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

Excipients: lactose monohydrate 65.5 mg, microcrystalline cellulose 20.0 mg, pregelatinized starch 10.0 mg, silicon dioxide colloid 1.0 mg, magnesium stearate 1.0 mg;

composition of the shell: Opadry II 85F18422 2.0 mg: polyvinyl alcohol partially hydrolyzed 40.0%, macrogol-3350 20.2%, talc 14.8%, titanium dioxide E 171 25.0%.

Description:

Round biconvex tablets covered with a film coat of white or almost white color.

Pharmacotherapeutic group:Diuretics

ATX: & nbsp

C.03.B.A.11 Indapamide

Pharmacodynamics:Hypotensive agent (diuretic, vasodilator).By pharmacological properties is close to thiazide diuretics (violation of reabsorption of sodium ions in the cortical segment of the Henle loop). Increases the release of kidney ions of sodium, chlorine and, to a lesser extent, potassium and magnesium ions. Possessing the ability to selectively block slow calcium channels, increases the elasticity of the walls of the arteries and reduces the overall peripheral vascular resistance. Helps reduce hypertrophy of the left ventricle of the heart. Does not affect the content of lipids in the blood plasma (triglycerides, lipoproteins low density, high-density lipoproteins density); not affects the carbohydrate metabolism (including in patients with concomitant diabetes mellitus). Reduces the sensitivity of the vascular wall to noradrenaline and angiotensin II, stimulates the synthesis prostaglandledyne E2, reduces the production of free and stable oxygen radicals. The hypotensive effect develops by the end of the first week, 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 the rate of absorption, but does not affect the amount of absorbed substance. The maximum concentration in the blood plasma is achieved 1-2 hours after ingestion. At repeated receptions of fluctuation of concentration of a preparation in a blood plasma in an interval between receptions of two doses decrease. The equilibrium concentration is established after 7 days of regular intake. The half-life of the drug is 14-24 hours (an average of 18 hours), communication with plasma proteins - 79%. It also binds to the elastin of the smooth muscles of the vascular wall. Has a high volume of distribution, passes through the histohematological barriers (including placental), penetrates into breast milk. Metabolised in the liver. The kidneys excrete 60-80% in the form of metabolites (in unchanged form, about 5% is excreted), through the intestine - 20%. In patients with renal insufficiency, pharmacokinetics does not change. Do not cumulate.

Indications:

Arterial hypertension.

Contraindications:

Hypersensitivity to the drug and other sulfonamide derivatives; lactose intolerance, galactosemia, glucose / galactose absorption disorder; expressed renal failure (anuria stage), hypokalemia, expressed hepatic (incl.with encephalopathy) insufficiency, pregnancy, lactation, age under 18 (efficacy and safety not established).

Carefully:

In case of violations of the liver and / or kidney function, violation of water-electrolyte balance, hyperparathyroidism, patients with an increased interval QT on ECG or simultaneous reception of drugs that extend the interval QT, 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 tabletka) 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 the case where treatment should begin with the taking of two drugs, the dose of Indapamide remains 2.5 mg in the morning once a day.

Side effects:

From the digestive system: nausea, anorexia, dryness in mouth, stomachalgia, vomiting, diarrhea, constipation, abdominal pain, possible development of hepatic encephalopathy, rarely - pancreatitist.

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

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

From the cardiovascular system: orthostatic hypotension, changes in ECG (hypokalemia), arrhythmia, palpitations.

From the urinary system: frequent infections, nocturia, polyuria.

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

Laboratory indicators: hyperuricemia, hyperglycemia, hypokalemia, hypochloraemia, hyponatremia, hypercalcemia, increase in blood plasma urea nitrogen, hypercreatininaemia, glucosuria.

From the hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia and hemolytic anemia.

Other: exacerbation of the systemic lupus erythematosus.

Overdose:

Symptoms: nausea, vomiting, weakness, impaired gastrointestinal function tract, water-electrolytetin some cases, excessive decrease in blood pressure, respiratory depression. Patients with cirrhosis may develop hepatic coma.

Treatment: gastric lavage, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction:

Saluretics, cardiac glycosides, gluco- and mineralocorticoids, tetracosactide, amphotericin B (IV), laxatives increase the risk of hypokalemia. With simultaneous admission with cardiac glycosides, it increases - the likelihood of developing digitalis intoxication; with calcium preparations - hypercalcemia; with metformin - may aggravate lactic acidosis.

Increases the concentration of lithium ions in blood plasma (decreased excretion by the kidneys), lithium has a nephrotoxic effect.

Astemizole, erythromycin in / in, pentamidine, sultopride, terfenadine, wincamine, antiarytmicheskie means I A class (quinidine, disopyramide) and III class (amiodarone, brethil tosylate, sotalol) mogut lead to the development of arrhythmia by the type of "pirouette" ("torsades de pointes").

Nonsteroidal, anti-inflammatory drugs, glucocorticosteroid agents, tetracosactide, sympathomimetics reduce the hypotensive effect, baclofen - Strengthens.

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

Angiotensin converting enzyme (ACE) inhibitors increase the risk of developing arterial hypotension and / or the presence of renal insufficiency (especially with existing renal artery stenosis).

Increases the risk of kidney dysfunction when using iodine-containing contrast media in high doses (dehydration of the body). Before using iodine-containing contrast agents, patients need to restore fluid loss.

Imipramine (tricyclic) antidepressants and antipsychotics (neuroleptics) 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:

In patients taking cardiac glycosides, laxatives, against the background of hyperaldosteronism, as well as in elderly patients, control of the content of potassium and creatinine ions is shown.

On the background of taking Indapamide, the concentration of potassium, sodium, magnesium ions in the blood plasma should be systematically monitored (electrolyte disturbances may develop), pH, the concentration of glucose, uric acid and residual nitrogen.

The most thorough control is indicated in patients with cirrhosis of the liver (especially with developed edema or ascites - the risk of developing metabolic alkalosis, an intensifying manifestation of hepatic encephalopathy), coronary heart disease, chronic heart failure, and also in elderly patients.

To the group of the raised risk also patients with the increased interval QT on ECG (congenital or developed against a background of some pathological process).

The first measurement of the concentration of potassium ions in the blood should be performed during the first week of treatment.

Hypercalcemia on the background of taking Indapamide may be a consequence of previously undiagnosed 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 is necessary compensate fortereu fluid and at the beginning of treatment carefully monitor kidney function.

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

Patients with hypertension and hyponatremia (due to taking diuretics) need to stop taking diuretics 3 days before the start of taking ACE inhibitors (if necessary, diuretics can be taken a little later) or they are given initial low doses of ACE inhibitors.

Proyone sulfonamide can aggravate the course of systemic red inolch(should be borne in mind when administering Indapamide).

Efficiency and safety in children is not established.

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

In some cases, individual reactions associated with changes in blood pressure are possible, especially at the beginning of treatment and with the addition of another antihypertensive agent. As a result, the ability to drive and work with mechanisms that require increased attention can be reduced.

Form release / dosage:

Tablets, film-coated, 2.5 mg.

Packaging:

By 10 tabThe outflow into the outline cell packaging or cell perforated packaging from a film of polyvinylchloride and aluminum foil.

3 contour packs together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In 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.

Terms of leave from pharmacies:On prescription

Registration number:P N002469 / 01

Date of registration:16.05.2008 / 05.09.2017

Expiration Date:Unlimited

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Information update date: & nbsp02.11.2017

Illustrated instructions

Instructions

Indapamide (Indapamide)