Indapamide-Astrafarm 2.5 mg tablets number 30

Author Ольга Кияница

2017-05-11

Amount in a package 30
Product form Pills
Manufacturer Astrafarm Ltd. (Ukraine, Cherry)
Registration certificate UA/11734/01/01
The main medicament Indapamide
morion code 144096

Indapamide (Indapamide) Instructions for use

Composition:

active ingredient: indapamide; 1 tablet contains 2.5 mg indapamide;
auxiliary substances: starch corn; lactose, monohydrate; povidone; magnesium stearate; sodium lauryl sulfate; Coating for Seloe Coat;

Composition of Seloe Coat :

  • gipromelose 2910, 5 sP;
  • PEG 6000;
  • titanium dioxide (E 171).

Dosage form

Tablets coated with 2.5 mg # 30.

Pharmacotherapeutic group

Netiasidic diuretics with moderate diuretic activity. ATS code C03B A11.

Clinical characteristics

Indications

Essential hypertension.

Contraindications

Hypersensitivity to indapamide, to other sulfonamides or to any other components of the drug. Severe renal failure, hepatic encephalopathy and severe liver function impairment, hypokalemia.

Method of administration and dose

For oral use: 1 tablet (2.5 mg) per day, preferably in the morning. The tablet should be swallowed whole without chewing, drinking with water. The tablet is not divisible.

The maximum daily dose is 1 tablet.

The use of higher doses of the drug does not increase the antihypertensive effect, but the diuretic effect increases.

The duration of treatment depends on the course of the disease and the therapeutic effect of treatment.

Patients from risk groups (see section "Peculiarities of use").

Adverse reactions

Most undesirable effects, both clinical and laboratory, are dose-dependent.

From the blood system: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia.

From the nervous system: dizziness (vertigo), fatigability, headache, paresthesia, fainting.

From the cardiovascular system: arrhythmia, arterial hypotension, torsade de pointes - paroxysmal ventricular tachycardia of the type "pyruvate" (which may be lethal) (see sections "Peculiarities of use", "Interaction with other drugs and other types of interactions"). .

From the digestive tract: vomiting, nausea, constipation, dry mouth, pancreatitis.

From the urinary system: renal failure.

On the hepatobiliary system: a liver function impairment, hepatic encephalopathy may occur in case of hepatic failure (see sections "Peculiarities of use" and "Contraindications"), hepatitis.

On the skin: Hypersensitivity reactions, mainly from the skin, in patients who are prone to allergic and asthmatic reactions: macular papules rashes, purpura, angioedema and / or urticaria, toxic skin necrosis, Stevens-Johnson syndrome. Possible exacerbation of already existing systemic lupus erythematosus. Reactions of photosensitivity reactions were reported (see section "Peculiarities of application").

Laboratory Indicators: lengthening QT interval on the electrocardiogram (see sections "Peculiarities of application", "Interaction with other drugs and other types of interactions"); increased levels of uric acid and glucose in blood plasma during thiazide and thiazide-like diuretics: the rationality of these diuretics should be weighed carefully before being given to patients with gout and diabetes mellitus; increase in liver enzymes.

From the side of metabolism: hypercalcemia; a decrease in potassium levels with the emergence of hypokalemia, in particular serious, in certain categories of high-risk patients (see section "Peculiarities of use"); Hypnotherapy with hypovolaemia can lead to dehydration and orthostatic hypotension. The associated loss of chlorine ions can cause secondary compensatory metabolic alkalosis (the frequency and severity of this phenomenon are low).

Overdose

First of all, there are manifestations of water-electrolyte disturbances (hyponatremia, hypokalemia). Possible nausea, vomiting, arterial hypotension, convulsions, dizziness, drowsiness, polyuria or oliguria up to anuria (caused by hypovolemia), confusion of consciousness.

Treatment First aid measures include the rapid removal of the drug by washing the stomach and / or the appointment of activated charcoal, followed by the restoration of the water-electrolyte balance in the hospital setting.

Use during pregnancy or breastfeeding

Pregnancy

Diuretics should be avoided in pregnant women and never used for the treatment of physiological edema in pregnant women. Diuretics can lead to fetoplacental ischemia with a risk of delayed fetal growth.

Breastfeeding

The use of indapamide during breast-feeding is not recommended due to the presence of data on breast-milk ingestion.

Where are you

The drug is not used by children due to insufficient data on safety and efficacy for this group of patients.

Application features

In patients with impaired liver function, the use of thiazide-like diuretics may cause encephalopathy, especially with electrolyte imbalance. In this case, the use of diuretics should be stopped immediately.

In elderly patients, creatinine plasma levels should be at a level that responds to age, body weight, and the sex of patients. Elderly patients with indapamide may be prescribed if the kidney function is not broken or if the kidney function is insignificant.

Renal failure and diuretics. Patients with severe renal insufficiency (creatinine clearance less than 30 ml / min) use of the drug is contraindicated. Thiazide and thiazide-like diuretics are most effective if the function of the kidneys is not disturbed or if the impairment of function is negligible (creatinine plasma levels below 25 mg / l, i.e., 220 μmol / L in adults). Hypovolemia caused by loss of water and sodium due to diuretics, at the beginning of treatment causes a decrease in glomerular filtration. This can lead to an increase in blood urea and creatinine plasma levels. This transient functional renal failure has no effect on individuals with normal renal function, but may worsen existing renal failure.

Light sensitivity. Reactions of photosensitivity reactions have been reported in patients taking thiazide and thiazide-like diuretics. When such reactions occur, treatment with diuretics is recommended. If there is a need to re-appoint a diuretic, it is recommended to protect the affected areas from the sun or from sources of artificial ultraviolet radiation.

The level of potassium in the blood plasma. Reducing the level of potassium in the blood plasma with the onset of hypokalemia is a major risk in the use of thiazide and thiazide-like diuretics. The risk of hypokalemia (<3.4 mmol / l) should be avoided in certain categories of high-risk patients, such as elderly patients, inadequately eaten patients and / or patients who take many medicines, patients with cirrhosis of the liver, which accompanied by swelling and ascites, patients with ischemic heart disease and patients with heart failure. In this case, hypokalemia increases the cardiotoxicity of cardiac glycosides and the risk of arrhythmias.

Patients with an elongated QT interval of congenital or iatrogenic genesis are also at risk. In such patients, hypokalemia, as well as bradycardia, can contribute to the development of severe heart rhythm disturbances, in particular paroxysmal ventricular tachycardia of the "pirout" type, which may have a fatal outcome.

In all of the above cases, more frequent monitoring of blood potassium levels is required. The first analysis should be done during the first week of treatment. In case of finding hypokalemia, its correction is necessary.

Blood glucose level. In patients with diabetes mellitus, it is especially important to monitor blood glucose levels in the presence of hypokalemia.

The level of sodium in the blood plasma. Any diuretic may cause hyponatraemia, which sometimes has serious consequences. Reducing sodium in blood plasma may be asymptomatic first, so regular monitoring is necessary.Monitoring should be done more often in elderly patients and with cirrhosis of the liver.

The level of calcium in the blood plasma. Thiazide and thiazide-like diuretics can reduce calcium excretion with urine and lead to insignificant and temporal increases in the level of calcium in the blood plasma. Expression of hypercalcemia can be a consequence of previous undiagnosed hyperparathyroidism. Treatment should be stopped and the function of parathyroid glands should be examined.

Patients with gout. Patients with elevated uric acid tend to increase the number of gout attacks.

The drug contains lactose, therefore, patients with congenital galactomy intolerance, glucose malabsorption syndrome and galactose, lupus lupus insufficiency are not recommended for appointment.

Athletes may indapamide cause a positive reaction to doping control.

Ability to influence the reaction speed when driving or operating with other mechanisms

The drug does not disturb the care, but in the event of symptoms associated with lowering blood pressure, especially at the start of treatment or in combination with another antihypertensive agent, it may affect the ability to drive a car or work with other mechanisms.

Interaction with other drugs and other types of interactions

Not recommended combinations

Lithium: It is possible to increase the level of lithium in the blood plasma and the emergence of symptoms of overdose as a result of reduced lithium intake (as with an insoluble diet). If a diuretic is required, careful monitoring of the level of lithium in plasma and the adaptation of its dose should be carried out.

Combinations requiring caution

Drugs that can cause torsades de pointes (paroxysmal ventricular tachycardia type pirouet):

  • antiarrhythmic drugs of Class Ia (Quinidine, Hydroquinidine, Disopyramide);
  • Antiarrhythmic drugs of Class III (amiodarone, sotalol, dopetilid, ibutylid);
  • some antipsychotic drugs:
  • phenothiazines (chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine);
  • benzamides (amiselupride, sulpiride, sulfopride, thiapride);
  • butyrofenones (droperidol, haloperidol);
  • other medicines: bepridil, cisapride, dipemanil, erythromycin intravenous, halofantrine, misrolastin, pentamidine, sparfloxacin, moxifloxacin, vincamine intravenous.

The risk of ventricular arrhythmias, in particular, torsades de pointes (hypokalemia is a risk factor), is rising.

Before administering such a combination, check the level of potassium and, if necessary, correct it. It is necessary to control the clinical status of patients, plasma electrolytes and ECG. In the presence of hypokalemia, it is necessary to prescribe drugs that do not cause torsades de pointes.

Nonsteroidal anti-inflammatory drugs (for systemic use), including selective COX-2 inhibitors, high doses of salicylates (greater than 3 g / day):

  • may reduce the antihypertensive effect of indapamide;
  • in dehydrated patients, the risk of acute renal failure (due to decreased glomerular filtration) is increased. Before starting treatment, it is necessary to restore the water balance and check the function of the kidneys.

ACE inhibitors. Sudden arterial hypotension and / or acute renal failure may occur in patients with reduced sodium levels (especially in patients with renal artery stenosis). Patients with arterial hypertension, who had a previous diuretic use, led to a decrease in sodium levels, or, within 3 days prior to initiating treatment with an ACE inhibitor, stop receiving diuretics and then, if necessary, restore diuretic therapy; or initiating an ACE inhibitor with a low initial dose followed by a gradual dose increase. In patients with congestive heart failure, the use of an ACE inhibitor should be initiated with a minimum dose and, possibly, after a reduction in the dose of a preschedule potassium diuretic.

In any case, it is necessary to monitor the function of the kidneys (creatinine of the blood plasma) during the first weeks of treatment with an ACE inhibitor.

Drugs that can simultaneously cause hypokalemia: glucose and mineralocorticoids (for systemic use), amphotericin B (intravenous), tetracozactide, laxatives, stimulating peristalsis: increased risk of hypokalemia (additive effect). It is necessary to monitor and, if necessary, correct correction of the level of potassium in the blood plasma, especially with concurrent therapy with cardiac glycosides. It is recommended to prescribe laxatives that do not stimulate peristalsis.

Cardiac glycosides: the presence of hypokalemia promotes cardiotoxicity of cardiac glycosides. Monitoring of blood potassium levels and ECG monitoring should be monitored and, if necessary, corrected therapy.

Baclofen enhances the antihypertensive effect of the drug. At the beginning of therapy it is necessary to restore the electrolyte balance of the patient and monitor the function of the kidneys.

Combinations requiring attention

Potassium-sparing diuretics (amiloride, spironolactone, triamterene)

Such a combination does not exclude the possibility of hypokalemia (especially in patients with diabetes mellitus or with renal insufficiency) or hyperkalaemia. Monitoring of blood potassium levels and ECG monitoring should be monitored and, if necessary, corrected therapy.

Metformin: The risk of lactic acidosis in the development of functional renal failure due to diuretics, especially loop diuretics, is increased. Metformin should not be prescribed if the plasma creatinine level exceeds 15 mg / l (135 μmol / L) in men and 12 mg / l (110 μmol / L) in women.

Iodine-contrast agents: in the event of dehydration caused by diuretics, an increased risk of developing acute renal failure, especially with the use of large doses of iodine-contrast agents. It is necessary to restore the water balance before the appointment of iodine-contrast funds.

Imipramine-like antidepressants, neuroleptics: increased risk of orthostatic hypotension due to antihypertensive effect (additive effect).

Calcium salts: possible hypercalcemia due to reduced calcium elimination by the kidneys.

Ciclosporin, tacrolimus: it is possible to increase the plasma creatinine without affecting the level of circulating cyclosporine, even in the absence of a decrease in water / sodium levels.

Corticosteroids, tetracozactide (systemic action): reduction of antihypertensive action of indapamide due to water and sodium ions delayed by corticosteroids.

Pharmacological properties

Pharmacodynamics. Indapamide is a sulfonamide diuretic, which is pharmacologically similar to thiazide diuretics.Indapamide inhibits sodium reabsorption in the cortical kidney segment.

This increases the excretion of sodium and chlorides in the urine and, to a lesser extent, excretion of potassium and magnesium, thereby increasing diuresis. The antihypertensive effect of indapamide manifests itself at doses that give a negligible diuretic effect. Moreover, its antihypertensive effect persists even in hypertensive patients undergoing hemodialysis.

Indapamide acts on the vessels level by:

  • reduction of contractility of smooth muscle of vessels associated with changes in transmembrane exchange of ions (mainly calcium);
  • stimulation of the synthesis of prostaglandin PGE2 and prostacyclin PGI2 (vasodilator and platelet aggregation inhibitor).

Indapamide reduces hypertrophy of the left ventricle.

Moreover, studies of varying duration (short, medium, and prolonged) with the participation of patients with arterial hypertension have shown that indapamide:

  • Does not affect the metabolism of lipids (triglycerin, cholesterol / LDL and cholesterol / HDL),
  • does not affect the metabolism of carbohydrates, even in patients with arterial hypertension and diabetes mellitus.

When the recommended dose is exceeded, the therapeutic effect of thiazides and thiazide-like diuretics does not increase, while the number of undesirable effects increases. If the treatment is not effective, increasing the dose is not recommended.

Pharmacokinetics.

Absorption

The bioavailability of indapamide is high - 93%.

The maximum plasma concentration is reached 1-2 hours after the dose of 2.5 mg.

Distribution

Binding to blood plasma proteins is above 75%.

The half-life is 14-24 hours (on average 18 hours).

At regular intake, the level of stable concentration of indapamide in blood plasma (plateau) increases as compared with the concentration of indapamide in plasma after the administration of a single dose.

This concentration level in the blood plasma remains stable for a long time without the occurrence of cumulation.

Removing

Renal clearance is 60-80% of the total clearance.

Indapamide vыvodytsya preymuschestvenno metabolites in the video, part of the drug, kotoraja vыvodytsya kidneys in neyzmenennom video - 5%. In patsyentov with renal insufficiency pharmacokinetic parameters of yzmenyayutsya not.

Pharmaceutical characteristics

Basic Physical and Chemical properties: tablets kruhloy forms with dvoyakovыpukloy poverhnostyu, pokrыtыe obolochkoy White color. In razlome see two layer.

Shelf life

3 years.

Storage conditions

Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Packaging

30 tablets in blister, 1 blister in a box.

Vacation category

By recipe


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