Captopril Sandoz

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Captopril Sandoz: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Captopril Sandoz

ATX code: C09AA01

Active ingredient: captopril (Captopril)

Producer: Salutas Pharma, GmbH (Germany)

Description and photo update: 2019-12-07

Prices in pharmacies: from 85 rubles.

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Captopril Sandoz is an antihypertensive drug, an angiotensin-converting enzyme (ACE) inhibitor.

Release form and composition

The drug is available in the form of tablets: white, with a uniform surface, round; dosage 6.25 mg - biconvex, dosage 12.5 mg - convex on one side, on the other - dividing risk, dosages 25 and 50 mg - in the form of a quatrefoil, with a chamfer and a cross-shaped line on two sides, dosage 100 mg - one side convex, on the other there is a cruciform risk (10 pcs. in blisters, in a cardboard box 1, 2, 3, 4, 5 or 10 blisters and instructions for the use of Captopril Sandoz).

1 tablet contains:

active substance: captopril - 6.25; 12.5; 25; 50 or 100 mg;
auxiliary components: lactose monohydrate, corn starch, microcrystalline cellulose, stearic acid.

Pharmacological properties

Pharmacodynamics

Captopril Sandoz is an antihypertensive drug. Its active substance, captopril, is an ACE inhibitor, the action of which is associated with a decrease in the rate of conversion of angiotensin I to angiotensin II; a decrease in the formation of angiotensin II contributes to a decrease in the secreted aldosterone. At the same time, there is a decrease in the total peripheral vascular resistance, blood pressure (BP), pre- and afterload on the heart. Arteries dilate more than veins. The drug reduces the degradation of bradykinin (one of the effects of ACE), increases the synthesis of prostaglandin. The antihypertensive effect does not depend on the plasma renin activity, therefore, a decrease in blood pressure is observed at a normal hormone level and a reduced one, which is due to the effect on the tissue renin-angiotensin system (RAS). Coronary and renal blood flow increases. Against the background of long-term use of captopril, the severity of hypertrophy of the myocardium and the walls of resistive arteries decreases. The blood supply to the ischemic myocardium improves, platelet aggregation decreases.

A decrease in blood pressure is accompanied by a decrease in myocardial oxygen demand and does not cause reflex tachycardia.

In heart failure, Captopril Sandoz helps to reduce the concentration of sodium ions, in therapeutic doses does not affect the value of blood pressure.

The maximum decrease in blood pressure is observed 1–1.5 hours after taking the pill. The duration of the hypotensive effect is dose-dependent; optimal blood pressure values are achieved during a certain period of therapy.

Abrupt withdrawal of Captopril Sandoz may be accompanied by a significant increase in blood pressure.

Promotes a decrease in the tone of the efferent arterioles of the glomeruli of the kidneys, improves intraglomerular hemodynamics, preventing the development of diabetic nephropathy.

Pharmacokinetics

After oral administration, captopril is rapidly absorbed in the gastrointestinal tract (GIT), absorption is up to 75% of the dose taken. The bioavailability of the drug is reduced by 30-40% with simultaneous food intake.

Plasma protein binding (mainly albumin) is 25-30%.

It does not penetrate the blood-brain barrier. Less than 0.002% of the dose taken is excreted in breast milk.

Captopril is metabolized in the liver to form pharmacologically inactive metabolites (captopril disulfide dimer and captopril-cysteine sulfide).

The half-life (T _1/2) can be 2-3 hours.

Up to 95% of the dose is excreted through the kidneys during the first 24 hours, of which 40–50% are unchanged, and the remainder is in the form of metabolites. 6 hours after a single dose, captopril is detected in urine only in the form of metabolites.

With renal failure, T _1/2 can increase up to 32 hours. In chronic renal failure, it accumulates. In this regard, patients with impaired renal function should reduce the dose and / or increase the interval between taking the drug.

Indications for use

arterial hypertension;
renovascular hypertension;
chronic heart failure - as part of complex therapy;
dysfunction of the left ventricle in a clinically stable state after myocardial infarction;
diabetic nephropathy in patients with type 1 diabetes mellitus (with albuminuria more than 30 mg / day).

Contraindications

Absolute:

hereditary angioedema;
idiopathic edema;
a history of angioedema due to the use of other ACE inhibitors;
primary hyperaldosteronism;
severe renal dysfunction, bilateral renal artery stenosis or stenosis of an artery of a solitary kidney with progressive azotemia, hyperkalemia, azotemia, condition after kidney transplantation;
simultaneous use with aliskiren or aliskiren-containing agents in case of impaired renal function with creatinine clearance (CC) less than 60 ml / min or in patients with diabetes mellitus;
lactose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency;
period of pregnancy;
breast-feeding;
age up to 18 years;
hypersensitivity to ACE inhibitors, including history;
individual intolerance to the components of the drug.

Captopril Sandoz tablets should be taken with caution in patients with hypertrophic obstructive cardiomyopathy, connective tissue diseases (including systemic lupus erythematosus, scleroderma), inhibition of bone marrow circulation, cerebrovascular pathologies, diabetes mellitus, ischemic heart disease, stenosis of the mitral valve and obstructing the outflow of blood from the left ventricle of the heart), a history of angioedema, impaired liver function, bilateral stenosis of the renal arteries or stenosis of an artery of a single kidney, chronic renal failure, renovascular hypertension, following a diet with limited sodium chloride, during anesthesia, or general hemodialysis using high-flow membranes (such as AN69),desensitizing therapy, apheresis of low-density lipoproteins (LDL), concomitant therapy with potassium-sparing diuretics, potassium or lithium preparations, taking potassium-containing salt substitutes, conditions accompanied by a decrease in circulating blood volume (including diarrhea, vomiting, hemodialysis), patients of the black race …

Captopril Sandoz, instructions for use: method and dosage

Captopril Sandoz tablets are taken orally 1 hour before meals.

The doctor determines the dosage regimen individually, starting treatment with the appointment of the drug in the lowest effective dose.

Recommended dosage for Captopril Sandoz:

arterial hypertension: initial dose - 12.5 mg 2 times a day. During the first hour after taking the first dose, the patient's condition should be monitored for tolerance. In the case of arterial hypotension, the patient must take a horizontal position. Such a reaction to the first dose is not a reason to discontinue further therapy. In the absence of a sufficient clinical effect, the dose is gradually increased (with an interval of 14–28 days) until an optimal antihypertensive effect is achieved. The usual maintenance dose for mild to moderate hypertension is 25 mg 2 times a day. The maximum daily dose is 150 mg, it should be taken 50 mg 3 times a day. The initial dose in the elderly is 6.25 mg 2 times a day;
chronic heart failure (as part of complex therapy, including other diuretics, digitalis preparations): the initial dose is 6.25 mg or 12.5 mg 3 times a day. The average maintenance dose of Captopril Sandoz is 25 mg 2-3 times a day. The maximum daily dose is 150 mg. Before prescribing Captopril Sandoz, it is recommended that you temporarily stop taking or reduce the dose of the diuretic in order to avoid an excessive decrease in blood pressure. To achieve a sustained dose effect of captopril in patients with symptomatic hypotension, the dose of concurrently prescribed vasodilators can be reduced;
dysfunction of the left ventricle after myocardial infarction (you can start taking the drug 3 days after myocardial infarction in a clinically stable patient): the initial dose is 6.25 mg once a day. Then, taking into account the tolerability of the drug, the daily dose can be increased to 75 mg, dividing it into 2-3 doses. The maximum daily dose is 150 mg. Shows the simultaneous use of other drugs for the treatment of myocardial infarction (including thrombolytics, beta-blockers and acetylsalicylic acid);
diabetic nephropathy in patients with type 1 diabetes mellitus: from 75 to 100 mg per day, divided into 2-3 doses. If it is necessary to further reduce blood pressure, it is possible to prescribe other antihypertensive drugs in addition to therapy with captopril.

The recommended dosage of Captopril Sandoz for patients with impaired renal function, taking into account CC (initial daily dose / maximum daily dose):

CC 40 ml / min: 25-50 mg / 150 mg;
CC 21-40 ml / min: 25 mg / 100 mg;
CC 10–20 ml / min: 12.5 mg / 75 mg;
CC less than 10 ml / min: 6.25 mg / 37.5 mg.

It is recommended to constantly adjust the dose of captopril based on the therapeutic response, keeping it as low as possible.

Side effects

Unwanted disorders (classified as follows: very often - ≥ 1/10, often - ≥ 1/100 and <1/10, infrequently - ≥ 1/1000 and <1/100, rarely - ≥ 1/10 000 and <1 / 1000, very rarely - <1/10 000, the frequency has not been established - according to the reports, it is not possible to establish the frequency of occurrence of adverse reactions):

on the part of the blood and lymphatic system: very rarely - pancytopenia (more often with impaired renal function), neutropenia, agranulocytosis, anemia (including aplastic and hemolytic anemia), lymphadenopathy, eosinophilia, thrombocytopenia, autoimmune pathologies, increased titer for antinuclear antibodies;
from the side of metabolism and nutrition: rarely - anorexia; very rarely - hypoglycemia, hyperkalemia;
from the nervous system: often - sleep disturbances, taste disturbances, dizziness; rarely - headache, drowsiness, asthenia, paresthesia; very rarely - impaired consciousness, fainting, stroke and other cerebrovascular disorders, depression;
from the respiratory system, chest and mediastinal organs: often - shortness of breath, unproductive dry irritating cough; very rarely - allergic alveolitis, rhinitis, bronchospasm, eosinophilic pneumonia;
on the part of the cardiovascular system: infrequently - pallor, flushing, palpitations, tachycardia, tachyarrhythmia, arrhythmia, Raynaud's syndrome, orthostatic hypotension, peripheral edema, angina pectoris; very rarely - cardiac arrest, cardiogenic shock;
on the part of the organ of vision: very rarely - deterioration in visual acuity;
from the musculoskeletal system: very rarely - arthralgia, myalgia;
from the genitourinary system: rarely - frequent urination, impaired renal function, polyuria, oliguria, acute renal failure; very rarely - impotence, gynecomastia, nephrotic syndrome;
from the digestive system: often - dryness of the oral mucosa, abdominal pain, diarrhea, constipation, nausea, vomiting; rarely - stomatitis, aphthous ulceration, anorexia; very rarely - glossitis, angioedema of the intestinal mucosa, peptic ulcer, pancreatitis, jaundice, cholestasis, liver dysfunction, hepatitis, liver necrosis;
dermatological reactions: often - itching (with and without rashes), skin rashes (including vesicular and bullous rashes), alopecia; very rarely - photosensitivity, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, pemphigoid reactions, erythema multiforme;
general disorders: infrequently - weakness, increased fatigue, chest pain; very rarely - fever;
laboratory parameters: very rarely - an increase in the concentration of creatinine and urea nitrogen in the blood plasma, proteinuria, hyponatremia, hyperkalemia, an increase in the activity of hepatic transaminases, a decrease in the level of hematocrit and hemoglobin in the blood, an increase in the concentration of bilirubin in the blood serum, metabolic acidosis, an increase in the erythrocyte sedimentation rate (ESR);
others: the frequency has not been established - a symptom complex consisting of nausea, vomiting, facial hyperemia and a decrease in blood pressure.

Overdose

Symptoms: marked lowering of blood pressure (including collapse), bradycardia, myocardial infarction, imbalance in water and electrolyte balance, acute renal failure, stupor, thromboembolic complications, acute cerebrovascular accident.

Treatment: during the first 0.5 hour - gastric lavage, intake of absorbents (activated carbon). It is necessary to give the patient a horizontal position by lifting his legs. Further, measures are applied to restore blood pressure. Intravenous (iv) administration of 0.9% sodium chloride solution is shown in order to replenish the circulating blood volume. To relieve conditions associated with bradycardia or severe vagal reactions, atropine is used, if necessary, an artificial pacemaker is temporarily prescribed. Close observation and symptomatic therapy are shown. Peritoneal hemodialysis is ineffective; hemodialysis is possible.

special instructions

When prescribing Captopril Sandoz, an examination of renal function should be performed; during therapy, it is important to regularly monitor blood pressure and the functional state of the kidneys.

Patients with chronic heart failure should be treated under close medical supervision.

In rare cases, taking Captopril Sandoz may cause hypotension. The likelihood of developing severe arterial hypotension increases with a reduced volume of circulating blood, a violation of water and electrolyte balance, chronic heart failure, or the use of hemodialysis. A pronounced decrease in blood pressure is especially dangerous for patients with cerebrovascular accidents and cardiovascular diseases due to the increased risk of stroke or myocardial infarction. In this regard, it is recommended to start treatment only with low doses and 4-7 days before the start of captopril use, stop taking a diuretic or replenish the circulating blood volume.

Against the background of the use of Captopril Sandoz, the risk of developing hyperkalemia increases with renal failure, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium preparations or other drugs that increase the potassium content in the blood (including heparin), as well as in patients on a low-salt or salt-free diet. It is recommended to avoid the combination of captopril with potassium-sparing diuretics and potassium preparations.

Taking ACE inhibitors increases the risk of developing neutropenia, agranulocytosis, anemia or thrombocytopenia, therefore it is recommended to accompany treatment with captopril with regular monitoring of the number of leukocytes in the blood. During the first 90 days, studies are carried out with an interval of 30 days, then - once every 90 days. In the absence of risk factors, including impaired renal function, neutropenia is rare. It is necessary to use captopril with caution in diseases of the connective tissue and simultaneous therapy with immunosuppressive drugs (allopurinol, procainamide), especially in patients with impaired renal function. In this category of patients, a clinical blood test should be performed every 14 days during the first 90 days, then once every 60 days. Captopril Sandoz is discontinued if the leukocyte count in the blood is less than 1 x 10⁹ / l. Patients in this group are at high risk of developing severe infectious diseases that do not respond to antibiotic treatment. Therefore, when prescribing the drug, the doctor should inform patients about the need to seek advice if a sore throat, fever and other signs of infection occur. Usually, after the cancellation of Captopril Sandoz, the number of leukocytes is quickly restored to normal levels.

When carrying out hemodialysis, it should be borne in mind that the use of dialysis membranes with high permeability (for example, AN69) increases the risk of developing anaphylactoid reactions. It is recommended to first interrupt the drug intake before desensitizing therapy with hymenoptera venom. Before performing an LDL apheresis procedure using dextran sulfate, you should stop taking an ACE inhibitor in order to prevent the development of life-threatening anaphylactoid reactions.

An immediate cancellation of therapy and careful medical supervision are required if the patient develops angioedema. With facial swelling, an antihistamine is usually sufficient to relieve symptoms. With edema of the tongue, pharynx or larynx, immediate subcutaneous administration of epinephrine (adrenaline) is indicated and measures are taken to ensure free airway.

An unproductive prolonged cough caused by the intake of an ACE inhibitor is reversible; after treatment is discontinued, it stops.

With an increase in the activity of hepatic transaminases or the appearance of symptoms of jaundice, taking the tablets should be stopped immediately and urgent measures should be taken.

The use of an ACE inhibitor as part of a combination therapy, including a thiazide diuretic, is recommended to be accompanied by regular monitoring of the level of potassium in the blood.

When carrying out a planned surgical operation using general anesthesia, the patient should inform the anesthesiologist about the use of captopril. Captopril Sandoz should be discontinued 12 hours before the start of general anesthesia.

In black patients, ACE inhibitors, including captopril, exhibit a less pronounced antihypertensive effect.

It should be borne in mind that a laboratory urine test for acetone while taking captopril can give a false positive result.

Influence on the ability to drive vehicles and complex mechanisms

During the period of treatment with Captopril Sandoz, patients should not engage in potentially hazardous activities, the performance of which requires the speed of psychomotor reactions and increased concentration of attention, including driving.

Application during pregnancy and lactation

The use of Captopril Sandoz is contraindicated during gestation and lactation.

When planning pregnancy, taking ACE inhibitors (including captopril) should be discontinued and switched to alternative antihypertensive therapy with an established safety profile.

If conception occurs during the treatment period, it is required to immediately stop taking Captopril Sandoz and ensure that the patient is regularly monitored for fetal development. This is due to an increased risk of developing birth defects in the fetus when using the drug in the first trimester of pregnancy.

Women of childbearing age should be informed about the high degree of danger of treatment with ACE inhibitors during pregnancy associated with disease and death of the fetus and / or newborn. Long-term use of captopril in the II and III trimesters has a toxic effect on the fetus, causing oligohydramnios, decreased renal function, and delayed ossification of the skull bones. In newborns, it can manifest itself as neonatal renal failure, arterial hypotension, and hyperkalemia.

In breast milk, approximately 1% of the taken dose of captopril is found.

Pediatric use

The use of Captopril Sandoz under the age of 18 is contraindicated due to the lack of information on its efficacy and safety in this group of patients.

With impaired renal function

The appointment of Captopril Sandoz is contraindicated in cases of severe renal dysfunction, bilateral renal artery stenosis or stenosis of an artery of a single kidney with progressive azotemia, hyperkalemia, azotemia, condition after kidney transplantation.

The drug should be taken with caution in chronic renal failure, bilateral renal artery stenosis or stenosis of an artery of a single kidney.

The dosage regimen of Captopril Sandoz is set taking into account QC.

For violations of liver function

Captopril Sandoz should be taken with caution if liver function is impaired.

Use in the elderly

Caution is advised when treating elderly patients.

The initial dose in this category of patients should be no more than 6.25 mg 2 times a day.

Drug interactions

antagonists of angiotensin II receptors (ARA II), aliskiren and other drugs that affect the RAAS (renin-aldosterone-angiotensin system): a combination with these drugs causes a double blockade of the RAAS, which can result in a pronounced decrease in blood pressure, hyperkalemia, impaired renal function (including acute renal failure). Therefore, if it is necessary to use ACE inhibitors in combination with other drugs that affect the RAAS, it is necessary to carefully monitor blood pressure, renal function, and the content of electrolytes in the blood plasma;
potassium preparations, potassium-sparing diuretics, potassium supplements, salt substitutes: increase the risk of hyperkalemia, therefore, monitoring of plasma potassium is required;
thiazide and loop diuretics: a reduced volume of circulating blood while taking high doses of diuretics increases the risk of arterial hypotension, therefore, special care should be taken at the beginning of combination therapy with captopril;
aldesleukin, alprostadil, beta-blockers, alpha ₁ adrenoblokatory, alpha ₂ -adrenomimetikami central action, cardiotonics, diuretics, calcium channel blockers slow, muscle relaxants, nitrate, minoxidil, vasodilators, antipsychotics, antidepressants, anxiolytics, hypnotics: potentiate the antihypertensive effect of captopril;
estrogens (including combined oral contraceptives), nonsteroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2, indomethacin: with long-term combined use, they weaken the hypotensive effect of captopril; against the background of taking NSAIDs, the following reversible effects may develop - an increase in the content of potassium in the blood serum against a background of decreased renal function, in rare cases - the occurrence of acute renal failure (more often with dehydration, the presence of impaired renal function or in old age);
lithium preparations: the excretion of lithium slows down, and its concentration in the blood increases, therefore, if a combination with lithium preparations is necessary, careful monitoring of the serum lithium concentration should be carried out;
allopurinol, procainamide: increase the risk of developing neutropenia and Stevens-Johnson syndrome;
gold preparations: against the background of intravenous administration of sodium aurothiomalate, a symptom complex may develop, including facial flushing, lowering blood pressure, nausea and vomiting;
sympathomimetics: it is possible to reduce the antihypertensive effect of captopril;
insulin, oral hypoglycemic agents: can lead to the development of hypoglycemia;
antacids: the absorption of captopril in the gastrointestinal tract slows down when taking antacids or food;
epoetin, carbenoxolone, glucocorticosteroids, naloxone: help to weaken the action of captopril;
probenecid: the renal clearance of captopril decreases, causing an increase in its concentrations in the blood serum;
azathioprine, cyclophosphamide and other immunosuppressants: increase the likelihood of developing hematological disorders;
digoxin: the concentration of digoxin in the blood plasma increases by 15–20%;
propranolol: increases its bioavailability;
cimetidine: helps to slow down the metabolism of captopril and increase its concentration in blood plasma;
clonidine: reduces the severity of the antihypertensive effect of the drug;
ethanol: contributes to a significant increase in the hypotensive effect of captopril, therefore, the use of alcoholic beverages or ethanol-containing drugs is not recommended during the period of therapy with Captopril Sandoz.

Analogs

The analogues of Captopril Sandoz are: Captopril, Captopril-AKOS, Captopril Velpharm, Captopril-STI, Captopril-FPO, Captopril-Ferein, Captopril-Sar, Angiopril-25, Captopril-UBF, Vero-Captoprilos, Capintopril-Biord dr.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

Shelf life: tablets with a dosage of 6.25; 25 or 50 mg - 3 years; dosage of 12.5 or 100 mg - 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Captopril Sandoz

Reviews of Captopril Sandoz are often positive. Most patients taking the drug as an emergency aid with a sharp rise in blood pressure indicate its rapid antihypertensive effect.

Price for Captopril Sandoz in pharmacies

The price of Captopril Sandoz 25 mg can be 80–97 rubles. for a package containing 20 tablets, and 134-155 rubles. per pack of 40 tablets.

Captopril Sandoz: prices in online pharmacies

Drug name

Price

Pharmacy

Captopril Sandoz 25 mg tablets 20 pcs.

RUB 85

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Captopril Sandoz tablets 25mg 40 pcs.

126 RUB

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Captopril Sandoz 25 mg tablets 40 pcs.

126 RUB

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!