Indap, capsules 2.5mg, 30pcs

Composition

1 capsule contains:

Active ingredient:

indapamide 2.5 mg;

Auxiliary substances:

MCC granulated;

lactose monohydrate;

corn starch;

magnesium stearate;

colloidal silicon dioxide;

titanium dioxide;

gelatin;

dye indigocarmin

Pharmacological action

Indap – diuretic, antihypertensive, vasodilator.

Pharmacodynamics

Indapamide belongs to the group of non-thiazide sulfonamides, and its pharmacological properties are similar to those of thiazide-like diuretics. Reduces smooth muscle tone of the arteries, reduces heart rate. It has moderate saluretic and diuretic effects, which are associated with the blockade of reabsorption of sodium, chlorine, hydrogen and, to a lesser extent, potassium ions in the proximal tubules and cortical segment of the distal tubules of the kidneys. Having the ability to selectively block slow calcium channels, it increases the elasticity of arterial walls and reduces OPSS. Helps to reduce hypertrophy of the left ventricle of the heart. It does not affect the content of lipids in plasma (triglycerides, LDL, HDL), does not affect carbohydrate metabolism (including in patients with concomitant diabetes mellitus). The decrease in OPSS is also due to a decrease in the sensitivity of vascular wall adrenoreceptors to norepinephrine and angiotensin II, and an increase in the synthesis of PGS with vasodilating activity (PGE2 and prostacyclin — PGI2). Reduces the production of free and stable oxygen radicals.

When administered in high doses, it does not affect the degree of blood pressure reduction, despite an increase in diuresis. The antihypertensive effect manifests itself by the end of the 1st week, persists for 24 hours against the background of a single dose, reaches a maximum in 8-12 weeks after the start of taking the drug.

Pharmacokinetics

After oral use, indapamide is rapidly and completely absorbed from the gastrointestinal tract, with high bioavailability (93%). Food intake slightly slows down the rate, but does not affect the completeness of absorption. After oral use of the drug at a dose of 2.5 mg, T_max is 1-2 hours. Binding to plasma proteins is about 75%. It also binds to the smooth muscle elastin of the vascular wall. It has a_highVd, passes through histohematic barriers (including placental), penetrates into breast milk.

It is metabolized in the liver. T_1/2 averages 14-18 hours. It is mainly excreted through the kidneys-60-80% (in most cases-in the form of metabolites,5% — unchanged), through the intestines-20-23%. In patients with renal insufficiency, the pharmacokinetics do not change. It doesn’t accumulate.

Indications

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

Contraindications

• hypersensitivity to indapamide, other sulfonamide derivatives and components of the drug;
• acute cerebrovascular accident;
• severe hepatic (including with encephalopathy) and/or renal failure, anuria;
• hypokalemia;
• concomitant use of drugs that prolong the interval QT;
• lactose intolerance, galactosemia, glucose and galactose malabsorption syndrome;
• pregnancy and lactation;
• age up to 18 years (efficacy and safety have not been established).

With caution:  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 failure; ascites; coronary heart disease; chronic heart failure; prolongation of the QT interval; hyperparathyroidism.

Side effects

From the digestive system:  possible nausea, discomfort, or epigastric pain.

From the central nervous system:  possible weakness, fatigue, dizziness, nervousness.

From the cardiovascular system:  orthostatic hypotension is possible.

From the side of metabolism:  hypokalemia, hyperuricemia, hyperglycemia, hyponatremia, hypochloremia are possible.

Allergic reactions:  possible skin manifestations.

Interaction

It is not recommended to use indapamide and lithium preparations simultaneously (due to the possibility of developing a toxic effect of lithium against the background of a decrease in its renal clearance).

Co-use of indapamide with astemizole, erythromycin (IV), sultoprid, terfenadine, vincamine, class Ia antiarrhythmic drugs (quinidine, disopyramide) and class III antiarrhythmic drugs (amiodarone, sotalol) may weaken the hypotensive effect of indapamide and lead to the development of pirouette-type arrhythmia due to a synergistic effect (prolongation) on the duration of the QT interval.

NSAIDs, corticosteroids, and adrenostimulants reduce the hypotensive effect, while baclofen increases it.

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

When taken 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.

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

Indapamide increases the risk of developing renal failure when using high-dose iodine-containing contrast agents for dehydration of the body. Before using iodine-containing contrast agents, patients need to restore fluid loss.

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

When used concomitantly with cyclosporine, it is possible to increase the level of creatinine in blood plasma.

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 BCC 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.

How to take, course of use and dosage

Inside, in the morning, regardless of food intake, the capsule is swallowed without chewing, washed down with water. Assign 2.5 mg / day (1 capsule).

The drug can be used as monotherapy or in combination with other antihypertensive agents (beta-blockers, BCC, ACE inhibitors). 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 advisable to add another antihypertensive drug that is not a diuretic to the treatment regimen. In cases where treatment is necessary to start with 2 medications, the dose of Indap® remains equal to 2.5 mg / day 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.

Special instructions

When prescribing the drug to patients taking cardiac glycosides, laxatives against the background of hyperaldosteronism, as well as the elderly, regular monitoring of potassium ions and creatinine levels is indicated.

When taking indapamide, the concentration of potassium, sodium, and magnesium 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 due to the risk of developing metabolic alkalosis, which increases the manifestations of hepatic encephalopathy), as well as in CHD, heart failure and the elderly. The high-risk group also includes patients with an extended QT interval on the ECG (congenital or developed against the background of a pathological process). The first determination of the concentration of potassium ions in the blood should be carried out during the first week of using the drug.

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 need to compensate for water 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 ACE inhibitors are prescribed in low initial doses.

When prescribing indapamide, it should be borne in mind that sulfonamide derivatives can exacerbate the course of systemic lupus erythematosus.

Form of production

Capsules

Storage conditions

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

Shelf life

3 years

Active ingredient

Indapamide

Conditions of release from pharmacies

By prescription

Dosage form

Capsules