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

Excipients: Ludypress LCE (lactose monohydrate, povidone), lupus (monohydrate lactose, povidone, crospovidone), silicon dioxide colloid (aerosil), magnesium stearate; sheath: hypromellose (hydroxypropylmethylcellulose), titanium dioxide, macrogol (polyethylene glycol-4000), talc.

Description:

The tablets covered with a film cover, white or almost white color, round, biconcave. The core is white or white with a yellowish hue.

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 sodium reabsorption 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. He affects the content of lipids in the blood plasma (triglycerides, low-density lipoproteins, high-density lipoproteins); significantly does not affect carbohydrate metabolism, but in the presence of hypokalemia, blood glucose levels may increase. Reduces the sensitivity of the vascular wall to noradrenaline and angiotensin II, stimulates the synthesis of prostaglandin PgE2a 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.

With a systematic admission, the therapeutic effect is observed after 1-2 weeks, reaches a maximum by 8-12 weeks and lasts up to 8 weeks; after taking a single dose the maximum effect is observed after 24 hours.

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 drug. The maximum concentration in the blood plasma is achieved 1-2 hours after taking the drug inside. 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 period on the average is 14-18 hours, the connection with blood plasma proteins is 71-79%. It also binds to the elastin of the smooth muscles of the vascular wall. Has a high volume of distribution, penetrates through the histohematological barriers (including placental), penetrates into breast milk. Metabolised in the liver. With urine output 60-80% in the form of metabolites (in unchanged form is about 5%), 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, severe renal failure (anuria stage), severe hepatic insufficiency (including encephalopathy), hypokalemia; deficiency of lactase, lactose intolerance, glucose-galactose malabsorption (the preparation contains lactose); pregnancy, lactation, age under 18 years (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 Q-T on ECG or simultaneous reception of drugs that extend the interval Q-T, diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).

Dosing and Administration:

Tablets are taken orally, without chewing.

With arterial hypertension, appoint 2.5 mg (1 tablet) 1 time per day in the morning.

With insufficient efficiency after 4-8 weeks, it is advisableto therapy add antihypertensive drugs with a different mechanism of action (increasing the dose is not advisable - in the absence of a significant increase in the effect, there is an increase in side effects).

Side effects:

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

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

From the digestive system: nausea, vomiting, diarrhea or constipation, decreased appetite, dry mouth, abdominal pain, hepatic encephalopathy (against liver failure), pancreatitis.

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

From the urinary system: infection, nocturia, polyuria.

Allergic reactions: skin itch, patchy-papular rash, hives, hemorrhagic vasculitis.

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

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

Other: exacerbation of systemic lupus erythematosus.

Overdose:

Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water-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 (loop, thiazide), 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 (intravenously), pentamidine, sultopride, terfenadine, wincamine, antiarrhythmic drugs Ibut of class (quinidine, disopyramide) and III class (amiodarone, brethil tosylate, sotalol) can lead to the development of arrhythmia by the type of "pirouette" due to the lengthening of the interval Q-T.

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) inhibitors increase 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 antipsychotic drugs increase the hypotensive effect and increase the risk of developing orthostatic hypotension.

Cyclosporine increases the risk of developing 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, 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 shown in patients with cirrhosis of the liver (especially with edema or ascites - the risk of metabolic alkalosis, increasing manifestations of hepatic encephalopathy), coronary heart disease, chronic heart failure, and also 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 during the first week of treatment.

Hypercalcemia with indapamide may be a consequence of previously 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 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 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.

Derivatives of sulfonamides can aggravate the course of systemic lupus erythematosus (it should be borne in mind when administering indapamide).

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

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 2.5 mg.

Packaging:

10 tablets in a planar cell packaging made of a polyvinylchloride film and aluminum foil.

3 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002423 / 01

Date of registration:09.04.2008 / 27.02.2010

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

MAKIZ-PHARMA, LLC Russia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp31.10.2017

Illustrated instructions

Instructions

Indapamide Stade (Indapamide Stada)