Properties
- Form
- tableti
- Dosage mg
- 50მგ+25
- Pack
- 1
What is it?
Composition Active Ingredient: 1 tablet contains 50 mg captopril and 25 mg hydrochlorothiazide Excipients: Microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, stearic acid, and magnesium stearate Description: White, round, biconvex, scored, approximately 10 mm diameter tablets Pharmacological Properties Captopril: Captopril is an angiotensin-converting enzyme inhibitor. Angiotensin-converting enzyme (ACE) is a peptidyl dipeptidase that converts angiotensin I to angiotensin II, which has a vasoconstrictive effect. By inhibiting ACE, aldosterone secretion decreases and serum potassium concentration increases. Removal of the negative feedback of angiotensin II on renin secretion leads to increased plasma renin activity in serum. Since ACE also degrades the vasodepressor peptide, bradykinin, its inhibition results in increased activity of the circulating and local kallikrein-kinin system (and consequently activation of the prostaglandin system). This mechanism is likely involved in both the hypotensive effect of ACE inhibitors and some of the drug's side effects. Hydrochlorothiazide: Hydrochlorothiazide is a benzothiadiazine derivative. By acting directly on the kidney, thiazide increases the excretion of both sodium chloride and associated water. Thiazides primarily act on the early distal tubules of the kidney. They inhibit the electroneutral Na-Cl cotransporter located on the luminal cell membrane. Potassium and magnesium are excreted in large amounts, while calcium is excreted in small amounts. Hydrochlorothiazide reduces bicarbonate excretion, and chloride excretion exceeds sodium excretion. Consequently, metabolic alkalosis may develop with the use of hydrochlorothiazide. Hydrochlorothiazide is actively excreted in the proximal tubules. The diuretic effect is maintained in cases of metabolic acidosis or alkalosis. Altered sodium balance, reduction in plasma volume and extracellular water volume, changes in renal vascular resistance, and decreased responsiveness to adrenaline and angiotensin II are the likely mechanisms by which hydrochlorothiazides cause an antidiuretic effect. Pharmacokinetics Captopril: In patients with hypertension, captopril lowers blood pressure without a compensatory increase in heart rate. Hemodynamic studies of captopril have revealed a significant reduction in peripheral arterial resistance. No clinically significant changes in renal blood flow and glomerular filtration rate were observed. In most patients, the antihypertensive effect appears 20-30 minutes after oral administration of captopril, with the maximum effect usually achieved 60-90 minutes later. The maximum effect of a determined dose of captopril usually appeared 3-4 weeks later. With the recommended daily dose, the antihypertensive effect also persists during long-term therapy. Sudden discontinuation of captopril does not cause a rapid and excessive increase in blood pressure (withdrawal effect). Hydrochlorothiazide: The effect of hydrochlorothiazide (electrolyte and water excretion) appears 2 hours after administration, reaches its maximum in 3-6 hours, and lasts for 6-12 hours. The antihypertensive effect develops after 3-4 days and can persist for 1 week after discontinuation of therapy. Dosage and Administration As a rule, hypertension treatment should be initiated with a single ingredient and at a low dose (gradually). The prescription of the fixed combination Capto-HCT Denk 50/25 is justified only if the individual doses of the individual drugs (i.e., captopril and hydrochlorothiazide) have been adjusted (titrated) beforehand. If clinically justified, a transition from monotherapy to the fixed combination may occur. In patients undergoing combination therapy, the normal daily dose is 1/2-1 tablet of Capto-HCT Denk 50/25 (equivalent to 25-50 mg captopril and 12.5-25 mg hydrochlorothiazide). Note: When transitioning from captopril monotherapy to combination therapy with Capto-HCT Denk 50/25, especially in patients with signs of dehydration (e.g., nausea/vomiting, prior diuretic use), severe heart failure, or renal hypertension, an excessive hypotensive effect is expected, and monitoring for 2 hours is recommended. Dosage in patients with impaired renal function (creatinine clearance 30-60 ml/min and/or serum creatinine up to 1.8 mg/dl) and elderly patients (over 65 years of age). The dose should be carefully adjusted (by titrating individual components). Capto-HCT Denk 50/25 does not need to be taken with food. The daily dose should be taken in the morning as a single dose and followed by sufficient fluid (approximately 1 glass of water). The doctor will determine the duration of treatment. Side Effects Cardiovascular System: Occasionally, especially at the beginning of therapy, as well as in cases of dehydration (e.g., vomiting, diarrhea, diuretic treatment), in patients with a history of heart failure, and in patients with renal hypertension, an excessive hypotensive effect (orthostasis) may occur with increased doses of Capto-HCT Denk 50/25, characterized by symptoms such as dizziness, weakness, visual disturbances, and rarely loss of consciousness (syncope). ECG changes and arrhythmias due to hypokalemia are common during hydrochlorothiazide treatment. In individual cases, side effects associated with severe hypotension have been reported: tachycardia, palpitations, chest pain, angina pectoris, myocardial infarction, transient ischemic attack, cerebral apoplexy. Kidney: Impaired or disturbed renal function is rare, but acute renal failure may develop in individual cases. Proteinuria has been reported in rare cases, sometimes accompanied by impaired renal function. Individual cases of interstitial nephritis of non-bacterial origin with the development of acute renal failure have been observed during hydrochlorothiazide treatment. Respiratory System: Dry, irritating cough and bronchitis are common. In rare cases, dyspnea, sinusitis, and rhinitis may develop. There may also be isolated cases of bronchitis, glossitis, dry mouth, and thirst. Allergic alveolitis (eosinophilic pneumonia) associated with captopril has been reported in individual cases. In individual cases, pulmonary edema has also developed suddenly, accompanied by symptoms of shock. This is thought to be an allergic reaction to hydrochlorothiazide. Angioneurotic edema involving the pharynx, larynx, and/or tongue, caused by ACE inhibitor-containing drugs, has been reported in individual cases. Gastrointestinal System/Liver: Nausea, upper gastrointestinal complaints, and indigestion are rare. Vomiting, diarrhea, constipation, loss of appetite, pancreatitis, and especially cholecystitis if the patient already has cholelithiasis, may also occur rarely. In rare cases, a syndrome starting with cholestatic jaundice and progressing to liver necrosis (sometimes with fatal outcome) has been observed in patients undergoing ACE inhibitor therapy. Its connection to medication intake is unknown. Liver function abnormalities, hepatitis, and intestinal obstruction (partial and complete ileus) have been observed in individual cases. Skin and Blood Vessels: Allergic skin reactions, such as exanthema, are rare. Urticaria, itching, as well as angioneurotic edema of the lips, face, and/or extremities have been observed in rare cases. Severe skin reactions such as erythema multiforme and pemphigoid reactions, and lupus erythematosus (due to hydrochlorothiazide) have been reported in individual cases. Associated with the above changes may be: fever, myalgia, arthralgia, vasculitis, eosinophilia, leukocytosis, and/or elevated ANA titer, or elevated ESR. Rarely, thrombosis and embolism may develop with high doses of hydrochlorothiazide due to fluid loss. Elderly patients and those with venous system diseases are particularly susceptible. Decreased lacrimation may rarely occur during hydrochlorothiazide treatment. Psoriasiform skin changes, photosensitivity, redness, sweating, alopecia, onycholysis, gynecomastia, and worsening of Raynaud's syndrome have been observed in individual cases. Nervous System: Headache, fatigue, drowsiness, weakness, apathy due to water and electrolyte imbalance are rare. Depression, dizziness, insomnia, impotence, paresthesia, balance disorders, confusion, mood changes, tinnitus, blurred vision, transient decrease in taste sensation may also occur in rare cases. Musculoskeletal System: Muscle spasms, skeletal muscle weakness, muscle pain, and paresis due to hypokalemia may develop in rare cases. Laboratory Diagnostic Parameters: Reduction in hemoglobin, hematocrit, or platelet count is not common. Rarely, especially in patients with impaired renal function, collagenosis-induced vascular disease, or those receiving concomitant therapy with allopurinol, procainamide, or certain immunosuppressants, anemia, thrombocytopenia, leukopenia, neutropenia, eosinophilia, and in individual cases, agranulocytosis and pancytopenia may occur. Hemolysis/hemolytic anemia associated with G-6-PD deficiency has also been observed in individual cases. However, its association with ACE inhibitors has not been proven. Rarely, the hydrochlorothiazide component can cause hypokalemia, hypochloremia, hypomagnesemia, hypercalcemia, glucosuria, and metabolic alkalosis. Elevated serum glucose, cholesterol, triglycerides, urea, and amylase levels have been observed. In rare cases, especially in patients with impaired renal function, serum urea, creatinine, and potassium levels increase, while sodium concentration decreases. In patients with diabetes mellitus, serum potassium concentration increases, and urinary protein excretion may also increase. In individual cases, bilirubin and liver enzyme concentrations may increase. Note: The above blood tests should be regularly checked before therapy and during treatment. If a drug side effect not listed in the instructions occurs, inform your doctor or pharmacist. Contraindications - Hypersensitivity to captopril, thiazides, or sulfonamides. (cross-reactivity possible); - Predisposition to tissue swelling (angioneurotic edema); - Severe renal dysfunction (serum creatinine > 1.8 mg/dl and creatinine clearance < 30 ml/min); - Need for dialysis; - Renal artery stenosis; - History of kidney transplantation; - Hemodynamically significant aortic or mitral valve stenosis impeding blood flow or other obstructive diseases of the left ventricle (e.g., hypertrophic cardiomyopathy).; - Primary hyperaldosteronism; - Severe hepatic dysfunction (precoma/hepatic coma) or primary liver disease; - Clinically significant electrolyte imbalance (hypercalcemia, hypernatremia, hypokalemia); - Not for use in pregnant women, children, and nursing mothers. - Capto-HCT Denk 50/25 should only be taken after consulting a doctor. Special caution is advised for patients with the following conditions: - Clinically significant proteinuria (more than 1 g/day); - Impaired immune system or collagenosis-induced vascular disease (e.g., lupus erythematosus, scleroderma); - Concomitant use of immunosuppressive drugs (e.g., corticosteroids/cytostatics, antimetabolites) or use of allopurinol, procainamide, or lithium; - Gout; - Hypovolemia; - Cerebrovascular circulation problems; - Coronary heart disease; - Manifest or latent diabetes mellitus; - Impaired liver function. Pregnancy and Lactation: Pregnancy in women of childbearing potential is not permitted during treatment with Capto-HCT Denk 50/25. Contraceptive measures are required during treatment. If the patient becomes pregnant, she should change her antihypertensive medication to another drug with lower risk to the baby, as Capto-HCT Denk 50/25 can harm the fetus, especially during the last 6 months of pregnancy, which can even be fatal. Capto-HCT Denk 50/25 is excreted in breast milk. Breastfeeding should be discontinued before starting treatment. Effects on Driving and Operating Machinery: Regular medical check-ups are necessary when taking these medications. Various reactions in individuals can affect their ability to safely operate a vehicle or machinery. This is particularly important at the start of treatment, when changing medication, or when used with alcohol. Note: Physiological saline and alcohol should be avoided. Special Precautions: Renal function should be assessed before taking Capto-HCT Denk 50/25. Water and electrolyte imbalances should be corrected before starting therapy. In particular, the initiation of Capto-HCT Denk 50/25 therapy must be under medical supervision. Intensive monitoring of blood pressure and laboratory diagnostic parameters is also necessary in patients with: - Impaired renal function (serum creatinine up to 1.8 mg/100 ml and/or creatinine clearance 30-60 ml/min); - Renal hypertension; - Age over 65 years; - Pre-existing heart failure. Serum electrolytes, serum creatinine, glucose levels, as well as complete blood count should be promptly rechecked in at-risk patients (with impaired renal function, diabetes mellitus, collagenosis-induced vascular diseases, and elderly patients) and in those receiving immunosuppressive and cytostatic drugs or allopurinol, procainamide, digitalis glycosides, glucocorticoids, laxatives, and also during the initial period of treatment. If symptoms such as fever, swollen lymph nodes, and/or sore throat occur during Capto-HCT Denk 50/25 therapy, the white blood cell count must be urgently checked. Dialysis or hemofiltration (polyacrylonitrile, sodium-2-methylallylsulfonate) with high-flux membranes (e.g., ~AN 69~) should not be performed during Capto-HCT Denk 50/25 treatment due to the risk of hypersensitivity reactions (anaphylactic reaction), which are sometimes associated with a fatal outcome. In case of emergency dialysis or hemofiltration, antihypertensive drugs (but not ACE inhibitors) should be changed or other dialysis membranes used before the procedure. During LDL (low-density lipoprotein) apheresis with dextran sulfate (in cases of severe hypercholesterolemia), hypersensitivity reactions may occur if the patient is undergoing ACE inhibitor therapy. Desensitization therapy for insect stings (e.g., bees or wasps) in combination with ACE inhibitors can cause hypersensitivity and sometimes life-threatening reactions (e.g., hypotension, dyspnea, vomiting, allergic skin reactions). If LDL apheresis or desensitization therapy is necessary, Capto-HCT Denk 50/25 should be temporarily replaced with another antihypertensive agent (but not an ACE inhibitor). Overdose In case of overdose, the following symptoms may occur: persistent diuresis, electrolyte imbalance, severe hypotension, loss of consciousness (including coma), convulsions, paresis, arrhythmia, bradycardia, cardiogenic shock, renal failure, paralytic ileus. If overdose is suspected, seek medical attention immediately. Drug Interactions If the patient is taking or has recently taken any medication, including over-the-counter drugs, they should inform their doctor or pharmacist. It should be noted that this information also applies to medications that the patient has taken recently. Physiological saline: Reduces the hypotensive effect of Capto-HCT Denk 50/25. Antihypertensive agents (e.g., other diuretics, beta-blockers), nitrates, vasodilators, barbiturates, phenothiazines, tricyclic antidepressants: Increase the hypotensive effect of Capto-HCT Denk 50/25. Analgesics, anti-inflammatory agents (e.g., salicylic acid derivatives, indomethacin): Likely reduce the hypotensive effect of Capto-HCT Denk 50/25. Acute renal failure may develop, especially in cases of hypovolemia. High-dose salicylates: Hydrochlorothiazide increases the toxic effects on the CNS caused by salicylates. Potassium, potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene), and also other drugs that increase serum potassium levels (e.g., heparin): Captopril increases serum potassium concentration. Lithium: Increased serum lithium levels (regular monitoring required!) increase the cardiotoxic and neurotoxic effects of lithium. Alcohol: Increased effect of alcohol; increased hypotensive effect of Capto-HCT Denk 50/25. Digitalis glycosides: The effects and side effects of digitalis glycosides may be increased if there is a pre-existing deficiency of potassium and magnesium. Oral antidiabetic agents (e.g., sulfonylureas/biguanides), insulin: The effect of hydrochlorothiazide may be reduced, or the hypoglycemic effect caused by captopril may be increased. Catecholamines (e.g., adrenaline): The effect of hydrochlorothiazide is reduced. Diuretics (e.g., furosemide), glucocorticoids, ACTH, carbenoxolone, amphotericin B, penicillin G, salicylates, or laxatives: Hydrochlorothiazide increases potassium and magnesium excretion. Allopurinol, cytostatic agents, immunosuppressive drugs, systemic corticosteroids, procainamide: Reduced white blood cell count (leukopenia). Cytostatic agents (cyclophosphamide, fluorouracil, methotrexate): Hydrochlorothiazide increases bone marrow toxicity (especially granulocytopenia). Hypnotics and anesthetics, narcotics: Increase hypotension. Cholestyramine and colestipol: Reduce the absorption of hydrochlorothiazide. Curare-type muscle relaxants: Hydrochlorothiazide increases and prolongs the muscle relaxant effect. Methyldopa: In individual cases of hemodialysis, antibodies are formed against hydrochlorothiazide. Storage Conditions and Expiration Dates The preparation should be stored at a temperature below 25°C, protected from light. Keep out of reach of children. Shelf life is 5 years. The preparation should not be used after the expiry date indicated on the packaging. Dispensing from Pharmacy Prescription only
