COMPOSITION

Each tablet contains captopril 25 mg or 50 mg.

THERAPEUTIC INDICATIONS

- Arterial hypertension (including renovascular);
- Chronic cardiac insufficiency (as combined therapy);
- Ischemic cardiac disease (dysfunction of left ventricle of heart after myocardial infarction in patients with the stable clinic state).

CONTRAINDICATIONS

- Hypersensitivity to Captopril and other inhibitors of ATP;
- Angioedema (including inherited or associated with application of inhibitors of ATP in past history);
- Apparent renal dysfunction, azotemia, hyperkalemia, double stenosis of renal arteries or stenosis of the single kidney with progressive azotemia, a state after renal transplantation, transplantation;
- Apparent hepatic dysfunction;
- Aortic stenosis, mitral stenosis, the presence of other barriers for blood outflow from left ventricle of heart;
- Arterial hypotension;
- Cardiogenic shock;
- Pregnancy and lactation period;
- Infancy under 18.

ADVERSE EFFECTS

Effects from CVS: arterial hypotension, tachycardia, peripheric edema.
Effects from hematosis system: very seldom – granulocytopenia, anemia, anemia, agranulocytosis.
Effects from respiratory system: dry cough, pulmonary edema, bronchiospasm.
Effects from CNS and peripheric nervous system: vertigo, headache, ataxia, paresthesia, fatigue, sleepiness, asthenia, visual impairment.
Effects from digestive system: dry mouth, aphthous stomatitis, nausea, loss of appetite; seldom – diarrhea, abdominal pains, increase in hepatic enzyme activity, signs of hepatocellular injuries and cholestasis (in rare cases).
Effects from urinary tracts: proteinuria, renal impairement (elevation of urea and creatinine blood level).
Effects from water-electrolytic and water-electrolytic: hyperkalemia, hyponatremia, acidosis.
Allergic and immunopathologic reactions: angioedema, serum sickness, lymphodenopathy, in rare cases – appearance of antinuclear antibodies in blood.
Dermatologic reactions: rash, usually maculo-papular, not often vesicular or bullous kind, pruritus, hyperphotosensitivity, erythema (including Stevens-Johnson syndrome).

DOSAGE AND ADMINISTRATION

Captopril is prescribed prior 1 hour to meal.
In arterial hypertension: 25 mg 2 times daily. If necessary the dose is gradually (2-4 weeks' interval) increased until the optimal effect is achieved. In case of slight or moderate arterial hypertension: 12.5 mg 2 times daily as the initial dose (if necessary the dose is increased every 2-4 weeks), 25 mg 2 times as the usual maintaining daily dose, 50 mg 2 times daily as the maximum dose. In severe arterial hypertension: 50 mg 3 times as the maximum daily dose. The maximum daily dose is 150 mg.
If Captopril is applied in the combination with other antihypertensive agents the dose is adjusted individually.
For the treatment of cardiac insufficiency: 6.25 mg 3 times daily as the initial dose (if necessary the dose is increased every 2 weeks). The average maintaining daily dose is 25 mg 2-3 times daily. Further if necessary the dose is gradually increased (with 2 weeks' interval). The maximum daily dose is 150 mg.
In ischemic heart begin the drug application in 3 days after myocardial infarction. The initial dose is 6.25 mg 3 times daily with the gradual increase up to 75 mg daily (25 mg 3 times daily). If necessary the dose is gradually increased to the maximum daily dose of 150 mg (50 mg 3 times daily).
For patients with renal impairment: in moderate dysfunction (creatinine clearance (CC) is not less than 30 ml/min /1.73 m 2) – 75-100 mg/daily. In more apparent renal impairment (CC is less than 30 ml/min /1.73 m 2) the initial dose is not more than 12.5-25 mg/daily.
Further if necessary the dose is increased with a more prolong intervals, but use the lower as usual daily dose. The maximum daily dose depends on CC:
35–130 ml/min/1.73 m2 — 150 mg;
20–35 ml/min /1.73 m2 — 75 mg;
less than 20 ml/min /1.73 m2 — 37.5 mg.
The dose is adjusted for elderly patients individually. The treatment is recommended to initiate from the lowest therapeutic dose and maintain on the level of the smallest effective dose.

DRUG INTERACTIONS

Diuretics, vasodilators, ganglionic blockers, adrenoceptor antagonists potentiate Captopril hypotensive action.
The co-administration of Captopril with indometacin (and, possible, with other non-steroidal anti-inflammatory agents), clonidine may reduce the hypotensive effect.
The co-administration with potassium-sparing diuretics or with potassium agents may result in hyperkalemia.
The co-administration with lithium salts may increase lithium serum concentrations.
Captopril application in patients receiving allopurinol or procaineamide hydrochloride increases the risk of the development of granulocytopenia and/or Stevens-Johnson syndrome.
The co-administration with probenecid reduces Captopril urinary elimination.
Captopril application in patients receiving immunosuppressants (e.g. cyclophosphacin or azatioprine) increases the risk of the development of hematologic abnormalities.

MANUFACTURED FORM

Tablets for oral use 25 mg or 50 mg. 10 tablets are in PVC and aluminum foil blisters. 2 blisters with a leaflet are in a carton box.