Pharmacological properties

Indapamid — diuretic of moderate action, belongs to group of not thiazide sulphamides, has antihypertensive effect. the antihypertensive effect is shown only at initially raised hell. reduces a tone of smooth muscle tissue of arteries, opss. has the moderate saluretichesky and diuretic effect caused by blockade of a reabsorption of sodium, chlorine, water and to a lesser extent — potassium in proximal tubules and a cortical segment of distal tubules of nephron.

Indapamid reduces a hypertrophy of a left ventricle of heart. Indapamid does not influence metabolism of lipids (TG, the XC LDL and the XC LPVP), also does not influence metabolism of carbohydrates, even at patients with AG and SD, reduces a microalbuminuria.

Antihypertensive effect of medicament remains at patients who are on a hemodialysis.

Indication

Ag.

Use

is Appointed on 2.5 mg of 1 times a day (morning). the maximum daily dose — 2.5 mg (1 capsule). capsules are swallowed without chewing, washing down with water. it is possible to apply with other antihypertensive drugs, except for diuretics. at insufficient efficiency of treatment the dose of medicament should not be raised, better to add therapy with other antihypertensive drug. at use of an indapamid in higher dose the antihypertensive action does not raise, increases only saluretichesky effect.

Contraindication

Hypersensitivity to sulphamides or any component of drug, severe forms of insufficiency of function of a liver, hepatic encephalopathy, a serious illness of a liver, the period of pregnancy and feeding by a breast, severe forms of insufficiency of function of kidneys, a hypopotassemia, children's age.

Side effects

Majority of by-effects are dose-dependent and arise when exceeding dosing.

are noted Sometimes by changes of water and electrolytic balance:

• decrease in level of potassium and emergence of a hypopotassemia (especially at patients of risk groups);
• a hyponatremia which can lead to a hypovolemia and dehydration of an organism with possible development of orthostatic hypotension. The accompanying loss of ions of chlorine can cause a compensatory metabolic alkalosis;
• increase in level of uric acid and glucose in blood plasma.

It is very rare: hypercalcemia.

Clinical manifestations

from a GIT: seldom — nausea, vomiting, a constipation, dryness in a mouth; very seldom — pancreatitis, an abnormal liver function. Patients with a liver failure have a hepatic encephalopathy.

from kidneys and urinary tract: renal failure.

from central nervous system: seldom — dizziness, an asthenia, paresthesia, fatigue, a headache.

from a cardiovascular system: arrhythmia, arterial hypotension.

Allergic reactions: the majority — in the form of dermatological reactions, especially at the patients inclined to an allergy: spotty and papular rash on skin, a purpura, an itching, aggravation of a system lupus erythematosus; very seldom — a small tortoiseshell.

Hematologic disturbances: very seldom — thrombocytopenia, a leukopenia, an agranulocytosis, aplastic anemia, hemolytic anemia.

Other: in some cases — a Quincke's disease, a toxic epidermal necrolysis, Stephens's syndrome — Johnson, reaction of photosensitivity.

Special instructions

can use Drug in the form of monotherapy or in a combination with other antihypertensive medicaments (blockers of β-adrenoceptors, blockers of calcium channels, inhibitors apf).

In an abnormal liver function thiazide diuretics can cause hepatic encephalopathy. In that case they should be cancelled immediately.

. If during treatment there is a reaction of photosensitivity, it is recommended to stop treatment. In case of need in repeated use of an indapamid, it is recommended to protect vulnerable areas of a body from the sun or artificial ultra-violet radiation.

When prescribing medicament should weigh carefully expediency of use of medicament sick with gout and diabetes.

Prior to the beginning of and during use of medicament needs to control the level of potassium, sodium, calcium, glucose in blood plasma, to carry out monitoring of function of kidneys (creatinine, urea in blood plasma), ECG control, especially in the presence of disturbances of water and electrolytic balance, in gout, diabetes, a liver or renal failure, at patients of advanced age.

sodium Level in blood plasma. Concentration of sodium in blood plasma needs to be defined before an initiation of treatment, and then to control its changes through regular intervals. Treatment using diuretics can be followed by a hyponatremia, sometimes with serious consequences, at the same time decrease in concentration of sodium in blood in an initial stage can have symptomless character. Therefore it is regularly recommended to control the plasma level of sodium, especially at patients of old age and patients with cirrhosis.

potassium Level in blood plasma. Prolonged use thiazide and similar diuretics is connected by it with risk of decrease in potassium concentration in blood plasma and development of a hypopotassemia. Especially it concerns patients of risk group (elderly people; the patients who are at the same time accepting other medicines; patients with the cirrhotic ascites which is followed by hypostases; the iznemozhdenny patients and patients with diseases of coronary vessels and dysfunction of heart that is predisposed to cardiac arrhythmia). The hypopotassemia can cause heavy arrhythmias including life-threatening ventricular tachycardia (torsade de pointes). Due to the above it is necessary to control as often as possible potassium level in blood plasma and to prevent emergence of a hypopotassemia.

calcium Level in blood plasma. Thiazide and similar to them diuretics can lower calcium discharge with urine that can lead to slight temporary increase of concentration of calcium in blood plasma. The hypercalcemia can be also a consequence of a hyperparathyreosis undetected earlier. In that case treatment it is necessary to suspend and perform examination of function of epithelial bodies.

glucose Level in blood. At patients with diabetes, especially in the presence of a hypopotassemia, it is necessary to control glucose level in blood.

Level of uric acid. At patients from the uric acid raised by concentration gout attacks are possible therefore the dose of medicament should be controlled depending on the level of indicators of uric acid in blood plasma.

only at normal or minimum reduced function of kidneys (creatinine level in blood plasma of 25 mg/l, that is adults have 20 µmol/l).

At the dehydrated patients note risk of emergence of OPN therefore in an initiation of treatment they need to drink a large amount of liquid.

Hypovolemia caused by loss of water and sodium at treatment by diuretics reduces glomerular filtration which sometimes is followed by increase in level of urea and creatinine in blood plasma. At patients with normal function of kidneys such temporary renal failure usually does not lead to serious consequences, nevertheless its emergence substantially can strengthen the available renal failure. Indapamid can give positive reaction to doping tests.

Drug contains lactose as excipient therefore to patients with the most rare hereditary forms of intolerance of a galactose, or a syndrome glucose-galaktoznoy of malabsorption is not recommended to insufficiency of lactase medicament use.

Use during pregnancy and feeding by a breast. It is impossible to use medicament in physiological hypostases during pregnancy at all. Administration of medicament can become the cause of the fetoplacental ischemia menacing to growth of a fruit. In this regard it is impossible to appoint medicament during pregnancy.

Indapamid gets into breast milk. In case of need uses of medicament it is necessary to stop breastfeeding.

Children. Drug is not used at children.

Ability to influence speed of response at control of vehicles or work with other mechanisms. In an initiation of treatment or at combination therapy with other antihypertensive medicaments it is recommended to refrain from control of vehicles and occupations potentially dangerous types of activity requiring special attention and speed of psychomotor reactions as with decrease in the ABP can attention level will decrease.

Interaction

Undesirable combinations:

• . In need of this combination it is necessary to control systematically lithium level in blood plasma and to carry out the corresponding korrigirovaniye of doses;
• undesirable combinations with the medicaments (which are not relating to antiarrhytmic) which can cause torsade de pointes (ventricular tachycardia): astemizol, bepridit, erythromycin, galofantrin, pentamidine, sultoprid, terfenadin, Vincaminum. At combination therapy with indapamidy with a hypopotassemia, bradycardia or with the extended R-Q interval these medicaments cause ventricular tachycardia in patients.

Combination, demanding extra care

System NPVP (antirheumatic means) and high doses of salicylates can cause reduction of hypotensive action of an indapamid. Patients with dehydration can have OPN (decrease in glomerular filtration). Therefore in an initiation of treatment it is necessary to carry out control of function of kidneys of the patient against the background of a large amount of the drunk water.

Drugs which can cause a hypopotassemia: Amphotericinum (in / c), the glucocorticoids and mineralokortikoida, laxative medicaments stimulating a vermicular movement. It is necessary to control potassium level in blood plasma.

GKS of systemic action (tetrakozaktid): reduction of expressiveness of hypotensive action of an indapamid at the expense of a delay of water and ions of sodium under the influence of GKS.

Heart glucosides: there is a risk of strengthening of toxic effect of heart glucosides and risk of emergence of a hypopotassemia. Control of plasma level of potassium and ECG control is necessary.

Baclofenum: increases antihypertensive effect. In an initiation of treatment the patient needs to drink a large amount of water at systematic control of function of kidneys.

At the patients with a hypopotassemia applying digoxin, the hypopotassemia can increase risk of toxic effect of digoxin. In such cases it is necessary to control systematically potassium level in blood plasma, to register the ECG, if necessary — to change treatment.

APF Inhibitors in an initiation of treatment and at parallel deficiency of sodium (especially at patients with a renal artery stenosis) increase risk of developing of sudden arterial hypotension or OPN.

At essential AG if the previous therapy by diuretic means caused deficiency of sodium, it is recommended to p for 3 days prior to treatment by APF inhibitor to stop use of diuretic means.

At patients with chronic heart failure at combination therapy of an indapamid with APF inhibitor treatment with low doses of APF inhibitor and diuretic. At the same time for the first weeks of treatment it is necessary to carry out by APF inhibitor systematic control of function of kidneys (creatinine level in blood plasma).

Antiarrhytmic medicaments of a class _a (quinidine, Disopyramidum) and class ІІІ (Amiodaronum, bretelium, sotalol): there is a risk of aritmogenny action, ventricular tachycardia against the background of a hypopotassemia, bradycardia and lengthening of an interval of Q-T. It is necessary to carry out monitoring of potassium, Q–T interval.

Metformin: developing of a lactacidemia owing to development of a renal failure is possible. It is not recommended to appoint metformin when the level of creatinine exceeds 15 mg/l (135 µmol/l) at men and 12 mg/l (110 µmol/l) — at women.

Yodokontrastny means: high doses of yodokontrastny substances in a combination with indapamidy in simultaneous dehydration increase risk of development of OPN. It is necessary to restore water balance before purpose of yodokontrastny means.

Tricyclic antidepressants (Imipraminum): note increase in expressiveness of hypotensive action of an indapamid and increase in risk of developing orthostatic hypotension.

Salt of calcium: emergence of a hypercalcemia is possible.

Cyclosporine: increase in level of creatinine in blood plasma is possible.

Corticosteroids: reduction of expressiveness of hypotensive action of an indapamid in view of a delay of water and ions of sodium under the influence of corticosteroids.

Kaliysberegayushchy diuretics (amiloride, Spironolactonum, Triamterenum): can cause emergence of a hypopotassemia, and in patients with dysfunction of kidneys or diabetes — a hyperpotassemia. In these cases it is necessary to control potassium level in blood plasma, the ECG, if necessary — to change treatment.

Anticoagulants (coumarin derivatives): simultaneous use of Indap reduces effect of anticoagulants.

Overdose

At prolonged use or reception in high doses electrolytic disturbances, such as hyponatremia, hypopotassemia and gipokhloremichesky alkalosis can arise. nausea, vomiting, arterial hypotension, spasms, dizziness, drowsiness, confusion of consciousness, a polyuria, an oliguria and even an anury are possible (as a result of a hypovolemia).

Treatment: gastric lavage, use of activated carbon with further recovery of water and electrolytic balance in the conditions of a hospital, symptomatic therapy.

Storage conditions

In original packing at a temperature up to 25 °C.