the surface is permissible.

Pharmacotherapeutic group:Angiotensin converting enzyme inhibitor

ATX: & nbsp

C.09.A.A.01 Captopril

Pharmacodynamics:

Captopril is an inhibitor of angiotensin converting enzyme (ACE).

Reduces the formation of angiotensin II from angiotensin I. Reduces the concentration of angiotensin II, which leads to a direct decrease in the release of aldosterone. This reduces the overall peripheral vascular resistance, blood pressure (BP), post- and preload on the heart. Expands arteries more than veins. It causes a decrease in the degradation of bradykinin (one of the effects of ACE) and an increase in the synthesis of prostaglandin. The antihypertensive effect does not depend on the plasma renin activity, the decrease in blood pressure is noted with normal and even decreased activity of the hormone, which is due to the effect on the tissue renin-angiotensin-aldosterone system (RAAS). Strengthens coronary and renal blood flow. With prolonged use reduces the severity of myocardial hypertrophy and the walls of arteries of resistive type. Improves the blood supply of the ischemic myocardium. Reduces the aggregation of platelets. Helps reduce sodium ions in patients with heart failure.

Reduction of blood pressure in contrast to direct vasodilators (hydralazine, minoxidil, etc.) is not accompanied by reflex tachycardia and leads to a decrease in myocardial oxygen demand. With heart failure in an adequate dose does not affect BP. The maximum decrease in blood pressure after oral administration is observed after 60-90 minutes. The duration of the antihypertensive effect depends on the dose of the drug taken and reaches optimal values within a few weeks.

Temporary abolition of captopril should not occur dramatically, as this can cause a significant increase in blood pressure.

Pharmacokinetics:

Absorption - fast, is about 75% of the dose. Eating reduces bioavailability by 30-40%. The maximum concentration in the blood plasma is noted after 1 h after ingestion.

It binds to blood plasma proteins - 25-30%, mainly with albumin. Less than 0.002% of the dose of captopril is secreted with breast milk, does not penetrate the blood-brain barrier.

Metabolized in the liver with the formation of disulfide dimer captopril and captopril-cysteine sulfide. Metabolites are pharmacologically inactive. The half-life (T_1/2) captopril is about 2-3 hours. About 95% is excreted by the kidneys during the first day, 40-50% of them in unchanged form, the rest - in the form of metabolites. In 4 hours after a single oral intake, about 38% of unchanged captopril and 28% of metabolites are contained in the urine, in 6 hours only in the form of metabolites; in daily urine - 38% of unchanged captopril and 62% - in the form of metabolites.

Cumulates in chronic kidney failure. T_1/2 with renal insufficiency - 3,5-32 h, therefore, in patients with impaired renal function, the dose of the drug should be reduced and / or the interval between receiving doses should be increased.

Indications:

- Ahypertension, including renovascular;

- chronic heart failure (CHF) (as part of combination therapy);

- violations of left ventricular function after a myocardial infarction with a clinically stable condition;

- Diabetic nephropathy on the background of type 1 diabetes mellitus (with albuminuria more than 30 mg / day).

Contraindications:

Hypersensitivity to captopril or other ACE inhibitors, as well as to any of the excipients of the drug; angioedema in anamnesis on the background of the use of ACE inhibitors,hereditary and / or idiopathic angioedema; severe kidney and / or liver dysfunction, bilateral renal artery stenosis, single kidney stenosis with progressive azotemia, post-transplant kidney transplantation status, refractory hyperkalemia, pregnancy, breastfeeding period, age 18 years, lactose intolerance, lactase deficiency and glucose-galactose syndrome malabsorption, simultaneous use with aliskiren and aliskirenoderzhaschimi drugs in patients with diabetes mellitus or impaired renal function (glomerular filtration rate (GFR) <60 ml / mi / 1.73 m²) (see the sections "Special instructions" and "Interaction with other medicinal products").

Carefully:

Use with caution in patients with severe systemic autoimmune diseases (including systemic lupus erythematosus and scleroderma), oppression of bone marrow hematopoiesis (risk of developing neutropenia and agranulocytosis), cerebral ischemia, chronic heart failure (CHF), diabetes mellitus (increased risk development of hyperkalemia), with primary hyperaldosteronism; in patients on hemodialysis,diet with restriction of salt, coronary heart disease, in conditions accompanied by a decrease in the volume of circulating blood (bcc) (including vomiting, diarrhea, diuretics), with simultaneous intake of potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for dietary salt and lithium, immunosuppressants , allopurinol, procainamide (risk of neutropenia and agranulocytosis), hypercaliamia, hemodialysis using high-flow membranes (for example, AN69®), surgical intervention / general anesthesia, aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyopathy, desensitizing therapy, low density lipoprotein apheresis (LDL), in patients with Negroid races, and elderly patients.

Pregnancy and lactation:

Pregnancy

Captopril is contraindicated for use in pregnancy (see section "Contraindications").

Captopril should not be used in the first trimester of pregnancy. Appropriate controlled clinical studies of the use of ACE inhibitors in pregnant women have not been conducted. Available limited data on the effect of the drug in the first trimester of pregnancysuggest that the use of ACE inhibitors does not lead to a defectm development of the fetus associated with fetoxicitythe. Epidemiological data suggesting a risk of teratogenic effect of ACE inhibitors in the first trimester of pregnancy were not convincing, however, a slight increase in risk can not be ruled out. When planning a pregnancy or when it comes to the onset of the drug Captopril, you should immediately stop taking the drug and, if necessary, prescribe another antihypertensive therapy with a proven safety profile during pregnancy.

It is known that the effect of ACE inhibitors on the fetus in the II and III trimesters of pregnancy can lead to disruption of its development (decreased kidney function, oligohydramnion, slowing ossification of the skull bones) and fetal death, as well as complications in the newborn (kidney failure, arterial hypotension, hyperkalemia ).

If the patient received ACE inhibitors during the second or third trimester of pregnancy, an ultrasound examination of the newborn is recommended to assess the condition of the skull bones and kidney function.

The use of ACE inhibitors during pregnancy can cause developmental disorders (including arterial hypotension, neonatal hypoplasia of the bones of the skull, anuria, reversible and irreversible renal failure).

After childbirth, children should be closely monitored for arterial hypotension, renal dysfunction of newborns whose mothers were taken during pregnancy Captopril.

Breastfeeding period

Captopril penetrates into breast milk in small amounts (less than 1% of the daily intake). In connection with the risk of serious adverse events in the child, breastfeeding should be stopped or the drug can be withdrawn Captopril at the mother for the period of breastfeeding.

Dosing and Administration:

Captopril is administered orally an hour before meals. The dosage regimen is set individually.

With arterial hypertension the drug is prescribed in the initial dose of 12.5 mg (for the implementation of this dosage regimen should take the drug in tablets of 25 mg with a risk) 2 times a day. Pay attention to the tolerability of the first dose during the first hour.If the arterial hypotension develops, the patient should be transferred to the "lying" position with raised legs (this reaction to the first dose should not be an obstacle to further therapy). If necessary, the dose gradually (with an interval of 2-4 weeks) is increased to achieve the optimal effect.

With a mild to moderate degree of hypertension, the usual maintenance dose is 25 mg 2 times a day; the maximum dose is 50 mg twice a day. With severe arterial hypertension, the initial dose is 12.5 mg (this drug should be taken in tablets of 25 mg with a risk) twice a day. The dose is gradually increased to a maximum daily dose of 150 mg (50 mg 3 times daily).

With CHF used together with other diuretics and / or r combinations with cardiac glycosides (in order to avoid an initial excessive decrease in blood pressure, prior to the appointment of the drug, the diuretic is withdrawn, it is necessary to exclude the presence of a pronounced decrease in BCC).

The initial daily dose is 6.25 mg (for this dosage regimen to take the drug in tablets of 12.5 mg with a risk or in tablets of 25 mg with a cross-shaped risk) 3 times a day,if necessary, increase the dose gradually (at intervals of not less than 2 weeks). The average maintenance dose is 25 mg 2-3 per day, and the maximum 150 mg per day. In case of symptomatic arterial hypotension in heart failure, the dose of diuretics and / or other concomitantly administered vasodilators can be reduced to achieve a stable effect of Captopril.

In cases of violations of left ventricular function after a previous myocardial infarction in patients in a clinically stable state, the use of Captopril can begin as early as 3 days after myocardial infarction. The initial dose is 6.25 mg per day (for this dosage regimen, it is necessary to take the drug in tablets of 12.5 mg with a risk or in tablets of 25 mg with a cross-shaped risk), then the daily dose can be increased to 37.5-75 mg for 2-3 doses (depending on the tolerability of the drug) up to a maximum dose of 150 mg per day.

With type 1 diabetes mellitus, complicated by nephropathy, Captopril appoint a dose of 75-100 mg in 2-3 divided doses. In type 1 diabetes mellitus with microalbuminuria (albumin release 30-300 mg / day) the dose of the drug is 50 mg 2 times a day.With proteinuria more than 500 mg per day, the drug is effective at a dose of 25 mg 3 times a day.

Patients with impaired function kidneys should adjust the dose of captopril: should reduce the dose of the drug or increase the intervals between admission. If necessary, additionally prescribed "loop" diuretics, and not diuretics thiazide series.

Recommended dosage adjustment regimen for captopril in patients with impaired renal function

Glomerular filtration rate (ml / min / 1.73 m²)	The initial daily dose (mg)	The maximum daily dose (mg)
40	25-50	150
21-40	25	100
10-20	12,5	75
<10	6,25	37,5

In old age the drug should be used in an initial dose of 6.25 mg (for this dosage regimen, it is necessary to take the drug in tablets of 12.5 mg with a risk or in tablets of 25 mg with a cross-like risk) twice a day to prevent impairment of renal function, and the ability to support it at this level. Dose of the drug Captopril it is recommended to regulate constantly depending on the patient's therapeutic response and to maintain at the lowest possible level.

Side effects:

The frequency of adverse reactions was determined in accordance with the recommendations of the World Health Organization: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000,<1/1000); very rarely (<1/10000), including individual messages; frequency (frequency can not be calculated from available data).

On the part of the blood and lymphatic system: very rarely - neutropenia, agranulocytosis, pancytopenia (in patients with kidney dysfunction), lymphadenopathy, eosinophilia, thrombocytopenia, anemia (including aplastic, hemolytic), autoimmune diseases.

From the side of metabolism and nutrition: rarely - Anorexia, rarely - hyperkalemia, hypoglycemia.

From the side of the psyche: often - sleep disorders, very rarely - confusion, depression.

From the cardiovascular system: infrequently - tachycardia or tachyarrhythmia, palpitations, orthostatic hypotension, angina pectoris, Raynaud's syndrome, "flushes" of blood to the face, pallor, peripheral edema; very rarely - cardiac arrest, cardiogenic shock.

From the respiratory system: often - cough (dry unproductive), dyspnea; very rarely - bronchospasm, rhinitis, allergic alveolitis, eosinophilic pneumonia, pulmonary edema.

From the central nervous system: often - a taste disorder, dizziness,drowsiness; rarely - headache, paresthesia; very rarely - a disorder of cerebral circulation, including stroke and syncope.

From the sense organs: rarely - violation of visual acuity.

From the digestive system: often - dryness of the oral mucosa, nausea, vomiting, abdominal pain, diarrhea, constipation; rarely - stomatitis, aphthous stomatitis, gingival hyperplasia; rarely - angioedema of the intestine; glossitis, peptic ulcer, pancreatitis, impaired liver function, cholestasis, jaundice, hepatitis (including rare cases of hepatonecrosis), increased activity of "hepatic" enzymes.

From the skin and subcutaneous tissues: often - cutaneous itching with rashes and without rashes, alopecia; infrequently - angioedema; very rarely: urticaria, Stevens-Johnson syndrome, multiforme erythema, photosensitivity, erythroderma, exfoliative dermatitis, pemphigoid reactions,

From the musculoskeletal system: rarely - mialgand arthralgia.

From the genitourinary system: rarely - impaired renal function, acute renal failure, increased urea and creatinine levels in the blood, polyuria, oliguria, increased frequency of urination; rarely - nephrotic syndrome; sexual dysfunction, gynecomastia.

General disorders and symptoms: infrequently - chest pain, fatigue, malaise; rarely - fever.

Laboratory indicators: rarely - proteinuria, eosinophilia, hyperkalemia, hyponatremia, hypoglycemia, increased plasma urea nitrogen concentration, acidosis, increased serum creatinine and bilirubin concentration, decreased hemoglobin and hematocrit, decreased number of leukocytes, platelets, increased titer for antinuclear antibodies, increased ESR.

With the use of ACE inhibitors, including captopril, patients receiving intravenously a preparation of gold (sodium aurotomy malate), was described symptom complex, which includes flushing of the facial skin, nausea, vomiting, arterial hypotension.

Overdose:

Symptoms: marked decrease in blood pressure, including collapse, shock, stupor, bradycardia, water-electrolyte balance disorders, renal failure.

Treatment: gastric lavage, administration of adsorbents and sodium sulfate within 30 minutes after administration,it is necessary to put the patient in the "lying" position with raised legs and take measures aimed at restoring blood pressure (increase in the volume of BCC, including intravenous infusion of 0.9% sodium chloride solution), symptomatic therapy. With bradycardia - the introduction of atropine. An artificial pacemaker can be considered. Peritoneal hemodialysis is ineffective.

Interaction:In patients taking diuretics, captopril can potentiate antihypertensive effect. Such an action is also exerted by a strict limitation intake of table salt in the body (salt-free diets), hemodialysis. Usually a pronounced decrease in blood pressure occurs within 1 hour after the first doses of captopril.

Vasodilators (for example, nitroglycerine) in combination with captopril should be used at the lowest effective doses due to the risk of excessive BP reduction. Caution should be exercised when using captopril at the same time (without or with a diuretic) and drugs that affect the sympathetic nervous system (eg, ganglion blockers, alpha and beta blockers).

When simultaneous use of captopril and non-steroidal anti-inflammatory drugs (NSAIDs), there may be a decrease in antihypertensive action, especially in hypertension accompanied by low renin activity. In patients with risk factors (elderly patients, patients with hypovolemia, taking diuretics, with impaired renal function), concurrent use of NSAIDs (including cyclooxygenase-2 inhibitors) and ACE inhibitors, including captopril, can lead to impaired renal function, up to acute renal failure. Usually, kidney dysfunction in such cases is reversible. Periodically monitor kidney function in patients taking captopril and NSAIDs.

With captopril therapy, potassium-sparing diuretics (eg triamterene, amiloride, spironolactone and its derivative - eplerenone), potassium preparations, potassium supplements, substitutes for edible salt (contain large amounts of potassium) should be prescribed only with proven hypokalemia, t. their simultaneous application increases the risk of hyperkalemia.

With simultaneous use of ACE inhibitors (especially in combination with diuretics) and lithium salts, an increase in the concentration of lithium in the blood plasma is possible, and, therefore,toxicity of lithium preparations. Periodically determine the concentration of lithium in blood plasma.

When captopril is prescribed on the foyer, reception of allopurinol or procainamide increases the risk of developing neutropenia and / or Stevens-Johnson syndrome.

The use of captopril in patients taking immunosuppressants (for example, cyclophosphamide or azathioprine), increases the risk of hematological disorders.

Aliskiren

In patients with diabetes mellitus or renal dysfunction (GFR less than 60 ml / min / 1.73 m²) increases the risk of hyperkalemia, worsening kidney function and increasing the incidence of cardiovascular morbidity and mortality (see "Contraindications").

In the literature, it was reported that in patients with established atherosclerotic disease, heart failure or diabetes with target organ damage, simultaneous therapy with an ACE inhibitor and angiotensin II receptor antagonists (ARA II) is associated with a higher incidence of arterial hypotension, syncope, hyperkalemia impaired renal function (including acute renal failure) compared with the use of only one a drug that affects the RAAS. Double blockade (eg, when combined with an inhibitor ACE with ARA II) should be limited to individual cases with thorough monitoring of kidney function, potassium and blood pressure.

Captopril may enhance the effect of insulin and hypoglycemic agents administered internally, which may require a reduction in the dose of hypoglycemic drugs when used concomitantly with captopril.

Captopril may cause a false positive urine test for acetone.

With simultaneous use with thiazide diuretics, vasodilators (minoxidil), verapamil, beta-adrenoblockers, tricyclic antidepressants or ethanol, the antihypertensive effect is enhanced.

Sympathomimetics can reduce the antihypertensive effect of captopril and ACE inhibitors.

Estramustine

Simultaneous application can lead to an increased risk of side effects, such as angioedema.

Baclofen

Strengthens the antihypertensive effect of ACE inhibitors. You should carefully monitor blood pressure and, if necessary, reduce the dose of captopril.

Glyptins (linaglyptin, saxagliptin, sitagliptin, vildagliptin)

Co-administration with ACE inhibitors may increase the risk of developing angioedema due to inhibition of dipeptidyl peptidase IV (DPP-IV) glyptin.

Preparations of gold

Tricyclic antidepressants, antipsychotics (antipsychotics) and means for general anesthesia

Simultaneous use with ACE inhibitors can lead to an increase in antihypertensive action (see section "Special instructions").

Special instructions:

Before the beginning, and also regularly during the treatment with the drug Captopril should monitor blood pressure and kidney function. In patients with CHF, the drug is used under close medical supervision.

Arterial hypotension

In patients with arterial hypertension with captopril, severe arterial hypotension is observed only in rare cases; the likelihood of developing this condition increases with increased loss of fluid and salts (for example, after intensive treatment with diuretics), in patients with CHF or who are on dialysis.The possibility of a sharp decrease in blood pressure can be reduced to a minimum with a preliminary cancellation (for 4-7 days) diuretic or increased intake of sodium chloride (table salt) (approximately one week prior to commencement of administration) or by the administration of captopril at the start of treatment in small doses (6.25-12.5 mg / day). With the use of antihypertensive drugs, a marked decrease in blood pressure in patients with impaired cerebral circulation, cardiovascular disease, may increase the risk of myocardial infarction or stroke.

Impaired renal function

With the use of ACE inhibitors, proteinuria can be noted, mainly in patients with impaired renal function, and also with the use of high doses of drugs. In most cases, proteinuria decreased or disappeared within 6 weeks, regardless of whether captopril treatment continued or not. Parameters of renal function such as residual blood nitrogen and creatinine in patients with proteinuria rarely changed. Patients with kidney disease should determine the protein content in the urine before starting therapy and periodically throughout the course of therapy.

Against a background of prolonged use of captopril, approximately 20% of patients have an increase in the concentration of urea and serum creatinine by more than 20%, compared with the norm or the baseline value. Less than 5% of patients, especially in severe nephropathies, require discontinuation of treatment due to increased creatinine.

In some patients with kidney disease, especially with severe renal artery stenosis, there is an increase in the concentration of urea nitrogen and creatinine in the serum after lowering blood pressure. In these cases, a reduction in the dose of captopril and / or cancellation of the diuretic may be required.

Impaired liver function

In rare cases, on the background of the administration of ACE inhibitors, there was a syndrome of cholestatic jaundice with the transition to fulminant liver necrosis, sometimes with a lethal outcome. The mechanism of development of this syndrome is unclear. If there is jaundice or a significant increase in the activity of "liver" enzymes against the background of taking ACE inhibitors, you should stop taking the drug (see the "Side effect" section), the patient should be under appropriate medical supervision.

Hyperkalemia

Hyperkalemia can develop during treatment with ACE inhibitors, including captopril. Risk factors for hyperkalemia include renal failure, decreased renal function, age over 70 years, diabetes mellitus, certain concomitant conditions (dehydration, acute heart failure, metabolic acidosis), simultaneous intake of potassium-sparing diuretics (such as spironolactone and its derivative eplerenone, triamterene, amiloride), food additives / potassium preparations or potassium-containing substitutes for edible salt, as well as the use of other drugs that increase the potassium content in the blood (for example, heparin). Application of food additives / potassium preparations, potassiumeregulating diuretics, potassium-containing substitutes for edible salt can lead to a significant increase in potassium in the blood, especially in patients with reduced renal function. Hyperkalemia can lead to serious, sometimes fatal heart rhythm disturbances. If simultaneous administration of captopril and the above drugs is required, treatment should be carried out with caution in the context of regular monitoring of potassium in the blood serum (see section "Interaction with other medicinal products").

Hemodialysis

In patients on hemodialysis using high-permeability membranes (for example, AN69®), cases of development of anaphylactic reactions against the background of therapy with ACE inhibitors were noted. The use of ACE inhibitors should be avoided when using this type of membrane.

Neutropenia / agranulocytosis / thrombocytopenia / anemia

Against the background of taking ACE inhibitors, neutropenia / agranulocytosis, thrombocytopenia and anemia can occur. In patients with normal renal function and in the absence of other aggravating factors, neutropenia develops rarely. With extreme caution follow the apply captopril in patients with systemic connective tissue diseases, with immunosuppressant, allopurinol or procainamide, especially in patients with impaired renal function. Due to the fact that most lethal cases of neutropenia against the background of ACE inhibitors developed in such patients, it is necessary to monitor the number of leukocytes in the blood before the treatment, in the first 3 months of therapy - every 2 weeks, then every 2 months.

If the number of white blood cells is less than 4000 / μL, a repeated blood test is performed, below 1000 / μL - the drug is stopped, while monitoring the patient.

Usually, the recovery of the number of neutrophils occurs within 2 weeks after discontinuation of the drug Captopril. In 13% of cases, neutropenia was fatal. In almost all cases, the lethal outcome of neutropenia was noted in patients with systemic connective tissue diseases, renal or heart failure, anda the background of the use of immunosuppressants or a combination of both of these factors.

Some patients had severe infections, in some cases, resistant to intensive antibiotic therapy. When administering captopril, it is recommended that such patients periodically check the white blood cell count. Patients should inform the doctor of any signs of infectious diseases (eg, sore throat, fever).

Cough

Against the background of therapy with an ACE inhibitor, a persistent unproductive dry cough may occur, which ceases after the drug is discontinued. This should be taken into account in the differential diagnosis of cough.

Surgery / general anesthesia

The use of ACE inhibitors in nazi who are undergoing surgery with the use of general anesthesia can lead to a marked decrease in blood pressure, especially when using drugs for general anesthesia that have antihypertensive effects. With the development of arterial hypotension, blood pressure should be maintained by replenishing the BCC. It is necessary to alert the surgeon / anesthesiologist that the patient is taking ACE inhibitors.

Mitral stenosis / aortic stenosis / hypertrophic obstructive cardiomyopathy

Captopril, like other ACE inhibitors, should be administered with caution to patients with obstruction of the left ventricular outflow tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), and also to patients with mitral stenosis.

Increased sensitivelyctь / angioedema

When taking ACE inhibitors, including captopril, in rare cases and in any period of therapy, development of angioedema of the face, upper and lower extremities, lips, mucous membranes, tongue, vocal cords and / or larynx can be observed (see "Side act"). When symptoms appear, taking the drug should be stopped immediately, and the patient should be observed until the signs of edema disappear completely.If the swelling affects only the face and lips, then its manifestations usually pass on their own, although antihistamines can be used to treat the symptoms.

Angioneurotic edema, laryngeal edema accompanied may lead to legal outcome. Swelling of the tongue, vocal cords, or larynx can lead to airway obstruction. When these symptoms appear, urgent therapy is required, including subcutaneous injection of epinephrine (adrenaline) and / or ensuring airway patency. The patient should be under medical supervision until the symptoms disappear completely and persistently.

Patients with a history of angioneurotic edema, non-reception of the ACE inhibitors, the risk of its development when receiving the drugs in this group (see. The section "Contra ') can be raised,

In rare cases, against the background of therapy with ACE inhibitors, angioedema develops in the intestine. Thus, patients have a pain in the abdomen as an isolated symptom or in combination with nausea and vomiting in some cases without prior angioneurotic edema of the face and at normal levels of C1-esterase.The diagnosis was established using computed tomography of the abdominal region, ultrasound examination or surgical intervention. Symptoms disappeared after discontinuation of ACE inhibitors. Therefore, patients with abdominal pain receiving ACE inhibitors should take into account the possibility of developing angioedema of the intestinal tract during differential diagnosis (see section "Side effect").

Anaphylactoid reactions during apheresis of low density lipoproteins (LDL)

In rare cases in patients receiving ACE inhibitors, during the procedure of apheresis of LDL with the use of dextran sulfate may develop life threatening anaphylactoid reactions. To prevent anaphylactoid reaction, therapy with an ACE inhibitor should be temporarily discontinued before each apheresis procedure.

Anaphylactoid reactions during desensitization

There are some reports of the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy, for example, by the venom of Hymenoptera.ACE inhibitors should be used with caution in patients prone to allergic reactions undergoing desensitization procedures. The use of ACE inhibitors should be avoided for patients receiving immunotherapy with bee venom. However, this reaction can be avoided by the temporary withdrawal of the ACE inhibitor before the desensitization procedure begins.

Ethnic differences

It should be borne in mind that in patients of the Negroid race the risk of angioedema development is higher. Like other ACE inhibitors, Captopril It is less effective in reducing blood pressure in patients of the Negroid race.

This effect is probably associated with a marked predominance of low-grade status in patients of the Negroid race with arterial hypertension.

Patients with diabetes mellitus

When using the drug for patients with diabetes mellitus receiving hypoglycemic agents for ingestion or insulin, during the first month of therapy it is necessary to regularly monitor the concentration of glucose in the blood (see section "Interaction with other drugs").

It is not recommended simultaneous use of ACE inhibitors and APA II in patients with diabetic nephropathy.

Lithium preparations

Simultaneous use of the drug Captopril and lithium preparations is not recommended (see section "Interaction with other medicinal products").

Double blockade of RAAS

There have been reports of cases of arterial hypotension, fainting, stroke, hyperkalemia and renal dysfunction (including acute renal failure) in susceptible patients, especially when used simultaneously with drugs that affect this system. Therefore, the double blockade of RAAS due to the combination of an ACE inhibitor with APA II or aliskiren is not recommended. The combination with aliskiren is contraindicated in patients with diabetes mellitus or renal dysfunction (GFR <60 mL / min / 1.73 m²) (see the sections "Contraindications" and "Interaction with other medicinal products").

When using captopril, a false positive reaction can be observed when analyzing urine for acetone.

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

During the period of treatment it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.possibly dizziness, especially after taking the initial dose.

Form release / dosage:

Tablets 50 mg, 100 mg.

Packaging:

For 10, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 10, 20, 30, 40, 50 or 100 tablets in cans of polymer or cans of polyethylene terephthalate.

One jar or 1, 2, 3, 4, 5 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002918

Date of registration:17.03.2015

Expiration Date:17.03.2020

The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp05.12.2017

Illustrated instructions

Instructions

Captopril (Captopril)