Hypotensive agent, thiazide-like diuretic of moderate potency and long duration of action, benzamide derivative. It has moderate saluretic and diuretic effects, which are associated with blockade of reabsorption of sodium, chloride, hydrogen and, to a lesser extent, potassium ions in proximal tubules and cortical segment of distal tubule of nephron.
The vasodilatory effects and reduction of total peripheral vascular resistance have in their basis the following mechanisms: reduction of reactivity of the vascular wall to noradrenaline and angiotensin II; increased synthesis of prostaglandins with vasodilatory activity; inhibition of calcium flow in vascular smooth muscle walls.
Limits the tone of arterial smooth muscle, reduces total peripheral vascular resistance. Helps reduce left ventricular hypertrophy. In therapeutic doses does not affect lipid and carbohydrate metabolism (including in patients with concomitant diabetes).
The antihypertensive effect develops at the end of the first/beginning of the second week with continued use and lasts for 24 hours with a single dose.
One film-coated tablet contains:
Indapamide – 2.5 mg;
Pregelatinized starch – 41.8 mg
Microcrystalline cellulose – 45 mg
Colloidal silica (aerosil) – 0.5 mg/p>
Magnesium stearate – 0.2 mg
Hypromellose – 1.008 mg
Macrogrol – 0.36 mg
Lactose monohydrate – 1.296 mg and titanium dioxide – 0.936 mg
Concomitant use of indapamide with lithium preparations may increase plasma lithium concentrations.
Astemizole, erythromycin (IV), pentamidine, sultopride, vincamine, class IA (quinidine, disopyramide) and class III antiarrhythmic drugs (amiodarone, brettilia tozilate, sotalol) may increase the possibility of torsades de pointes heart rhythm disturbances (ventricular tachycardia pirouette type).
Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, and sympathomimetics decrease the hypotensive effect; baclofen increases it.
Saluretics, cardiac glycosides, gluco- and mineralocorticosteroids, tetracosactide, amphotericin B (IV), laxatives increase the risk of hypokalemia.
In concomitant use with cardiac glycosides increases the risk of digitalis intoxication, with calcium preparations – hypercalcemia, with metformin – possible aggravation of lactic acidosis.
The combination with potassium-saving diuretics may be effective in some patients; however, the possibility of hypo- or hyperkalemia is not completely excluded, especially in patients with diabetes and renal insufficiency.
Angiotensin-converting enzyme (ACE) inhibitors increase the risk of arterial hypotension and/or acute renal failure (especially if renal artery stenosis is present).
Iodine contrast agents in high doses increase the risk of renal dysfunction (dehydration). Patients need to restore fluid loss before using iodine-containing contrast agents.
Tricyclic antidepressants and antipsychotics increase the hypotensive effect and increase the risk of orthostatic hypotension.
Cyclosporine increases the risk of hypercreatininemia.
Limits the effect of indirect anticoagulants (coumarin or indandion derivatives) due to the increased concentration of clotting factors as a result of decreased circulating blood volume and increased production by the liver (dose adjustment may be required).
It increases the blockade of neuromuscular transmission that develops under the influence of nondepolarizing myorelaxants.
Directions for use
Overly, preferably in the morning, regardless of meals, 2.5 mg (1 tablet) daily with plenty of fluid.
If the desired therapeutic effect is not achieved after 4 to 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 that another antihypertensive medication, not a diuretic, be included in the drug regimen.
In cases where it is necessary to start treatment with two drugs, the dose of Indapamide remains 2.5 mg in the morning once daily.
In long-term use or when taking Indapamide in high doses electrolyte disorders such as hyponatremia, hypokalemia, hypochloremic alkalosis may develop. These disorders are more frequently observed in patients with chronic heart failure (II-IV functional class, according to NYHA classification); liver diseases, with vomiting and diarrhea, and in patients on salt-free diet.
The concomitant use of Indapamide with cardiac glycosides and corticosteroids increases the risk of hypokalemia. In addition, the renal excretion of magnesium may be increased, which may lead to hypomagnesemia.
Orthostatic hypotension may occur, which may be provoked by alcohol, barbiturates, narcotic drugs, and concomitant use of other hypotensive agents.
In patients taking cardiac glycosides, laxatives, against a background of hyperaldosteronism, as well as in elderly patients, careful monitoring of potassium and creatinine is indicated.
The most careful control is indicated in patients with cirrhosis of the liver, coronary heart disease, and chronic heart failure.
High risk patients with prolonged QT interval on electrocardiogram (congenital or developed against a background of some pathological process) are also included in this group. The first measurement of potassium concentration in blood should be done in the first week of treatment.
Hypercalcemia on Indapamide may be due to previously undiagnosed hyperparathyroidism.
In diabetic patients it is extremely important to monitor blood glucose concentrations, especially in the presence of hypokalemia.
Significant dehydration can lead to acute renal failure (decreased glomerular filtration). Patients should compensate for fluid loss and carefully monitor renal function at the beginning of treatment.
Indapamide may give a positive result in doping control.
Patients with arterial hypertension and hyponatremia (due to diuretics) should discontinue diuretics 3 days before starting ACE inhibitors (diuretics may be resumed somewhat later if necessary), or use initial low-dose ACE inhibitors.
Sulfonamide derivatives may exacerbate systemic lupus erythematosus (should be kept in mind when using Indapamide).
Biconvex-shaped, film-coated tablets are white. Cross-section shows an inner layer of white or white with a creamy tint.
After oral administration, it is quickly 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. Maximal concentration in blood is reached 1-2 hours after oral intake. The equilibrium concentration is reached after 7 days of regular use.
The drug is 70-80% bound to blood plasma proteins. It has a high volume of distribution, passes through histohematic (including placental) barriers and into breast milk. It is metabolized in liver.
Period of half-life of indapamide is on average 14-18 hours. It is excreted from the body by kidneys (up to 80%) mainly as metabolites, through the intestine – 20%. Pharmacokinetics does not change in patients with renal insufficiency. It does not cumulate.
- Hypersensitivity to indapamide, other sulfonamide derivatives or other drug components
- Acute cerebral circulation disorder
- Severe renal impairment (creatinine clearance less than 30 ml/min) and/or liver function (including with encephalopathy
- Current use of QT interval prolonging drugs
- Lactation period
- Age under 18 years of age (efficacy and safety not established).
- The tablet jacket contains lactose; therefore, the drug should not be taken by patients with rare hereditary conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
With caution in:
- Diabetes mellitus in decompensation
- Hyperuricemia (especially accompanied by gout and urate nephrolithiasis)
- Hyponatremia and other disorders of water-electrolyte exchange
- Moderate hepatic and/or renal insufficiency
- Ischemic heart disease
- Chronic heart failure
- In debilitated patients and patients with prolonged QT interval on ECG or receiving concomitant therapy with other antiarrhythmic agents.
Metabolism disorders: hypokalemia, hyponatremia, hypochloremic alkalosis, hypercalcemia, increased plasma urea nitrogen, hypercreatininemia, glucosuria, hyperuricemia, hyperglycemia.
Digestive system disorders: dry mouth, vomiting, gastralgia, anorexia, abdominal discomfort, pancreatitis, constipation or diarrhea, hepatic encephalopathy (with liver failure).
In the central nervous system: asthenia, dizziness, nervousness, headache, drowsiness, increased fatigue, general weakness, insomnia, depression, tension, irritability, anxiety, lethargy, listlessness, agitation, paresthesia, tingling sensation in extremities.
Sensory organs: conjunctivitis, visual impairment.
Respiratory system: rhinitis, cough, pharyngitis, sinusitis.
Cardiovascular system: orthostatic hypotension, arrhythmia, palpitations, electrocardiogram changes characteristic of hypokalemia.
Urinary system disorders: nycturia, polyuria, increased incidence of infections.
Hematopoietic disorders: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia.
Allergic reactions: skin rash, itching, urticaria, hemorrhagic vasculitis.
Others: flu-like syndrome, chest pain, malaise, muscle spasm, back pain, decreased libido and potency, rhinorrhea, increased sweating, weight loss, exacerbation of systemic lupus erythematosus, and there have been cases of photosensitivity reactions.
Symptoms: nausea, vomiting, weakness, gastrointestinal dysfunction, water-electrolyte disorders, decreased blood pressure, dizziness, drowsiness, confusion, respiratory depression, in patients with liver dysfunction may develop hepatic coma.
Treatment: Gastric lavage and/or administration of activated charcoal with subsequent restoration of normal water-electrolyte balance, symptomatic therapy. There is no specific antidote.
Arifon, Indapamide, Indapamide, Arifon retard
3 years. Do not use after the expiration date stated on the package.
|Conditions of storage|
In a dry, light-protected place at a temperature not exceeding 25ºC. Store out of the reach of children.
ALSI Pharma, Russia
Buy Indapamide-ALSI, 2.5mg 30 pcs with delivery to USA, UK, Europe and over 120 other countries.