Indapamide Canon - instructions for use, dose, side effects, contraindications

Excipients: starch potato 18.2 mg, crospovidone 0.8 mg, lactose monohydrate 62.5 mg, magnesium stearate 0.8 mg, povidone K-30 4.5 mg, silicon dioxide colloid 0.7 mg, cellulose microcrystalline 30 mg;

film sheath: shell (can be used a ready-made mixture of Opadrai white or a ready-made mixture of Vivacoat) 5 mg, including: giprolose (hydroxypropyl cellulose) 1.6875 mg, hypromellose (hydroxypropylmethylcellulose) 1.66875 mg, talc 1 mg, titanium dioxide 0.625 mg.

Description:

Round, biconvex tablets, covered with a film shell of white or almost white color. On the cross-section - white.

Pharmacotherapeutic group:Diuretics

ATX: & nbsp

C.03.B.A.11 Indapamide

Pharmacodynamics:

Indapamide belongs to the sulfonamide derivatives and is pharmacologically similar to thiazide diuretics.

Has moderate saluretic and diuretic effects, which are due to inhibition of the reabsorption of sodium, chlorine and, to a lesser extent, potassium and magnesium ions in the proximal tubules of the kidneys and in the cortical segment of the distal tubule of the nephron.

Indapamide reduces the tone of the smooth muscles of the arteries and has a vasodilating effect, reduces the overall peripheral resistance of the vessels. These effects are mediated by a decrease in the reactivity of the vascular wall to norepinephrine and angiotensin II; an increase in the synthesis of prostaglandin E2, which has vasodilator activity; suppression of calcium current in smooth muscle cells of blood vessels.

Indapamide reduces the hypertrophy of the left ventricle of the heart. Has antihypertensive effect in doses that do not have a pronounced diuretic effect. In therapeutic doses does not affect lipid and carbohydrate metabolism (including in patients with concomitant diabetes mellitus).

With a systematic admission, the therapeutic effect of indapamide develops in 1-2 weeks, peaks at 8-12 weeks and persists for up to 8 weeks. After taking a single dose, the maximum effect is observed after 24 hours.

Pharmacokinetics:

Indapamide after oral administration is rapidly and completely absorbed in the gastrointestinal tract (bioavailability high - 93%). Eating somewhat slows down the absorption rate of indapamide, but does not affect the completeness of absorption. Relationship with blood plasma proteins - 71-79%. It also binds to the elastin of the smooth muscles of the vascular wall. Has a high volume of distribution, passes through the histohematological barriers (including through the placental). The time to reach the maximum concentration in the blood is 1-2 hours.

Indapamide is metabolized in the liver to inactive metabolites (about 5-7% of the accepted dose of the drug is excreted by the kidneys unchanged).

The half-life of indapamide is on average 16 hours. The drug is excreted from the body by the kidneys 60-80% in the form of metabolites, through the intestine 20-23%.

In patients with renal insufficiency, the pharmacokinetic parameters of the drug do not change.

Do not cumulate.

Indications:

Arterial hypertension.

Contraindications:

- Hypersensitivity to indapamide, other derivatives of sulfonamide or to other components of the drug;

- severe renal failure (creatinine clearance (CK) less than 30 ml / min);

- hepatic encephalopathy or severe hepatic insufficiency;

- hypokalemia;

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

- age under 18 years (effectiveness and safety not established);

- pregnancy;

- the period of breastfeeding.

Carefully:

Dysfunction of the liver and / or kidneys (QC more than 30 ml / min), diabetes mellitus, advanced age, water-electrolyte balance disorders, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), hyperparathyroidism; patients with an elongated interval QT on the ECG or receiving therapy, as a result of which the lengthening of the interval is possible QT (astemizole, erythromycin (intravenously), pentamidine, sultopride, terfenadine, wincamine, antiarrhythmic drugs of IA class (quinidine, disopyramide) and III class (amiodarone, brethil tosylate)).

Pregnancy and lactation:

Taking indapamide during pregnancy is not recommended. The use of the drug may cause fetoplacental ischemia with the risk of slowing the development of the fetus.

If you need to use the drug during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Assigned inside, regardless of food intake, preferably in the morning. The drug Indapamide Kanon should be taken without chewing, squeezed with enough liquid.

With arterial hypertension, the drug Indapamid Canon is administered at a dose of 2.5 mg once a day. An increase in the dose does not lead to an increase in antihypertensive action.

If after 4-8 weeks of treatment the desired therapeutic effect is not achieved, the dose of the drug should not be increased (the risk of side effects increases without increasing the antihypertensive effect). Instead, it is recommended that another antihypertensive drug that is not a diuretic be included in the treatment regimen. In the case of starting treatment with two antihypertensive drugs, the dose of the drug Indapamide Kanon remains equal to 2.5 mg once in the morning.

In the treatment elderly patients the threshold value of the concentration of creatinine in the blood plasma varies depending on age, body weight and gender.

For elderly patients, the use of Indapamid Canon is possible only with normal kidney function or with minor renal dysfunction.

Side effects:

Classification of the incidence of side effects in accordance with the recommendations of the World Health Organization: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10000 to <1/1000) , very rarely (<1/10000), including individual messages; the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

From the side of the cardiovascular system: very rarely - orthostatic hypotension, arrhythmia, palpitation, changes in ECG, characteristic of hypokalemia.

From the side of the digestive tract: infrequent - vomiting, rarely - decreased appetite, dry mouth, nausea, abdominal pain, diarrhea, or constipation; very rarely - pancreatitis. Patients with hepatic insufficiency may develop hepatic encephalopathy.

From the central nervous system: often - dizziness, headache, increased excitability, sleep disorders, depression, fatigue, malaise, asthenia, tension, irritability, anxiety, paresthesia, muscle spasms.

From the respiratory system: often - cough, pharyngitis, sinusitis, very rarely - rhinitis.

From the genitourinary system: very rarely - kidney failure.

From the hematopoiesis: very rarely - thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia.

From the skin and subcutaneous fat: hypersensitivity reactions, mainly dermatological, in patients with a predisposition to allergic and asthmatic reactions:

often - itching, maculopapular rash; infrequently - hemorrhagic vasculitis; very rarely - angioedema and / or urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome; frequency is unknown - in patients with acute form of systemic lupus erythematosus, the course of the disease may worsen;

Individual cases of photosensitivity reactions are described.

From the laboratory indicators: very rarely - hypercalcemia, hyperuricemia; frequency unknown - hypochloraemia, hyponatremia, hyperglycemia, hypokalemia, increased blood urea nitrogen concentration, hypercreatininaemia, glucosuria.

Overdose:

Symptoms: associated with a violation of the water-electrolyte balance - nausea, vomiting, severe lowering of blood pressure, dizziness, convulsions, drowsiness, confusion, polyuria or oliguria, leading anuria (due to hypovolemia).

Treatment: gastric lavage, administration of activated carbon with the subsequent restoration of the water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction:

When used simultaneously with lithium preparations, indapamide leads to an increase in the concentration of lithium ions in the blood plasma (by reducing its excretion by the kidneys).

When used concomitantly with iodine-containing contrast media in high doses indapamide increases the risk of developing kidney dysfunction (by reducing the volume of circulating blood (BCC)). Before using iodine-containing contrast agents, patients need to correct the BCC.

Indapamide reduces the effect of indirect anticoagulants (coumarin or indanedione derivatives) by increasing the concentration of clotting factors (as a result of a decrease in BCC).

Indapamide enhances the action of nondepolarizing muscle relaxants.

The risk of hypokalemia increases with simultaneous use of indapamide with diuretics ("loop", thiazide), cardiac glycosides, glucocorticosteroids, mineralocorticoids, tetracosactide, amphotericin B (intravenously), laxatives.

With the simultaneous administration of indapamide with cardiac glycosides, the likelihood of developing digitalis intoxication increases; with calcium preparations - hypercalcemia; with metformin - aggravation of lactic acidosis.

Astemizole, erythromycin (intravenously), pentamidine, sultopride, terfenadine, wincamine, antiarrhythmic drugs IA class (quinidine, disopyramide) and III class (amiodarone, brethil tosylate) may increase the risk of arrhythmia of the "pirouette" type due to the lengthening of the interval QT.

Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, adrenostimulants reduce the hypotensive effect of indapamide, baclofen - Strengthens.

Angiotensin converting enzyme inhibitors, when used concurrently with indapamide, increase the risk of orthostatic hypotension and / or acute renal failure (especially in the presence of renal artery stenosis).

Imipramine (tricyclic) antidepressants and antipsychotics (neuroleptics) increase the hypotensive effect of indapamide and increase the likelihood of orthostatic hypotension.

Cyclosporine increases the risk of hypercreatininaemia.

Special instructions:

In the course of therapy with the drug Indapamide Kanon, the concentration of sodium and magnesium ions (since electrolyte disturbances can develop), glucose, uric acid and residual nitrogen, and the pH of the blood should be systematically monitored in the blood.

Patients taking cardiac glycosides, laxatives, patients with hyperaldosteronism, as well as elderly people, when taking the drug Indapamide Kanon, are shown careful control of the content of potassium and creatinine ions in the blood.

The first measurement of the concentration of potassium ions in the blood should be made during the first week of treatment.

The most thorough control is indicated for patients with cirrhosis of the liver (especially with edema or ascites) because of the risk of developing metabolic alkalosis that worsens the course of hepatic encephalopathy; with ischemic heart disease, chronic heart failure, and also in elderly patients. The high-risk group also includes patients with lengthening of the interval QT on an electrocardiogram (congenital or developed against a background of a pathological process).

Hypercalcemia on the background of taking the drug Indapamide Kanon may be a consequence of previously undiagnosed hyperparathyroidism.

In some patients, the combination of indapamide with potassium-sparing diuretics may be effective, but it is possible that hypo- or hyperkalemia may develop, especially in patients with diabetes mellitus and renal insufficiency.

Patients with diabetes should monitor the concentration of glucose in the blood, especially when there is hypokalemia.

Significant dehydration against the background of therapy with the drug Indapamide Kanon can lead to the development of acute renal failure (due to a decrease in the glomerular filtration rate).

Patients should be compensated for BCC at the beginning of treatment and carefully monitor kidney function.

Derivatives of sulfonamides can exacerbate the course of systemic lupus erythematosus (must be considered when administering the drug Indapamide Kanon).

Indapamide can give positive results in the conduct of doping control.

Efficacy and safety in children under 18 years of age is not established.

Against the background of taking thiazide and thiazide-like diuretics, cases of development of photosensitivity reactions were reported (see the "Side effect" section). In the case of developing photosensitivity reactions against the background of taking the drug should stop treatment. If it is necessary to continue therapy with diuretics, it is recommended to protect the skin from exposure to sunlight or artificial ultraviolet rays.

Effect on the ability to drive transp. cf. and fur:

At the beginning of indapamide treatment, one should refrain from driving motor vehicles and practicing potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions, since it is possible to develop dizziness.

Form release / dosage:

Tablets, film-coated, 2.5 mg.

Packaging:

For 10 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 1, 2, 3, 4 contour cell packs of 10 tablets or by 1,2.3 contour cell packs of 30 tablets together with instructions for use are placed in a pack of cardboard.

Storage conditions:In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N003197 / 01

Date of registration:15.12.2008

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia

Representation: & nbspCANONFARMA PRODUCTION CJSC CANONFARMA PRODUCTION CJSC Russia

Information update date: & nbsp02.11.2017

Illustrated instructions

Instructions

Indapamide Canon (Indapamide Canon)