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

Excipients: lactose monohydrate 76,960 mg, povidone-K30 2,820 mg, crospovidone 0,880 mg, magnesium stearate 0,880 mg, sodium lauryl sulfate 0.440 mg, talc 3.520 mg;

shell: hypromellose 1,7222 mg, macrogol 6000 0.3445 mg, talc 1.9030 mg, titanium dioxide E 171 0.4303 mg.

Description:

Round, biconvex, film-coated tablets are white.

Pharmacotherapeutic group:diuretic

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 urinary excretion 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, low-density lipoproteins, high-density lipoproteins); does not affect carbohydrate metabolism (including in patients with concomitant diabetes mellitus). Reduces the sensitivity of the vascular wall to noradrenaline and angiotensin II, stimulates the synthesis of prostaglandin 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 - 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 syndrome; severe renal failure (anuria stage), hypokalemia, expressed hepatic (including encephalopathy) insufficiency, pregnancy, lactation, age under 18 (efficacy and safety not established); simultaneous reception of drugs that extend the interval QT.

Carefully:

With violations of the liver and / or kidney function, violation of water-electrolyte balance, hyperparathyroidism, patients with an increased interval QT on an electrocardiogram or receiving a combination therapy with other antiarrhythmic drugs, 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 of Indapamide remains 2.5 mg in the morning once a day.

Side effects:

From the digestive system: nausea, anorexia, dry mouth, stomachalgia, vomiting, diarrhea, constipation,abdominal pain, possible development of hepatic encephalopathy, rarely pancreatitis.

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

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

From the side of the cardiovascular system: Orthostatic hypotension, changes in the electrocardiogram (hypokalemia), arrhythmias, 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, elevated plasma urea nitrogen urea, hypercreatininemia, 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, dysfunction of the gastrointestinal tract, lead-in electrolyte disorders, in some cases - excessive lowering of 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, the likelihood of developing digitalis intoxication increases; with calcium preparations - hypercalcemia; with metformin - may aggravate lactic acidosis.

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

Astemizole, erythromycin in / in, pentamidine, sultopride, terfenadine, wincamine, antiarrhythmic drugs I A class (quinidine, disopyramide) and III class (amiodarone, brethil tosylate, sotalol) can lead to the development of arrhythmias of the type "pirouette" "torsades de pointes".

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

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

Inhibitors of angiotensin converting (ACE) enzyme increases the risk of hypotension and / or acute renal failure (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.

Imipraminovye (tricyclic) antidepressants and antipsychotic drugs (neuroleptics) 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:

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

Against 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, glucose concentration, uric acid and residual nitrogen.

The most careful control is indicated in patients with cirrhosis of the liver (especially with developed edema or ascites - the risk of metabolic alkalosis, which increases manifestations of hepatic encephalopathy), coronary heart disease, heart failure, and also in the elderly.

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 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 must compensate for the loss of water and at the beginning of treatment carefully monitor the kidney function.

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

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

Derivatives of sulfonamide can aggravate the course of systemic lupus erythematosus (it 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:

For 10 tablets, coated with a film sheath, into a contoured cell packaging made of a polyvinylchloride film and aluminum foil printed lacquered.

3 contour squares, together with instructions for use, are placed in a cardboard pack.

Storage conditions:

Store in a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N014730 / 01

Date of registration:25.01.2008

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

HEMOFARM, LLC Russia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp18.10.2015

Illustrated instructions

Instructions

Indapamide (Indapamide)