KAPOTEN

Active material: Captopril
When ATH: C09AA01
CCF: ACE inhibitor
ICD-10 codes (testimony): I10, I15.0, I50.0, N08.3
When CSF: 01.04.01.01
Manufacturer: BRISTOL-MYERS SQUIBB AUSTRALIA Pty. Ltd. (Australia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills from white to white with Valium-colored molasses, square with rounded edges, lenticular Phillips scored on one side and embossed inscription “SQUIBB” and the number of “452” – another, with a characteristic odor; Slight marbling.

Excipients: microcrystalline cellulose, corn starch, stearic acid, lactose.

10 PC. – blisters (4) – packs cardboard.
14 PC. – blisters (2) – packs cardboard.
14 PC. – blisters (4) – packs cardboard.

Pharmacological action

ACE inhibitor. Inhibits the formation of angiotensin II and eliminates its vasoconstrictor effect on the arterial and venous vessels.

Decreases round, afterload, lowers blood pressure. Reduces preload, It reduces the pressure in the right atrium and the pulmonary circulation.

Decreases selection of aldosterone in the adrenal glands.

Pharmacokinetics

Absorption

When ingestion bioavailability of captopril 60-70%. Simultaneous food intake slows down the absorption of the drug on 30-40 %.

Distribution

Linking blood protein is 25-30%.

Deduction

T_1/2 is 2-3 no. The drug is excreted from the body mainly in the urine, to 50 % unchanged.

Testimony

- Arterial hypertension, incl. renovascular;

- Congestive heart failure (in a combination therapy in those cases, when diuretics do not provide adequate effect);

- Left ventricular dysfunction after myocardial infarction in patients in stable clinical condition;

- Diabeticheskaya nephropathy (mikroalьʙuminurija >30 mg / day) in insulin-dependent diabetes mellitus.

Dosage regimen

Capoten appointed interior for an hour before a meal. The batch is individually.

At hypertension the initial dose is at 12.5 mg 2 times / day. If necessary, increase the dose gradually (intervals 2-4 of the week) until the optimum effect. At mild to moderate hypertension average therapeutic dose is 25 mg 2 times / day; The maximum dose is on 50 mg 2 times / day. At severe hypertension the initial dose is at 12.5 mg 2 times / day. Dose gradually increased to the maximum daily dose 150 mg (by 50 mg 3 times / day).

At chronic heart failure the initial dose is at 6.25 mg 3 times / day. If necessary, increase the dose every 2 of the week. Maintenance dose – by 25 mg 2-3 times / day. The maximum daily dose – 150 mg.

At left ventricular dysfunction after myocardial infarction patients, are clinically stable, the use of the hood can be started by 3 day 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 admission (depending on tolerability) up to a maximum – 150 mg / day.

At diabetic nephropathy a daily dosage of 75 mg 100 mg, divided by 2-3 admission. At insulin-dependent diabetes mellitus with microalbuminuria (albumin clearance 30-300 mg / day) dose is on 50 mg 2 times / day. With a total clearance of a protein 500 mg / day, the drug is effective in a dose of 25 mg 3 times / day.

Patients with renal impairment of mild or moderate degree (CC ≥ 30 ml / min / 1.73 m²) Capoten administered in a daily dose of 75-100 mg. At severe renal impairment (CC <30 ml / min / 1.73 m²) Initial dose is no more than 12.5 mg 2 times / day. With the lack of an effective dose is gradually increased every 1-2 weeks before the onset of the therapeutic effect, but the maximum daily dose should be reduced or increased the interval between doses of the drug.

Elderly patients Dose selected individually. Treatment is recommended to start with the smallest therapeutic dose 6.25 mg 2 times / day, and possible to maintain it at this level.

If you want to appoint more “loop” Diuretic, thiazide diuretics but not number.

Side effect

Cardio-vascular system: orthostatic hypotension, tachycardia, peripheral edema, decrease in blood pressure.

The respiratory system: dry cough (usually passes after drug withdrawal), bronchospasm, pulmonary edema.

Allergic reactions: angioneurotic edema of extremities, person, lips, mucosas, language, pharynx or larynx.

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

From the water-electrolyte balance: hyperkalemia, giponatriemiya.

From the urinary system: proteinuria, increase of urea nitrogen and creatinine in blood plasma, Acidosis.

From the hematopoietic system: neutropenia, agranulocytosis, thrombocytopenia, anemia; rarely – a positive test for antibodies to the nuclear antigen.

From the digestive system: taste disturbance, dry mouth, stomatitis, giperplaziya right, stomach ache, diarrhea, hepatitis, increase in liver enzymes in the blood plasma, giperʙiliruʙinemija.

Contraindications

- Angioedema (hereditary or associated with the use of ACE inhibitors in history);

- Expressed by the human kidney;

- Expressed human liver;

- Hyperkalemia;

- Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney with progressive azotemia;

- Condition after kidney transplantation;

- Aortic stenosis and similar obstructive changes, impede the outflow of blood from the left ventricle;

- Pregnancy;

- Lactation (breast-feeding);

- Up to 18 years;

- Hypersensitivity to the drug and other ACE inhibitors.

FROM caution It should be prescribed for severe autoimmune diseases of connective tissue (incl. SLE, scleroderma), suppression of bone marrow hematopoiesis (the risk of neutropenia and agranulocytosis), cerebral ischemia, diabetes (increased risk of hyperkalemia), patients, hemodialysis, patients, a diet with restriction of sodium, with primary hyperaldosteronism, CHD, states, accompanied by a decrease in the bcc (incl. vomiting, diarrhea), elderly patients.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Cautions

Before, and regularly during treatment Kapotenom^® should monitor kidney function. In patients with chronic heart failure Capoten^® It should be used under close medical supervision.

Against the background of the prolonged use of the hood^® approximately 20% patients an increase in the content of urea and creatinine in blood serum for more than 20% compared with the normal or original value. Less than 5% patients, especially in severe renal disease, It requires discontinuation of treatment due to rising concentrations of creatinine.

In patients with hypertension when using the hood^® marked hypotension observed only in rare cases; chance of developing the condition increases with increased loss of fluids and salts (eg, After intensive treatment with diuretics), in patients with heart failure or dialysis.

Possibility of a sharp decline in blood pressure can be minimized by pre-cancellation (for 4-7 days) diuretic or increasing revenues sodium chloride (about a week before you start taking), or by assigning the hood^® at the beginning of treatment in small doses (6.25-12.5 mg / day).

First 3 Months of therapy should be monitored on a monthly basis the number of white blood cells, further – 1 once every 3 Months. Patients with autoimmune diseases the number of leukocytes in the first 3 months of treatment should be monitored every 2 Sun., then – every 2 Months. If the white blood cell count of less than 4,000 cells / mm, It shows an overall analysis of blood, If less than 1000 / mm – the drug is stopped.

In some cases, treatment with ACE inhibitors, incl. Kapotena^®, observed increase in the concentration of potassium in blood serum. The risk of hyperkalemia in the application of ACE inhibitors increased in patients with renal insufficiency and diabetes mellitus, as well as taking potassium-sparing diuretics, potassium supplements or other formulations, causing an increase in the potassium concentration in the blood (eg, Heparin). Avoid concurrent use with Kapotenom^® potassium-sparing diuretics and potassium preparations.

In hemodialysis patients, receiving Capoten^®, avoid using dialysis membranes with high permeability (eg, AN 69), because in such cases the increased risk of anaphylactoid reactions.

In case of angioedema drug overturned and conduct a thorough medical supervision. If localized swelling on the face, Special treatment is usually not required (to reduce the severity of symptoms can be used antihistamines); in that case, If the swelling spreads to the language, pharynx or larynx and there is a threat to the development of airway obstruction, immediately enter 0.5 ml 0.1% epinephrine solution (adrenaline).

Upon receipt of the hood^® there may be a false positive reaction in the analysis of urine for acetone.

Precautions should be prescribed Capoten^® sick, We are on a salt-free diet or malosolevoy, tk. in this case it increases the risk of hypotension.

In the event after taking the hood^® symptomatic hypotension, patients should take a horizontal position with raised legs.

Use in Pediatrics

The safety and efficacy of the drug in children and adolescents under the age of 18 years not set.

Effects on ability to drive vehicles and management mechanisms

During the period of treatment should refrain from driving vehicles and Occupation potentially hazardous activities, require high concentration and speed of psychomotor reactions, tk. dizziness, especially after receiving the initial dose.

Overdose

Symptoms: a sharp decrease in blood pressure.

Treatment: effectively administering drugs plazmozameshchath, isotonic sodium chloride solution and hemodialysis.

Drug Interactions

Diuretic, vasodilators (eg, minoksidil) enhance the antihypertensive effect of the drug Capoten^®.

Indomethacin and other NSAIDs can reduce the antihypertensive effect of the drug Capoten^®.

The simultaneous use of the hood^® with potassium-sparing diuretics (triamterene, amiloride and spironolactone) medications or potassium can lead to hyperkalemia.

Concomitant use of lithium salts and hood^® can increase the concentration of lithium in blood serum.

Against the backdrop of the simultaneous use of the hood^® with allopurinol and procainamide may occur neutropenia and / or Stevens-Johnson syndrome.

In an application with Kapotenom^® immunosuppressants (eg, azathioprine and cyclophosphamide) It increases the risk of haematological disorders.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 5 years.