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

auxiliary substances: Itablet pills: potato starch, milk sugar (lactose), microcrystalline cellulose, povidone or kollidone, magnesium stearate, silicon dioxide colloid; tablet shell: hydroxypropylmethylcellulose, tween-80, titanium dioxide, talc, acidic red 2C for pharmaceutical purposes, povidone (colidon).

Description:

The tablets covered with a cover of pink color, round, biconcave form. Two layers are visible on the cross-section.

Pharmacotherapeutic group:Diuretics

ATX: & nbsp

C.03.B.A.11 Indapamide

Pharmacodynamics:

A hypotensive agent, a thiazide-like diuretic with a moderate in strength and long duration of action, a benzamide derivative. Has moderate saluretic and diuretic effects, which are associated with the 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. 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 the smooth-muscle walls of blood vessels.

Reduces the tone of the smooth muscles of the arteries, reduces the overall peripheral resistance of the 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 is achieved after 7 days of regular intake. The preparation binds to blood plasma proteins by 70-80%. 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 the sulfonamide or other components of an acute ischemic expressed human kidney (anuria) and / or the liver (including encephalopathy), diabetes decompensation.

Carefully:

Hyperuricemia (accompanied by gout and urate nephrolithiasis) pregnancy, lactation period, age under 18 years (efficacy and safety not established for age younger than 18 years).

Dosing and Administration:

Inside, preferably in the morning, regardless of food intake of 2.5 mg (1 tablet) per day, squeezed a sufficient amount of liquid.

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 of Indapamide remains 2.5 mg in the morning once a day.

Side effects:

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

From the gastrointestinal tract: dry mouth, anorexia, abdominal discomfort, constipation, or diarrhea.

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

From the sense organs: conjunctivitis, impaired vision.

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

From the side of 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, malaise, muscle spasm, 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 use of activated charcoal followed by restoration of normal water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction:

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

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

Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, sympathomimetics reduce hypotensive effect, baclofen increases.

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

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

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

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 the risk of kidney dysfunction (dehydration). 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 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 or when taking Indapamide 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 diseases, with vomiting and diarrhea, as well as in people on a salt-free diet.

The simultaneous administration of indapamide 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 taking Indapamide 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 to stop taking diuretics 3 days before taking angiotensin-converting enzyme inhibitors (if necessary, diuretics can be takento resume a little later), or they are prescribed initial low doses of angiotensin-converting enzyme inhibitors.

Derivatives of sulfonamide can aggravate the course of systemic lupus erythematosus (it must be borne in mind when administering Indapamide).

Form release / dosage:

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

Packaging:

For 10 or 20 tablets in a contour mesh box made of PVC film and foil.

1, 2, 3 or 5 packs with instructions in a pack.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000834

Date of registration:04.08.2010

Expiration Date:Unlimited

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp03.11.2017

Illustrated instructions

Instructions

Indapamide (Indapamide)