Composition
One tablet contains: Â
- active ingredients:
- captopril in terms of 100% substance-50 mg, hydrochlorothiazide in terms of 100% substance-25 mg;
- excipients: Â
- microcrystalline cellulose – 118.5 mg,
- pregelatinized starch (corn) – 30 mg,
- stearic acid-6 mg,
- magnesium stearate-0.3 mg,
- lactose monohydrate-70.2 mg
Pharmacological action
Caposide® is a combined drug that has antihypertensive and diuretic effects.
Captopril is an angiotensin-converting enzyme (ACE) inhibitor, reduces the formation of angiotensin II from angiotensin I, reduces the release of aldosterone, reduces total peripheral vascular resistance( OPSS), blood pressure (BP), post-and preload. Dilates the arteries to a greater extent than the veins.
Increases coronary and renal blood flow. With prolonged use, hypertrophy of the myocardium and arterial walls of the resistant type decreases. Captopril improves blood supply to the ischemic myocardium; reduces platelet aggregation.
Hydrochlorothiazide is a medium-strength thiazide diuretic that reduces the reabsorption of sodium ions at the level of the cortical segment of the Henle loop. It does not affect the acid-base state (CBS). Lowers blood pressure by changing the reactivity of the vascular wall, reducing the pressor effect of endogenous vasoconstrictors (epinephrine, norepinephrine) and increasing the depressive effect on the autonomic ganglia (to a lesser extent, by reducing the volume of circulating blood (BCC)). Increases the hypotensive effect of captopril.
The diuretic effect is noted after 2 hours and reaches a maximum in 4 hours after ingestion. The action lasts for 6-12 hours. The efficacy and safety of captopril in children have not been established. The literature describes limited experience with the use of captopril in children.
Children, especially newborns, may be more likely to develop hemodynamic side effects. There have been cases of excessive, prolonged, and unpredictable increases in blood pressure, as well as related complications, including oliguria and seizures.
Indications
Arterial hypertension (patients who are indicated for combination therapy)
Contraindications
- Hypersensitivity to captopril, any other component of the drug or to other ACE inhibitors, thiazide diuretica and other derivatives of sulfanilamide (possible cross-allergic reactions);
- hereditary angioedema, or idiopathic, including in the anamnesis in patients receiving ACE inhibitors;
- aortic stenosis,
- mitral stenosis;
- hypertrophic obstructive cardiomyopathy;
- bilateral renal artery stenosis, renal artery stenosis to a solitary kidney;
- kidney transplantation (history);
- congestive heart failure;
- cardiogenic shock,
- hypotension,
- severe liver failure (precoma or coma);
- severe renal insufficiency (serum creatinine blood of more than 1.8 mg/100 ml or creatinine clearance less than 20-30 ml/min, anuria);
- primary aldosteronism;
- concurrent use with aliskiren and iliskilendirmesi drugs in patients with diabetes or impaired renal function (EGFR less than 60 ml/min),
- pregnancy,
- lactation,
- age under 18 years (effectiveness and safety not established),
- lactose intolerance, lactase deficiency syndrome glucose-galactose malabsorption.
With caution • Impaired liver function, progressive liver disease, • moderate renal insufficiency (creatinine clearance 30-60 ml/min), • proteinuria (more than 1 g/day), • hypokalemia (not corrected by drugs); • hyponatremia, • hypovolemia, • hypercalcemia, • gout, hyperuricemia, • systemic connective tissue diseases and other autoimmune diseases (including systemic lupus erythematosus, scleroderma, nodular periarteritis); • elderly (over 65 years of age•, * simultaneous use of drugs that suppress the body’s protective reactions (glucocorticosteroids, cytostatics, immunosuppressants), allopurinol, procainamide; * surgical intervention/general anesthesia, use in black patients, hemodialysis using high-strength membranes (for example, AN69®), desensitizing therapy, simultaneous use of potassium-sparing diuretics, potassium preparations, potassium-containing substitutes and lithium, acute myopia and secondary angle-closure glaucoma.
Side effects
From the urinary system: proteinuria; in rare cases, especially in patients with renal insufficiency, there may be an increase in the concentration of urea, creatinine and potassium ions in the blood serum (the risk of hyperkalemia is also increased in patients with diabetes mellitus), as well as hyponatremia. From the side of metabolism: hyperlipidemia, hyperglycemia; hyperuricemia (up to exacerbation of gout). From the cardiovascular system: “flushes” of blood to the skin of the face, fever, dizziness: headache; tachycardia; palpitations; swelling of the lower legs; pronounced decrease in blood pressure (including orthostatic) with symptoms of dizziness, a feeling of weakness, in rare cases-fainting, tachycardia; palpitations; with a sharp or prolonged excessive decrease in blood pressure-a transient violation of cerebral circulation; stroke; myocardial infarction. From the side of water-electrolyte metabolism: disorders of water-electrolyte balance: dry mouth, thirst, fatigue, depression, drowsiness, weakness. In rare cases, a decrease in the formation of tear fluid. From the respiratory system: bronchospasm, ” dry ” cough; in rare cases-respiratory failure, sinusitis, rhinitis, laryngitis. Allergic reactions: angioedema of the larynx, pharynx and / or tongue; allergic reactions (up to the development of pulmonary edema), skin rash (exanthema, in rare cases-urticaria). Dermatological reactions: exfoliative dermatitis, erythema multiforme (including Stevens-Johnson syndrome), and toxic epidermal necrolysis (Lyell’s syndrome). These skin changes can be accompanied by a rise in body temperature, pain in the muscles and joints, and the development of vasculitis. In some cases-skin changes that resemble psoriasis, photosensitization, hair loss, nail disorders (onycholysis). From the digestive system: nausea, vomiting, constipation or diarrhea, a feeling of discomfort in the stomach, abdominal pain, decreased appetite, acute cholecystitis (against the background of cholelithiasis), hemorrhagic pancreatitis, hepatitis, cholestatic jaundice, increased activity of “liver” enzymes, hyperbilirubinemia. With prolonged use: gum hyperplasia, asthenia, taste changes, impaired kidney function, nephritis. From the central and peripheral nervous system: headache, fatigue, in rare cases – depression, depression, sleep disorders, decreased potency, convulsions; balance disorders, dizziness, tinnitus, visual disturbances, myopia progression, tremor, paresthesia, taste disorders. From the hematopoietic system: anemia, decreased hematocrit, thrombocytopenia, leukopenia, neutropenia (up to the development of pancytopenia and agranulocytosis – especially against the background of simultaneous use of allopurinol, procainamide, and immunosuppressants), eosinophilia, increased titer of antinuclear antibodies.
Interaction
Increases the neurotoxicity of salicylates, the effect of competitive muscle relaxants, ethanol. Reduces the excretion of quinidine, the effect of oral hypoglycemic drugs (LS), norepinephrine, epinephrine and anti-gouty drugs. Caposide increases the concentration of digoxin in blood plasma by 15-20%, increases the bioavailability of propranopol. The risk of developing an immunosuppressive effect increases when combined with procainamide, as well as drugs that block tubular secretion (a decrease in the number of white blood cells and granulocytes). Increases the side effects of cardiac glycosides, especially when administered concomitantly with drugs that increase the excretion of potassium and magnesium ions and / or delay calcium ions(for example, diuretics, adrenal hormones, laxatives, amphotericin B, carbenoxolone, penicillin G, salicylates). Cimetidine slows down the metabolism of captopril in the liver and increases its concentration in plasma. The combination with nitrates, thiazide diuretics, verapamil, beta-blockers and other antihypertensive drugs, as well as tricyclic antidepressants, sleeping pills and ethanol increases the severity of the hypotensive effect. When administered concomitantly with lithium preparations, there may be a slowdown in the elimination of lithium ions (increased damaging effect on the heart and central nervous system). Drugs that intensively bind to proteins enhance the diuretic effect. With simultaneous use of methyldopa, red blood cell hemolysis may develop. Colestyramine reduces the absorption of Caposide. Table salt and nonsteroidal anti-inflammatory drugs (NSAIDs) reduce the severity of hypotensive effects. Potassium salts, potassium-sparing diuretics and heparin contribute to the development of hyperkalemia. use of Caposide during hemodialysis using certain highly permeable dialysis membranes (for example, polyacrylonitrile-metalylsulfonate membranes) increases the risk of allergic reactions (anaphylactoid reactions).
How to take it, course of use and dosage
Caposide is taken orally, regardless of food intake.
Start with 1/2 table, increasing the dose to 1 table.1 time per day (maintenance dose).
Overdose
Possible increase in the severity of side effects.
Treatment:Â symptomatic therapy.
Special instructions
At the beginning of treatment, an excessive decrease in blood pressure may occur, especially in patients with chronic heart failure, severe hypertension (including renal genesis) and/or renal insufficiency.
Before starting treatment, it is necessary to compensate for the deficiency of sodium ions and BCC (reduce the dose of previously prescribed diuretics or, in some cases, completely cancel them), as well as determine the indicators of renal function.
It is necessary to regularly monitor the plasma concentrations of potassium and calcium ions (especially in patients treated with digitalis preparations, glucocorticosteroids (corticosteroids), often using laxatives, as well as in elderly patients), glucose, uric acid, lipids (cholesterol and triglycerides (TG)), urea and creatinine, and the activity of “liver” enzymes.
Particularly careful monitoring of blood pressure levels and laboratory parameters is necessary in the following cases:: in patients with renal insufficiency; patients with severe arterial hypertension (including renal genesis); in elderly patients (older than 65 years); in patients with impaired water-electrolyte balance and decompensated CHF; and also receiving simultaneously allopurinol, lithium salts, procainamide and drugs that reduce immunity.
If fever, enlarged lymph nodes, and/or signs of laryngitis and/or pharyngitis occur, the white blood cell count should be determined immediately.
During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Tablets
Storage conditions
The drug should be stored in a dry place protected from light, out of reach of children, at a temperature not exceeding 20°C.
Shelf
life is 3 years.
Active ingredient
Hydrochlorothiazide, Captopril
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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