Indapamid retard-Teva - instructions for use, dose, side effects, contraindications

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

The results of clinical studies showed that when using indapamide in monotherapy in doses that did not exert a pronounced diuretic effect, a 24-hour antihypertensive effect was demonstrated.

Antihypertensive activity of indapamide is associated with improving the elastic properties of large arteries, reducing arteriolar and general 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 unwanted effects continues to increase.If the desired therapeutic effect can not be achieved, further dose increases are not advisable.

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

- does not affect the 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 quickly and completely absorbed in the gastrointestinal tract (GIT). Food intake slightly increases the absorption rate 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 achieved after 12 hours. At repeated receptions fluctuations of concentration of an indapamide in a blood plasma are smoothed out.

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

When you re-take the drug is not observed its cumulation.

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

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

When renal failure the pharmacokinetic properties of indapamide do not change.

Indications:Arterial hypertension.

Contraindications:

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

Carefully:

Dysfunction of the liver and kidneys, violations of water-electrolyte balance, use in patients with an increased interval QT on the ECG; use in weakened patients or in patients receiving concomitant therapy with drugs that can increase the interval QT (cm.section "Interaction with other medicinal products"), hyperparathyroidism, diabetes mellitus, hyperuricemia and gout.

Pregnancy and lactation:

A drug Indapamide retard-Teva is not recommended for use during pregnancy and during breastfeeding.

As a rule, during pregnancy, do not prescribe diuretic drugs. Do not use these drugs to treat physiological swelling in pregnancy. Diuretic drugs can cause fetoplacental ischemia and lead to impaired fetal development.

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

Dosing and Administration:

Inside, 1 tablet a day, in the morning.

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

In severe renal failure (creatinine clearance less than 30 ml / min) drug intake Indapamide retard-Teva is contraindicated (see Contraindications section). Thiazide and thiazide-like diuretics are effective only with normal kidney function or with minimal disturbances.

In the treatment elderly patients the threshold value of the concentration of creatinine in the blood plasma varies depending on age, body weight and gender. For elderly patients, the drug Indapamide retard-Teva can be prescribed only with normal kidney function or with minimal disturbances.

In severe violations of liver function drug intake Indapamide retard-Teva is contraindicated (see Contraindications section).

A drug Indapamide retard-Teva is not recommended for treatment children under 18 years old in connection with the lack of information about the safety and effectiveness of such therapy.

Side effects:

The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%; frequency (frequency can not be calculated from available data).

From the side of the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia.

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

From the cardiovascular system: very rarely - arrhythmia, marked decrease in blood pressure; Unspecified frequency - arrhythmia of the type "pirouette" (possibly fatal) (see the sections "Interaction with other medicinal products" and "Special instructions").

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 - a violation of liver function; Unspecified frequency - the possibility of developing hepatic encephalopathy in the case of liver failure (see the sections "Contraindications", "Special instructions"); 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: in patients with acute form of systemic lupus erythematosus, the course of the disease may worsen.

Cases of photosensitivity reactions are described (see section "Special instructions" and "Interaction with other medicinal products").

Laboratory indicators: frequency, unspecified QT interval on the ECG (see section "Special instructions."), increasing the concentration of uric acid and glucose in the blood: thiazide and thiazide diuretics should be used with caution in patients with gout and diabetes, increased activity of "liver" transaminases.

In clinical studies, hypokalemia (a potassium level in the blood plasma of 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 potassium content in the blood plasma decreased, on average, by 0.23 mmol / l; very rarely - hypercalcemia; unspecified frequency - reduced potassium and hypokalemia, especially significant for patients at risk (see section "Special instructions".), hyponatremia, accompanied by hypovolemia, dehydration and orthostatic hypotension.Simultaneous hypochloraemia can lead to metabolic alkalosis of compensatory nature (the probability and severity of this effect is low).

Overdose:

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

Treatment: to the initial measures of detoxification is the rapid removal of the drug by washing the stomach and the appointment of activated charcoal. Then, under the conditions of a specialized center, the water-electrolyte balance is restored. Indapamide even in very high doses (up to 40 mg, that is, 27 times more than the therapeutic dose) does not have a toxic effect.

Interaction:

With the simultaneous use of indapamide with lithium preparations the concentration of lithium in the blood plasma can be increased due to a decrease in its excretion with signs of an overdose. If necessary, diuretic drugs can be used with lithium preparations, while monitoring the concentration of lithium in the blood plasma, and if necessary adjust the dose.

Indapamide is not recommended to combine with diuretics capable of causing hypokalemia (bumetanide, furosemide, piretanide, thiazide diuretics, xypamide).

Preparations that can cause the development of arrhythmia such as "pirouette":

- antiarrhythmic drugs IA class (quinidine, hydroquinidine, disopyramide);

- antiarrhythmic drugs of III class (amiodarone, dofetilide, ibutilide) and sotalol;

- some neuroleptics: phenothiazines - chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine; benzamides - amisulpride, sulpiride, sultopride, tiapride; butyrophenones - droperidol, haloperidol;

- other: bepridil, cisapride, difemanyl, erythromycin for intravenous use, halofantrine, misolastine, pentamidine, sparfloxacin, moxifloxacin, wincamine for intravenous use, astemizole.

An increased risk of developing ventricular arrhythmias, including the type of "pirouette" (a risk factor is hypokalemia). It is necessary to monitor the potassium content in the blood serum and, if necessary, appropriate correction before the beginning of the combination therapy. In addition, during the combined treatment should be carried out clinical monitoring, monitoring the content of electrolytes in the blood and ECG.

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

With simultaneous application with inhibitors of angiotensin-converting enzyme (ACE) in the presence of sodium deficiency (especially in patients with renal artery stenosis), a sudden decrease in blood pressure and / or the development of acute renal failure are possible.

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

When used simultaneously with baclofen it is possible to increase the antihypertensive effect of indapamide.

When used simultaneously with cardiac glycosides Possible development of hypokalemia, predisposing to the realization of toxic effects of cardiac glycosides.

With simultaneous application with potassium-sparing diuretics (amiloride, spironolactone, triamterene) the development of hypokalemia or hyperkalemia (especially in patients with renal insufficiency and (or) diabetes) is completely impossible to exclude.

When used simultaneously with metformin the risk of development of lactic acidosis, induced by metformin is increased. A predisposing factor may be functional renal failure associated with the use of diuretics, and especially "loop" diuretics.

Metformin should not be used if the creatinine concentration in the blood plasma exceeds 15 mg / L (135 μmol / L) in men and 12 mg / L (110 μmol / L) in women.

Against the backdrop of dehydration caused by diuretics, there is an increased risk of developing acute renal failure, particularly when used iodine-containing contrast agents in high doses.

Before the appointment of iodine-containing contrast agents, rehydration should be performed.

When used simultaneously with antidepressants, structurally similar to imipramine, and neuroleptics it is possible to increase the antihypertensive effect of indapamide and increase the risk of orthostatic hypotension (additive effect).

With simultaneous application with calcium salts the risk of developing hypercalcemia increases due to a decrease in the excretion of calcium by the kidneys.

With simultaneous application with cyclosporin and tacrolimus the risk of formation of a high concentration of creatinine in the blood plasma increases in the absence of any changes in the concentration of cyclosporine in the circulating blood, even without a deficiency of fluid or sodium in the body.

With simultaneous application with corticosteroids (mineral and glucocorticosteroids) and tetracosactide (with systemic administration), it is possible to reduce the antihypertensive effect of indapamide (corticosteroids cause fluid retention and sodium in the body).

Special instructions:

In patients with impaired liver function drug therapy Indapamide retard-Teva can lead to the development of hepatic encephalopathy, especially with accompanying violations of the water-electrolyte balance. In this case, the diuretic should be discontinued immediately.

With drug therapy Indapamide retard-Teva, individual cases of development photosensitivity reactions (see section "Side effect"). When there are signs of a photosensitivity reaction, taking 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 the exposed areas of the body from direct sunlight and artificial ultraviolet radiation. The content of sodium in blood plasma must be determined before the beginning of therapy with the drug Indapamide retard-Teva, which may be accompanied by the development of hyponatremia, sometimes with very serious consequences. Reduction of the content of sodium in blood plasma can initially be asymptomatic, therefore regular monitoring is necessary.

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

With arterial hypertension, when previous therapy with diuretics could lead to sodium deficiency in the body, it is necessary:

- stop diuretic therapy 3 days before the start of the ACE inhibitor, and resume therapy with a diuretic if necessary, or

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

With chronic heart failure it is necessary to start therapy with an ACE inhibitor with a very low initial dose. In addition, early treatment with an ACE inhibitor may require a reduction in the dose of a diuretic that can cause hypokalemia.

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

In the treatment of patients at risk (elderly patients, weakened patients, patients receiving multicomponent drug therapy, patients with cirrhosis with peripheral edema and ascites, patients with coronary heart disease, patients with heart failure) it is necessary to prevent hypokalemia.In such patients, hypokalemia contributes to the cardiotoxicity of cardiac glycosides, and also increases the risk of heart rhythm disturbances.

Patients with an elongated interval QT (hereditary or iatrogenic pathology) also fall into the category of risk. Thus, hypokalemia, as well as bradycardia, acts as a factor predisposing to the development of serious cardiac rhythm disturbances, in particular, pirouette-type arrhythmias. In the treatment of patients at risk, regular monitoring of the potassium content in the blood plasma is necessary. The initial measurement of the potassium content should be performed within the first week after initiation of therapy with the drug Indapamide retar d-Teva, the detection of hypokalemia requires appropriate correction.

Particular care should be taken with concomitant therapy with cardiac glycosides.

A drug Indapamide retard d-Teva reduces the excretion of calcium by the kidneys, which leads to a slight and temporary increase in the calcium content in the blood plasma. Expressed hypercalcemia can be observed in patients with previously unidentified hyperparathyroidism.Before the start of the parathyroid gland function, drug therapy Indapamide retard-Teva should be discontinued. In the treatment of patients with diabetes, especially in the presence of hypokalemia, it is necessary to monitor the concentration of glucose in the blood.

In the treatment of patients with hyperuricemia the likelihood of exacerbation of gout is increasing. A drug Indapamide retard-Teva is effective enough with normal kidney function or with its minimal disorders (creatinine concentration in the blood plasma is below 25 mg / l, that is, 220 μmol / l for an adult). In the treatment of elderly patients, the threshold value of creatinine concentration in the blood plasma varies depending on age, body weight and gender. Hypovolemia secondary to such effects as a diuretic, such as loss of fluid and sodium, at the beginning of treatment leads to a decrease in the glomerular filtration rate. 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 substance of the drug Indapamide retard-Teva can cause a positive test result for doping.

Effect on the ability to drive transp. cf. and fur:

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

Care must be taken when driving vehicles (especially at the beginning of therapy or when adding other antihypertensive drugs to the therapy).

Form release / dosage:

Controlled-release tablets coated with a film coat, 1.5 mg.

Packaging:

For 10 tablets in a blister of aluminum foil / PVC / PVDNH.

For 1, 2, 3, 5, 9 or 10 blisters, together with instructions for use in a cardboard bundle.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002253

Date of registration:26.09.2013 / 17.03.2017

Expiration Date:26.09.2018

Date of cancellation:2018-09-26

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

MERCKLE, GmbH Germany

Representation: & nbspTeva Teva Israel

Information update date: & nbsp02.11.2017

Illustrated instructions

Instructions

Indapamid retard-Teva (Indapamide retard-Teva)