Indapamide Retard-Teva, controlled-release pills 1.5mg 30pcs

Composition

Active ingredient:

indapamide 1.5 mg;

Auxiliary substances:  

lactose monohydrate 119.1 mg,

hypromellose 77.4 mg,

colloidal silicon dioxide 1 mg,

magnesium stearate 1 mg;

Composition of the film shell:

hypromellose 5 mg, glycerol 85% 0.7 mg, titanium dioxide 1 mg

Pharmacological action

Diuretic MEDIATX: C. 03. B. A. 11 Indapamide Pharmacodynamics :

Indapamide is a sulfonamide derivative whose structure includes an indole ring.

It is characterized by a pharmacological relationship with thiazide diuretics. Indapamide implements its effects by inhibiting sodium reabsorption in the distal convoluted tubules. Under the action of indapamide, the excretion of chlorine and sodium ions by the kidneys increases, as well as, to a lesser extent, the excretion of potassium and magnesium, which is accompanied by an increase in diuresis and an antihypertensive effect.

The results of clinical studies showed that when using indapamide in monotherapy at doses that do not have a pronounced diuretic effect, a 24-hour hypotensive effect was demonstrated.

The antihypertensive activity of indapamide is associated with an improvement in the elastic properties of large arteries, a decrease in arteriolar and total peripheral vascular resistance.

Indapamide reduces the severity of left ventricular hypertrophy.

Thiazide and thiazide-like diuretics at a certain dose are characterized by the formation of a plateau of therapeutic effect, while the severity of undesirable effects continues to increase. If the desired therapeutic effect cannot be achieved, further dose increase is not advisable.

In short-term, medium-term and long-term studies in patients with arterial hypertension, it was found that indapamide:

– does not affect the parameters of lipid metabolism (triglycerides, low – density lipoprotein cholesterol and high-density lipoprotein cholesterol);

– does not affect the metabolism of carbohydrates (even in patients with diabetes mellitus). Pharmacokinetics: Suction:  indapamide is rapidly and completely absorbed in the gastrointestinal tract (GIT). Food intake slightly increases the rate of absorption of indapamide, but does not affect the completeness of absorption. After ingestion of a single dose, the maximum concentration of indapamide in the blood serum is reached after 12 hours. With repeated doses, fluctuations in the concentration of indapamide in blood plasma are smoothed out.

Distribution and metabolism:  the binding of indapamide to plasma proteins is 79%. The equilibrium concentration is reached after 7 days of taking the drug.

With repeated use of the drug, its accumulation is not observed.

Deduction:  indapamide is mainly excreted by the kidneys (70% of the dose) and through the intestine (22%) in the form of inactive metabolites.

The plasma half-life of indapamide varies from 14 to 24 hours (average 18 hours).

In patients with renal insufficiency, the pharmacokinetic properties of indapamide do not change.

Indications

Arterial hypertension.

Use during pregnancy and lactation

Medication Indapamide retard-Teva is not recommended for use during pregnancy and lactation.

As a general rule, diuretics should not be prescribed during pregnancy. Do not use these drugs to treat physiological edema during pregnancy. Diuretics can cause fetoplacental ischemia and lead to impaired fetal development.

It is not recommended to prescribe the drug to nursing mothers (indapamide is excreted in breast milk).

Contraindications

Hypersensitivity to indapamide, other sulfonamide derivatives or any of the components of the drug, severe renal insufficiency (creatinine clearance less than 30 ml / min), severe hepatic impairment or hepatic encephalopathy, hypokalemia, pregnancy, breastfeeding, age under 18 years (insufficient data on safety and efficacy), lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

With caution:

Impaired liver and kidney function, impaired water and electrolyte balance, use in patients with an extended QT interval on the ECG; use in weakened patients or in patients receiving concomitant therapy with drugs that may increase the QT interval, hyperparathyroidism, diabetes mellitus, hyperuricemia and gout.

Side effects

the Frequency of side effects is classified in accordance with the recommendations of the world health organization: very often – at least 10%; often – not less than 1% but < 10%; infrequently – no more than 0.1% but < 1%; rarely – not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) – less than 0.01%; unspecified frequency (frequency cannot be estimated according to the available data).

From the circulatory and lymphatic system: very rarely – thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia.

From the central nervous system: rarely-asthenia, headache, paresthesia, vertigo; unspecified frequency-syncope.

From the cardiovascular system:  very rarely – arrhythmia, marked decrease in blood pressure; unspecified frequency-arrhythmia of the “pirouette” type (possibly fatal).

From the digestive system:  infrequently-vomiting; rarely-nausea, constipation, dryness of the oral mucosa; very rarely-pancreatitis.

From the urinary system:  very rarely – kidney failure.

From the liver and biliary tract: very rarely-impaired liver function; unspecified frequency-the possibility of developing hepatic encephalopathy in case of liver failure; hepatitis.

From the skin and subcutaneous fat: hypersensitivity reactions, mainly dermatological, in patients with a predisposition to allergic and asthmatic reactions: often-maculopapular rash; infrequently – hemorrhagic vasculitis; very rarely – angioedema and/or urticaria, toxic epidermal necrolysis, Stevens – Johnson syndrome; unspecified frequency: patients with acute systemic lupus erythematosus may worsen the course diseases.

Cases of photosensitivity reactions are described.

Laboratory parameters:  unspecified frequency – increased QT interval on the ECG, increased uric acid and glucose concentrations in the blood: thiazide and thiazide-like diuretics should be used with caution in patients with gout and diabetes mellitus, increased activity of “hepatic” transaminases. In clinical studies, hypokalemia (blood plasma potassium content less than 3.4 mmol/l) was observed in 10% of patients and less than 3.2 mmol/l in 4% of patients after 4-6 weeks of treatment. After 12 weeks of therapy, the level of potassium in the blood plasma decreased, on average, by 0.23 mmol / l; very rarely – hypercalcemia; unspecified frequency-decrease in potassium content and development of hypokalemia, especially significant for patients at risk (see the section “Special instructions”), hyponatremia, accompanied by hypovolemia, dehydration and orthostatic hypotension. Simultaneous hypochloremia can lead to metabolic alkalosis of a compensatory nature (the probability and severity of this effect is low).

Interaction

When indapamide is co-administered with lithium preparations, the concentration of lithium in the blood plasma may increase due to a decrease in its excretion with signs of overdose. If necessary, diuretics can be used with lithium preparations, while monitoring the concentration of lithium in the blood plasma, and if necessary, adjust the dose.

Indapamide should not be combined with diuretics that can cause hypokalemia (bumetanide, furosemide, pyrethanide, thiazide diuretics, xypamide).

Drugs that can cause the development of arrhythmia of the “pirouette”type:  – Class IA antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide);- class III antiarrhythmic drugs (amiodarone, dofetilide, ibutilide) and sotalol;- some neuroleptics: phenothiazines – chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine; benzamides – amisulpride, sulpiride, sultopride, tiapride; butyrophenones – droperidol, haloperidol; – others: bepridil, cisapride, difemanil, erythromycin for intravenous use, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine for intravenous use, astemizole.

Increased risk of developing ventricular arrhythmias, including the “pirouette” type (hypokalemia is a risk factor). It is necessary to monitor the content of potassium in the blood serum and, if necessary, appropriate correction before starting combination therapy. In addition, in the course of combined treatment, clinical monitoring, monitoring of blood electrolyte levels and ECG should be carried out.

When used concomitantly with nonsteroidal anti-inflammatory drugs (intended for systemic use), including selective cyclooxygenase-2 (COX-2) inhibitors, high doses of acetylsalicylic acid (more than 3 g / day) it is possible to reduce the antihypertensive effect of indapamide. There is a risk of acute renal failure in patients with dehydration (decreased glomerular filtration rate). Patients need to compensate for fluid loss and regularly monitor kidney function, both at the beginning of therapy and during treatment.

When used concomitantly with angiotensin-converting enzyme (ACE) inhibitors against the background of sodium deficiency (especially in patients with renal artery stenosis), a sudden decrease in blood pressure and / or the development of acute renal failure may occur.

Concomitant use with drugs that cause hypokalemia (amphotericin B for intravenous use, glucocorticosteroids, mineralocorticosteroids for systemic use, tetracosactide, laxatives that stimulate intestinal motility) increases the risk of hypokalemia (additive effect).

When used concomitantly with baclofen, the antihypertensive effect of indapamide may be enhanced.

When used concomitantly with cardiac glycosides, hypokalemia may develop, predisposing to the realization of toxic effects of cardiac glycosides.

When used concomitantly with potassium-sparing diuretics (amiloride, spironolactone, triamterene), the development of hypokalemia or hyperkalemia (especially in patients with renal insufficiency and / or diabetes mellitus) cannot be completely excluded.

Concomitant use with metformin increases the risk of metformin-induced lactic acidosis. Functional renal failure associated with the use of diuretics, and especially “loop” diuretics, may be a predisposing factor.

Metformin should not be used if the plasma creatinine concentration exceeds 15 mg / l (135 mmol/l) in men, and 12 mg/l (110 mmol/l) for women.

Against the background of dehydration caused by diuretics, there is an increased risk of acute renal failure, in particular when using high-dose iodine-containing contrast agents.

Before prescribing iodine-containing contrast agents, rehydration should be performed.

Concomitant use with antidepressants structurally similar to imipramine and neuroleptics may increase the antihypertensive effect of indapamide and increase the risk of orthostatic hypotension (additive effect).

When used concomitantly with calcium salts, the risk of hypercalcemia increases due to a decrease in the excretion of calcium by the kidneys.

When used concomitantly with cyclosporine and tacrolimus, the risk of developing an increased concentration of creatinine in blood plasma increases in the absence of any changes in the concentration of cyclosporine in the circulating blood, even without a lack of fluid or sodium in the body.

When used concomitantly with corticosteroids (mineral and glucocorticosteroids) and tetracosactide (with systemic use), it is possible to reduce the antihypertensive effect of indapamide (corticosteroids cause fluid retention and sodium in the body).

How to take, course of use and dosage

Inside,1 tablet a day, in the morning.

The tablet should be swallowed with a sufficient amount of liquid. Tablets should not be broken or chewed.

In severe renal insufficiency (creatinine clearance less than 30 ml/min), the drug should be administered Indapamide retard-Teva is contraindicated. Thiazide and thiazide-like diuretics are effective only for normal renal function or minimal impairment.

In the treatment of elderly patients, the threshold value of creatinine concentration in blood plasma varies depending on age, body weight and gender. For elderly patients, the drug Indapamide retard-Teva can only be prescribed for normal renal function or with minimal impairment. In severe hepatic impairment, the drug is used Indapamide retard-Teva is contraindicated. Medication Indapamide retard-Teva is not recommended for the treatment of children under 18 years of age due to a lack of information on the safety and effectiveness of such therapy.

Overdose

Symptoms: nausea, vomiting, marked decrease in blood pressure, convulsions, dizziness, drowsiness, confusion, polyuria, oliguria up to anuria (due to hypovolemia).

Treatment: Initial detoxification measures include rapid removal of the drug by gastric lavage and use of activated charcoal. Then, in the conditions of a specialized center, the water-electrolyte balance is restored. Indapamide, even in very high doses (up to 40 mg, i. e. 27 times the therapeutic dose), does not have a toxic effect.

Special instructions

In patients with impaired liver function, therapy with the drug Indapamide retard-Teva can lead to the development of hepatic encephalopathy, especially with concomitant violations of the water-electrolyte balance. In this case, the diuretic should be stopped immediately. During drug therapy Indapamide retard-Teva isolated cases of photosensitivity reactions have been reported. If there are signs of a photosensitivity reaction, take the drug Indapamide retard-Teva should be discontinued. If it is necessary to resume therapy with the drug Indapamide retard-Teva, it is recommended to protect exposed areas of the body from direct sunlight and artificial ultraviolet radiation. The sodium content in the blood plasma should be determined before starting therapy with the drug Indapamide retard-Teva, which can be accompanied by the development of hyponatremia, sometimes with very serious consequences. A decrease in the sodium content in the blood plasma may initially be asymptomatic, so regular monitoring is necessary.

In the treatment of elderly patients and patients with cirrhosis of the liver, the blood sodium content should be determined more often.

In case of arterial hypertension, when previous diuretic therapy could lead to sodium deficiency in the body, it is necessary to:

– stop diuretic therapy 3 days before the start of ACE inhibitor use, and resume diuretic therapy if necessary, or

– prescribe an ACE inhibitor at a low initial dose, and then gradually increase the dose of the drug.

In patients with chronic heart failure, it is necessary to start therapy with an ACE inhibitor with a very low initial dose. In addition, when starting therapy with an ACE inhibitor, it may be necessary to reduce the dose of a diuretic that can cause hypokalemia.

In all cases, renal function (plasma creatinine) should be monitored during the first weeks after starting ACE inhibitor therapy. Drug therapy Indapamide retard-Teva is characterized by a high risk of lowering the blood potassium content with the development of hypokalemia.

Hypokalemia should be prevented in the treatment of patients at risk (elderly patients, debilitated patients, patients receiving multicomponent drug therapy, patients with cirrhosis of the liver with peripheral edema and ascites, patients with coronary heart disease, patients with heart failure). In such patients, hypokalemia contributes to increased cardiotoxicity of cardiac glycosides, and also increases the risk of developing cardiac arrhythmias.

Patients with an extended QT interval (hereditary or iatrogenic pathology) are also considered at risk. Thus, hypokalemia, as well as bradycardia, acts as a factor predisposing to the development of serious cardiac arrhythmias, in particular, arrhythmias of the “pirouette”type. When treating patients at risk, regular monitoring of the potassium content in the blood plasma is necessary. The initial measurement of potassium should be performed within the first week after starting therapy with the drug Indapamide retar d-Teva, detection of hypokalemia requires appropriate correction.

Special care should be taken when concomitant therapy with cardiac glycosides.

Medication Indapamide retar d-Teva reduces the excretion of calcium by the kidneys, which leads to a slight and temporary increase in the content of calcium in the blood plasma. Severe hypercalcemia may occur in patients with previously undiagnosed hyperparathyroidism. Before starting a study of the function of the parathyroid glands, therapy with the drug Indapamide retard-Teva should be discontinued. When treating patients with diabetes mellitus, especially in the presence of hypokalemia, it is necessary to monitor the concentration of glucose in the blood. When treating patients with hyperuricemia, the likelihood of exacerbation of the gout course increases. Medication Indapamide retard-Teva is quite effective for normal renal function or with minimal violations (the concentration of creatinine in blood plasma is below 25 mg/l, that is,220 mmol/l for an adult). In the treatment of elderly patients, the threshold value of creatinine concentration in blood plasma varies depending on age, body weight and gender. Hypovolemia, secondary to diuretic effects such as fluid and sodium loss, leads to a decrease in glomerular filtration rate at the beginning of treatment. As a result, the concentration of urea and creatinine in the blood plasma increases. In patients with normal renal function, such transient functional renal failure passes without consequences. For athletes, of particular importance is the fact that the Active ingredient of the drug Indapamide retard-Teva may cause a positive doping test result. Influence on the ability to drive vehicles and fur. :

The effect of the substances that make up the drug does not lead to a violation of psychomotor reactions.

Caution should be exercised when driving vehicles (especially at the beginning of therapy or when other antihypertensive agents are added to the therapy).

Form of production

Controlled release film-coated tablets,1.5 mg.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children.

Shelf

life is 3 years.

Do not use after the expiration date.

Active ingredient

Indapamide

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets