Composition, form of production and packaging
Tablets of prolonged action, covered with a film coat from white to almost white, round, biconvex.
indapamide 1.5 mg
Excipients: lactose monohydrate, hypromellose, magnesium stearate, silicon dioxide colloidal anhydrous.
Sheath composition: titanium dioxide (E171), magnesium stearate, glycerol, macrogol 6000.
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
Hypotensive agent (diuretic, vasodilator). By pharmacological properties is close to thiazide diuretics (violation of reabsorption of sodium ions 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. Does not affect the content of lipids in the blood plasma (triglycerides, low-density lipoproteins, high-density lipoproteins); does not affect carbohydrate metabolism (including in patients with diabetes mellitus). Reduces the sensitivity of the vascular wall to noradrenaline and angiotensin II, stimulates the synthesis of prostaglandin E 2 , reduces the production of free and stable oxygen radicals.
The hypotensive effect develops by the end of the first week, persists for 24 hours against a background of a single dose.
After oral administration, it is quickly and completely absorbed from the digestive tract; bioavailability is high (93%). Eating somewhat slows the rate of absorption, but does not affect the amount of absorbed substance. C max in blood plasma - 12 hours after ingestion. 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. T 1/2- 18 h, communication with blood plasma proteins - 79%. It also binds to the elastin of the smooth muscles of the vascular wall. Has a high V d , passes through the histohematological barriers (including placental), penetrates into breast milk.
Metabolised in the liver. The kidneys excrete 60-80% in the form of metabolites (in unchanged form, about 5% is excreted), through the intestine - 20%. In patients with renal insufficiency, pharmacokinetics does not change. Do not cumulate.
- arterial hypertension.
Tablets are taken orally, without chewing. The daily dose of the drug is 1 tab. Indapamide 1 time / day (in the morning), squeezed with enough liquid.
On the part of the digestive system: nausea, anorexia, dry mouth, gastralgia, vomiting, diarrhea, constipation, abdominal pain, possibly development of hepatic encephalopathy; rarely - pancreatitis.
From the side of the central nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression; rarely - fatigue, general weakness, malaise, muscle spasm, tension, irritability, anxiety.
On the part of the respiratory system: cough, pharyngitis, sinusitis; rarely rhinitis.
From the cardiovascular system: orthostatic hypotension, changes in the ECG (hypokalemia), arrhythmia, palpitations.
From the urinary system: frequent infections, nocturia, polyuria.
Allergic reactions: rash, hives, itching, hemorrhagic vasculitis.
Laboratory indicators: hyperuricemia, hyperglycemia, hypokalemia, hypochloraemia, hyponatremia, hypercalcemia, an increase in the blood plasma of urea nitrogen, hypercreatininemia, glucosuria.
From the hemopoietic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia and hemolytic anemia.
Other: exacerbation of systemic lupus erythematosus.
- syndrome of impaired glucose / galactose absorption;
- severe renal failure (anuria stage);
- severe hepatic (including with encephalopathy) insufficiency;
- lactation period;
- age under 18 years (effectiveness and safety not established);
- simultaneous reception of drugs that extend the QT interval;
- hypersensitivity to the drug and other sulfonamide derivatives.
With caution appoint for violations of the liver and / or kidney function, violation of water-electrolyte balance, giierparathyroidism, patients with an increased interval of QT on the ECG or receiving combination therapy with other antiarrhythmic drugs, diabetes mellitus in decompensation stage, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).
PREGNANCY AND LACTATION
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution is prescribed for violations of kidney function.
- severe renal failure (anuria stage).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution is prescribed for violations of liver function.
- marked hepatic (including with encephalopathy) insufficiency.
APPLICATION FOR CHILDREN
Contraindicated in children under the age of 18 years (efficacy and safety not established).
APPLICATION IN ELDERLY PATIENTS
In patients taking cardiac glycosides, laxatives, against hyperaldosteronism, as well as in the elderly, regular monitoring of the content of potassium and creatinine ions is shown.
On the background of taking indapamide, the concentration of potassium, sodium, magnesium ions in the blood plasma (electrolyte disturbances may develop), pH, glucose concentration, uric acid and residual nitrogen should be systematically monitored.
The most thorough control is indicated in patients with cirrhosis of the liver (especially with edema or ascites - the risk of metabolic alkalosis, which increases manifestations of hepatic encephalopathy), coronary heart disease, heart failure, and also in the elderly.
Patients with an increased QT interval on the ECG (congenital or developing against a background of a pathological process) also belong to the high-risk group.
The first measurement of the potassium concentration in the blood should be performed within 1 week of treatment.
Hypercalcemia on the background of taking indapamide may be a consequence of previously undiagnosed 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 arterial hypertension and hyponatremia (due to taking diuretics) should stop taking diuretics 3 days before the initiation of angiotensin converting enzyme inhibitors (if necessary, diuretics can be taken a little later) or they are given initial low doses of ACE inhibitors.
Derivatives of sulfonamides can exacerbate the course of systemic lupus erythematosus (should be borne in mind when administering indapamide).
Efficiency and safety in children is not established.
Impact on the ability to drive vehicles and manage mechanisms
In some cases, individual reactions associated with changes in blood pressure are possible, especially at the beginning of treatment and with the addition of another antihypertensive agent. As a result, the ability to drive and work with mechanisms that require increased attention can be reduced.
Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water-electrolyte disorders, in some cases - excessive decrease in blood pressure, respiratory depression. In patients with cirrhosis, the development of hepatic coma is possible.
Treatment: gastric lavage, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.
Saluretics, 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 IV, pentamidine, sultopride, terfenadine, vincamine, antiarrhythmic agents of the IA class (quinidine, disopyramide) and class III (amiodarone, brethil tosylate, sotalol) can lead to the development of torsades de pointes, .
NSAIDs, GCS, tetracosactide, sympathomimetics reduce the hypotensive effect, baclofen - strengthens.
Combination with potassium-sparing diuretics can be effective in some patients, however, the possibility of hypo- or hyperkalemia, especially in patients with diabetes mellitus and renal insufficiency, is not completely excluded.
ACE inhibitors increase the risk of 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 antipsychotics increase the hypotensive effect and increase the risk of developing orthostatic hypotension.
Cyclosporine increases the risk of 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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Store in a dry, dark place at a temperature of 15 В° to 25 В° C. Shelf life - 3 years.