Indapamide-Teva: instructions for use. Indapamide-teva diuretic with mild action

Registration number : LSR-006069/08

Trade name of the drug: Indapamide -Teva

International generic name : indapamide

Dosage form: film-coated tablets

Compound
1 tablet contains:
active substance: indapamide hemihydrate 2.5 mg; Excipients: lactose monohydrate 63.5 mg, corn starch 20.0 mg, povidone 7.0 mg, calcium phosphate dihydrate 3.0 mg, magnesium stearate 1.5 mg, talc 2.5 mg; film coating: opadry (Opadry® OY-B-28920) 2.5 mg (polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum).

Description
Biconvex film-coated tablets, almost white.

Pharmacotherapeutic group: diuretic

ATX code: S03BA11

pharmachologic effect
Pharmacodynamics. Antihypertensive drug, thiazide-like diuretic with moderate strength and long-lasting action, benzamide derivative. It has moderate saluretic and diuretic effects, which are associated with blockade of the reabsorption of sodium, chlorine, hydrogen ions and, to a lesser extent, potassium ions in the proximal tubules and the cortical segment of the distal tubule of the nephron. Vasodilating effects and a decrease in total peripheral vascular resistance are based on the following mechanisms: decreased reactivity vascular wall to norepinephrine and angiotensin II; increased synthesis of prostaglandins with vasodilatory activity; inhibition of calcium flow into the smooth muscle walls of blood vessels.
Reduces the tone of the smooth muscles of the arteries, reduces the total peripheral vascular resistance.
Helps reduce hypertrophy of the left ventricle of the heart. IN therapeutic doses does not affect lipid and carbohydrate metabolism(including in patients with concomitant diabetes mellitus).
The antihypertensive effect develops at the end of the first/beginning of the second week with continuous use of the drug and persists for 24 hours with a single dose.
Pharmacokinetics. After oral administration, it is quickly and completely absorbed from gastrointestinal tract.
Bioavailability is high (93%). Eating slightly slows down the rate, but does not affect the completeness of absorption.
Maximum concentration in the blood is achieved 1-2 hours after ingestion. Equilibrium concentration is achieved after 7 days of regular use. The drug is 70-80% bound to blood plasma proteins. It has a high volume of distribution, passes through histohematic (including placental) barriers, and penetrates into breast milk.
Metabolized in the liver. The half-life of indapamide averages 14-18 hours. Excreted from the body by the kidneys (up to 80%), mainly in the form of metabolites, through the intestines - 20%. In patients with renal failure, pharmacokinetics do not change. Does not accumulate.

Indications for use
Arterial hypertension.

Contraindications
Hypersensitivity to the drug and other sulfonamide derivatives, lactose intolerance, galactosemia, glucose/galactose malabsorption syndrome; severe renal failure (anuria stage), hypokalemia, severe hepatic failure (including with encephalopathy), age under 18 years (efficacy and safety have not been established); simultaneous use of drugs that prolong the QT interval.
With caution: prescribed for impaired liver and/or renal function, water-electrolyte imbalance, hyperparathyroidism, patients with an increased QT interval on the electrocardiogram (ECG) or receiving combination therapy with other antiarrhythmic drugs, diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).

Use during pregnancy and lactation
The drug is not used during pregnancy, since diuretics can cause fetoplacental ischemia with the risk of fetal malnutrition.
Indapamide is eliminated from breast milk. Considering the possibility of adverse events occurring in infants Breastfeeding during treatment is not recommended.

Directions for use and doses
Orally, preferably in the morning, regardless of food intake, 2.5 mg (1 tablet) per day, with a sufficient amount of liquid.
Maximum daily dose- 1 tablet.

Side effect
From the outside of cardio-vascular system: orthostatic hypotension, ECG changes (as manifestations of hypokalemia), arrhythmia, palpitations.
From the nervous system: headache, dizziness, nervousness, asthenia, drowsiness, vertigo, insomnia, depression, rarely - increased fatigue, malaise, muscle spasms, tension, irritability, anxiety.
From the outside digestive system: constipation or diarrhea, dyspepsia (including nausea, vomiting), dry mouth, anorexia, abdominal pain, hepatic encephalopathy(on the background liver failure).
From the outside genitourinary system: infections, nocturia, polyuria.
From the outside respiratory system: cough, pharyngitis, sinusitis, rarely - rhinitis.
Allergic reactions: itchy skin, maculopapular rash, urticaria, hemorrhagic vasculitis.
From the hematopoietic organs: thrombocytopenia, leukopenia, agranulocytosis, aplasia bone marrow, hemolytic anemia.
Laboratory indicators: hypercalcemia, hyperuricemia, hypochloremia, hyponatremia, hyperglycemia, hypokalemia, hypercalciuria, increased blood urea nitrogen, hypercreatininemia, glucosuria.
Others: flu-like syndrome, pain in chest, back pain, infections, decreased potency, decreased libido, rhinorrhea, sweating, weight loss, tingling in the extremities, pancreatitis, exacerbation of systemic lupus.

Overdose
Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water and electrolyte disturbances, decreased blood pressure, respiratory depression. Patients with impaired liver function may develop hepatic coma.
Treatment: gastric lavage and/or administration activated carbon followed by restoration of normal water and electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction with other drugs
With simultaneous use of indapamide with lithium preparations, an increase in the concentration of lithium in the blood plasma is possible.
Astemizole, erythromycin (iv), pentamidine, sultopride, vincamine, IA antiarrhythmic drugs (quinidine, disopyramide) and III class(amiodarone, bretylium, sotalol) may increase the likelihood of disorders heart rate like torsades de pointes ( ventricular tachycardia"pirouette" type).
Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, sympathomimetics reduce the hypotensive effect, baclofen increases.
Sapuretics, cardiac glycosides, gluco- and mineralocorticosteroids, tetracosactide, amphotericin B (iv), laxatives increase the risk of hypokalemia.
When used simultaneously with cardiac glycosides, the likelihood of developing digitalis intoxication increases, with calcium preparations - hypercalcemia, with metformin - aggravation is possible lactic acidosis.
A combination with potassium-sparing diuretics may be effective in some categories of patients, however, the likelihood of developing hypo- or hyperkalemia is not completely excluded, especially in patients with diabetes mellitus and renal failure.
Angiotensin-converting enzyme inhibitors increase the risk of developing arterial hypotension and/or acute renal failure(especially with existing stenosis renal artery).
Contrast agents containing iodine high doses ah increase the risk of developing renal dysfunction (dehydration). Before using contrast agents containing iodine, patients need to restore fluid loss.
Tricyclic antidepressants and antipsychotic drugs enhance the hypotensive effect and increase the risk of developing orthostatic hypotension. Cyclosporine increases the risk of developing hypercreatininemia.
Reduces the effect indirect anticoagulants(coumarin or indanedione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in circulating blood volume and an increase in their production by the liver (dose adjustment may be required).
Strengthens the blockade of neuromuscular transmission that develops under the influence of non-depolarizing muscle relaxants.

special instructions
At long-term use or upon admission medicinal product Indapamide-Teva in large dosages may develop electrolyte disturbances, such as hyponatremia, hypokalemia, hypochloremic alkalosis. These disorders are more often observed in patients with chronic heart failure (II-IV f.k, according to the MYHA classification); liver diseases, vomiting and diarrhea, as well as in persons on a salt-free diet.
The simultaneous administration of the drug Indapamide-Teva with cardiac glycosides and corticosteroids increases the risk of hypokalemia. In addition, urinary excretion of magnesium may increase, which can lead to hypomagnesemia.
Orthostatic hypotension may occur, which can be provoked by alcohol intake, barbiturates, narcotic drugs and simultaneous administration others antihypertensive drugs.
In patients taking cardiac glycosides, laxatives, against the background of hyperaldosteronism, as well as in the elderly, careful monitoring of potassium and creatinine levels is indicated.
The most careful monitoring is indicated in patients with liver cirrhosis, coronary disease heart, chronic heart failure.
To the group increased risk also include patients with an increased QT interval on the electrocardiogram (congenital or developed against the background of any pathological process). The first measurement of potassium concentration in the blood should be performed within 1 week of treatment.
Hypercalcemia while taking the drug Indapamide-Teva may be a consequence of previously undiagnosed hyperparathyroidism.
In patients with diabetes mellitus, it is extremely important to control blood glucose levels, especially in the presence of hypokalemia.
Significant dehydration can lead to the development of acute renal failure (decreased glomerular filtration rate). Patients need to compensate for fluid loss and carefully monitor renal function at the beginning of treatment.
The drug Indapamide-Teva can give positive result during doping control.
Patients with arterial hypertension and hyponatremia (due to taking diuretics) need to stop taking diuretics 3 days before starting angiotensin-converting enzyme inhibitors (if necessary, diuretics can be resumed a little later), or they are prescribed initial low doses of angiotensin-converting enzyme inhibitors.
Sulfonamide derivatives can aggravate the course of systemic lupus erythematosus (must be kept in mind when prescribing the drug Indapamide-Teva).

Release form
Film-coated tablets 2.5 mg.
10 tablets in a PVC/aluminum foil blister; 3 blisters per cardboard box along with instructions for use.

Storage conditions
At a temperature not higher than 25°C.
Keep out of the reach of children!

Best before date
2 years.
Do not use after the expiration date.

Conditions for dispensing from pharmacies
On prescription

Legal entity in whose name the RU was issued:
Teva Pharmaceutical Enterprises Ltd., Israel

Manufacturer: Balkanfarma-Dupnitsa AD,
st. Samokovskoe highway 3,2600 Dupnitsa, Bulgaria

Address for receiving complaints:
119049, Moscow, st. Shabolovka 10, bldg.],

Indapamide – medicine, which is used to reduce blood pressure. This drug is prescribed for hypertension when other medications are ineffective, and also if the patient develops edema due to heart failure or high blood pressure caused by impaired kidney function and excess sodium in the body.

Indapamide is needed to reduce the workload on the heart due to hypertension, but it may not be used in all cases. How to take the drug correctly and when is described in detail in the instructions for use.

Many people believe that Indapamide is a diuretic and use it as a diuretic, but this is not entirely correct. To understand when you can take a medicine, you need to find out which group it belongs to and what properties it has.

Drug group

Indapamide is a diuretic with antihypertensive effects. At its core, it is an organotropic drug, as it has a selective effect. INN of the drug is Indapamide, similar to the name of the active ingredient and trade name medicines. The active substance of the drug belongs to non-thiazide diuretics, sulfonamide derivatives. The drug code according to ATC is C03BA11, and according to OKPD-2, Indapamide is assigned the code 24.41.32.146.

The scope of use of the drug is limited. It is used in cardiological practice to reduce high blood pressure and prevent the development of edema in chronic heart failure. Less commonly prescribed in nephrology and only with the development of renal hypertension, provided that the functioning of the organ is maintained.

Release forms and prices

Indapamide is used only for internal use, therefore it is available in the form of tablets and capsules of 1.5 and 2.5 mg active component. The drug is produced by various manufacturers, so you can see different ones on pharmacy shelves. trade names: Indapamide Stada, Indapamide Ozone and others. Estimated cost of the drug different manufacturers presented in the table (Table 1).

Table 1 - Cost

Name	Dosage	Average cost, rub
	Caps., 2.5 mg	95
	Table 2.5 mg	70
Canon	Retard, tablet, 1.5 mg	110
	Table, 2.5 mg	34
Indapamide Retard (Takhimfarmpreparaty)	Table, 1.5 mg	60
Indapamide Retard with control. release (Izvarino Pharma)	Table, 1.5 mg	140
Ozone	Table, 2.5 mg	25
	Caps., 2.5 mg	30
	Retard, tablet, 1.5 mg	45
Stada	Extended tablets, 1.5 mg	110
	Table, 2.5 mg	23
Farmland (Belarus)	Table, 2.5 mg	60

All of these drugs have the same effect on the body, but it is believed that the quality may vary from one manufacturer to another. For example, Teva buys raw materials in Italy, and most Russian manufacturers buy raw materials in China. That is why Indapamide Teva has a slightly higher cost.

Compound

The active substance of any form of the drug is indapamide hemihydrate. Other components that have an auxiliary effect, but do not affect healing effect, the composition of drugs from different manufacturers may differ slightly.

Differences in the composition of capsules and tablets from different manufacturers have virtually no effect on the antihypertensive effect active substance, but may slightly affect the dissolution and absorption of the drug.

Pharmacological characteristics

Indapamide is a substance that has a diuretic and hypotonic effect by suppressing the reabsorption of sodium, chlorine, magnesium and potassium ions (to a lesser extent) in the renal tubules.

The drug also has a vasodilator and antispasmodic effect by stimulating the synthesis of PGE2, reducing the susceptibility of blood vessels to the influence of norepinephrine and angiotensin I and inhibiting calcium flow in the vascular smooth muscle epithelium. This influence makes it possible to reduce general tone arteries, improve blood circulation and reduce overall vascular resistance.

Indapamide has a protective effect on the heart muscle and helps reduce left ventricular hypertrophy. Taking it helps prevent the development of heart complications in patients with hypertension. When taking the drug in therapeutic doses, there is no effect on the metabolism of carbohydrates and lipids, so its use is acceptable for patients with diabetes.

IN Not large doses– 1.5 mg – the drug has a hypotonic effect and has virtually no effect on diuresis. But when taking large dosages, a pronounced diuretic effect begins to appear, while the effect on blood pressure remains unchanged.

The drug is very quickly absorbed from the gastrointestinal tract, and the rate of absorption is higher if you take the medicine on an empty stomach. Maximum plasma concentration is achieved 60-120 minutes after administration. The drug is excreted primarily in the urine and only about 20% through the intestines. The half-life is about 15-17 hours. Pharmacokinetic properties remain unchanged in patients with mild renal dysfunction.

Diuretic or not?

Indapamide is a mild diuretic that helps remove excess liquid from the body and improve general state patients with hypertension. When taking tablets, the following effects are observed:

The hypotonic effect of the drug is due to the listed properties. Taking the pills regularly reduces blood pressure and relieves increased stress on the cardiovascular system, which helps reduce the risk of stroke or heart attack.

At what pressure is it indicated, and what are the contraindications?

Indapamide, due to its antihypertensive properties, can only be used to treat patients with high blood pressure. If a patient with hypotension takes the pills, his condition will worsen significantly, as vascular tone will decrease, and functional disorders from the side of the heart.

The instructions for the drug indicate 2 indications for use - arterial hypertension and swelling caused by heart failure.

If it is necessary to reduce blood pressure quickly, then Indapamide will not be suitable, so it is not prescribed for relief hypertensive crises- in this case, you should use other means.

The drug copes well with renal hypertension, effectively and without consequences reduces high blood pressure in patients with one kidney and in those on hemodialysis.

The medication has contraindications that must be taken into account:

Patients with a decompensated stage of diabetes mellitus should take special care, and be sure to regularly donate blood for sugar levels. Caution is also required in cases of fluid and electrolyte imbalance, Burnett's syndrome and an extended QT interval on the electrocardiogram.

Instructions for use

Capsules and tablets are taken according to the same regimen, so there is no significant difference in administration different forms. But there are differences in the effects of regular tablets and long-acting products.

Dosage 1.5 mg

Extended-release tablets have a smaller amount of the active ingredient, since the gradual release allows you to maintain its concentration for a long time, and then gradually reduce it, preventing the pressure from rising sharply.

Long-acting tablets should be taken only once a day, in the morning before breakfast, with a big amount liquids. It is best to take the medicine at the same time every day.

Dosage 2.5 mg

Indapamide in a dosage of 2.5 mg is available in the usual form and does not have a prolonged effect. Tablets or capsules with this dosage are also taken in the morning, preferably before meals.

Some manufacturers indicate that the dosage of the drug cannot be increased, others allow an increase in the dose if there is no observed positive effect. In the second case, it is recommended to drink 5 mg (that is, two tablets once in the morning). In any case, you must adhere to the recommendations of your doctor.

Duration of treatment

Indapamide is intended for long-term use, since a pronounced antihypertensive effect is observed only after 10 days of administration. Usually the course of treatment lasts several weeks and when the pressure returns to normal, treatment is canceled.

For many patients, if there are no contraindications, and do not appear adverse reactions, are prescribed to take the pills for 1 year or longer.

But if you need to take Indapamide for more than 1-2 months, then you must monitor the level of potassium and sodium in the body, since the drug can disrupt the water-electrolyte balance.

How to take: before or after meals?

Manufacturers indicate that it is best to take the drug shortly before meals to improve the absorption of the active substance. Taking the medicine after food does not change the percentage of absorption, but affects its speed. Therefore, to achieve quick effect You need to take the pills before meals, but if you can take them only after breakfast, there’s nothing wrong with that.

Therapy during pregnancy

Not enough research has been conducted on the effect of the drug on the fetus and pregnancy, so pregnant women try not to prescribe this drug. But it has been proven that it, like other synthetic diuretics, can negatively affect phyto-placental blood flow and provoke a slowdown in fetal development.

If Indapamide is prescribed to women who are breastfeeding, the child must be switched to artificial feeding until the end of treatment.

Using different pharmaceutical forms of the drug

The use of Indapamide from different manufacturers is practically the same, but some features can be noticed in the instructions.

Drugs	Characteristic
Indapamide Stada	Shtada has two forms of release - regular tablets and tablets with modified action. It is the second form that is most popular among patients and doctors. Tablets of any dosage must be taken only once a day, in the morning, before meals. The manufacturer indicates that if a sufficient therapeutic effect is not observed within 1-2 months, then it is necessary to discontinue treatment and switch to other drugs.
Indapamide Teva	Teva is popular because it is better absorbed and causes less side effects. This is explained by the higher purification of raw materials, which the manufacturer purchases from Italy. Capsules and tablets with a dosage of 2.5 mg are taken, as well as one tablet in the morning. But the manufacturer indicates that if the effect is insufficient, you can increase the dose 2-3 times, but not more than 10 mg per day. Of course, increasing the dose must be agreed with your doctor.
Indapamide Canon	The canon does not have any special differences in composition or application. The manufacturer produces both regular and controlled-release tablets. The instructions indicate that it is not recommended to exceed the indicated dosage, since there is no increase in the hypotonic effect. It is better to introduce another drug with an antihypertensive effect into the treatment regimen.
Indapamide Farmland	Tablets from Belarusian manufacturer, which are sold mainly in Belarus. The drug does not have any special differences from tablets from other manufacturers, therefore it has similar instructions by application.
Indapamide Ozone	This Russian manufacturer offers the cheapest tablets and capsules. The abstract indicates that, regardless of the form of release, you need to take 1 tablet or capsule in the morning on an empty stomach. If it is necessary to take an antihypertensive drug from another group at the same time, the dosage of Indapamide remains unchanged.

Some application features

Indapamide has some application features that are not always indicated in the instructions, and attending physicians are not always ready to give it to the patient full information about the drug.

Effect on potency

It has long been proven that hypertension negatively affects the potency of men, which is especially unpleasant, since more and more young people suffer from high blood pressure. It was also found that most antihypertensive drugs have a negative effect on potency, especially if taken for a long time.

Therefore, men are left with a choice - to treat impotence, but suffer from hypertension, or reduce blood pressure, but suffer from sexual impotence. Today there are no drugs that can solve both problems at the same time. Indapamide is one of the drugs that negatively affects libido and potency, especially if taken for long periods.

A man should be aware of this when he is prescribed Indapamide and be prepared for unwanted reactions. However, this only applies to long-term use of the drug; if the course of treatment is only a few months, then taking the drug in therapeutic doses will not cause complications.

For gout

Patients with gout should be prepared for the fact that taking the drug may worsen the patient's condition. This is due to the drug's ability to increase levels uric acid in the blood and disruption of water-electrolyte balance.

If there is a need to take the drug in the presence of such a pathology, then patients need to regularly monitor their blood counts and, if uric acid increases critically, stop treatment and switch to other drugs.

For type 2 diabetes

Indapamide for type 2 diabetes mellitus is prescribed when the progression of the disease causes increased blood pressure, disrupts heart function and provokes swelling of the extremities.

This is one of those drugs that does not cause a worsening of diabetes mellitus, provided that the dosage is adequately selected. Patients are recommended to take extended-release tablets, since they contain a smaller amount of the active substance.

The most important thing is not to take pills in the decompensated stage of diabetes, severe liver and kidney disorders. In addition, during therapy it is necessary to undergo regular examinations.

Weight loss product: dosage, risks and reviews

One of the side effects is weight loss, which is why some people take this drug to lose weight. But Indapamide, like all diuretics, gives only temporary results.

To understand how to lose weight by taking Indapamide, you don’t need to understand the properties of the tablets for a long time. The medicine is a diuretic and removes excess fluid from the body - it is due to this that body weight is reduced and volumes may even decrease. That is why the drug is prescribed to people suffering from excess weight and swelling.

This method is only suitable for those who urgently and temporarily need to lose a few extra pounds. But after finishing taking the pills, the body begins to replenish lost fluid, and the weight returns to its original levels.

You can only take medication for weight loss for a short time. The dosage, as in the treatment of hypertension, is 1 tablet once a day. Take the remedy long time It is not recommended for weight loss purposes, as the body can react with a strong decrease in blood pressure and an imbalance in water and electrolyte balance. Loss of electrolytes will lead to malfunctions of the heart and internal organs.

Olga: “A medical friend advised me to take Indapamide when I couldn’t fit into my prom dress. She explained that this is a mild drug that has a temporary effect. Indeed, after 10 days of taking it, I lost a lot of weight, but the weight began to return after I stopped taking the pills.”

Natalya: “I took Indapamide for blood pressure, but I noticed a pleasant side reaction of the body - I began to lose weight. The weight did not decrease much - only 4.5 kg, but since the drug removes excess fluid, one should not have expected a greater result.”

Most opinions about Indapamide as a means of weight loss are positive, but everyone notes that if you do not adhere to a diet, the weight will rapidly increase after the end of the course. Experts advise against taking diuretics for weight loss, since this is a medicine of chemical origin, and can not only help you lose weight, but also harm your health.

Possible side effects and compatibility

Indapamide should be taken only after studying the instructions and the paragraph where possible adverse reactions of the body are indicated.

Negative body reactions and overdose

Taking Indapamide one tablet per day rarely causes adverse reactions, but long-term treatment or increasing the dosage, you may encounter undesirable reactions that primarily affect metabolism.

The drug can cause a lack of potassium and sodium in the body, a violation acid-base balance associated with chlorine deficiency, as well as an increase in the amount of sugar, nitrogen and creatine in the blood.

At high doses it also suffers nervous system, resulting in the following reactions:

1. Dizziness and headaches.
2. Drowsiness, apathy, lethargy, lethargy.
3. Increased fatigue, weakness.
4. Sleep disorders.
5. Nervousness, aggression.
6. Depression, anxiety.
7. Tingling in the limbs.

From the cardiovascular system the following are observed:

1. Hypotension.
2. Arrhythmia.
3. Tachycardia.
4. Changes on the ECG.

Other reactions:

1. Allergic reactions.
2. Hemorrhagic vasculitis, exacerbation of SLE.
3. Nocturia, polyuria, renal dysfunction.
4. Lack of appetite, dry mouth.
5. Nausea, vomiting.
6. Stool disorders.
7. Pancreatitis.
8. Hepatic encephalopathy.
9. Cough, sinusitis.
10. Hemolytic anemia.
11. Thrombocytopenia, leukopenia, agranulocytosis.
12. Bone marrow aplasia.

In case of overdose, symptoms of water-electrolyte imbalance are observed - a critical decrease in blood pressure, vomiting, dizziness, convulsions.

These conditions are accompanied by drowsiness, headaches and confusion. If there are symptoms of overdose, gastric lavage and therapy are necessary, aimed at restoring water and electrolyte balance.

Consequences for women

At long-term use drug, a woman may notice a decrease sexual desire to your partner. This is a temporary effect that goes away some time after stopping the drug.

Many women suffer from swelling before the onset of menstruation and wonder whether it is possible to take diuretics during this period to get rid of swelling. Indeed, taking diuretics during this period effectively eliminates swelling, but at the same time, negative reactions may occur - failure hormonal levels, scanty discharge during menstruation and even amenorrhea. This is why diuretics should be taken with extreme caution during menstruation.

Compatibility with Bisoprolol and Concor

Patients with persistent hypertension are often prescribed to take Indapamide at the same time. This combination leads to a more powerful effect, and the pressure decreases much faster. But it should be remembered that the dosage of both drugs should be prescribed only by a doctor, otherwise a hypotensive crisis may occur.

Indapamide also works well. They are often prescribed to achieve a more lasting hypotonic effect. If you take the drugs in recommended dosages, the risk of developing unwanted reactions is minimal. But many patients note that with long-term treatment, cough and chest pain appear.

Alcohol compatibility

It is undesirable to take all drugs, one way or another, affecting blood vessels simultaneously with alcoholic beverages. In addition, doctors say that any medication should not be taken if you plan to drink alcohol. This is completely unacceptable, since such a combination can lead to undesirable consequences.

Since Indapamide affects the blood vessels of the kidneys, and alcohol negatively affects their work, the effect of the drug can be significantly reduced. Alcohol also affects blood pressure - how stronger drink, the higher the likelihood of improving performance.

Moreover, if an older patient drinks alcohol, then the risk of a critical increase in blood pressure and the development of complications is much higher. Frequent consumption of alcoholic beverages also has an effect - the more often, the more likely it is to worsen the course of hypertension. Therefore, with regular consumption of alcohol, Indapamide ceases to reduce blood pressure to normal levels.

Another negative consequence consuming alcohol simultaneously with diuretics - rapid leaching of sodium, potassium and other elements from the body. This leads to the development of undesirable reactions:

With long-term treatment and alcohol consumption, the load on the heart and blood vessels increases significantly, which can lead to stroke, heart attack and functional cardiac disorders. In some people, especially those with cardiovascular disorders, capillaries may burst due to alcohol consumption and diuretic treatment. small vessels, the rarest but fatal complication is cardiac arrest.

Analogs

Based on the active substance, there are other drugs that contain only one component or combine several substances.

Structural

You can compare the cost structural analogues Indapamide to understand what can replace it (Table 2).

Table 2 - Cost of analogues

Arifon tablets are more expensive, but it is recommended to take them, since they are created in France from purified and high-quality raw materials. There is also Arifarm based on indapamide and with a modified release. They are prescribed for more persistent and strong effect. The cost of 30 tablets is more than 400 rubles.

Prestarium/Indapamide in one tablet

Prestarium arginine combi are tablets that contain indapamide and. The combination of these substances allows you to quickly but gently reduce arterial pressure, as well as pressure in the ventricles of the heart and pulmonary vessels. With the help of the drug you can normalize the pulse rate, improve blood circulation and reduce overall vascular resistance.

The drug has more indications for use than Indapamide:

• Arterial hypertension.
• Renovascular hypertension.
• Chronic heart failure.
• Cardiac dysfunction caused by ischemia.
• Prevention of recurrent stroke.

The drug is available in several forms, differing in the content of indapamide/perindopril:

1. 0.625 mg/2 mg – 280 rub.
2. 1.25 mg/4 mg – 340 rub.
3. 2.5 mg/8 mg –450 rub.

Exists similar drug called, its price ranges from 300 to 1000 rubles, depending on the dosage and number of tablets in the package. Similar tablets produced by the Teva company - Indapamide / Perindopril, costing from 300 rubles.

Drugs with this combination should not be taken without the recommendation of the attending physician. Only he will be able to decide whether it is necessary to enhance the effect of Indapamide with other drugs, or whether one drug can be used.

pharmacodynamics. Mechanism of action. Indapamide is a sulfonamide diuretic with an indole ring, which is pharmacologically related to thiazide diuretics and is prescribed for the treatment of hypertension. Indapamide acts at the level of the kidneys and blood vessels.

Indapamide inhibits sodium reabsorption in the renal cortical segment. This increases urinary excretion of sodium and chloride and, to a lesser extent, potassium and magnesium, thereby increasing urine output.

Pharmacodynamic effects. Clinical researches Phases II-III of indapamide monotherapy demonstrated that the antihypertensive effect of indapamide lasts 24 hours. The diuretic effect of indapamide is moderate. The antihypertensive effect of indapamide is associated with an improvement in arterial elasticity and a decrease in arteriolar resistance and peripheral vascular resistance. Indapamide reduces left ventricular hypertrophy.

If the recommended dose is exceeded therapeutic effect thiazides and thiazide-like diuretics do not increase, while the number of adverse events increases. If treatment is not effective enough, increasing the dose is not recommended.

As has been shown in studies of different durations(short-term, medium-term and long-term) involving patients with hypertension, indapamide:

• does not affect lipid metabolism (TG, cholesterol/LDL and cholesterol/HDL);
• does not affect carbohydrate metabolism, even in patients with diabetes and hypertension.

Indapamide acts at the level of the vascular wall by:

• a decrease in the contractility of vascular smooth muscles, which is associated with changes in transmembrane ion exchange (mainly calcium);
• stimulation of the synthesis of prostaglandins PGE 2 and prostacyclin PGI 2 (vasodilator and platelet aggregation inhibitor).

Pharmacokinetics. Active substance— 1.5 mg of indapamide is contained in a prolonged-release tablet created on the basis of a matrix. The distribution of indapamide in the matrix system ensures uniform release from the tablet.

Absorption. The released fraction of indapamide is quickly and completely absorbed into the gastrointestinal tract. Eating slightly increases the rate of absorption, but does not affect the amount of drug absorbed.

Cmax in blood plasma after taking a single dose is achieved after approximately 12 hours; further use of the drug reduces fluctuations in the level of indapamide in blood plasma in the interdose interval. There are intra-individual fluctuations.

Distribution. Binding to blood plasma proteins is 79%. T ½ is 14-24 hours (average 18 hours). A stable concentration level is reached after 7 days. Regular use does not cause accumulation.

Removal. Indapamide is excreted in urine (70% of the dose) and feces (22%) in the form of inactive metabolites.

High risk patients. Pharmacokinetic parameters do not change in patients with moderate renal failure.

essential hypertension in adults.

mode of application. For oral use.

Dosing. 1 tablet per day, preferably in the morning. The tablets should be swallowed whole, without chewing, with water.

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

Special patient groups

Kidney failure(see SPECIAL INSTRUCTIONS and CONTRAINDICATIONS). In patients with severe renal impairment (creatinine clearance<30 мл/мин) применение препарата противопоказано. Тиазидные и тиазидоподобные диуретики наиболее эффективны, если функция почек не нарушена или если нарушения незначительны.

Elderly age(see SPECIAL INSTRUCTIONS). In elderly patients, plasma creatinine levels should be appropriate for age, body weight and gender. In elderly patients, Indapamide-Teva SR can be prescribed if renal function is not impaired or if the impairment is minor.

Patients with liver dysfunction(see SPECIAL INSTRUCTIONS and CONTRAINDICATIONS). In case of severe liver dysfunction, treatment is contraindicated.

hypersensitivity to indapamide, other sulfonamides or any other components of the drug; severe renal failure; hepatic encephalopathy or severe liver dysfunction; hypokalemia.

The most commonly reported adverse reactions were hypersensitivity reactions, mainly dermatological, in patients prone to allergic and asthmatic reactions, and maculopapular rash.

During clinical studies, hypokalemia (the level of potassium in the blood plasma<3,4 ммоль/л) отмечалась у 10% пациентов, в 4% случаев уровень калия снизился до <3,2 ммоль/л через 4-6 нед лечения. После 12 нед терапии среднее снижение уровня калия в плазме крови составляло 0,23 ммоль/л.

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

During treatment with indapamide, the following side effects were observed, listed below with the following frequency of occurrence: very often (≥1/10), often (≥1/100 to<1/10), нечасто (от ≥1/1000 до <1/100), редко (≥1/10 000), очень редко (<1/10 000), частота неизвестна (не может быть определена согласно имеющейся информации).

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

From the nervous system: rarely - dizziness, fatigue, headache, paresthesia; frequency unknown - fainting.

From the side of the organ of vision: frequency unknown - myopia, blurred vision, visual impairment.

From the heart: very rarely - arrhythmia; frequency unknown - paroxysmal ventricular tachycardia of the torsades de pointes type, which can be fatal (see SPECIAL INSTRUCTIONS, INTERACTIONS).

From the vascular system: very rarely - arterial hypotension.

From the digestive system: infrequently - vomiting; rarely - nausea, constipation, dry mouth; very rarely - pancreatitis.

From the kidneys and urinary tract: very rarely - renal failure.

From the hepatobiliary system: very rarely - liver dysfunction; frequency is unknown - in case of liver failure, hepatic encephalopathy may occur (see SPECIAL INSTRUCTIONS, CONTRAINDICATIONS), hepatitis.

From the skin and its derivatives. Hypersensitivity reactions, mainly from the skin, in patients with a tendency to allergic and asthmatic reactions: often - maculopapular rash; infrequently - purpura; very rarely - angioedema and/or urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome; frequency unknown - possible exacerbation of existing acute systemic lupus erythematosus. Photosensitivity reactions have been reported (see WARNINGS).

From the side of metabolism and metabolism: very rarely - hypercalcemia; frequency unknown - a decrease in potassium levels with the occurrence of hypokalemia, in particular serious, in certain categories of high-risk patients (see SPECIAL INSTRUCTIONS); hyponatremia with hypovolemia can lead to dehydration and orthostatic hypotension; the concomitant loss of chloride ions can cause secondary compensatory metabolic alkalosis (the frequency and severity of this phenomenon is low).

Research: frequency unknown - interval prolongation Q-T on an ECG (see SPECIAL INSTRUCTIONS, INTERACTIONS); increased levels of uric acid and glucose in the blood plasma during treatment with diuretics, the rationality of prescribing which should be carefully weighed before prescribing to patients with gout or diabetes mellitus; increased levels of liver enzymes.

patients with liver dysfunction. In patients with impaired liver function, the use of thiazide diuretics can cause hepatic encephalopathy, especially if there is an electrolyte imbalance. In this case, you should immediately stop using diuretics.

Photosensitivity. Cases of photosensitivity reactions have been reported in patients taking thiazide and thiazide-like diuretics (see ADVERSE EFFECTS). If such reactions occur, treatment with diuretics is recommended to be discontinued. If it is necessary to re-prescribe diuretics, vulnerable areas should be protected from the sun or sources of artificial ultraviolet radiation.

Excipients. The drug contains lactose, so it should not be prescribed to patients with congenital galactose intolerance, glucose-galactose malabsorption syndrome, or Lapp lactase deficiency.

Water-electrolyte balance

Plasma sodium level. Before starting treatment, it is necessary to monitor the level of sodium in the blood plasma and then, during treatment, regularly monitor it. A decrease in plasma sodium levels may initially be asymptomatic, so regular monitoring is necessary. Sodium levels should be monitored more frequently in elderly patients and in patients with cirrhosis. Any diuretic can cause hyponatremia, sometimes with serious consequences.

Hyponatremia with hypovolemia can lead to dehydration and orthostatic hypotension; the concomitant loss of chloride ions can cause secondary compensatory metabolic alkalosis (the frequency and severity of this phenomenon is low).

Plasma potassium levels. A decrease in plasma potassium levels with the occurrence of hypokalemia is the main risk when using thiazide and thiazide-like diuretics. The likelihood of developing hypokalemia (<3,4 ммоль/л) необходимо предупреждать у определенных категорий пациентов высокого риска, таких как пациенты пожилого возраста, больные с недостаточным питанием и/или принимающие много лекарственных средств, пациенты с циррозом печени, особенно с отеками или асцитом, пациенты с ИБС и сердечной недостаточностью. В таких случаях гипокалиемия приводит к повышению кардиотоксичности сердечных гликозидов и риску развития аритмий.

The risk group also includes patients with extended Q-T- interval of congenital or iatrogenic genesis. In such patients, hypokalemia, as well as bradycardia, can contribute to the development of severe cardiac arrhythmias, in particular paroxysmal ventricular tachycardia of the torsades de pointes type, which can be fatal.

Regular monitoring of potassium levels in the blood is necessary in all cases mentioned above. The first analysis should be performed during the 1st week of treatment. If hypokalemia is detected, it should be corrected.

Plasma calcium levels. Thiazide and thiazide-like diuretics may reduce urinary calcium excretion and lead to a slight and temporary increase in its plasma level. Severe hypercalcemia may be a consequence of previously undiagnosed hyperparathyroidism. In this case, treatment should be stopped and a study of the function of the parathyroid glands should be performed.

Blood glucose level. Monitoring blood glucose levels is necessary in patients with diabetes, especially in the presence of hypokalemia.

Uric acid. Patients with elevated uric acid levels may tend to have more gout attacks.

Kidney function and diuretics. Thiazide and thiazide-like diuretics are most effective if renal function is not impaired or if the impairment is minor (plasma creatinine<25 мг/л, то есть 220 мкмоль/л у взрослых). У пациентов пожилого возраста уровень креатинина в плазме крови должен соответствовать возрасту, массе тела и полу. Гиповолемия, связанная с потерей воды и натрия, из-за применения диуретиков в начале лечения приводит к снижению клубочковой фильтрации. Это может приводить к повышению уровня мочевины и креатинина в крови. Такая транзиторная функциональная почечная недостаточность не имеет последствий у лиц с нормальной функцией почек, но может ухудшить существующую почечную недостаточность.

U athletes indapamide may cause a positive reaction during doping control.

Use during pregnancy and lactation. Pregnancy. There are no or limited data on the use of indapamide in pregnant women (less than 300 cases). The consequence of long-term use of thiazide diuretics during the third trimester of pregnancy may be a decrease in the pregnant woman's blood volume and uteroplacental blood supply, which can lead to fetoplacental ischemia and delayed fetal development. Animal studies have not revealed direct or indirect toxic effects on reproduction. As a preventive measure, the use of indapamide should be avoided during pregnancy.

Lactation. There is insufficient data on the penetration of indapamide/metabolites into breast milk. Hypersensitivity to sulfonamide derivatives and hypokalemia may occur. A risk to newborns/infants cannot be excluded. Indapamide is a thiazide-like diuretic, the use of which during breastfeeding is associated with a decrease or even inhibition of lactation. Indapamide is contraindicated during breastfeeding.

Fertility. Reproductive toxicity studies have shown no effect on fertility in male or female rats. No effect on human fertility is expected.

Children. The safety and effectiveness of Indapamide-Teva SR in children have not been established. No data available.

The ability to influence reaction speed when driving vehicles or working with other mechanisms. Indapamide does not affect alertness. But if adverse reactions (see SIDE EFFECTS), including symptoms associated with a decrease in blood pressure, occur, especially at the beginning of treatment or when used in combination with another antihypertensive drug, the ability to drive a car or operate machines may be impaired.

Lithium: it is possible to increase the level of lithium in the blood plasma due to a decrease in lithium excretion (as with a salt-free diet). If a diuretic is required, plasma lithium levels should be carefully monitored and the dosage adjusted.

Combinations to use with caution

Drugs that can cause paroxysmal ventricular tachycardia of the torsade de pointes type:

• class Ia antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide);
• class III antiarrhythmic drugs (amiodarone, sotalol, dofetilide, ibutilide);
• some antipsychotic drugs: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine); benzamides (amisulpride, sulpiride, sultopride, tiapride); butyrophenones (droperidol, haloperidol);
• other medicines: bepridil, cisapride, difemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine IV.

When using indapamide with the above-mentioned drugs, the risk of ventricular arrhythmias increases, in particular torsades de pointes - paroxysmal ventricular tachycardia of the pirouette type (hypokalemia is a risk factor).

Before prescribing such a combination, the potassium level is checked and, if necessary, corrected. The clinical condition of patients, plasma electrolytes and ECG should be monitored. If hypokalemia is present, drugs that do not cause torsade de pointes should be prescribed.

NSAIDs (for systemic use), including selective COX-2 inhibitors, high doses of salicylates (≥3 g/day): may reduce the hypotensive effect of indapamide. Patients with dehydration have an increased risk of acute renal failure (due to decreased glomerular filtration). Before starting treatment, it is necessary to restore fluid balance and check kidney function.

ACE inhibitors: sudden arterial hypotension and/or acute renal failure may occur in patients with hyponatremia (especially in patients with renal artery stenosis).

AG. In patients with hypertension in whom previous use of a diuretic has led to hyponatremia, it is necessary to stop the use of diuretics 3 days before starting treatment with ACE inhibitors and then, if necessary, restore diuretic therapy or begin prescribing an ACE inhibitor with a low initial dose followed by a gradual increase. .

In patients with congestive heart failure The use of an ACE inhibitor should be started at the lowest dose and possibly after reducing the dose of the concomitant diuretic. In all cases, careful monitoring of renal function (plasma creatinine level) is necessary during the first weeks of treatment with ACE inhibitors.

Drugs that can cause hypokalemia when coadministered: gluco- and mineralocorticoids (for systemic use), amphotericin B (iv), tetracosactide, laxatives that stimulate peristalsis. The risk of hypokalemia increases (additive effect). The level of potassium in the blood plasma should be monitored and, if necessary, corrected; special attention should be paid to simultaneous therapy with cardiac glycosides. It is recommended to prescribe laxatives that do not stimulate peristalsis.

Cardiac glycosides: the presence of hypokalemia increases the cardiotoxicity of cardiac glycosides. The level of potassium in the blood plasma, ECG control should be monitored and therapy should be adjusted if necessary.

Baclofen: enhances the hypotensive effect of the drug. At the beginning of therapy, it is necessary to restore water and electrolyte balance and monitor renal function.

Combinations that require attention

Potassium-sparing diuretics (amiloride, spironolactone, triamterene): this combination does not exclude the possibility of hypokalemia or hyperkalemia (especially in patients with diabetes mellitus or with renal failure). Plasma potassium levels and ECG control should be monitored and therapy adjusted if necessary.

Metformin: the risk of lactic acidosis increases in the event of the development of functional renal failure as a result of taking diuretics and especially loop diuretics. Metformin should not be prescribed if blood creatinine levels exceed 15 mg/L (135 µmol/L) in men and 12 mg/L (110 µmol/L) in women.

Iodocontrast agents: When dehydration occurs due to diuretics, the risk of developing acute renal failure increases, especially when using high doses of iodinated contrast agents. It is necessary to restore the fluid balance before prescribing iodine contrast agents.

Imipramine-like antidepressants, neuroleptics: the risk of developing orthostatic hypotension increases (additive effect).

Calcium salts: Hypercalcemia may occur due to decreased elimination of calcium in the urine.

Cyclosporine, tacrolimus: the risk of increasing plasma creatinine without affecting the level of circulating cyclosporine, even if there is no water and sodium deficiency.

Corticosteroids, tetracosactide (systemic): reduction of the hypotensive effect of indapamide due to the retention of water and sodium ions under the influence of corticosteroids.

indapamide does not exhibit toxicity at a dose of 40 mg, that is, at a dose 27 times higher than the therapeutic dose.

Overdose symptoms primarily manifested by water and electrolyte disturbances (hyponatremia, hypokalemia). Clinically possible: nausea, vomiting, hypotension, convulsions, drowsiness, dizziness (vertigo), confusion, polyuria or oliguria up to anuria (due to hypovolemia).

Treatment. First aid measures include rapid elimination of the drug by gastric lavage and/or administration of activated carbon, followed by restoration of water and electrolyte balance in a hospital setting.

at a temperature not exceeding 30 °C.

One film-coated tablet contains 2.5 mg of active substance indapamide hemihydrate .

Excipients: colloidal silicon dioxide, pregelatinized starch, magnesium stearate and MCC.

Shell composition: macrogol 6000, lactose monohydrate, hypromellose, titanium dioxide (E171).

Release form

• in tablet form, 2.5 mg – Indapamide;
• in the form of capsules of 2.5 mg - Indapamide Verte;
• in tablet form, 1.5 mg - Indapamide Retard And Indapamide MV Stada.

Packing - 10 pieces in contour packaging made of PVC film or foil with molded cells. There are 3 packages (blisters) in a cardboard box. Another form of release is possible. The package includes instructions explaining what the medicine Indapamide is used for, what contraindications exist and side effects.

pharmachologic effect

The medicine belongs to the category diuretics And antihypertensive drugs .

Pharmacodynamics and pharmacokinetics

According to its pharmacological properties, the drug is close to thiazide diuretics . Increases the concentration of sodium, chlorine, potassium and magnesium ions in the urine. Increases the elasticity of arterial walls, gently reduces the resistance of peripheral vessels. Has no effect on carbohydrate metabolism and content lipids in the blood, helps reduce hypertrophy of the left ventricle of the heart .

Indapamide is a stimulant of production , has a significant effect on the production of free oxygen radicals.

The medicine begins to act 30 minutes after administration (bioavailability is about 93%), the therapeutic effect lasts for 24 hours. The maximum concentration in the blood is 12 hours after the tablet is dissolved in the gastrointestinal tract. The half-life is 18 hours. Eating may slightly prolong the absorption time, but the drug is nevertheless completely absorbed. The kidneys excrete up to 80% of the substance in the form, the intestines - up to 20%.

Indications for use of Indapamide

Indications for use Indapamida Retard, Indapamide Teva And Indapamide MV Stada, like other forms of medicine - hypertonic disease moderate severity, chronic heart failure .

Contraindications

Knowing what Indapamide tablets are used for, it is also important to study all the contraindications, among which the absolute ones are:

• renal And liver failure ;
• allergic reactions to derivatives sulfonamide ;
• age under 18 years;

Side effects

The drug, as a diuretic, can lead to a decrease in potassium content in the blood serum, a decrease in sodium concentration, which leads to. Due to this, symptoms such as dry mouth , nausea , , .

Rare side effects - heart rhythm disturbances , hemolytic anemia .

Indapamide tablets, instructions for use

The tablets are taken strictly in accordance with the instructions - once a day, preferably in the morning, one tablet or capsule.

The medicine can be combined with other antihypertensive drugs, but only the attending physician can determine how to take the drugs in various combinations.

Instructions for use Indapamide Retard and instructions for use Indapamida MV Stada(made in Germany) do not contain differences regarding the conditions of administration and dosage. However, the drug Retard It is distinguished by a longer and, at the same time, milder effect of the reagent due to the slow release of the active substance.

The doctor decides how long you can take Indapamide, taking into account the stage hypertension , but in medical practice this remedy refers to medications that are prescribed for a long period of time (including for life).

Overdose

The toxicity of the drug appears at a dose of 40 mg. Signs of poisoning –, nausea , vomit , sharp decrease in pressure , dry mouth .

Emergency measures - gastric lavage, restoration of electrolyte balance, rehydration (only in hospital settings).

Interaction with other drugs

• Antidepressants and antipsychotics enhance the hypotensive effect and increase the likelihood of developing orthostatic hypotension .
• Aluretics, cardiac glycosides, laxatives increase the risk of developing potassium deficiency .
• may lead to development with ventricular fibrillation.
• Nonsteroidal anti-inflammatory drugs and glucocorticosteroids reduce the hypotensive effect.
• Drugs containing may lead to fluid deficiency in the body.
• promotes development hypercreatininemia .

Terms of sale

To dispense the drug at the pharmacy, a prescription in Latin, written by a doctor, is presented.

Best before date

3 years (expiration date indicated on the packaging).

Storage conditions

Indapamide's analogs

Level 4 ATX code matches:

Similar drugs: Indapen , Lorvas , Acrylamide , Indopres , Oxodoline , Cyclomethiazide .

Indapamide and its analogues are taken strictly as prescribed by a doctor.

Reviews about Indapamide

Reviews about Indapamide Retard, in general, indicate the high effectiveness of the drug. Hypertensive patients generally tolerate the medication well. Reviews from doctors and patients, as well as a forum where issues of treating hypertension are discussed, convincingly confirm this fact.

Side effects occur rarely and are characterized by mild severity. Many people diagnosed with hypertension take the pills for life.

Indapamide price, where to buy

The price ranges from 26 to 170 rubles per package.

Price Indapamida Retard- from 30 to 116 rubles (the cost depends on the pricing policy of the pharmacy chain and the manufacturing company).

Price of tablets Indapamide Retard-Teva with controlled release of the active substance, on average, higher than that of drugs with a conventional mechanism of action.

• Online pharmacies in Russia Russia
• Online pharmacies in Ukraine Ukraine
• Online pharmacies in Kazakhstan Kazakhstan

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Indapamide MV extended-release tablets 1.5 mg 30 pcs.Stada Arzneimittel AG [Stada Arzneimittel]

Indapamide tablets 2.5 mg 30 pcs. Hemofarm Hemofarm [Hemofarm]

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Indapamide retard 1.5 mg 30 tabletsKanonpharma production, JSC

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Indapamide retard tablets 1.5 mg No. 30

Indapamide-Teva capsules 2.5 mg No. 30

Indapamide-Teva tablets 2.5 mg No. 30

Indapamide tablets 2.5 mg No. 30

Pharmacy IFC

Indapamide Hemofarm A.D. (Serbia)/Hemofarm LLC, Russia

Dosage form:  controlled-release film-coated tablets Compound:

1 tablet contains:

active substance: indapamide 1.50 mg;

excipients va: lactose monohydrate 119.10 mg, hypromellose 77.40 mg, colloidal silicon dioxide 1.00 mg, magnesium stearate 1.00 mg;

shell: hypromellose 5.00 mg, glycerol 85% 0.70 mg, titanium dioxide 1.00 mg.

Description:

Round, biconvex, film-coated tablets, white or almost white, with a bevel.

On a cross-section, the core of the tablet is white or almost white.

Pharmacotherapeutic group:Diuretic ATX:  

C.03.B.A.11 Indapamide

Pharmacodynamics:

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

It is characterized by pharmacological affinity with thiazide diuretics. realizes its effects by inhibiting sodium reabsorption in the distal convoluted tubules. Under the influence of indapamide, the excretion of chloride 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 indapamide was used in monotherapy in doses that did 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 increasing the dose is not advisable.

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

Does not affect lipid metabolism (triglycerides, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol);

- does not affect carbohydrate metabolism (even in patients with diabetes). Pharmacokinetics:

Drugs that can cause the development of pirouette-type arrhythmias:

Class IA antiarrhythmic drugs (hydroquinidine, disopyramide);

Class III antiarrhythmic drugs (dofetilide, ibutilide) and;

Some neuroleptics: phenothiazines -, cyamemazine,; benzamides - , sultopride, ; butyrophenones - , ;

Others: bepridil, cisapride, difemanil, for intravenous use, halofantrine, mizolastine, pentamidine, for intravenous use, .

Increased risk of developing ventricular arrhythmias, including torsade de pointes (hypokalemia is a risk factor). It is necessary to monitor the potassium level in the blood serum and, if necessary, appropriate correction before starting combination therapy. In addition, during combined treatment, clinical monitoring, control of electrolytes in the blood and ECG should be carried out.

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) the antihypertensive effect of indapamide may be reduced. There is a risk of developing acute renal failure in patients with dehydration (decreased glomerular filtration rate). Patients need to compensate for fluid loss and regularly monitor renal function, both at the beginning of therapy and during treatment.

When used simultaneously with angiotensin-converting enzyme inhibitors(ACE) 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 is possible.

When used simultaneously with medications that cause hypokalemia(amphotericin B for intravenous use, glucocorticosteroids, mineralocorticosteroids for systemic use, laxatives that stimulate intestinal motility) the risk of hypokalemia increases (additive effect).

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

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

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

When used simultaneously with metformin the risk of developing metformin-induced lactic acidosis increases. 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 plasma creatinine concentration exceeds 15 mg/l (135 µmol/l) in men and 12 mg/l (110 µmol/l) in women.

Against the background of dehydration caused by diuretics, there is an increased risk of developing acute renal failure, in particular when using iodinated contrast agents in high doses.

Rehydration should be performed before administering iodinated contrast agents.

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

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

When used simultaneously with cyclosporine and tacrolimus the risk of developing an increased 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.

When used simultaneously with corticosteroids(mineral and glucocorticosteroids) and tetracosactide(when administered systemically), the antihypertensive effect of indapamide may be reduced (corticosteroids cause fluid and sodium retention in the body).

Special instructions:

In patients with impaired liver function Therapy with Retard-Teva can lead to the development of hepatic encephalopathy, especially with concomitant disturbances in water and electrolyte balance. In this case, the diuretic should be stopped immediately.

During therapy with Retard-Teva, isolated cases of development photosensitivity reactions(see section "Side effects"). If signs of a photosensitivity reaction appear, use of the drug Retard-Teva should be stopped. If it is necessary to resume therapy with Retard-Teva, it is recommended to protect exposed areas of the body from exposure to direct sunlight and artificial ultraviolet radiation. The sodium content in the blood plasma must be determined before starting therapy with Retard-Teva, which may be accompanied by the development of hyponatremia, sometimes with very serious consequences. A decrease in plasma sodium may initially be asymptomatic, so regular monitoring is necessary.

During treatment elderly patients and patients with liver cirrhosis Blood sodium levels should be determined more frequently.

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

Discontinue diuretic therapy 3 days before starting the ACE inhibitor, 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.

For chronic heart failure It is necessary to begin ACE inhibitor therapy with a very low initial dose. In addition, when initiating 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. Therapy with Retard-Teva is characterized by a high risk of reducing potassium levels in the blood with the development of hypokalemia.

When treating patients at risk (elderly patients, debilitated patients, patients receiving multicomponent drug therapy, patients with liver 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 increases the cardiotoxicity of cardiac glycosides and also increases the risk of developing cardiac arrhythmias.

Patients with long QT interval(hereditary or iatrogenic pathology) also belong to the risk category. Thus, hypokalemia, as well as bradycardia, acts as a factor predisposing to the development of serious heart rhythm disturbances, in particular pirouette-type arrhythmias. When treating patients at risk, regular monitoring of potassium levels in the blood plasma is necessary. An initial measurement of potassium levels should be performed within the first week after starting therapy with Retar d-Teva; detection of hypokalemia requires appropriate correction.

Particular caution should be observed during concomitant therapy with cardiac glycosides.

The drug retar d-Teva reduces the excretion of calcium by the kidneys, which leads to a slight and temporary increase in calcium levels 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 Retard-Teva should be discontinued. When treating patients with diabetes, 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 gout increases. The drug Retard-Teva is quite effective with normal renal function or with minimal impairment (plasma creatinine concentration below 25 mg/l, that is, 220 µmol/l for an adult). When treating elderly patients, the threshold value for plasma creatinine concentration varies depending on age, body weight and gender. Hypovolemia, secondary to diuretic effects such as loss of fluid and sodium, 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 substance of the drug Retard-Teva can cause a positive doping test result.

Impact on the ability to drive vehicles. Wed and fur.:

The effect of the substances included in the drug does not lead to impaired psychomotor reactions.

Caution must be exercised when driving (especially at the beginning of therapy or when adding other antihypertensive drugs to therapy).

Release form/dosage:

Controlled-release film-coated tablets, 1.5 mg.

Package:

10 tablets in a blister made of aluminum foil/PVC/PVdC.

1, 2, 3, 5, 9 or 10 blisters along with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25°C.

Keep out of the reach of children.

Best before date:

3 years.

Do not use after the expiration date.

Conditions for dispensing from pharmacies: On prescription Registration number: LP-002253 Registration date: 26.09.2013 / 17.03.2017 Expiration date: 26.09.2018 Cancellation date: 2018-09-26 Owner of the Registration Certificate:Teva Pharmaceutical Enterprises Ltd. Israel Manufacturer:   Representative office:   Teva Israel Information update date:   02.11.2017 Illustrated instructions