Dicardplus tabs 12.5mg #30

Dicardplus user manual

You can buy Dicardplus here

Composition

1 tablet, 12.5 mg contains:
Active ingredient: chlorthalidone - 12.50 mg.
Excipients: microcrystalline cellulose (type 101) - 52,900 mg, pregelatinized starch - 1,875 mg, dye quinoline yellow varnish (D&C Yellow No. 10) - 0.100 mg, microcrystalline cellulose (type 102) - 5,000 mg, sodium carboxymethyl starch - 1,500 mg, silicon colloidal dioxide - 0.375 mg, stearic acid - 0.750 mg.

Pharmacodynamics

Chlorthalidone - a thiazide-like diuretic - suppresses the active reabsorption of sodium ions in the renal tubules (cortical segment of the ascending part of Henley's loop), increasing the excretion of sodium and chlorine ions and increasing diuresis. In addition, chlorthalidone increases the excretion of potassium, magnesium and bicarbonate ions, retains calcium ions and uric acid.
The antihypertensive effect of chlorthalidone develops gradually with the achievement of the maximum therapeutic effect 2-4 weeks after the start of therapy.
In patients with arterial hypertension, chlorthalidone provides a gradual decrease in blood pressure (BP). Despite the fact that the mechanism of action of chlorthalidone is not fully understood, its antihypertensive effect is based on the excretion of sodium and fluid. With long-term use, the maintenance of the antihypertensive effect is provided, probably due to a decrease in the total peripheral vascular resistance. Cardiac output returns to its original values, a slight decrease in blood plasma volume remains, and an increase in plasma renin activity is possible.
Increases the excretion of bicarbonate, phosphate and magnesium (mainly in the proximal tubules) and sodium, chloride and potassium (mainly in the distal regions); increased excretion of potassium ions is due to increased (depending on the blood flow rate) secretion of potassium, which increases with high salt intake. In contrast, the elimination of calcium ions (distal) is reduced, which has a beneficial effect on hypercalciuria and kidney stones.
The diuretic effect develops within 2-4 hours after taking chlorthalidonan inside, reaches a maximum after 12 hours and lasts for 2-3 days.
Like most thiazide diuretics, chlorthalidone is a carbonic anhydrase inhibitor, its inhibitory effect on carbonic anhydrase is 70 times higher than that of hydrochlorothiazide.

Pharmacokinetics

Suction

After oral administration, chlorthalidone is absorbed from the gastrointestinal tract by approximately 65%. The maximum concentration in blood plasma was observed approximately 12 hours after ingestion.

Distribution

Despite the fact that a small amount of chlorthalidone enters the bloodstream, most of the chlorthalidone binds to carbonic anhydrase of erythrocytes (98%), and not to blood plasma proteins. The concentration in erythrocytes is 50-80 times higher than the concentration in blood plasma or serum.

Metabolism

Chlorthalidone is mainly excreted unchanged. There are no data on comparative amounts of chlorthalidone excreted unchanged and in the form of metabolites. No metabolites have been identified. Metabolism and excretion through the intestines with bile are auxiliary routes of excretion.

Withdrawal

50-65% of the dose taken orally is excreted by the kidneys unchanged, 10% is excreted through the intestines.
The average half-life (T1 / 2) is 40-60 hours.

Pharmacokinetics in special groups

Elderly patients

Chlorthalidone in elderly patients is excreted more slowly than in young patients, which is presumably associated with age-related changes in renal function and leads to an increase in T1 / 2. The decrease in elimination is not clinically significant.

In case of impaired renal function

Cumulation of chlorthalidone is possible.

If liver function is impaired

Pharmacokinetic data are not available.

Indications for use

    arterial hypertension (in monotherapy or in combination with other antihypertensive drugs);
    chronic heart failure of II or III functional class according to NYHA classification.
    edematous syndrome.

Contraindications for Dicardplus

    hypersensitivity to chlorthalidone, other sulfonamide derivatives, as well as to any of the excipients of Dicardplus;
    anuria;
    hepatic encephalopathy or severe liver dysfunction (more than 9 points on the Child-Pugh scale);
    severe renal dysfunction (creatinine clearance (CC) less than 30 ml / min);
    refractory hypokalemia, hyponatremia and hypercalcemia;
    difficult to control diabetes mellitus;
    Addison's disease;
    pregnancy and the period of breastfeeding (see section "Use during pregnancy and during breastfeeding");
    age up to 18 years (efficacy and safety have not been established);
    simultaneous use of lithium preparations.

Carefully

Caution should be exercised in case of hypokalemia, hyponatremia, hypercalcemia, impaired renal function (CC more than 30 ml / min), diabetes mellitus, with simultaneous use with cardiac glycosides, lithium preparations (see section "Interaction with other drugs"), in patients with ischemic heart disease, progressive liver disease (risk of developing hepatic coma), liver cirrhosis (risk of developing hypomagnesemia), with hypercholesterolemia, hyperglyceridemia, hyperuricemia, systemic lupus erythematosus, when used in patients with gout, with hyperparathyroidism, with aggravated allergic bronchial anamnesis ...

Application during pregnancy and during breastfeeding

Pregnancy

There have been no controlled clinical studies of the use of chlorthalidone in pregnant women.
The use of diuretics in the treatment of physiological edema or arterial hypertension during pregnancy should be avoided, since their use is associated with the risk of hypovolemia, increased blood viscosity and a decrease in placental blood flow. Several cases of fetal bone marrow suppression, thrombocytopenia, fetal jaundice and neonatal jaundice have been reported with the use of thiazide diuretics.
During pregnancy, the use of chlorthalidone is contraindicated in hypertension. In other cases, the use is possible only for strict indications in the minimum effective dose and when the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Chlorthalidone is excreted in breast milk. If necessary, use during lactation, breastfeeding should be discontinued.

Method of administration and dosage

Dicardplus is taken orally, strictly according to the doctor's prescription. The tablet should be swallowed whole, without chewing, with a sufficient amount of liquid.
The dose of the drug Dicardplus is selected individually for each patient.
If the drug Dicardplus is included in the treatment regimen of a patient whose condition has been stabilized with another antihypertensive agent, it is necessary to reduce the dose of the antihypertensive agent from the very beginning in order to avoid the possible occurrence of severe arterial hypotension.

Arterial hypertension

Monotherapy
In the treatment of arterial hypertension, the recommended initial dose of Dicardplus is 12.5-25 mg / day. This dose is sufficient to provide the maximum antihypertensive effect in most patients. If the decrease in blood pressure when taking a dose of 25 mg per day is unsatisfactory, the dose is increased to 50 mg per day. If a further decrease in blood pressure is required, it is possible to include additional antihypertensive therapy to the treatment regimen.
When treating patients with arterial hypertension, the dose of Dicardplus should not exceed 50 mg per day (increased risk of side effects without increasing the antihypertensive effect).
Combination therapy
If a combination therapy is required for the treatment of arterial hypertension, the dose is first adjusted by using each drug in monotherapy. If the optimal maintenance dose matches the ratio of the combination product, the fixed-dose combination product is allowed. If dose adjustment is required, each drug is reapplied as monotherapy.
Stable chronic heart failure (NYHA functional class II or III)
The recommended initial dose of the drug Dicardplus is 25 to 50 mg / day, in severe cases, it is possible to increase the dose to 100-200 mg / day. The standard maintenance dose is the minimum effective dose, for example, 25-50 mg per day, daily or every other day. If the patient's response is unsatisfactory, cardiac glycosides or an ACE inhibitor may be used alone or both.

Edematous syndrome

The standard initial dose of the drug Dicardplus is 50-100 mg per day, preferably in the morning after a meal, once. Or, therapy begins with a dose of 100 mg every other day or 3 times a week. Some patients may require a dose of 150-200 mg daily or every other day. Doses exceeding 200 mg per day do not increase the therapeutic effect.
In patients with edema, a decrease in the dose of Dicardplus to the minimum maintenance dose is possible after 7 days of therapy or upon reaching body weight before edema appears.

Special patient groups

In patients with CC below 30 ml / min, chlorthalidone and thiazide diuretics lose their diuretic effect, the use of the drug Dicardplus is contraindicated (see section "Contraindications").
Patients with renal insufficiency of mild to moderate severity and elderly patients are recommended the minimum effective dose of Dicardplus.
In elderly patients, chlorthalidone is excreted more slowly than in healthy young patients, despite the same absorption. Thus, it may be necessary to reduce the recommended dose of Dicardplus. During therapy with Dicardplus, a thorough medical examination of elderly patients should be carried out: to monitor the concentration of creatinine in the blood plasma, taking into account age, body weight.
In patients with severely impaired liver function, the use of Dicardplus is contraindicated (see section "Contraindications").

Side effect of Dicardplus

The frequency of adverse reactions was determined in accordance with the recommendations of the World Health Organization: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rare (<1/10000), including isolated messages; unspecified frequency (frequency cannot be estimated from available data).
Disturbances from the blood and lymphatic system: rarely - thrombocytopenia, leukopenia, agranulocytosis, eosinophilia; frequency unknown - aplastic anemia.
Metabolic and nutritional disorders: very often - hyperlipidemia; very rarely - glucosuria, decompensation of existing diabetes mellitus, hypochloremic alkalosis, hyperglycemia, hyperuricemia.
Digestive system disorders: often - nausea, vomiting, loss of appetite, gastrospasm; rarely - constipation, diarrhea; very rarely - pancreatitis.
Nervous system disorders: rarely - headache; the frequency is unknown - dizziness, vertigo, paresthesia, agitation.
Violations of the organ of vision: the frequency is unknown - xantopia, visual impairment.
Heart disorders: rarely - arrhythmia.
Vascular disorders: often - a marked decrease in blood pressure and associated symptoms (orthostatic hypotension).
Disturbances from the respiratory system, chest and mediastinal organs: rarely - allergic pulmonary edema.
Disturbances from the liver and biliary tract: rarely - intrahepatic cholestasis, jaundice.
Violations of the skin and subcutaneous tissues: often - urticaria, skin rash; rarely - photosensitivity, cutaneous vasculitis, hypersensitivity reactions; frequency unknown - Lyell's syndrome (toxic epidermal necrolysis), purpura.
Musculoskeletal and connective tissue disorders: frequency unknown - muscle spasms.
Renal and urinary tract disorders: rarely - interstitial nephritis.
Genital and breast disorders: very rare - sexual dysfunction.
General disorders and disorders at the injection site: frequency unknown - weakness.
Laboratory and instrumental data: very often - hypokalemia, hyponatremia; often - hypomagnesemia; rarely, hypercalcemia.

Overdose

Symptoms: nausea, weakness, drowsiness, hypovolemia, marked decrease in blood pressure, dizziness and imbalance in water and electrolyte balance, arrhythmia, convulsions.
Treatment: there is no specific antidote. To reduce absorption, you should rinse the stomach, take activated charcoal.
Careful monitoring of blood pressure and water-electrolyte balance should be carried out and appropriate corrective measures (infusion therapy), symptomatic therapy should be taken.

Interaction with other medicinal products

Unwanted drug combination

Lithium - diuretics reduce the renal clearance of lithium and increase the risk of developing the toxic effects of lithium; simultaneous use is not recommended.
If necessary, the use of appropriate combination therapy is recommended to regularly monitor the concentration of lithium in the blood serum.

Combinations of drugs requiring attention

With thiazide diuretics, drugs such as ethanol, barbiturates, and narcotics may potentiate the risk of orthostatic hypotension.
Chlorthalidone enhances the effect of curariform muscle relaxants and antihypertensive agents (including guanethidine, methyldopa, beta-blockers, vasodilating agents, blockers of "slow" calcium channels), angiotensin-converting enzyme (ACE) inhibitors, monoamine oxidase inhibitors.
The simultaneous use of chlorthalidone with allopurinol may lead to an increase in the incidence of hypersensitivity reactions to allopurinol. Chlorthalidone may increase the risk of developing side reactions due to amantadine.
Anticholinergic drugs (eg, atropine, biperiden) can increase the bioavailability of chlorthalidone, reducing gastrointestinal motility and evacuation of gastric contents.
The hypokalemic effect of chlorthalidone is enhanced by simultaneous use with glucocorticosteroids, adrenocorticotropic hormone, amphotericin, or β2-blockers, carbenoxolone. Patients during combination therapy should monitor serum potassium levels.
Hypoglycemic agents (for oral administration and insulin) - dose adjustment of hypoglycemic agents may be required when used with chlorthalidone.
The pharmacological effects of calcium and vitamin D salts may increase to a clinically significant level when used concomitantly with chlorthalidone. The resulting hypercalcemia is usually transient, but patients with hyperparathyroidism may be at risk of developing persistent hypercalcemia, accompanied by symptoms (weakness, fatigue, anorexia).
Concomitant use with cyclosporine may increase the risk of developing hyperuricemia and complications such as gout.
Cholestyramine interferes with the absorption of chlorthalidone. A decrease in the pharmacological effect of chlorthalidone is possible.
Muscle relaxants of a non-depolarizing type of action (for example, tubocurarine) - an increase in the effect of muscle relaxants.
Pressor amines (for example, epinephrine, norepinephrine) - a decrease in the severity of the response to the intake of pressor amines.
Non-steroidal anti-inflammatory drugs (NSAIDs) (including cyclooxygenase-2 (COX-2) inhibitors) - can reduce the diuretic, natriuretic and antihypertensive effect of diuretics.
In some patients with impaired renal function (for example, elderly patients or patients with dehydration, including those taking diuretics) receiving NSAID therapy, including COX-2 inhibitors, treatment with angiotensin II receptor antagonists or ACE inhibitors may cause further deterioration of renal function, including the development of acute renal failure. These effects are reversible. The simultaneous use of these drugs should be carried out with caution in patients with impaired renal function.
Cytostatic drugs, for example, cyclophosphamide, methotrexate: the myelo-suppressing effect increases by slowing down the elimination from the body.
Cardiac glycosides: Hypokalemia and hypomagnesemia caused by the use of thiazide diuretics increase the risk of arrhythmias during treatment with cardiac glycosides.
A decrease in the volume of circulating fluid caused by taking a diuretic may increase the nephrotoxicity of aminoglycosides.
Chlorthalidone reduces the activity of prothrombin. Thiazide-like diuretics may increase the suppression of bone marrow function caused by chemotherapy in the treatment of neoplastic diseases (eg, neutropenia).
Iodine-containing contrast agents - with dehydration caused by taking diuretics, the risk of developing acute renal failure increases, especially with the introduction of high doses of iodine-containing drugs. The patient should be rehydrated prior to administering such agents.

Special instructions for Dicardplus

Arterial hypotension against the background of a violation of the water-electrolyte balance
Patients with reduced circulating blood volume and / or hyponatremia (as a result of vomiting, diarrhea, taking large doses of diuretics, or following a diet with limited salt intake) may develop clinically significant arterial hypotension after starting therapy with Dicardplus. Hypovolemia and water-electrolyte balance should be corrected before starting treatment. Transient arterial hypotension is not a contraindication to further treatment, which can be continued after BP stabilization.
Hypokalemia can be avoided by using potassium-containing drugs or foods rich in potassium (fruits, vegetables), especially in the case of increased potassium loss (increased diuresis, prolonged treatment) or concomitant treatment with cardiac glycosides or corticosteroid drugs.

Liver dysfunction

With the use of thiazide and thiazide-like diuretics in patients with impaired liver function, hepatic encephalopathy may develop, especially in case of a violation of the water-electrolyte balance. In this case, diuretics should be stopped immediately.

Photosensitivity

There is information about cases of development of photosensitivity reactions when using thiazide diuretics (see section "Side effects"). If a photosensitivity reaction occurs during treatment, it is recommended to suspend the treatment. If a decision is made to resume taking a diuretic, it is necessary to protect areas of the body that may be exposed to sunlight or ultraviolet A rays and avoid sun exposure.

Water and electrolyte balance

- sodium content in blood plasma:
Before starting therapy, the sodium content in the blood plasma should be determined. Against the background of the use of Dicardplus, it is necessary to regularly monitor this indicator. Continuous monitoring of sodium is necessary, as the initial decrease in plasma sodium may be asymptomatic. More frequent monitoring of the sodium content is necessary for patients with liver cirrhosis and elderly patients (see sections "Side effects", "Overdose").
All diuretic drugs can cause hyponatremia, sometimes with very serious consequences. Hyponatremia and hypovolemia can lead to dehydration and orthostatic hypotension. A concomitant decrease in chlorine content can lead to secondary compensatory metabolic alkalosis: the frequency and severity of this effect are negligible.
- potassium content in blood plasma:
When treating with thiazide and thiazide-like diuretics, the main risk is a sharp decrease in the content of potassium in the blood plasma and the development of hypokalemia. It is necessary to avoid the development of hypokalemia (<3.4 mmol / L) in patients of the following categories: elderly, weakened or receiving concomitant drug therapy, patients with liver cirrhosis, peripheral edema or ascites, coronary heart disease, heart failure. Hypokalemia in these patients increases the toxic effect of cardiac glycosides and increases the risk of arrhythmias. If hypokalemia occurs, appropriate treatment should be prescribed.

Diuretics and renal dysfunction

Thiazide and thiazide-like diuretics are fully effective only in patients with normal or slightly impaired renal function. In elderly patients, the normal concentration of creatinine in the blood plasma is calculated taking into account age and body weight.
It should be borne in mind that at the beginning of treatment, patients may experience a decrease in the glomerular filtration rate due to hypovolemia, which, in turn, is caused by the loss of fluid and sodium during the use of diuretics. As a result, the concentration of urea and creatinine may increase in blood plasma. If kidney function is not impaired, this temporary functional renal failure usually goes away without consequences, but with existing renal failure, the patient's condition may worsen. In patients with impaired renal function, Dicardplus can accumulate and cause the development of azotemia. With the development of oliguria, the possibility of discontinuing Dicardplus should be considered.

Diabetes

Thiazide treatment interferes with glucose tolerance. During a long course of treatment with manifest and latent diabetes mellitus, systematic control of carbohydrate metabolism is necessary; dose adjustment of hypoglycemic agents may be required. During the period of treatment, periodic monitoring of the concentration of uric acid is necessary. Alcohol, barbiturates, narcotic analgesics enhance the antihypertensive effect of thiazide diuretics.
Chlorthalidone can increase the concentration of cholesterol and triglycerides in the blood.

Hypercalcemia

Thiazide diuretics can cause a decrease in renal calcium excretion and lead to a transient moderate increase in serum calcium in the absence of an established violation of calcium metabolism. Severe hypercalcemia may be evidence that the patient has hyperparathyroidism. Reception of thiazide diuretics should be discontinued prior to studies of the functions of the parathyroid glands.
It has been shown that thiazides increase the excretion of magnesium by the kidneys, which can lead to hypomagnesemia.

Systemic lupus erythematosus

There is evidence that thiazide diuretics can cause exacerbation of systemic lupus erythematosus or lupus-like reactions. However, no cases of exacerbation of the course of systemic lupus erythematosus against the background of the use of chlorthalidone have been reported. Increased monitoring of patients with impaired uric acid metabolism is required.

Athletes

Chlorthalidone can give false positive results during doping tests.

Hypersensitivity reactions

Hypersensitivity reactions can develop in patients with aggravated allergic history or bronchial asthma.

Influence on the ability to drive vehicles, mechanisms

There were no special studies to study the effect of the drug Dicardplus on the ability to drive vehicles and mechanisms.
Care should be taken when driving, operating machinery and performing other work that requires increased concentration of attention (risk of dizziness).

Storage conditions

At a temperature not higher than 25 ° C.
Keep out of the reach of children.
Shelf life is 2 years. Do not use after the expiration date.

Terms of sell

A prescription is not required to buy Dicardplus.