Indapamide, pills 2.5mg 30pcs

Composition

Active ingredient:  

Indapamide 2.5 mg;

Auxiliary substances:  

Pregelatinized starch;

MCC;

Colloidal silicon dioxide (aerosil);

Magnesium stearate;

Hypromellose; 

Macrogol.

Lactose monohydrate;

Titanium Dioxide

Characteristics

Round biconvex tablets covered with a white film coating. On a cross-section, the core is white or almost white in color.

Pharmacological action

Indapamide is a thiazide-like diuretic, an antihypertensive agent.

It causes a decrease in arterial smooth muscle tone, a decrease in OPSS, and also has moderate saluretic activity due to impaired reabsorption of sodium, chlorine, and water ions in the cortical segment of the Henle loop and the proximal convoluted tubule of the nephron.

The decrease in OPSS is caused by several mechanisms: a decrease in the sensitivity of the vascular wall to norepinephrine and angiotensin II; an increase in the synthesis of prostaglandins with vasodilating activity; inhibition of the influx of calcium ions into the smooth muscle elements of the vascular wall.

In therapeutic doses, it has almost no effect on lipid and carbohydrate metabolism.

The antihypertensive effect is manifested only with initially elevated blood pressure, develops by the end of the first week and reaches a maximum after 3 months of systematic use.

After oral use, it is rapidly and completely absorbed from the gastrointestinal tract, Cmax in plasma is reached in 1-2 hours. Binding to plasma proteins is 79%. It is widely distributed in the body. It doesn’t accumulate.

T1 / 2 is 18 hours. It is excreted by the kidneys mainly in the form of metabolites,5% – unchanged.

Active ingredients

Indapamide

Indications

Arterial hypertension; sodium and water retention in chronic heart failure.

Use during pregnancy and lactation

Indapamide is not recommended during pregnancy and lactation.

Contraindications

Hypersensitivity to indapamide, other sulfonamide derivatives or other components of the drug; anuria, refractory hypokalemia, hepatic encephalopathy or severe hepatic insufficiency, severe renal insufficiency (creatinine clearance less than 30 ml/min), pregnancy, breast-feeding, age under 18 years (insufficient data on efficacy and safety);lactose intolerance, lactase deficiency, glucose-galactose deficiency malabsorption (the drug contains lactose).

Side effects

the Frequency of possible side effects listed in accordance with the classification of the world health organization: very often — more than 10%; often — more than 1% and less than 10%; infrequently — more than 0.1% and less than 1%;rarely — less than 0.01% and less than 0.1%; very rarely — less than 0.01% (including individual cases); frequency unknown — cannot be determined according to reports. From the blood and lymphatic system: very rarely — thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia. Nervous system disorders, rarely-vertigo, fatigue, headache, paresthesia; frequency unknown-syncope. From the cardiovascular system-very rarely — arrhythmia, hypotension; frequency unknown-increased QT interval on the ECG, arrhythmia of the “pirouette” type (“torsade de pointes”) (possibly fatal). From the digestive system: infrequently-vomiting; rarely-nausea, constipation, dry mouth; very rarely-pancreatitis. From the side of the kidneys and urinary tract: very rarely-renal failure. From the liver and biliary tract: very rarely-impaired liver function; frequency unknown-with liver failure, hepatic encephalopathy, hepatitis may occur. From the immune system: hypersensitivity reactions, mainly dermatological, in patients with a predisposition to allergic and asthmatic reactions: often-maculopapular rash; infrequently-hemorrhagic vasculitis; very rarely-angioedema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome; frequency unknown-in patients with acute systemic lupus erythematosus, the course of the disease may worsen. Cases of photosensitivity reactions are described. Laboratory parameters: very rarely — hypercalcemia; frequency unknown — increased uric acid and glucose concentrations in the blood (thiazide and thiazide-like diuretics should be used with caution in patients with gout and diabetes mellitus);increased activity of “hepatic” transaminases; decreased potassium content and development of hypokalemia, especially significant for patients at risk (see the section “Special instructions”); hyponatremia, accompanied by hypovolemia, dehydration and otrostatic hypotension. Simultaneous hypochloremia can lead to metabolic alkalosis of a compensatory nature (the probability and severity of this effect is low).

Interaction

With the simultaneous use of corticosteroids, tetracosactide for systemic use, the hypotensive effect decreases due to the retention of water and sodium ions under the influence of corticosteroids.

When used concomitantly with ACE inhibitors, the risk of hyponatremia increases.

When used concomitantly with NSAIDs (for systemic use), the hypotensive effect of indapamide may decrease. With significant fluid loss, acute renal failure may develop (due to a sharp decrease in glomerular filtration).

When used concomitantly with calcium preparations, hypercalcemia may develop due to a decrease in the excretion of calcium ions in the urine.

When used concomitantly with cardiac glycosides, corticosteroids, the risk of hypokalemia increases.

Concomitant use of drugs that can cause hypokalemia (amphotericin B, gluco-and mineralocorticoids, tetracosactide, laxatives that stimulate intestinal motility) increases the risk of hypokalemia.

When used concomitantly with tricyclic antidepressants (including imipramine), the hypotensive effect increases and the risk of orthostatic hypotension increases (additive effect).

When used concomitantly with astemizole, bepridil, erythromycin (IV), pentamidine, sultoprid, terfenadine, vincamine, quinidine, disopyramide, amiodarone, bretilia tosilate, sotalol, there is a risk of developing arrhythmia of the “pirouette” type.

When used concomitantly with baclofen, the hypotensive effect increases.

When used concomitantly with halofantrine, the likelihood of heart rhythm disorders (including ventricular arrhythmia of the “pirouette” type) increases.

When used concomitantly with lithium carbonate, the risk of developing a toxic effect of lithium increases against the background of a decrease in its renal clearance.

Concomitant use with metformin may cause lactic acidosis, which is probably associated with the development of functional renal failure due to the action of diuretics (mainly loop).

When used concomitantly with cyclosporine, it is possible to increase the content of creatinine in blood plasma, which is observed even with a normal content of water and sodium ions.

How to take, course of use and dosage

Take 2.5 mg orally once a day (in the morning). If the hypotensive effect is not sufficiently pronounced after 2 weeks of treatment, the dose is increased to 5-7.5 mg / day.

The maximum daily dose is 10 mg, divided into 2 doses (in the morning).

Overdose

Symptoms:  nausea, vomiting, weakness, impaired gastrointestinal function, impaired water and electrolyte balance, in some cases – an excessive decrease in blood pressure, respiratory depression. Patients with cirrhosis of the liver may develop hepatic coma.

Treatment:  gastric lavage, correction of water and electrolyte balance; if necessary, conduct symptomatic therapy. There is no specific antidote.

Description

Round biconvex tablets covered with a white film coating. On a cross-section, the core is white or almost white in color.

Functional features

After oral use, it is rapidly and completely absorbed in the gastrointestinal tract; bioavailability is high (93%). Food intake slightly slows down the rate of absorption, but does not affect the amount of absorbed substance. The maximum concentration in blood plasma is reached 1-2 hours after ingestion. With repeated doses, fluctuations in the concentration of the drug in blood plasma in the interval between two doses are reduced. The equilibrium concentration is established after 7 days of regular use. The half-life of the drug is 14-24 hours (on average,18 hours), the relationship with plasma proteins is 79%. It also binds to the smooth muscle elastin of the vascular wall. It has a high volume of distribution, passes through histohematic barriers (including placental), and penetrates into breast milk. It is metabolized in the liver. 60-80% is excreted by the kidneys in the form of metabolites (about 5% is excreted unchanged), and 20% is excreted through the intestines. In patients with renal insufficiency, the pharmacokinetics do not change. It doesn’t accumulate.

Complete set

Film-coated tablets,2.5 mg. 10 tablets in a blister (contour cell package) made of aluminum foil printed varnished and polyvinyl chloride film. 3 blisters (contour cell packages) together with instructions for use of the drug in a pack of cardboard.

Special instructions

Regular monitoring of K + and creatinine levels is indicated in patients taking cardiac glycosides, laxatives, and hyperaldosteronism, as well as in the elderly.

While taking indapamide, the concentration of K+, Na+, and Md2+ ions in the blood plasma should be systematically monitored (electrolyte disturbances may develop), pH, glucose, uric acid, and residual nitrogen concentrations.

The most careful monitoring is indicated in patients with cirrhosis of the liver (especially with edema or ascites – the risk of developing metabolic alkalosis, which increases the manifestations of hepatic encephalopathy), coronary heart disease, heart failure, as well as in the elderly.

The high-risk group also includes patients with an extended QT interval on an electrocardiogram (congenital or developed against the background of a pathological process).

The first measurement of the K + concentration in the blood should be carried out during the first week of treatment. Hypercalcemia with indapamide may be a consequence of previously undiagnosed hyperparathyroidism.

In patients with diabetes, it is extremely important to monitor blood glucose levels, especially in the presence of hypokalemia.

Significant dehydration can lead to acute renal failure (decreased glomerular filtration rate) Patients should compensate for water loss and carefully monitor renal function at the beginning of treatment.

The result of doping control.

Patients with arterial hypertension and hyponatremia (due to taking diuretics) should stop taking diuretics 3 days before taking angiotensin-converting enzyme inhibitors 

(if necessary, diuretics can be resumed a little later), or they are prescribed initial low doses of angiotensin-converting enzyme inhibitors.

Sulfonamide derivatives can exacerbate the course of systemic lupus erythematosus (it is necessary to keep in mind when prescribing indapamide).

Application in pediatrics: efficacy and safety in children have not been established.

Composition

Tablet Form of production

Storage conditions

In a place protected from light and moisture, at a temperature of 15-25 °C

Shelf

life is 4 years. Do not use after the expiration date indicated on the package.

Active ingredient

Indapamide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets