Captopril Welfarm, tablets 25 mg 40 pcs

Pharmacotherapeutic group: angiotensin-converting enzyme inhibitor (ACE inhibitor)

ATX code: C09AA01

Pharmacological properties Pharmacodynamics

First generation angiotensin-converting enzyme (ACE) inhibitor containing a sulfhydryl group (SH-group). It has an antihypertensive effect.

Inhibiting ACE reduces the conversion of angiotensin I to angiotensin II and eliminates its vasoconstrictor effect on arterial and venous vessels. As a result of decreased concentration of angiotensin II, there is a secondary increase in plasma renin activity (due to elimination of negative feedback of renin release), which leads to a direct reduction of aldosterone secretion by the adrenal cortex. This reduces total peripheral vascular resistance (PPR) and arterial pressure (BP), resistance in the pulmonary vessels, reduces the post- and preload on the heart. Increases cardiac output and exercise tolerance.

Dilates arteries to a greater extent than veins. Causes a decrease in bradykinin degradation (one of the effects of ACE) and an increase in prostaglandin synthesis.

The antihypertensive effect does not depend on the activity of plasma renin; the decrease of BP is observed with normal and even reduced activity of the hormone due to the effect on tissue renin-angiotensin-aldosterone system (RAAS).

It enhances coronary and renal blood flow. With long-term use, it reduces the severity of myocardial hypertrophy and arterial wall resistance, prevents the progression of heart failure and slows the development of left ventricular dilatation.

It improves blood supply to ischemic myocardium. Reduces platelet aggregation. Helps reduce sodium ions in patients with heart failure.

Decreases the tone of the renal tubular arterioles, thus improving intra-column hemodynamics and prevents the development of diabetic nephropathy. In doses of 50 mg/day it shows angioprotective properties against the vessels of the microcirculatory bed and allows to slow the progression of chronic renal failure in diabetic nephroangiopathy.

The decrease of BP in contrast to direct vasodilators (hydralazine, minoxidil, etc.) is not accompanied by reflex tachycardia and leads to reduction of myocardial oxygen demand. In heart failure, an adequate dose has no effect on BP. Maximum BP reduction is observed 60-90 minutes after oral administration. The duration of antihypertensive effect depends on the dose of the drug taken and reaches optimal values within a few weeks of therapy.

Discontinuation of captopril should not be abrupt, as this may cause a significant increase in BP.

Pharmacokinetics

Absorption is fast and is about 75% of the administered dose (absorption of the drug is reduced by 30-40% if it is taken with food simultaneously), bioavailability is 35-40% (effect of “primary passage” through the liver). Binding with plasma proteins (mainly with albumin) is 25-30%. Time to reach maximum plasma concentration (Cmax = 114 ng/ml) when administered orally is 30-90 min. Less than 0.002% of the administered dose of captopril is secreted with breast milk. Across the blood-brain barrier and placental barrier penetration is insignificant (less than 1%).

Metabolized in the liver with the formation of captopril disulfide dimer and captopril-cysteine sulfide. Metabolites are pharmacologically inactive.

Half-life of captopril is about 2-3 hours. About 95% is excreted by kidneys during the first day, 40-50% of them are unchanged, the rest – as metabolites. In daily urine 38 % of unchanged captopril and 62 % as metabolites are determined.

Cumulates in chronic renal failure. The half-life in renal failure is 3.5-32 hours, so patients with impaired renal function should reduce the dose of the drug and/or increase the interval between doses.

Indications

– Arterial hypertension (including renovascular).

– Chronic heart failure (as part of complex therapy).

– Impaired left ventricular function after myocardial infarction with clinically stable condition.

– Diabetic nephropathy against type 1 diabetes (with albuminuria more than 30 mg/day).

Active ingredient

Captopril

Composition

Per tablet:

Active substance: captopril (in terms of dry substance) – 25.0 mg,

Auxiliary substances: lactose monohydrate (milk sugar), microcrystalline cellulose, magnesium stearate, talc, colloidal silicon dioxide (aerosil), crospovidone (collidon CL-M, collidon CL).

How to take, the dosage

Orally 1 hour before a meal. Dosing regimen is established individually.

In case of arterial hypertension, treatment should be started with the lowest effective dose of 12.5 mg twice daily. Attention should be paid to tolerability of the first dose within the first hour. If arterial hypotension developed, the patient should be transferred to the “lying” position with elevated legs (such reaction to the first dose should not be an obstacle to further therapy). If necessary, the dose is gradually (at 2-4 week intervals) increased until an optimal effect is achieved.

In mild to moderate arterial hypertension, the usual maintenance dose is 25 mg (1/2 tablet of 50 mg) 2 times a day; the maximum dose is 50 mg 2 times a day. In severe arterial hypertension, the maximum daily dose of Captopril Wellfarm is 150 mg (50 mg 3 times daily).

In chronic heart failure, it is prescribed together with diuretics and/or in combination with cardiac glycosides (to avoid an initial excessive decrease in blood pressure, the diuretic should be cancelled or the dose reduced before prescribing the drug). The initial daily dose is 6.25 mg (for this dosing regimen, use captopril in 12.5 mg tablets with a rib or in 25 mg tablets with a cross-shaped rib of other manufacturers) 3 times daily, further, if necessary, the dose is increased gradually (at intervals of at least 2-weeks). The average maintenance dose is 25 mg (1/2 tablet of 50 mg) 2-3 times per day, and the maximum dose is 150 mg per day. In case of symptomatic arterial hypotension in heart failure, the doses of diuretics and/or other simultaneously prescribed vasodilators may be reduced to achieve a sustained effect of Captopril Wellfarm.

In patients with impaired left ventricular function after myocardial infarction who are clinically stable, administration of Captopril Wellfarm may be started as early as 3 days after myocardial infarction. The initial dose is 6.25 mg per day (for this dosing regimen, use captopril in 12.5 mg tablets with a slash or in 25 mg tablets with a cross-shaped slash from other manufacturers). If necessary, the dose is gradually increased over several weeks to 75 mg per day in 2-3 doses (depending on tolerance of the drug) up to a maximum daily dose of 150 mg (50 mg 3 times a day).

If arterial hypotension develops, the dose may need to be reduced. Subsequent attempts to use the maximum daily dose of 150 mg should be based on patients’ tolerance to the drug.

In diabetic nephropathy, Captopril Wellfarm is prescribed in a dose of 75-100 mg per day in 2-3 doses. In insulin-dependent diabetes (type 1) with microalbuminuria (albumin excretion 30-300 mg per day) the drug dose is 50 mg 2 times per day. In case of total protein clearance of more than 500 mg per day, the drug is effective in a dose of 25 mg (1/2 tablet of 50 mg) 3 times a day.

In moderate degree of renal dysfunction (GFR – at least 30 ml/min/1.73 m²), captopril Wellfarm can be prescribed in a dose of 75-100 mg daily. If renal function impairment is more severe (FFR less than 30 ml/min/1.73 m²), the initial dose should be no more than 12.5 mg per day (for this dosing regimen, use captopril in 25 mg tablets with a rice of other manufacturers); subsequently, if necessary, the dose is gradually increased at fairly long intervals, but using a lower daily dose than in the treatment of arterial hypertension.

If necessary, “loop” diuretics rather than thiazide-type diuretics are additionally prescribed.

The recommended dosage adjustment schedule for Captopril Wellfarm in patients with impaired renal function

.table border=”1″ cellspacing=”0″ cellpadding=”0″>

The glomerular filtration rate

filtration rate (ml/min/1.73 m²)

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

Interaction

The concomitant use of ACE inhibitors with other drugs affecting the RAAS, including angiotensin II receptor antagonists (ARA II) and aliskiren, leads to increased incidence of severe blood pressure decrease, hyperkalemia, renal dysfunction (including acute renal failure). Parameters of blood pressure, renal function, and plasma electrolytes should be monitored when using captopril with other drugs affecting the RAAS.

The concomitant use of ACE inhibitors with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate or severe renal impairment (FFR less than 60 ml/min/1.73 m² body surface area) and is not recommended in other patients.

The concomitant use of ACE inhibitors with angiotensin II receptor antagonists is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

The combined use with potassium-saving diuretics (triamterene, amiloride, spironolactone and its derivative – eplerenone), potassium preparations, potassium supplements, salt substitutes (contain significant amounts of potassium ions) increases the risk of hyperkalemia. If their concomitant use with captopril is necessary, plasma potassium content should be monitored.

When high doses of diuretics (thiazide diuretics, “loop” diuretics) are used concomitantly with captopril due to decreased circulating blood volume, the risk of arterial hypotension increases, especially at the beginning of captopril therapy.

. The antihypertensive effect of captopril is potentiated by concomitant use with aldesleukin, alprostadil, beta-adrenoblockers, alpha1-adrenoblockers, central alpha2-adrenomimetics, diuretics, cardiotonics, “slow” calcium channel blockers, minoxidil, muscle relaxants, nitrates and vasodilators. Antidepressants, neuroleptics, anxiolytics and hypnotics may also increase the antihypertensive effect of captopril.

In long-term use, the antihypertensive effect of captopril is impaired by indomethacin and other nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (sodium ion retention, decreased prostaglandin synthesis, especially with low renin activity) and estrogens.

It has been described that NSAIDs and ACE inhibitors have an additive effect on increasing serum potassium, while reducing renal function. These effects are reversible. Rarely, acute renal failure may occur, especially in patients with previous renal dysfunction, in elderly patients, or with reduced circulating blood volume (in dehydration).

The use of ACE inhibitors in patients undergoing surgery with general anesthesia may lead to a significant decrease in BP, especially with the use of general anesthesia agents with antihypertensive effect.

Inhibits excretion of lithium drugs by increasing the concentration of lithium in the blood. If concomitant use of captopril and lithium drugs is necessary, the serum concentration of lithium should be monitored carefully.

When captopril is used with allopurinol or procainamide, there is an increased risk of Stevens-Johnson syndrome and/or neutropenia.

In concomitant use of ACE inhibitors and gold preparations (IV sodium aurothiomalate), a symptom complex including facial hyperemia, nausea, vomiting and decreased BP has been described.

Sympathomimetics may decrease the antihypertensive effect of captopril.

Insulin and oral hypoglycemic agents increase the risk of hypoglycemia.

Simultaneous administration of captopril with food or antacids slows down absorption of captopril in the gastrointestinal tract.

The use of ethanol is not recommended during therapy with captopril because ethanol increases the antihypertensive effect of captopril.

The antihypertensive effect of captopril is impaired by epoetins, estrogens and combined oral contraceptives, carbenoxolone, glucocorticosteroids, and naloxone.

Probenecid decreases renal clearance of captopril and increases its serum blood concentrations.

The use of captopril in patients taking immunosuppressants (e.g., azathioprine or cyclophosphamide) increases the risk of hematological disorders. Captopril increases the plasma concentration of digoxin by 15-20%.

Induces the bioavailability of propranololol.

Cimetidine, by slowing down metabolism in the liver, increases the plasma concentration of captopril.

Clonidine reduces the severity of the antihypertensive effect.

The interaction of ACE inhibitors with drugs containing co-trimoxazole [trimethoprim + sulfamethoxazole] causes an increased risk of hyperkalemia.

Interaction with type IV dipeptidyl peptidase (DPP-IV) inhibitors (glyptins), e.g. sitagliptin, saxagliptin, vildagliptin, linagliptin increases the risk of angioedema.

Interaction with racecadotril increases the risk of angioedema. Interaction with estramustine increases the risk of angioedema.

Special Instructions

Blood pressure and renal function should be regularly monitored before initiation as well as regularly during treatment with Captopril Wellfarm. In patients with chronic heart failure the drug should be used under close medical supervision.

Arterial hypotension

. In patients with arterial hypertension when using the drug captopril Wellfarm severe arterial hypotension is observed only rarely, the likelihood of this condition increases with a decrease in the volume of circulating blood and electrolyte-water balance (eg, after intensive treatment with diuretics), in patients with chronic heart failure or patients on hemodialysis. The possibility of a sharp drop in blood pressure can be minimized if the diuretic is cancelled beforehand (4-7 days before) or the volume of circulating blood is replenished (about a week before starting treatment) or if CAPTOPRIL Welfarm is used at low doses at the beginning of therapy (6.25-12.5 mg/day).

A pronounced decrease in blood pressure when using hypotensive drugs in patients with cerebrovascular disorders, with cardiovascular disease may increase the risk of myocardial infarction or stroke. If arterial hypotension develops, the patient should assume a horizontal position with elevated legs. Sometimes it may be necessary to replenish circulating blood volume.

Renovascular hypertension

There is an increased risk of arterial hypertension and renal failure in patients with bilateral renal artery stenosis of the single kidney when using ACE inhibitors. Impairment of renal function may occur with moderate changes in serum creatinine concentration. In such patients, therapy should be started under close medical supervision with low doses, carefully titrated and with monitoring of renal function.

The concomitant use of ACE inhibitors (including Captopril Wellfarm) with drugs containing aliskiren is contraindicated in patients with diabetes and/or with moderate to severe renal impairment (FFR less than 60 mL/min/1.73 m² body surface area) and is not recommended in other patients.

The concomitant use of ACE inhibitors with angiotensin II receptor antagonists is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Renal dysfunction

In patients with renal insufficiency or when taking high doses of ACE inhibitors (including Captopril Wellfarm) proteinuria may be observed. In most cases, proteinuria decreased or disappeared within 6 weeks, whether or not treatment with Captopril Wellfarm was continued. Renal function parameters such as residual blood nitrogen and creatinine rarely changed in patients with proteinuria. In patients with renal disease, urinary protein content should be determined before initiation of therapy and periodically during the course of therapy.

Hyperkalemia

In some cases when using Captopril Wellfarm, an increase in serum potassium has been observed. The risk of hyperkalemia when using ACE inhibitors is increased in patients with renal insufficiency and diabetes mellitus, as well as those taking potassium saving diuretics, potassium preparations and other drugs that cause increase in blood potassium content (e.g., heparin). Concomitant use of potassium-saving diuretics and potassium preparations should be avoided. Caution is used in patients on low-salt or no-salt diet (increased risk of hypotension and hyperkalemia).

Neutropenia/agranulocytosis

In the first 3 months of therapy the number of leukocytes in the blood is monitored monthly, then once in 3 months. Neutropenia/granulocytosis, anemia and thrombocytopenia have been reported in patients taking ACE inhibitors, including Captopril Wellfarm. In patients with normal renal function and no other complicating factors, neutropenia is rare. Captopril should be used with great caution in patients with connective tissue disease concomitantly receiving immunosuppressive therapy (allopurinol or procainamide), especially in existing renal dysfunction. Clinical blood counts in such patients are monitored every 2 weeks in the first 3 months, then every 2 months thereafter. If white blood cell count is below 4.0 × 10⁹ /l, a general blood test is indicated, below 1.0 × 10⁹ /l – the drug is discontinued. Such patients may develop severe infections that are not amenable to intensive antibiotic therapy. During treatment, all patients should be instructed that if signs of infection (e.g., sore throat, fever) are present, the doctor should be informed and a clinical blood count and leukocyte count performed. In most patients, the leukocyte count returns quickly to normal when treatment with Captopril is stopped.

Anaphylactoid reactions

Patients taking Captopril Wellfarm against the background of ongoing desensitization therapy with venom of hymenoptera, etc., have an increased risk of developing anaphylactoid reactions. This can be avoided by temporarily discontinuing the drug.

When performing hemodialysis in patients receiving Captopril Wellfarm, the use of dialysis membranes with high permeability (e.g., AN69^®) should be avoided because of the increased risk of anaphylactoid reactions in such cases. In rare cases, life-threatening anaphylactoid reactions may develop in patients receiving ACE inhibitors when low-density lipoprotein (LDL) apheresis is performed using dextran sulfate. To prevent anaphylactoid reactions, therapy with an ACE inhibitor should be discontinued before each LDL apheresis procedure using high-flow membranes.

Angioneurotic edema

In patients taking Captopril Welfarm, if abdominal pain occurs, it is necessary to differentiate with intestinal angioneurotic edema.

If angioedema develops, the drug should be withdrawn and close medical supervision and symptomatic therapy should be provided. If the swelling is localized to the face, special treatment is usually not required (antihistamines may be used to reduce symptoms); if the swelling spreads to the tongue, pharynx, or larynx and there is a threat of airway obstruction and life-threatening, epinephrine (adrenaline) should be immediately given subcutaneously (0.5 ml diluted 1:1000) and a free airway should be ensured.

The use of ACE inhibitors, including Captopril Wellfarm, should be stopped 12 hours before surgery, and the surgeon or anesthesiologist should be informed about the use of ACE inhibitors.

Cough

The development of unproductive, prolonged cough while taking ACE inhibitors is reversible and resolves after treatment is discontinued.

Diabetes mellitus

In diabetic patients taking oral hypoglycemic agents or insulin, blood glucose concentrations should be monitored regularly during the first month of treatment with Captopril Wellfarm.

Hepatic dysfunction

Hepatic dysfunction with cholestatic jaundice, fulminant hepatic necrosis, sometimes fatal, has been reported several times during therapy with ACE inhibitors.

If jaundice or increased hepatic transaminase activity develops during therapy with Captopril Wellfarm, the drug should be stopped immediately and the patient should be closely monitored and receive appropriate therapy if necessary.

Hypokalemia

The simultaneous use of ACE inhibitor and thiazide diuretic does not exclude the possibility of hypokalemia. Regular monitoring of blood potassium is recommended.

Surgery/anesthesia

Arterial hypotension can occur in patients who have undergone major surgical procedures or during the use of anesthetics that are known to decrease blood pressure. If arterial hypotension occurs, replenishment of circulating blood volume is recommended.

Ethnic differences

The ACE inhibitors, including Captopril Wellfarm, have a less pronounced antihypertensive effect in non-Hispanic patients, which appears to be related to the frequent occurrence of low renin activity in this patient group.

Laboratory data

Captopril may cause a false-positive urine test for acetone.

Influence on driving, operating machinery

During treatment, refrain from driving and engaging in potentially hazardous activities requiring increased concentration and rapid psychomotor reactions, as dizziness is possible, especially after taking the initial dose.

Synopsis

Round flat-cylindrical white or almost white tablets with a characteristic odor with a ridge and a bevel. The presence of “marbling” is allowed.

Contraindications

– hypersensitivity to captopril, other drug components or other ACE inhibitors (including history);

– hereditary and/or idiopathic angioedema, angioedema in anamnesis (with previous therapy with other ACE inhibitors);

– severe renal function impairment, refractory hyperkalemia, bilateral renal artery stenosis, stenosis of a single kidney with progressive azotemia, post renal transplantation condition, primary hyperaldosteronism;

– severe liver function impairment;

– pregnancy;

– breastfeeding period;

– age under 18 years (effectiveness and safety not established);

– lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

– concomitant use of ACE inhibitors (including captopril) with aliskiren and aliskiren-containing drugs in patients with type 2 diabetes or impaired renal function (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m² body surface area) (see

– concomitant use with angiotensin II receptor antagonists (APA II) in patients with diabetic nephropathy.

Caution

Hypertrophic obstructive cardiomyopathy, connective tissue diseases (especially systemic lupus erythematosus or scleroderma), suppression of medullary hematopoiesis (risk of neutropenia and agranulocytosis), cerebrovascular disease, coronary heart disease, diabetes (increased risk of hyperkalemia), diet with restriction of table salt, states conditions accompanied by decreased circulating blood volume (including diarrhea, vomiting, in patients on hemodialysis), mitral stenosis, aortic stenosis and similar changes that impede blood flow from the left ventricular heart, liver dysfunction, chronic renal failure, surgery/general anesthesia, hemodialysis using high-flow membranes (e.g., AN69^®), desensitization therapy, low-density lipoprotein (LDL) apheresis, administration of potassium-saving diuretics, potassium, potassium-containing salt substitutes and lithium, hyperkalemia, renovascular hypertension, when used in non-human race patients, in elderly patients (dose adjustment required).

Side effects

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: Very common (≥ 1/10); common (≥ 1/100, < 1/10); infrequent (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000), including individual reports; unspecified frequency (frequency cannot be calculated from available data).

Central nervous system disorders: frequent – taste disorder, sleep disturbances, dizziness, somnolence; rare – headache, paresthesia, asthenia; very rare – depression, cerebrovascular disorders, including stroke, syncope, impaired consciousness.

Skin disorders: frequently – skin itching with or without rashes, skin rash (maculopapular, less frequently – vesicular or bullous character), alopecia; very rarely – urticaria, Stevens-Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, exfoliative dermatitis, pemphigoid reactions.

Urogenital system disorders: rarely – renal failure, acute renal failure, polyuria, oliguria, increased frequency of urination, very rarely – nephrotic syndrome, sexual dysfunction, gynecomastia.

Metabolism: rarely – anorexia; very rarely – hyperkalemia, hypoglycemia.

Motor system disorders: very rarely – myalgia, arthralgia.

Digestive system disorders: often – dry mucous membrane of the mouth, nausea, vomiting, abdominal pain, diarrhea, constipation; rarely – stomatitis, aphthous ulcers of the inner surface of the mucous membrane of the cheeks and tongue, gum hyperplasia; very rarely – glossitis, peptic ulcer, pancreatitis, liver dysfunction, cholestasis, jaundice, hepatitis (including rare cases of hepatonecrosis), increased “liver” transaminases activity, increased serum bilirubin concentration, angioedema of intestinal mucosa.

Hematopoietic organs: very rarely – neutropenia, agranulocytosis, pancytopenia, especially in patients with renal dysfunction, anemia (including aplastic, hemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, autoimmune diseases, and/or titer increase for antinuclear antibodies.

Respiratory system: often – dry, irritating (non-productive) cough, shortness of breath; very rare – bronchospasm, rhinitis, allergic alveolitis, eosinophilic pneumonia, pulmonary edema.

Sensory system disorders: very rarely – visual acuity disorder.

Cardiovascular system disorders: infrequent – tachycardia or tachyarrhythmia, palpitations, angina pectoris, orthostatic hypotension, Raynaud’s syndrome, blood flushing to the face, paleness, peripheral edema; very rare – cardiogenic shock, cardiac arrest.

Laboratory measures: very rarely – proteinuria, eosinophilia, hyperkalemia, hyponatremia, hypoglycemia, increased concentration of urea nitrogen and creatinine in plasma, acidosis, decreased hemoglobin and hematocrit, decreased number of leukocytes, platelets, increased erythrocyte sedimentation rate (ESR).

Others: infrequent – chest pain, increased fatigue, weakness; very rare – fever; frequency unknown – symptom complex including facial hyperemia, nausea, vomiting and decreased blood pressure.

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Overdose

Symptoms: marked decrease in blood pressure, up to collapse, shock, stupor, bradycardia, water-electrolyte balance disorders, acute renal failure, myocardial infarction, acute violation of cerebral circulation, thromboembolic complications.

Treatment: gastric lavage, administration of adsorbents and sodium sulfate not later than 30 minutes after taking the drug; transfer the patient to the “lying” position with elevated legs, take measures aimed at restoring blood pressure, replenishment of circulating blood volume (for example, intravenous injection of 0.9% sodium chloride solution), symptomatic therapy – epinephrine (adrenaline) – subcutaneously or intravenously, antihistamines, hydrocortisone – intravenously. Atropine should be used in bradycardia or marked vagus reactions. Hemodialysis may be used; peritoneal hemodialysis is ineffective.

Pregnancy use

The use of the drug Captopril Wellfarm is contraindicated in pregnancy.

The drug Captopril Wellfarm should not be used in the first trimester of pregnancy. Appropriate controlled studies of the use of ACE inhibitors in pregnant women have not been performed. The limited data available on the effects of the drug in the first trimester of pregnancy indicate that the use of ACE inhibitors does not lead to fetotoxicity-related fetal malformations. Epidemiologic data suggesting a risk of teratogenicity following first trimester ACE inhibitor exposure have not been conclusive, but some increase in risk cannot be ruled out.

The use of ACE inhibitors in pregnancy can lead to fetal and/or neonatal morbidity and mortality. Prolonged use of captopril in the second and third trimesters is toxic to the fetus (decreased renal function, scarcity of water, delayed ossification of the skull bones) and the newborn (neonatal renal failure, arterial hypotension, hyperkalemia).

In addition, the use of ACE inhibitors in the first trimester of pregnancy is associated with a potentially increased risk of fetal birth defects.

Women planning to become pregnant should not use ACE inhibitors (including Captopril Welfarm). Women of childbearing age should be advised of the potential dangers of using ACE inhibitors (including Captopril Wellfarm). If pregnancy occurs during the use of Captopril Wellfarm, the drug should be discontinued as soon as possible and fetal development should be monitored regularly.

If the patient received the drug during the second and third trimesters of pregnancy, an ultrasound examination is recommended to evaluate the skull bones and fetal renal function.

If ACE inhibitor use is deemed necessary, patients planning pregnancy should be switched to an alternative hypotensive therapy with an established safety profile for use during pregnancy. Approximately 1% of the administered dose of Captopril Wellfarm is found in breast milk. Due to the risk of serious adverse reactions in the child, breastfeeding should be stopped or maternal therapy with the drug should be discontinued during breastfeeding.

Similarities

Capoten, Captopril