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

Excipients: lactose anhydrous (lactopress), microcrystalline cellulose, potato starch, povidone 25000 (polyvinylpyrrolidone 25000), sucrose (sugar), magnesium stearate.

Description:

Tablets white or white with a creamy shade of color with a characteristic odor, flat-cylindrical. A small marble is allowed.

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

ATX: & nbsp

C.09.A.A.01 Captopril

Pharmacodynamics:

Captopril is an inhibitor of the angiotensin-converting enzyme (ACE). Suppresses the formation of angiotensin II and eliminates its vasoconstrictive effect on arterial and venous vessels. Reduces the overall peripheral vascular resistance, reduces afterload, lowers blood pressure.Reduces preload, reduces pressure in the right atrium and a small circle of circulation. Reduces the formation of aldosterone in the adrenal glands.

Pharmacokinetics:

When administered, the bioavailability of captopril is 60-70%. Simultaneous food intake slows the absorption of the drug by 30-40%. Communication with plasma proteins is 25-30%. The half-life period is 2-3 hours. The drug is excreted from the body mainly by the kidneys, up to 50% unchanged.

Indications:

- arterial hypertension;

- chronic heart failure (as part of combination therapy), left ventricular dysfunction after a myocardial infarction with a clinically stable condition, diabetic nephropathy against a type 1 diabetes mellitus (for albuminuria more than 30 mg / day).

Contraindications:

Hypersensitivity to captopril and other ACE inhibitors, angioedema (history of therapy with ACE inhibitors or hereditary), severe liver and / or kidney dysfunction, hyperkalemia, bilateral renal artery stenosis, single-kidney artery stenosis with progressive azotemia, post-transplant condition kidney,Stenosis of the aortic aorta and similar changes that complicate the outflow of blood from the left ventricle, pregnancy, lactation, age under 18 years (efficacy and safety not established).

Carefully:

Severe autoimmune diseases of connective tissue (including systemic lupus erythematosus, scleroderma), oppression of bone marrow hematopoiesis (risk of neutropenia and agranulocytosis), cerebral ischemia, diabetes (increased risk of hyperkalemia), patients on hemodialysis, a diet with sodium restriction, primary hyperaldosteronism, ischemic heart disease, conditions accompanied by a decrease in the volume of circulating blood (including vomiting, diarrhea), and advanced age (dose adjustment is required).

Dosing and Administration:

Vero-captopril is prescribed an hour before meals. The dosage regimen is set individually.

With arterial hypertension the drug is prescribed in an initial dose of 12.5 mg twice a day. If necessary, the dose gradually (with an interval of 2-4 weeks) is increased to achieve the optimal effect. With mild or moderate arterial 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 2 times a day. The dose is gradually increased to a maximum daily dose of 150 mg (50 mg 3 times per day).

For the treatment of chronic heart failure Vero-captopril is prescribed in those cases when the use of diuretics does not provide an adequate effect. The initial daily dose is 6.25 mg 3 times a day. In the future, if necessary, the dose gradually (at intervals of not less than 2 weeks) is increased. The average maintenance dose is 25 mg 2-3 times a day, and the maximum - 150 mg per day.

In cases of violations of left ventricular function after a previous myocardial infarction in patients in a clinically stable state, the use of Verocaptopril can begin as early as 3 days after myocardial infarction. The initial dose is 6.25 mg / day, then the daily dose can be increased to 37.5-75 mg for 2-3 doses (depending on the drug's tolerance) up to a maximum of 150 mg per day.

With diabetic nephropathy Vero-Captopril is prescribed in a dose of 75-100 mg, divided into 2-3 doses. With insulin-dependent diabetes with microalbuminuria (release of albumin 30-300 mg per day), the dose of the drug is 50 mg 2 times a day.With a total protein clearance of more than 500 mg per day, the drug is effective at a dose of 25 mg 3 times per day.

Patients with impaired renal function: with a moderate degree of renal dysfunction (creatinine clearance (CK) of at least 30 ml / min / 1.73 m²) Vero-captopril can be administered at a dose of 75-100 mg / day. With a more pronounced degree of renal dysfunction (CC less than 30 ml / min / 1.73 m²) the initial dose should not exceed 12.5 mg / day; In the future, if necessary, with sufficiently long intervals, the dose of Vero-captopril is gradually increased, but a smaller, than usual, daily dose of the drug is used.

In old age dThe drug is selected individually, it is recommended to start therapy with a dose of 6.25 mg twice a day and, if possible, maintain it this level.

If necessary, additionally prescribed loop diuretics, and not diuretics thiazide series.

Side effects:

From the cardiovascular system: orthostatic hypotension, tachycardia, peripheral edema, marked decrease in blood pressure, "hot flashes" of blood to the skin of the face, fever.

From the respiratory system: dry cough usually occurring after withdrawal of the drug, bronchospasm, pulmonary edema.

Allergic reactions: angioedema, extremities, face, lips, mucous membranes, tongue, pharynx and larynx, skin rash (maculopapular, less often vesicular or bullous), itching, photosensitivity, serum sickness, lymphadenopathy.

From the central nervous system: headache, dizziness, ataxia, paresthesia, drowsiness, visual impairment.

From the side of water-electrolyte exchange: hyperkalemia, hyponatremia, proteinuria, elevated urea nitrogen and creatinine in the blood, acidosis.

From the hematopoiesis: neutropenia, agranulocytosis, thrombocytopenia, anemia, a positive test for antibodies to a nuclear antigen (rarely).

From the digestive system: loss of appetite, dyspepsia, nausea, constipation, dry mouth, stomatitis, gingival hyperplasia, increased activity of liver enzymes, abdominal pain, diarrhea, hepatitis, hyperbilirubinemia, cholestasis (in rare cases), pancreatitis (in rare cases) .

Overdose:

Symptoms: a sharp drop in blood pressure.

Treatment: the introduction of an isotonic solution of sodium chloride or other plasma-interfering solutions, hemodialysis.

Interaction:

Diuretics and vasodilators (for example, minoxidil) potentiate the hypotensive effect of Vero-captopril.

With the combined use of Vero-captopril with indomethacin (and, possibly, with other non-steroidal anti-inflammatory drugs), hypotensive action may decrease.

Simultaneous use with potassium-sparing diuretics or with potassium preparations can lead to hyperkalemia.

With the simultaneous use of lithium salts, it is possible to increase the concentration of lithium in the blood serum. The use of Vero-captopril in patients taking allopurinol or procainamide, increases the risk of developing neutropenia and / or Stevens-Johnson syndrome. The use of Vero-captopril in patients taking immunosuppressants (eg, cyclophosphacin or azathioprine) increases the risk of hematological disorders.

Special instructions:

Before starting, and also regularly during the treatment with Vero-captopril, kidney function should be monitored. Patients with chronic heart failure are treated under close medical supervision.

Against the background of prolonged use of Vero-captopril in approximately 20% of patientsan increase in urea and serum creatinine by more than 20% is observed 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 concentrations.

In patients with arterial hypertension with Vero-captopril, expressed Arterial hypotension is observed only in rare cases; the likelihood of developing this condition increases with increased loss of fluid and salts (eg, after intensive treatment with diuretics), in patients with heart failure or who are on dialysis.

The possibility of a sharp drop in blood pressure can be minimized by first canceling (for 4-7 days) a diuretic or increasing the intake of sodium chloride (about a week before the start of the procedure) or by prescribing Vero-captopril at the start of treatment in small doses (6, 25-12.5 mg / day).

In the first 3 months of therapy, the number of blood leukocytes is monitored monthly, then - once every 3 months; in patients with autoimmune diseases in the first 3 months - every 2 weeks, then every 2 months. If the number of white blood cells is less than 4000 / μL, a general blood test is performed, below 1000 μL - the drug is stopped.

In some cases, against the background of the use of ACE inhibitors, incl.Vero-captopril, an increase in the concentration of potassium in the blood serum is observed. The risk of hyperkalemia in the use of ACE inhibitors is increased in patients with renal insufficiency and diabetes mellitus, as well as taking potassium-sparing diuretics, potassium preparations or other drugs that cause an increase in the concentration of potassium in the blood (for example, heparin). You should avoid the simultaneous use of potassium-sparing diuretics and potassium preparations.

When hemodialysis in patients receiving Vero-captopril, the use of dialysis membranes with high permeability should be avoided (for example, AN69), because in such cases the risk of anaphylactoid reactions increases.

In the case of angioedema, the drug is withdrawn and carefully monitored. If the edema is localized on the face, special treatment is usually not required (to reduce the severity of symptoms can be used antihistamines); if the swelling spreads to the tongue, throat or larynx and there is a threat of development of airway obstruction, you should immediately enter epinephrine (epinephrine) subcutaneously (0.5 ml in a dilution of 1: 1000).

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

Be wary appoint patients who are on a low-salt or salt-free diet (increased risk of hypotension) and hyperkalemia.

In case of symptomatic arterial hypotension after taking Vero-captopril, the patient should take a horizontal position with raised legs.

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 of 25 mg.

Packaging:

10 tablets per contour cell pack.

For 20 or 40 tablets in a can of lightproof glass.

Each jar or 2 or 4 contour squares, together with the instruction for use, is placed in a pack of cardboard.

Storage conditions:

In a dry place, protected from light and out of reach of children, at a temperature not exceeding 25 ° C.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000486 / 01

Date of registration:11.02.2008 / 19.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Information update date: & nbsp30.01.2017

Illustrated instructions

Instructions

Vero-Captopril (Vero-Captopril)