Indap - instructions for use, doses, side effects, contraindications

Excipients: microcrystalline cellulose (granular), lactose monohydrate, corn starch, magnesium stearate, silicon dioxide colloid, titanium dioxide, gelatin, indigo carmine dye.

Description:

Hard gelatin capsules N4. The cap of the capsule is blue, the body is white. Contents of the capsules: white or almost white powder, or white or almost white powder with slices of mass, or white or almost white powder, compressed with a column and decomposing when pressed.

Pharmacotherapeutic group:Diuretics

ATX: & nbsp

C.03.B.A.11 Indapamide

Pharmacodynamics:

Indapamide belongs to the group of non-azide sulfonamides, by pharmacological properties it is close to thiazide-like diuretics. Reduces the tone of the smooth muscles of the arteries, reduces the overall peripheral vascular resistance. The drug has a 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 tubules of the kidneys. 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 plasma (triglycerides, low-density lipoproteins, high-density lipoproteins); does not affect carbohydrate metabolism (including in patients with concomitant diabetes mellitus). Reduction of the total peripheral vascular resistance is also due to a decrease in the sensitivity of adrenoceptors of the vascular wall to norepinephrine and angiotensin II, increased synthesis of prostaglandins with vasodilating activity (prostaglandin PgE2 and prostacyclin PgI2). Reduces the production of free and stable oxygen radicals. When administered in high doses does not affect the degree of lowering blood pressure, despite an increase in diuresis.

The antihypertensive effect appears at the end of the first week, persists for 24 hours against a background of a single dose, reaches a maximum after 8-12 weeks after the start of the drug.

Pharmacokinetics:

After oral administration indapamide quickly and completely absorbed from the gastrointestinal tract, high bioavailability (93%). Eating somewhat slows the rate of absorption, but does not affect the completeness of absorption. After taking the drug inside at a dose of 2.5 mg, the maximum concentration in the blood is reached after 1-2 hours. Binding to plasma proteins is about 75%. 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 half-life on average is 14-18 hours. It is excreted mainly through the kidneys - 60-80% (in most cases - in the form of metabolites, about 5% - unchanged), through the intestine - 20-23%. In patients with renal insufficiency, pharmacokinetics does not change. Do not cumulate.

Indications:

Arterial hypertension.

Contraindications:

- Hypersensitivity to indapamide, other derivatives of sulfonamides and components of the drug;

- acute disturbance of cerebral circulation;

- expressed hepatic (including with encephalopathy) and / or renal failure, anuria;

- hypokalemia;

- simultaneous reception of drugs that extend the interval Q-T;

- lactose intolerance, galactosemia, glucose absorption impairment syndrome, galactose;

- pregnancy and lactation;

- age to 18 years (efficacy and safety not established).

Carefully:

Diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), hyponatremia and other disorders of water-electrolyte metabolism, moderate hepatic and / or renal insufficiency, ascites, ischemic heart disease, chronic heart failure, lengthening of the interval Q-T, hyperparathyroidism.

Dosing and Administration:

Inside, in the morning, regardless of food intake, the capsule is swallowed without chewing, squeezed with water.

Assign 2.5 mg (1 capsule) 1 time per day.

The drug can be used as a monotherapy or in combination with other antihypertensive agents (with beta-adrenoblockers, slow calcium channel blockers, angiotensin-converting enzyme inhibitors). 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, another antihypertensive drug that is not a diuretic should be added to the treatment regimen. In cases where treatment should begin with the taking of two drugs, the dose of Indap remains equal to 2.5 mg in the morning once a day.

Side effects:

From the digestive system: nausea, vomiting, anorexia, dry mouth, abdominal discomfort, gastralgia, constipation or diarrhea, hepatic encephalopathy (against hepatic insufficiency).

From the central nervous system: fatigue, fatigue, malaise, vertigo, muscle spasm, nervousness, tension, irritability, agitation, anxiety, insomnia, depression, dizziness, drowsiness.

From the sense organs: conjunctivitis, impaired vision.

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

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

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

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

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

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

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

Overdose:

Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water-electrolyte disorders, in some cases - excessive reduction 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:

Not recommended at the same time indapamide and lithium preparations because of the possibility of developing a toxic effect of lithium on the background of a decrease in its renal clearance.

Joint use of indapamide with astemizole, erythromycin (intravenously), pentamidine, sultopride, terfenadine, vincamine, antiarrhythmic drugs Ia (quinidine, disopyramide) and III class (amiodarone, brethility, sotalol), can weaken the hypotensive effect of indapamide and lead to the development of piruette-type arrhythmias due to the synergistic effect (lengthening) on the duration of the interval Q-T.

Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide. adrenostimulants reduce the hypotensive effect, baclofen strengthens.

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

With simultaneous admission with cardiac glycosides, the likelihood of developing digitalis intoxication increases; with calcium preparations - hypercalcemia; with metformin, aggravation of lactic acidosis is possible.

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

Indapamide increases the risk of developing kidney failure when using iodine-containing contrast agents in high doses with dehydration of the body.Before using iodine-containing contrast agents, patients need to restore fluid loss.

Tricyclic antidepressants and antipsychotics can increase the antihypertensive effect of the drug and increase the risk of orthostatic hypotension.

With simultaneous use with cyclosporine, an increase in the level of creatinine in the blood plasma is possible.

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:

Indapamide is effective for the treatment of patients with arterial hypertension "at risk", i.e. with concomitant pathology: mild or moderate diabetes mellitus or with chronic renal failure, patients with hyperlipidemia.

With prolonged use of indapamide, electrolyte metabolism can sometimes occur, such as hyponatremia, hypokalemia.hypercalcemia and hypochloraemic alkalosis. These disorders are more often observed in patients with chronic heart failure, liver diseases, with vomiting and diarrhea, as well as in individuals on a salt-free diet, which necessitates the control of blood electrolytes.

Indapamide increases the release of magnesium in the urine, which can lead to hypomagnesemia. When using indapamide, the uric acid and residual nitrogen content in the blood plasma should also be systematically monitored.

Perhaps the appearance of orthostatic hypotension, which can be provoked by the intake of alcohol, barbiturates, narcotic drugs, as well as other antihypertensive drugs.

In the case of hypokalemia caused by indapamide, the toxicity of cardiac glycosides may increase. In patients taking cardiac glycosides, laxatives, with 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 (especially with edema or ascites - the risk of developing metabolic alkalosis, enhancing the manifestation of hepatic encephalopathy);coronary heart disease, chronic heart failure, as well as in the elderly. To the group of the raised risk also patients with the increased interval Q-T 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 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) need to stop taking diuretics 3 days before the start of taking ACE inhibitors (if necessary, diuretics can be resumed a little later),or they are given initial low doses of ACE inhibitors.

Indapamide may worsen the course of systemic lupus erythematosus.

Although indapamide practically does not affect carbohydrate metabolism; in patients with insulin-dependent diabetes mellitus, it is possible to increase the required doses insulin, and with latent diabetes it is necessary to monitor blood glucose.

Form release / dosage:Capsules, 2.5 mg.

Packaging:

10 capsules in the blister pack.

3 blisters in a cardboard box with instructions for use.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014138 / 01

Date of registration:18.08.2008 / 20.04.2017

Expiration Date:Unlimited

The owner of the registration certificate:PRO.MED.CS Prague as.PRO.MED.CS Prague as. Czech Republic

Manufacturer: & nbsp

PRO.MED.CS Praha, a.s. Czech Republic

Representation: & nbspPRO.MED.CS Prague as. PRO.MED.CS Prague as. Czech Republic

Information update date: & nbsp03.11.2017

Illustrated instructions

Instructions

Indap® (Indap®)