Indapamide-ALSI pills 2.5mg, 30pcs

Composition

One film coated tablet contains:

Active ingredient:  

Indapamide — 2.5 mg;

Auxiliary substances:  

Pregelatinized starch-41.8 mg

Microcrystalline cellulose-45 mg

Colloidal silicon dioxide (aerosil) – 0.5 mg

Magnesium stearate — 0.2 mg

Hypromellose — 1,008 mg

Macrogol-0.36 mg

Lactose monohydrate-1,296 mg and titanium dioxide-0,936 mg

Pharmacological action

Antihypertensive agent, a thiazide-like diuretic with moderate and long-lasting effects, a benzamide derivative. It has moderate saluretic and diuretic effects, which are associated with the blockade of reabsorption of sodium, chlorine, hydrogen ions, and to a lesser extent potassium ions in the proximal tubules and cortical segment of the distal nephron tubule.

Vasodilating effects and a decrease in total peripheral vascular resistance are based on the following mechanisms: reduced reactivity of the vascular wall to norepinephrine and angiotensin II; increased synthesis of prostaglandins with vasodilating activity; inhibition of calcium flow into the smooth muscle walls of blood vessels.

Reduces the smooth muscle tone of the arteries, reduces the total peripheral vascular resistance. Helps to reduce hypertrophy of the left ventricle of the heart. In therapeutic doses, it does not affect lipid and carbohydrate metabolism (including in patients with concomitant diabetes mellitus).

The antihypertensive effect develops at the end of the first/beginning of the second week with constant use of the drug and persists for 24 hours against the background of a single dose.

Indications

Arterial hypertension

Recommendations for use

Inside, preferably in the morning, regardless of food intake,2.5 mg (1 tablet) per day, washed down with a sufficient amount of liquid.

If the desired therapeutic effect is not achieved after 4-8 weeks of treatment, it is not recommended to increase the dose of the drug (the risk of side effects increases without increasing the antihypertensive effect). Instead, it is recommended to include another antihypertensive drug that is not a diuretic in the drug treatment regimen.

In cases where treatment is necessary to start with two medications, the dose of Indapamide remains equal to 2.5 mg in the morning once a day.

Contraindications

• Hypersensitivity to indapamide, other sulfonamide derivatives or other components of the drug
• Acute cerebrovascular accident
• Severe renal impairment (creatinine clearance less than 30 ml/min) and/or hepatic impairment (including those with encephalopathy
• Hypokalemia
• Concomitant use of drugs that prolong the QT interval
• Pregnancy
• Lactation period
• Age up to 18 years (efficacy and safety have not been established).
• The tablet shell contains lactose, so the drug should not be taken by patients with rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Use caution when using:

• Diabetes mellitus in the stage of decompensation
• Hyperuricemia (especially accompanied by gout and urate nephrolithiasis)
• Hyponatremia and other disorders of water and electrolyte metabolism
• Moderate hepatic and / or renal insufficiency
• Ascites
• Coronary heart disease
• Chronic heart failure
• Hyperparathyroidism
• In debilitated patients and patients with an extended QT interval on the ECG or receiving concomitant therapy with other antiarrhythmic agents.

Side effects

From the side of metabolism: hypokalemia, hyponatremia, hypochloremic alkalosis, hypercalcemia, increased urea nitrogen in blood plasma, hypercreatininemia, glucosuria, hyperuricemia, hyperglycemia.

From the digestive system: dryness of the oral mucosa, vomiting, gastralgia, anorexia, abdominal discomfort, pancreatitis, constipation or diarrhea, hepatic encephalopathy (on the background of liver failure).

From the central nervous system: asthenia, dizziness, nervousness, headache, drowsiness, increased fatigue, general weakness, insomnia, depression, tension, irritability, anxiety, lethargy, lethargy, restlessness, paresthesia, tingling sensation in the extremities.

From the sensory organs: conjunctivitis, visual impairment.

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

From the cardiovascular system: orthostatic hypotension, arrhythmia, palpitation sensation, changes in the electrocardiogram characteristic of hypokalemia.

From the urinary system: nocturia, polyuria, increased frequency of infections.

Hematopoietic disorders: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia.

Allergic reactions: skin rash, pruritus, urticaria, hemorrhagic vasculitis.

Other services:  flu-like syndrome, chest pain, malaise, muscle spasms, back pain, decreased libido and potency, rhinorrhea, increased sweating, weight loss, exacerbation of systemic lupus erythematosus, cases of photosensitivity reactions have been described.

Interaction

Concomitant use of indapamide with lithium preparations may increase the concentration of lithium in blood plasma.

Astemizole, erythromycin (IV), pentamidine, sultoprid, vincamine, class IA antiarrhythmic drugs (quinidine, disopyramide) and class III antiarrhythmics (amiodarone, bretilia tosilate, sotalol) may increase the likelihood of torsades de pointes (ventricular tachycardia of the “pirouette”type).

Nonsteroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, sympathomimetics reduce the hypotensive effect, baclofen increases.

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

When used concomitantly with cardiac glycosides, the likelihood of digitalis intoxication increases, with calcium preparations-hypercalcemia, with metformin – lactic acidosis may worsen.

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

Angiotensin converting enzyme (ACE) inhibitors increase the risk of hypotension and / or acute renal failure (especially in patients with existing renal artery stenosis).

High-dose iodine contrast agents increase the risk of developing kidney function disorders (dehydration of the body). Before using contrast iodine-containing agents, patients need to restore fluid loss.

Tricyclic antidepressants and antipsychotic medications increase the hypotensive effect and increase the risk of orthostatic hypotension.

Cyclosporine increases the risk of hypercreatininemia.

Reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of clotting factors as a result of a decrease in the volume of circulating blood and an increase in their production by the liver (dose adjustment may be required).

Increases the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants.

Overdose

Symptoms: nausea, vomiting, weakness, impaired gastrointestinal function, water and electrolyte disorders, decreased blood pressure, dizziness, drowsiness, confusion, respiratory depression, patients with impaired liver function may develop a hepatic coma.

Treatment: gastric lavage and / or use of activated charcoal followed by restoration of normal water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Description

Tablets of biconvex shape, covered with a film-coated white color. On the cross-section – the inner layer is white or white with a creamy tint of color.

Functional features

After oral use, it is rapidly and completely absorbed from the gastrointestinal tract. Bioavailability is high (93%). Food intake slightly slows down the rate, but does not affect the completeness of absorption. The maximum concentration in the blood is reached 1-2 hours after ingestion. The equilibrium concentration is reached after 7 days of regular use. The drug binds to plasma proteins by 70-80%. It has a high volume of distribution, passes through histohematic (including placental) barriers, and penetrates into breast milk. It is metabolized in the liver. The elimination half-life of indapamide is on average 14-18 hours. It is excreted from the body by the kidneys (up to 80%) mainly in the form of metabolites, through the intestines-20%. In patients with renal insufficiency, the pharmacokinetics do not change. It doesn’t accumulate.

Special instructions

With prolonged use or when taking Indapamide in large doses, electrolyte disturbances may develop, such as hyponatremia, hypokalemia, hypochloremic alkalosis. These disorders are more often observed in patients with chronic heart failure (functional class II-IV, according to NYHA classification); liver diseases, vomiting and diarrhea, as well as in people on a salt-free diet.

Concomitant use of Indapamide with cardiac glycosides and corticosteroids increases the risk of hypokalemia. In addition, the excretion of magnesium by the kidneys may increase, which can lead to hypomagnesemia.

Orthostatic hypotension may occur, which can be provoked by taking alcohol, barbiturates, narcotic drugs and simultaneous use of other antihypertensive agents.

In patients taking cardiac glycosides, laxatives, against the background of hyperaldosteronism, as well as in the elderly, careful monitoring of potassium and creatinine levels is indicated.

The most careful monitoring is indicated in patients with cirrhosis of the liver, coronary heart disease, and chronic heart failure.

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 blood potassium concentration should be made 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 the concentration of glucose in the blood, especially in the presence of hypokalemia.

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

Indapamide can give a positive result during doping control.

Patients with arterial hypertension and hyponatremia (due to taking diuretics) should stop taking diuretics 3 days before the start of taking ACE inhibitors (if necessary, diuretics can be resumed a little later), or use the initial low doses of ACE inhibitors.

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

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 ° C.

Keep out of reach of children.

Shelf

life is 3 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