Indapamide - instructions for use, dose, side effects, contraindications

A hypotensive agent, a thiazide-like diuretic with a moderate in strength and long duration of action, a benzamide derivative.Reduces the tone of the smooth muscles of the arteries, reduces the overall peripheral resistance of the vessels. Has moderate saluretic and diuretic effects, which are associated with blockade of reabsorption of sodium, chlorine, hydrogen ions and to a lesser extent potassium ions in the proximal tubules and cortical segment of the distal tubule of the nephron. The vasodilator effects and the reduction of the overall peripheral vascular resistance are based on the following mechanisms: a decrease in the reactivity of the vascular wall to norepinephrine and angiotensin II; an increase in the synthesis of prostaglandins with vasodilating activity; oppression of calcium current in smooth muscle cells of blood vessels. 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).

Antihypertensive effect develops at the end of the first / beginning of the second week with a constant intake of the drug and persists for 24 hours against a background of a single dose.

Pharmacokinetics:

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. Bioavailability is high (93%).Eating somewhat slows down the speed, but does not affect the completeness of absorption. The maximum concentration in the blood is achieved 1-2 hours after ingestion. Equilibrium concentration in the blood is achieved after 7 days of regular intake. Preparation for 70-80% binds to blood plasma proteins. Has a high volume of distribution, passes through the histohematological (including placental) barriers, penetrates into breast milk. Metabolised in the liver. The half-life of indapamide is on average 14-18 hours. It is excreted from the body by the kidneys (up to 80%) mainly in the form of metabolites, through the intestine - 20%. In patients with renal insufficiency, pharmacokinetics does not change. Do not cumulate.

Indications:

Arterial hypertension.

Contraindications:

Hypersensitivity to indapamide, other derivatives of sulfonamide or other components of the drug, decompensation of kidney function (anuria) and / or liver (including encephalopathy), hypokalemia, simultaneous use of drugs that extend the interval QT, pregnancy, lactation, age under 18 (efficacy and safety not established).

Carefully:

Diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).

Dosing and Administration:

Inside, regardless of food intake, with enough liquid.

Take the drug preferably in the morning. The dose is 2.5 mg (1 tablet) per day.

If after 4-8 weeks of treatment the desired therapeutic effect is not achieved, the dose of the drug should not be increased (the risk of side effects increases without increasing the antihypertensive effect). Instead, it is recommended that another antihypertensive drug that is not a diuretic be included in the drug regimen. In cases where treatment should start with the taking of two drugs, the dose Indapamide remains equal to 2.5 mg in the morning once a day.

Side effects:

From the side of metabolism: hypokalemia, hyponatremia, hypochloraemic alkalosis, increased urea nitrogen in the blood plasma, hypercreatininemia, glucosuria, hypercalcemia.

From the gastrointestinal tract: constipation or diarrhea, a feeling of discomfort in the abdomen, nausea, vomiting, anorexia, dry mouth.

From the central nervous system: asthenia, dizziness, nervousness, headache, drowsiness, fatigue, general weakness, insomnia, depression, malaise, muscle spasm, tension, irritability, anxiety.

From the sense organs: conjunctivitis, impaired vision.

From the respiratory system: rhinitis, cough, pharyngitis, sinusitis.

From the cardiovascular system: orthostatic hypotension, arrhythmia, heartbeat, electrocardiogram changes, characteristic of hypokalemia.

From the urinary system: nocturia, polyuria, an increase in the incidence of infections.

Allergic reactions: skin rash, itching, hives, hemorrhagic vasculitis.

Other: flu-like syndrome, chest pain, back pain, decreased libido and potency, rhinorrhea, sweating, weight loss, paresthesia, pancreatitis, exacerbation of systemic lupus erythematosus.

Overdose:

Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water-electrolyte disorders, lowering of arterial pressure, dizziness, drowsiness, confusion, respiratory depression; in patients with impaired liver function, hepatic coma may develop.

Treatment: gastric lavage and / or the administration of activated charcoal, followed by restoration of normal water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction:

With simultaneous application Indapamide with lithium preparations, an increase in the concentration of lithium in the blood plasma is possible.

Astemizole, erythromycin (with iv introduction), pentamidine, sultopride, wincamine, antiarrhythmic drugs Ia (quinidine, disopyramide) and III class (amiodarone, brethility, sotalol) increase the likelihood of heart rhythm disorders by type torsades de pointes (ventricular tachycardia of the "pirouette" type).

Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracoactide, sympathomimetics reduce hypotensive effect, baclofen - Increases.

Saluretics, cardiac glycosides, gluco- and mineralocorticosteroids, tetracosactide, amphotericin B (with iv introduction), laxatives increase the risk of hypokalemia.

With simultaneous use with cardiac glycosides, the likelihood of developing digitalis intoxication increases, with calcium preparations - hypercalcemia, with metromorphin - possibly aggravation of lactic acidosis.

Combination with potassium-sparing diuretics can be effective in some patients, however, the possibility of hypo- and hyperkalemia development is not completely excluded, especially in patients with diabetes mellitus and renal insufficiency.

Angiotensin converting enzyme inhibitors increase the risk of arterial hypotension and / or acute renal failure (especially with existing renal artery stenosis).

Contrasting iodine-containing drugs in high doses increase risk development of violations of kidney function (dehydration of the body). Before using iodine-containing contrast agents, patients need to restore fluid loss.

Tricyclic antidepressants and antipsychotic drugs increase the hypotensive effect and increase the risk of developing orthostatic hypotension.

Cyclosporine increases the risk of hypercreatininaemia.

Reduces the effect of indirect anticoagulants (coumarin or indanedione derivatives) due to an increase in the concentration of clotting factors as a result of a decrease in the volume of circulating blood and increase in their production by the liver (dosage adjustment may be required).

Strengthens the blockade of the neuromuscular transmission, which develops under the action of nondepolarizing muscle relaxants.

Special instructions:

With prolonged use Indapamideand in large doses electrolyte disorders such as hyponatremia, hypokalemia, hypochloraemic alkalosis can develop. These disorders are more often observed in patients with chronic heart failure (II-IV f.k. by classification NYHA), liver disease, with vomiting and diarrhea, as well as in individuals on a salt-free diet. Simultaneous appointment Indapamideand with cardiac glycosides and corticosteroids increases the risk of hypokalemia. In addition, the release of magnesium in the urine may increase, which can lead to hypomagnesemia. Perhaps the appearance of orthostatic hypotension, which can be provoked by drinking alcohol, barbiturates, narcotic drugs and simultaneous reception of other antihypertensive drugs. In patients taking cardiac glycosides, laxatives, against hyperaldosteronism, as well as in the elderly, careful monitoring of the potassium and creatinine content is shown.

The most thorough control is indicated in patients with cirrhosis of the liver, ischemic heart disease, chronic heart failure. To the group of the raised risk also patients with the increased interval QT on an electrocardiogram (congenital or developed against a background of a pathological process).

The first measurement of the potassium concentration in the blood should be performed within 1 week of treatment.

Hypercalcemia on the background of admission Indapamideand may be a consequence of previously not diagnosed hyperparathyroidism.

In patients with diabetes, it is extremely important to monitor blood glucose levels, especially when hypokalemia is present.

Significant dehydration can lead to the development of acute renal failure (reduced glomerular filtration). Patients need to compensate for fluid loss and at the beginning of treatment carefully monitor kidney function.

Indapamide can give a positive result in the conduct of doping control.

Patients with arterial hypertension and hyponatremia (due to taking diuretics) need 3 days before the onset of inhibitorsangiotensin-converting enzyme stop the use of diuretics (if necessary, the reception of diuretics can be resumed a little later), or they are prescribed low initial doses of inhibitors of angiotensin-converting enzyme.

Derivatives of sulfonamide can exacerbate the course of systemic lupus erythematosus (should be borne in mind when appointing Indapamidea).

Form release / dosage:

The tablets covered with a cover, 2,5 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

By 10, 20, 30, 40, 50 or 100 tablets into a polymer container.

Free space fill with cotton absorbent cotton.

One container or 1, 2, 3, 4, 5, 6, 8 or 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

For 10 or 20 containers or 10, 20, 40, 60, 80 and 100 contour packagings together with 10 instructions for use, box of cardboard (for hospitals).

Storage conditions:

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000528

Date of registration:01.06.2010

The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp17.10.2015

Illustrated instructions

Instructions

Indapamide (Indapamide)