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

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 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 blood plasma is 12 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 is 18 hours, the connection with plasma proteins is 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:

In case of 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:

Tablets are taken orally, without chewing.

The daily dose of the drug is 1 tablet of Indapamide 1 time per day (in the morning), with a sufficient amount of liquid.

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 cardiovascular system: Orthostatic hypotension, changes in the electrocardiogram (hypokalemia), arrhythmia, palpitations.

From the urinary system: frequent infections, nocturia, polyuria. Allergic reactions: rash, hives, itching, hemorrhagic vasculitis.

Laboratory indicators: hyperuricemia, hyperglycemia, hypokalemia, hypochloraemia, hyponatremia, hypercalcemia, elevated plasma urea nitrogen urea, hypercreatininemia, glucosuria.

Rarely: 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, water-electrolyte disorders, in some cases - excessive reduction 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 AT (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, antiarrhythmics IA 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.

Angiotensin converting enzyme (ACE) inhibitorsincrease the risk of developing arterial 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.

Imipramine (tricyclic) antidepressants and 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 hyperaldosteronism, as well as in the elderly, regular monitoring 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 thorough control is indicated in patients with cirrhosis of the liver (especially with 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 hypertension and hyponatremia (due diuretics) necessary 3 days prior to initiation of angiotensin converting enzyme inhibitors, diuretics stop (if necessary diuretics can be resumed later) or they are assigned the initial low dose of ACE inhibitors.

Derivatives of sulfonamides can exacerbate the course of systemic lupus erythematosus (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 of prolonged action, film-coated, 1.5 mg.

Packaging:

For 10 tablets in a blister of PVC / AL, 3 blisters together with instructions for use are placed in a cardboard pack.

Storage conditions:

Store in a dry, protected from light place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LSR-001566/08

Date of registration:14.03.2008 / 25.12.2015

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

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

Information update date: & nbsp02.11.2017

Illustrated instructions

Instructions

Indapamide (Indapamide)