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

Excipients: cellulose microcrystalline, lactose (sugar milk), potato starch, povidone (polyvinylpyrrolidone), silicon dioxide colloid (aerosil), talc (magnesium hydroxylate), magnesium stearate;

composition of the shell: methylcellulose water soluble, tween-80 (polysorbate), povidone (polyvinylpyrrolidone), titanium dioxide, talc (magnesium hydroxylicate).

Description:

The tablets covered with a film cover, white or almost white color, biconcave form. Two layers are visible on the cross-section.The inner layer is white or white with a yellowish hue.

Pharmacotherapeutic group:Diuretics

ATX: & nbsp

C.03.B.A.11 Indapamide

Pharmacodynamics:

Hypotensive agent (diuretic, vasodilator). By pharmacological properties is close to thiazide diuretics (violation of ion reabsorption Na⁺ in the cortical segment of the loop Henle). Increases urinary excretion of ions Na⁺, FROMl^- and to a lesser extent, K⁺ and Mg²⁺ . 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 concomitant diabetes mellitus). Reduces the sensitivity of the vascular wall to noradrenaline and angiotensin II, stimulates the synthesis of prostaglandin E2, 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.

Pharmacokinetics:

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract; bioavailability is high (93%). Eating somewhat slows the rate of absorption, but does not affect the amount of absorbed indapamide. The maximum concentration in the blood plasma is achieved 1-2 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. The connection with plasma proteins is 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 placental), penetrates into breast milk. The elimination half-life is 18 hours. 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.

Indications:

Arterial hypertension.

Contraindications:

Hypersensitivity to the drug and other sulfonamide derivatives, anuria, hypokalemia, expressed hepatic (incl.with encephalopathy) and / or renal failure, pregnancy, lactation, age under 18 (efficacy and safety not established); simultaneous reception of drugs that extend the interval QT, lactose intolerance, galactosemia, glucose / galactose absorption disorder syndrome.

Carefully:With diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), water-electrolyte metabolism disorders, hepatic and / or renal insufficiency, lengthening of the interval QT, hyperparathyroidism.

Dosing and Administration:

Tablets are taken orally, in the morning.

The daily dose of the drug is 2.5 mg (1 tablet) per day.

If after 4-8 weeks of treatment the desired therapeutic effect is not achieved, the dose of the drug should not be increased (an increase in the risk of side effects without increasing the antihypertensive effect). Instead, it is recommended that another antihypertensive drug that is not a diuretic be included in the drug regimen. In cases where treatment should start with the taking of two drugs, the dose of Indapamide remains 2.5 mg in the morning once a day.

Side effects:

From the digestive system: nausea / anorexia, dry mouth, gastralgia, vomiting, diarrhea, constipation, hepatic encephalopathy (against hepatic insufficiency).

From the central nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression, rarely - fatigue, general weakness, malaise, muscle spasm, tension, irritability, anxiety.

From the sense organs: conjunctivitis, impaired vision.

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

From the cardiovascular system: Orthostatic hypotension, changes in the electrocardiogram (hypokalemia), arrhythmia, palpitations.

From the urinary system: frequent infections, nocturia, polyuria.

Allergic reactions: rash, hives, itching, hemorrhagic vasculitis.

On the part of the organs of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia.

Laboratory indicators: hyperuricemia, hyperglycemia, hypokalemia, hypochloraemia, hyponatremia, hypercalciuria, an increase in the blood plasma of urea nitrogen, hypercreatininaemia, glucosuria.

Other: flu-like syndrome, chest pain, back pain, infection, decreased potency, decreased libido, rhinorrhea, sweating, weight loss, tingling in the limbs, pancreatitis, exacerbation of systemic lupus erythematosus.

Overdose:

Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, lead-in electrolyte disorders, in some cases - excessive lowering of blood pressure, respiratory depression. Patients with cirrhosis may develop hepatic coma.

Treatment: gastric lavage, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction:

Saluretics, cardiac glycosides, gluco- and mineralocorticoids, tetracosactide, amphotericin B (with intravenous administration), 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 ion concentration Li⁺ in blood plasma (decreased excretion in the urine), lithium has a nephrotoxic effect.

Astemizole, erythromycin (with intravenous administration), pentamidine, sultopride, terfenadine, wincamine, antiarrhythmic drugs I A class (quinidine, disopyramide) and III class (amiodarone, brethility, sotalol) can lead to the development of arrhythmias of the type "torsades de pointes".

Non-steroidal anti-inflammatory drugs, glucocorticosteroid agents, tetracosactide, sympathomimetics reduce the hypotensive effect, baclofen - Strengthens.

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

Angiotensin converting enzyme 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 contrasting iodine-containing drugs in high doses (dehydration of the body).Before using contrasting iodine-containing substances, patients need to restore fluid loss.

Imipramine (tricyclic) antidepressants and antipsychotic drugs 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.

Special instructions:

In patients taking cardiac glycosides, laxatives, against the background of hyperaldosteronism, as well as in the elderly, control of the level of potassium and creatinine in the blood is shown.

Against the background of taking indapamide, the concentration of ions K⁺, Na⁺, Mg²⁺ in the blood (may cause electrolyte disorders), pH, the concentration of glucose, uric acid and residual nitrogen.

The most thorough control is shown in patients with cirrhosis of the liver (especially with developed edema or ascites - the risk of developing metabolic alkalosis, hepatic encephalopathy), coronary heart disease, heart failure, as well as in the elderly.

To the group of the raised risk also patients with the increased interval QT on an electrocardiogram (congenital or developed against a background of a pathological process).

The first measurement of the concentration of ions K⁺ in the blood should be carried out during the first week after the start of treatment.

Hypocalcemia 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 in the presence of hypokalemia.

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 taking angiotensin converting enzyme inhibitors (if necessary, diuretics can be taken a little later), or initially prescribe low doses of angiotensin converting enzyme inhibitors.

Derivatives of sulfonamide can aggravate the course of systemic lupus erythematosus (it should be borne in mind when administering indapamide).

Efficiency and safety in children is not established.

Form release / dosage:

Tablets, film-coated, 2.5 mg.

Packaging:

For 10 tablets in a planar cell package.

For 20 or 30 tablets in a can of lightproof glass.

Each bank or 2, or 3 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

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

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N000980 / 01

Date of registration:19.11.2007 / 08.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Representation: & nbspVEROPHARM, AO VEROPHARM, AO Russia

Information update date: & nbsp30.01.2017

Illustrated instructions

Instructions

Vero Indapamide (Vero-Indapamide)