The instruction for medical use
of CAPTOPRIL medicine
the Trade name
the International unlicensed
name Captopril Dosage Form
of the Tablet of 25 mg
One tablet contains
active agent – captopril of 25 mg,
excipients: lactoses monohydrate, microcrystalline cellulose, magnesium or calcium stearate, silicon dioxide colloidal anhydrous
of the Tablet of white color, a ploskotsilindrichesky form, with a facet on both sides, with crosswise risky on one party and an engraving of G – on another.
the Drugs influencing a system renin-angiotensin.
Enzyme Angiotensin-converting (EAC) inhibitors. AKF inhibitors. Captopril.
The ATX C09AA01 code
Pharmacokinetics Later properties of intake is quickly and fully absorbed from digestive tract. The concomitant use of food reduces absorption by 30-55%. The maximum concentration (Cmax) in blood plasma is reached in 30-90 minutes. In blood plasma contacts proteins for 25-30%. It is widely distributed on all bodies and fabrics, gets through a placenta, into breast milk, there does not pass the blood-brain barrier. The dimeasure of captopril and captopril-tsisteindisulfida is metabolized in a liver with education disulfide. Elimination half-life makes 2-3 hours. The rest in the form of metabolites is excreted by kidneys of 40-50% in an invariable look.
Captopril has hypotensive, vasodilating, cardioprotective effect. Inhibits activity of angiotensin-converting enzyme that leads to reduction in the rate of transition of angiotensin I to angiotensin II (has vasoconstrictive effect, promotes release of Aldosteronum) and interferes with an inactivation of endogenous vozodilatator – bradykinin and E2 prostaglandin. Increases activity of a kallikrein-kinin system, increases release of biologically active agents having natriuretic and vasodilating effect, improving a renal blood stream. Reduces the general peripheric resistance of vessels, before – and an afterload by heart, pressure in a small circle and in pulmonary capillaries, increases warm emission.
– arterial hypertension (mono – and combination therapy)
– chronic heart failure (as a part of combination
– dysfunction of a left ventricle at a stable state at
patients after the postponed myocardial infarction
– a diabetic nephropathy against the background of diabetes like I
Route of administration and doses
take the Drug inside irrespective of meal.
the Initial dose of 25-50 mg 2 times a day, if necessary a single dose increase up to 100-150 mg 2 times a day, with an interval of 2-4 weeks. A maintenance dose of 25 mg 2-3 times a day. The maximum daily dose – 150 mg.
Chronic heart failure
the Initial dose on 6.25 – 12.5 mg 2 – 3 times a day with the subsequent increase each 2-3 weeks, to a maintenance dose of 25 mg 2-3 times a day or up to 50 mg 3 times a day. The maximum daily dose – 150 mg.
Dysfunction of a left ventricle
Treatment is usually begun in the range from the 3rd till 16th day after a myocardial infarction. The initial dose of captopril makes 6.25 mg/days in the first day. Then, next day, it increases to 12.5 mg three times a day within two days with gradual increase up to 25 – 50 mg of captopril three times a day. This dose is reached gradually within several weeks. In case of symptomatic hypotension as in heart failure, the dose of diuretics and/or other accompanying vazodilatator can be reduced to reach a steady condition of a dose of captopril.
The maximum daily dose – 150 mg.
The diabetic nephropathy in insulin-dependent diabetes mellitus
the Initial dose makes 6.25 mg/days. If necessary the dose is increased to 75-100 mg/days (in 2-3 receptions). In insulin-dependent diabetes with a microalbuminuria (discharge of albumine of 30-300 mg a day) the dose of drug makes 50 mg twice a day. At the general clearance of protein more than 500 mg a day drug is effective in a dose of 25 mg three times a day.
In a renal failure
the Initial dose of 6.25 mg 2-3 times a day with the subsequent increase. The maximum dose depends on clearance of creatinine.
The clearance of creatinine (ml/min. / 1.73м2)
the Daily initial dose (mg)
the Daily maximum dose (mg)
& gt, 40
25-50 150 21-40
100 10-20 12,5 75
10 6,25 37,5
Duration of treatment is defined by the attending physician in each case depending on pathology.
At patients of advanced age the initial dose makes 6.25 mg two times a day. The elderly patient the dose of drug is selected individually, considering a possibility of a renal failure or other bodies.
– dizziness, sleep disorders
– dryness in a mouth, disturbance of flavoring feelings (the metal or
salty smack independently disappearing in 2-3 months after
an initiation of treatment), nausea, vomiting, an abdominal pain, diarrhea, a constipation
– a hyponatremia
– dry cough, an asthma
– skin rash, an itching
– an alopecia
– tachycardia, heartbeat, stethalgias, a tachyarrhythmia, stenocardia
– arterial hypotension, Reynaud’s syndrome, inflows
– pallor of integuments
– feeling of fatigue, an asthenia
– increase in content in blood serum of creatinine, residual nitrogen and urea
– a renal failure, a polyuria, an oliguria, a proteinuria, the speeded-up urination
– a headache, drowsiness, paresthesias
– stomatitis, aphthous ulcers of a mucous membrane of a mouth
– a Quincke’s edema
– a nephrotic syndrome
– a neutropenia, an agranulocytosis, a pancytopenia, anemia, thrombocytopenia, a leukopenia, a lymphadenopathy, an eosinophilia, a leukopenia, a positive caption of antinuclear antibodies, increase in SOE
– a hyperpotassemia, a hypoglycemia
– a bronchospasm, rhinitis, an allergic alveolitis / eosinophilic pneumonia
– a glossitis, stomach ulcer, pancreatitis
– an abnormal liver function, a cholestasia, jaundice, hepatitis, necrosis of hepatic cells, increase in level of hepatic transaminases, bilirubin
– a Quincke’s disease, Stephens-Johnson’s syndrome, a multiformny erythema, a photosensitization, exfoliative dermatitis, an erythrosis, a bladderwort
– myalgias, arthralgias
– impotence, a gynecomastia
– confusion of consciousness, a depression
– disturbance of cerebral circulation, including a stroke and faints
– a disorder of vision
– cardiac arrest, cardiogenic shock
– a small tortoiseshell
– a nephrotic syndrome
– hypersensitivity to drug components
– a Quincke’s disease in the anamnesis or other vascular hypostases (for example, owing to the previous therapy by AKF inhibitors)
– a stenosis of renal arteries (bilateral or unilateral at one kidney)
– a state after transplantation of kidneys
– hemodynamically significant stenosis of an aorta or the mitral valve or, a hypertrophic cardiomyopathy
– primary hyper aldosteronism
– a hyperpotassemia, the progressing arrhythmia
– pregnancy and the period of a lactation
– children’s age up to 18 years
– hereditary intolerance of fructose, deficiency of Larr-lactoses enzyme, a glucose galactose malyabsorbation
– aferez lipoproteins of low density using dextransulphate (life-threatening anaphylactoid reactions can develop)
– the desensibilizing therapy against poisons of insects (life-threatening anaphylactoid reactions – falling of arterial blood pressure, suffocation, vomiting, allergic skin reactions)
– dialysis with use polyacrylonitrile-methallyl-sulfonatnykh of membranes with high-permeability (for example, AN 69 can develop) because of danger of development of anaphylactoid reactions (reaction of hypersensitivity), up to shock.
Captopril can be applied only after very careful comparison of possible advantage and risk in the conditions of regular control of clinical and laboratory indicators at:
– heavy renal failures (clearance of creatinine less than 30
– clinically significant proteinuria (more than 1 g/days)
– clinically significant disturbances of electrolytic balance
– primary disease of a liver or a liver failure
– disturbance of an immune response or collagenoses (for example, a system lupus erythematosus, a scleroderma)
– simultaneous system therapy by the medicines suppressing defense reactions (for example, kortikoida, cytostatics, antimetabolites), Allopyrinolum, procaineamide or lithium.
At simultaneous use of Captopril with kaliysberegayushchy diuretics, drugs of potassium the development of a hyperpotassemia is possible. Diuretics, vasodilators, anesthetics enhance hypotensive effect of Captopril.
At simultaneous use with non-steroidal anti-inflammatory drugs the decrease in antihypertensive effect and also manifestation of additive effect on increase in potassium in blood serum whereas function of kidneys can decrease is possible. These effects are reversible. However, in rare instances, at patients with disturbances of functions of kidneys and at elderly patients the acute renal failure is possible.
At simultaneous use with narcotic analgetics and antipsychotic means the development of orthostatic hypotension is possible.
Antacids reduce bioavailability of Captopril by 45%, increase time of achievement of the maximum concentration in blood plasma for 1.5 hours and slow down development of antihypertensive effect.
Captopril reduces hypoglycemic effect of antidiabetic drugs (insulin, sulphonylurea derivatives) and can cause development of a hyperglycemia.
At use of alpha blockers the increase in antihypertensive effects of Captopril and increase in risk of developing orthostatic hypotension is possible.
At simultaneous use with other antihypertensive drugs, strengthening of hypotensive effect of Captopril is possible.
At simultaneous use with nitroglycerine and other nitrates or vazodilatator, it is necessary to be careful.
Simultaneous use of Allopyrinolum, procaineamide, tsitostatik or immunodepressants with AKF inhibitors can result in the increased risk of a leukopenia, especially, at non-compliance with the recommended doses.
Simultaneous use of lithium with AKF inhibitors leads to increase in concentration of lithium in blood serum. Use of Captopril with lithium is not recommended, but if it is necessary, careful monitoring of level of lithium in blood serum is carried out.
At patients with arterial hypertension at Captopril use the profound arterial hypotension is observed only in rare instances, the likelihood of development of this state raises at the increased loss of liquid and salts (for example, after intensive treatment by diuretics), at patients with heart failure or being on dialysis.
In rare instances in uncomplicated arterial hypertension symptoms of hypotension can be observed.
Patients with heart failure have higher risk of developing arterial hypotension.
With extra care it is necessary to apply at patients with autoimmune diseases in view of increase in risk of emergence of a neutropenia and an agranulocytosis.
Cough when prescribing AKF inhibitors is unproductive, resistant, and passes after the therapy termination.
In rare instances, after long-term treatment by AKF inhibitors including Captopril, a heavy Quincke’s edema can develop. In this case immediate drug withdrawal and performing the corresponding therapy is required.
During therapy by Captopril regular monitoring of arterial blood pressure, a picture of peripheral blood, level of protein, potassium in plasma, urea, creatinine, function of kidneys, body weight, a diet is necessary.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
The care at control of vehicles or performance of other work requiring special attention since dizziness, especially after reception of an initial dose of Captopril is possible is necessary.
Symptoms: acute arterial hypotension, bradycardia, disturbance of cerebral circulation, thrombembolia, Quincke’s disease, disturbances of water and electrolytic balance.
Treatment: gastric lavage, reduction of a dose or full drug withdrawal, giving to the patient of horizontal position, intravenous administration of isotonic solution of sodium of chloride, transfusion of krovezamenyayushchy liquids, symptomatic therapy (epinephrine p / to or in/in, antihistamines, a hydrocortisone in / c). If necessary – a hemodialysis.
Form of release and packing
of the Tablet of 25 mg. 10 tablets in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. 2 blister strip packagings together with the instruction for use in the state and Russian languages in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not higher than 25 wasps.
To store out of children’s reach!
A period of storage
not to use drug after the expiration date specified on packing.
According to the prescription
Republic of Kazakhstan Abdi Ibrahim Global Pharm LLP Producer, Almaty, Dzhandosov St. 184 of
ph.: +7 (727) 309-74-07, fax: +7 (727) 309-74-14.
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