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

The tablets covered with a cover of white or almost white color, round, biconcave form. On the cross-section, two layers are visible, the inner layer is white or white with a creamy 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 (disruption of reabsorption Na⁺ in the cortical segment of the loop Henle). Increases urinary excretion of Na ions⁺, Cl^- 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 blood plasma (TG, 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 substance.

The maximum concentration in the blood plasma - 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 half-life is 18 hours, the connection with blood 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.

Metabolised in the liver. The kidneys excrete 60-80% in the form of metabolites (in an unchanged form of about 5%) 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 derivatives of sulfonamide, anuria, hypokalemia, expressed hepatic (including encephalopathy) and / or renal failure, pregnancy, lactation, age under 18 years (efficacy and safety not established); simultaneous reception of drugs that extend the interval QT.

Carefully:

With diabetes in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).

Dosing and Administration:

Tablets are taken orally, without chewing.

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

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 be included in the drug regiment ne being a diuretic. In cases where treatment is necessary to begin preparations, the dose Indapamide-OBL remains equal to 2.5 mg in the morning once a day.

Side effects:

From the gastrointestinal tract: nausea / anorexia, dry mouth, stomachalgia, vomiting, diarrhea, constipation.

From the 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.

Laboratory indicators: hyperuricemia, hyperglycemia, hypokalemia, hypochloraemia, hyponatremia, hypercalciuria, elevated plasma urea nitrogen, hypercreatininemia, 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, water-electrolyte disorders, in some cases - excessive reduction in 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 (IV), laxatives increase the risk of hypokalemia.

With simultaneous admission with cardiac glycosides, the likelihood of developing digitalis intoxication increases; with preparations of Ca²⁺ - 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 in / in, pentamidine, sultopride, terfenadine, wincamine, antiarrhythmic drugs Ibut of 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,However, the possibility of developing 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, laxative drugs against hyperaldosteronism, as well as in the elderly, control of the K content⁺ creatinine.

On the background of admission Indapamide-OBL should regularly monitor the concentration of K⁺, Na⁺, Mg²⁺ in plasma (electrolyte disturbances may develop), pH, glucose concentration, uric acid and residual nitrogen.

The most thorough control is indicated in patients with cirrhosis of the liver (especially developed edemas or ascites - the risk of metabolic alkalosis, increasing manifestations of hepatic encephalopathy), coronary heart disease, heart failure, and also 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 K⁺ in the blood should be carried out during the first week after the start 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 (decreased glomerular filtration). Patients need to compensate for the loss water and at the beginning of treatment carefully monitor kidney function.

Indapamide-OBL can give a positive result in the conduct of doping control.

Patients with arterial hypertension and hyponatremia (due to taking diuretics) need to stop taking diuretics 3 days before the initiation of prima of 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 the sulfonamide can aggravate the course of systemic lupus erythematosus (it is necessary to keep in view of the appointment Indapamide-OBL).

Efficiency and safety in children is not established.

Form release / dosage:The tablets covered with a cover, 2,5 mg.

Packaging:

For 10 or 30 tablets in a contour cell package.

For 1 circuit cell pack of 30 tablets or 3 contour packs of 10 tablets together with the instructions for use are placed in packs of cardboard.

Storage conditions:

In a dry, dark place, at a temperature of no higher than 25FROM.

Keep out of the reach of children.

Shelf life:2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:P N002521 / 01

Date of registration:19.05.2008 / 18.05.2012

Expiration Date:Unlimited

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia

Information update date: & nbsp02.11.2017

Illustrated instructions

Instructions

Indapamide-OBL (Indapamide-OBL)