The composition 1 tablets:
- active substance: carbamazepine;
- 1 tablet contains carbamazepine 200 mg;
- excipients: microcrystalline cellulose, povidone, magnesium stearate, sodium croscarmellose.
Dosage form. Tablets
Basic physical and chemical properties: tablets of white or almost white color, round, with a biconvex surface and a line on one side.
10 tablets in a blister, 2 blisters in a box.
Agents acting on the renin-angiotensin system. ACE inhibitors (ACE), monocomponent.
- Arterial hypertension.
- Heart failure. Captopril is indicated for the treatment of chronic heart failure with decreased ventricular systolic function, and in combination with diuretics and, if necessary, digitalis and β-blockers.
- Myocardial infarction
• for short-term (4 weeks) treatment, it is possible to prescribe captopril within 24 hours after myocardial infarction in patients with a stable condition;
• for long-term prevention of symptomatic heart failure, the drug is indicated in patients with clinically stable conditions with asymptomatic left ventricular dysfunction (ejection fraction ≤ 40%).
Diabetic nephropathy in patients with type I diabetes mellitus is manifested by macroproteinuria.
- Hypersensitivity to captopril or to excipients of the drug, as well as to other ACE inhibitors
- Quincke’s edema (including in the history, after the use of ACE inhibitors, hereditary/idiopathic)
- narrowing of the mouth of the aorta or mitral stenosis, the presence of other obstacles to the outflow of blood from the left
- the ventricle of the heart;
- hypertrophic cardiomyopathy with low cardiac output;
- primary hyperaldosteronism;
- severe renal impairment bilateral narrowing of the renal arteries or narrowing of an artery in a solitary kidney:
- condition after kidney transplant;
- congenital (idiopathic) angioedema;
- galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
- pregnancy; also contraindicated in women planning pregnancy (see section “Use during pregnancy or lactation”);
- the period of lactation (see section “Use during pregnancy or lactation”);
- the simultaneous use of captopril with preparations containing aliskiren in patients with diabetes mellitus or in patients with renal insufficiency (glomerular filtration rate <60 ml / min / 1.73 m2).
Method of application:
The dosage should be adjusted depending on the nature of the patient’s illness.
Captopril is taken by mouth before, during, or after a meal. The drug should be taken regularly, at the same time every day. If a tablet is missed, it should be taken as early as possible; however, if there are several hours left before taking the next dose, then it is recommended to take the next dose according to the schedule and not to take the missed dose. Do not take 2 doses of captopril at the same time.
If it is necessary to prescribe captopril at a dose of 6.25 mg, the drug should be used in the appropriate dosage or in another dosage form.
The recommended starting dose is 25-50 mg per day in 2 divided doses. After 2-4 weeks of treatment, dose titration can be carried out depending on the achieved blood pressure up to 100-150 mg per day in 2 divided doses. Captopril can be used alone or with other antihypertensive drugs, especially thiazide diuretics. A once-daily dosing regimen can be used when a concomitant antihypertensive drug such as a thiazide diuretic is added.
Patients with increased RAAS activity (hypovolemia, renovascular hypertension, decompensated heart failure) should begin therapy with a single dose of 6.25 mg or 12.5 mg. The beginning of such treatment should be carried out under close medical supervision, followed by the use of the drug 2 times a day. The dose can be gradually increased to 50 mg or 100 mg per day in 1 or 2 doses.
The initial dose is 6.25-12.5 mg 2 or 3 times a day. Titration to a maintenance dose (75-150 mg per day) should be carried out based on the patient’s response to treatment (physical examination data and drug tolerance). The dose should be increased gradually, at intervals of at least 2 weeks in order to assess the patient’s response to treatment. The maximum daily dose is 150 mg in 2 divided doses.
Short-term treatment. The use of the drug in the first 24 hours after myocardial infarction should be carried out according to the following scheme: the initial dose is 6.25 mg, after 2:00 – 12.5 mg, and after 12:00 – another 25 mg of captopril. From the next day, for 4 weeks, captopril should be taken at a dose of 100 mg per day, divided into 2 doses. At the end of the 4-week treatment, a re-assessment of the patient’s condition should be made to make a decision on treatment at the stage after myocardial infarction.
Long-term treatment. If the use of captopril is not started within the first 24 hours of the stage of acute myocardial infarction, it is recommended to start treatment between the third and sixteenth days after the infarction from the moment when the necessary treatment conditions are provided (stable hemodynamics and treatment of any residual ischemia). Treatment should be started in a hospital under strict control (in particular, blood pressure) until a dose of 75 mg per day is reached. The initial dose should be low (see section “Peculiarities of use”), especially if the patient has a normal or low pressure at the beginning of therapy. Treatment should begin with a dose of 6.25 mg, then switch to a dose of 12.5 mg 3 times a day for 2 days, then a dose of 25 mg 3 times a day in the absence of adverse hemodynamic reactions. The recommended dose for an effective cardiac contractor during long-term treatment is 75-150 mg daily in 2 or 3 doses. In symptomatic hypotension, as in heart failure, the dose of diuretics and/or other vasodilators can be reduced to achieve a stable dose of captopril. If necessary, the dose of captopril can be adjusted depending on the clinical response of the patient. Captopril can be used in combination with other treatments for myocardial infarction, such as thrombolytic drugs, β-blockers, and acetylsalicylic acid.
Diabetic nephropathy in patients with type I diabetes mellitus.
Captopril should be used at a dose of 75-100 mg per day in 2 divided doses, if necessary, combined with other antihypertensive drugs.
Impaired renal function.
Since captopril is mainly excreted by the kidneys, in case of impaired renal function, either reduce the dose of the drug or increase the interval between its users. If concomitant diuretic therapy is needed, loop diuretics (furosemide) should be preferred over thiazide.
For patients with impaired renal function, the following dosage regimen of captopril is recommended to prevent its accumulation in the body.
The efficacy and safety of the use of Captopril in children have not been studied enough. The use of captopril in children should be started under close medical supervision. The initial dose of captopril is 0.3 mg/kg body weight. For special groups of patients (children with renal insufficiency and in case of immaturity of the urinary system), the initial dose should be 0.15 mg/kg of body weight. Usually, captopril is prescribed for