Indapamide retard Tab n / a film about prolong. 1.5mg 30 pc

Description

Composition
Active substance:
1 tablet contains: 1.5 mg indapamide ;.
Product form:
Prolonged action tablets, film-coated, 1.5 mg.
Contraindications
Hypersensitivity to indapamide, other sulfonamide derivatives or any of the excipients;
Severe renal failure (less than 30 ml / min creatinine clearance);
Hepatic encephalopathy or severe hepatic dysfunction;
hypokalemia;
Pregnancy, lactation;
Age 18 years (effectiveness and safety have been established);
Simultaneous administration of drugs prolonging the interval QT;
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Carefully:
Used with caution in the human liver and / or kidney disease, disturbance of water-electrolyte balance, hyperparathyroidism, patients with increased QT interval on an electrocardiogram or receiving combination therapy in diabetes decompensated, hyperuricemia (especially accompanied gout and urate nephrolithiasis).
Dosage
1.5 mg
Indications
Arterial hypertension.
Interaction with other drugs
NOT RECOMMENDED COMBINATION lithium -Preparaty
With simultaneous use of indapamide and lithium preparations can be observed increase in the concentration of lithium in the blood plasma due to lower its excretion, accompanied by the appearance attributes overdose. If required, diuretic drugs may be administered in combination with lithium therapy, it should be careful to select a dose of drugs, constantly monitoring plasma lithium content.
COMBINATIONS, -Preparaty requires special caution, can cause arrhythmia type “pirouette” -antiaritmicheskie class IA agents (quinidine, gidrohinidin, disopyramide); -antiaritmicheskie Class III agents (amiodarone, dofetilide, ibutilide), sotalol; -Some neuroleptics: phenothiazines (Chlorpromazine, tsiamemazin, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol); -other: bepridil, cisapride, difemanil, erythromycin (w / w), halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, astemizole, vincamine (w / w).
Increased risk of ventricular arrhythmias, especially arrhythmias such as “pirouette” (a risk factor – hypokalemia).
You must define the content of potassium in the blood plasma and, if necessary, corrected before the start of combination therapy indapamide and the above-mentioned preparations. Necessary to monitor the patient’s clinical status, control of the content of plasma electrolytes, blood, ECG.
Patients with hypokalemia should be prescribed drugs that do not cause arrhythmia type “pirouette”. -Nesteroidnye antiinflammatory drugs (for systemic use), including selective inhibitors of cyclooxygenase-2 (COX-2), high-dose salicylates (> 3 g / day)
May reduce the antihypertensive effect of indapamide. With substantial fluid loss may develop acute renal failure (due to a decrease in glomerular filtration). Patients should compensate for the loss of fluid and at the beginning of treatment carefully monitor renal function. Inhibitor of angiotensin converting enzyme (ACE)
The use of ACE inhibitors in patients with a reduced content of sodium ions in blood (particularly in patients with renal artery stenosis) is accompanied by a risk of sudden hypotension and / or acute renal failure.
Patients with hypertension and possibly reduced due diuretics, content of sodium ions in plasma requires -this 3 days before treatment with an ACE inhibitor to stop taking diuretics. Subsequently, if necessary, diuretics can be resumed; -or begin therapy with an ACE inhibitor with a low dose with a gradual increase in the dose, if necessary.
In chronic heart failure, ACE inhibitor therapy should start with a low dose with a possible preliminary reduction doses of diuretics.
In all cases, during the first week of ACE inhibitors in patients need to monitor renal function (creatinine concentration in blood plasma). -Other drugs that can cause hypokalemia: amphotericin B (w / w), and gluco mineralokortikosteroidy (for systemic use), tetracosactide, laxatives, stimulating intestinal motility
Increased risk of hypokalaemia (additive effect).
Requires regular monitoring of potassium in the blood plasma, if necessary, correction. Particular attention should be given to patients while receiving cardiac glycosides.
It is recommended to use laxatives, do not stimulate bowel motility. -Baklofen
Noted increased hypotensive effect. Patients should compensate for the loss of fluid, and, at the beginning of treatment carefully monitor renal function. -Serdechnye glycosides
Hypokalemia increases the toxic effects of cardiac glycosides. With simultaneous use of indapamide and cardiac glycosides should be monitored in plasma potassium, ECG, and, if necessary, adjust therapy.
COMBINATIONS OF DRUGS REQUIRING THE ATTENTION -Kaliysberegayuschie diuretics (amiloride, spironolactone, triamterene)
Combination therapy with indapamide and potassium-sparing diuretics suitable for some patients, but it does not exclude the possibility of hypokalemia (especially in patients with diabetes and renal insufficiency) or hyperkalemia.
It is necessary to control the content of potassium in the blood plasma, ECG, and if necessary, adjust therapy. -Metformin
Functional renal failure that can occur in the background of diuretics, particularly “loop”, while metformin increases the risk of lactic acidosis.
It should appoint metformin if creatinine concentration exceeds 15 mg / L (135 pmol / l) in men and 12 mg / L (110 pmol / l) in women. -Yodsoderzhaschie contrast agents
Dehydration in patients receiving diuretics increases the risk of acute renal failure, especially when high doses of iodinated contrast agents.
Before using iodinated contrast agents to patients is necessary to compensate the loss of fluid. -Tritsiklicheskie antidepressants, antipsychotics (neuroleptics)
Preparations of these classes increase the antihypertensive effect of indapamide and increase the risk of orthostatic hypotension (additive effect). calcium -hydrochloric
With simultaneous application may develop hypercalcemia due to lower renal excretion of calcium ions. -Ciclosporin tacrolimus
Possible to increase the concentration of creatinine in the blood plasma concentration of unchanged circulating cyclosporine, even with normal fluid and sodium ions. -Kortikosteroidnye preparations tetrakozaktid (for systemic use)
Reduced hypotensive action (fluid retention and sodium ions by the action of corticosteroids).
Overdose
Indapamide even at doses up to 40 mg, i.e. 27 times the therapeutic dose not have a toxic effect.
Symptoms of acute poisoning with medication in the first place related to the violation of water-electrolyte balance (hyponatremia, hypokalemia). From the clinical symptoms of an overdose may occur nausea, vomiting, lower blood pressure, cramps, dizziness, drowsiness, confusion, polyuria or oliguria, anuria leading to (due to hypovolemia).
Treatment: gastric lavage and / or administration of activated charcoal, followed by reduction of water-electrolyte balance. No specific antidote.
pharmachologic effect
Pharmacological group:
Diuretic.
Pharmacodynamics:
Indapamide – sulfonamide derivative, according to the pharmacological properties similar to the thiazide diuretics (violation reabsorption of sodium ions in the cortical segment of loop of Henle). Increases the excretion of sodium by the kidneys, chlorine and to a lesser extent of potassium and magnesium ions, which is accompanied by an increase in diuresis and hypotensive effect. The hypotensive effect lasts for 24 hours on a background of a single administration in which the gain is observed moderate diuresis.
Antihypertensive activity is associated with the improvement of the elastic properties of the large arteries, decreasing blood and total peripheral vascular resistance. Indapamide reduces left ventricular hypertrophy. Thiazide and thiazide diuretics at a defined dose reach a plateau therapeutic effect, while the incidence of adverse events continues to increase with further increase in dose. Therefore it is not necessary to increase the dose if upon receiving the recommended dosage is not reached therapeutic effect.
Indapamide no effect on lipid content in the blood plasma (triglycerides, low density lipoprotein, high density lipoprotein); It does not affect the performance of carbohydrate metabolism, including diabetes mellitus patients.
Pharmacokinetics:
Suction
Once inside quickly and completely absorbed from the gastrointestinal tract; high bioavailability (93%). Eating slows down the rate of absorption, but does not affect the amount of the absorbed compound. Maximum plasma concentration achieved after 12 hours after ingestion of a single dose. Repeated receptions fluctuations in plasma concentrations of drug in the interval between receptions of two reduced doses.
Distribution
Communication with blood proteins – 79%. The half-life is 14 – 24 hours (mean 18 hours). It passes through the blood-tissue barriers (including placental) released into breast milk. The equilibrium concentration is reached after 7 days of treatment. Repeated dose accumulation was observed.
Metabolism
Indapamide is displayed as inactive metabolites in the kidneys (70%), and through the intestine (22%).
Patients belonging to high-risk patients
In patients with renal insufficiency does not change the pharmacokinetics of the drug.
Pregnancy and breast-feeding
As a general rule, during pregnancy, diuretic drugs are not used.
You can not use these drugs to treat physiological edema during pregnancy, because they can cause fetoplacental ischemia and can lead to disruption of the development of the fetus.
Indapamide is excreted in breast milk. If treatment with indapamide retard necessary during lactation, the breast-feeding should be discontinued.
Conditions of supply of pharmacies
On prescription.
side effects
Most adverse reactions are dose-dependent.
From the digestive system: nausea, anorexia, dryness of the oral mucosa, gastralgia, vomiting, diarrhea, constipation, abdominal pain, abnormal liver function, hepatic encephalopathy, hepatitis, increased activity “liver” transaminases, pancreatitis.
From hemopoiesis system: hyperuricemia, hyperglycemia, hypokalemia, chloropenia, hyponatremia, hypomagnesemia, hypercalcemia, elevated blood urea nitrogen plasma hypercreatininemia, glycosuria, thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia.
Allergic reactions: skin rash, angioedema, urticaria, pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome, hemorrhagic vasculitis.
On the part of the central nervous system: fatigue, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression, fatigue, weakness, malaise, muscle spasm, paresthesia, tension, irritability, anxiety.
The respiratory system: cough, pharyngitis, sinusitis, rhinitis.
In the cardiovascular system: syncope, marked reduction of blood pressure changes on the electrocardiogram (ECG) (typical of hypokalemia) lengthening QT interval on the ECG, arrhythmia, arrhythmia type “pirouette”, palpitations.
From the urinary system: frequent infections, nocturia, polyuria, renal insufficiency.
Other: exacerbation of systemic lupus erythematosus, photosensitivity reactions.
special instructions
Liver function abnormalities
By use of thiazide and thiazide diuretics in patients with impaired liver function hepatic encephalopathy may develop, particularly in the event of water and electrolyte balance. In this case, the diuretic should be stopped immediately.
photosensitivity reaction
In patients receiving thiazide and thiazide diuretics reported cases of photosensitivity reactions (see. “Side effects”). In the case of photosensitivity reactions in patients receiving the drug should be discontinued treatment. If necessary, continue diuretic therapy, it is recommended to protect the skin from exposure to sunlight or artificial UV rays.
Water-electrolyte balance -Contents sodium ions in the blood plasma
Prior to treatment is necessary to determine the content of sodium ions in the blood plasma. At this rate, should regularly monitor patients receiving the drug. All diuretic drugs can cause hyponatraemia, sometimes leading to dire consequences. A regular monitoring of the content of sodium ions, as initially decrease the sodium content in the blood plasma may not be accompanied by the appearance of pathological symptoms. The most careful control the sodium ion concentration is indicated in patients with cirrhosis and elderly patients (see. The sections “Side effect” and “Overdose”). -Contents potassium ions in the blood plasma
In therapy thiazide and thiazide diuretics main risk lies in the sharp decrease of potassium in the blood plasma and the development of hypokalemia. It is necessary to avoid the risk of hypokalemia (
Hypokalemia, as well as bradycardia, a condition conducive to the development of severe arrhythmia, and particularly arrhythmias such as “pirouette” that can lead to death. In all the above cases it is necessary to regularly monitor the content of potassium in the blood plasma. The first measurement of potassium ions in the blood should be held in the first week of starting treatment. When hypokalemia should be assigned the appropriate treatment. -Contents calcium in the blood plasma
It should be borne in mind that thiazide and thiazide diuretics can decrease the excretion of calcium by the kidneys, resulting in a slight and temporary increase in calcium in the blood plasma. Marked hypercalcemia may be a consequence of previously undiagnosed hyperparathyroidism.
Should stop taking diuretic medications before the test function of the parathyroid glands. -Contents plasma glucose
It is necessary to monitor the concentration of blood glucose in patients with diabetes, especially in the presence of hypokalemia.
Uric acid
Patients with gout may increase the incidence of seizures or worsen gout.
Diuretic drugs, and kidney function
Thiazide and thiazide diuretics fully effective only in patients with normal or mildly impaired renal function (creatinine concentration in blood plasma of adult below 25 mg / l or 220 mmol / l). Elderly patients normal creatinine concentration in plasma was calculated taking into account the age, weight and gender.
Note that at the beginning of treatment, patients may experience a decrease in glomerular filtration rate due to hypovolemia, which in turn is caused by the loss of fluids and sodium ions in patients receiving diuretics. As a consequence, the plasma can be increased concentration of urea and creatinine. When kidney function is compromised, such temporary functional renal failure usually takes place without consequences, however, the patient may deteriorate at existing renal failure.
Athletes
The active substance, which is part of the preparation of indapamide retard, may give a positive result in doping control in athletes.
Effect on ability to drive and use machines:
The active ingredients of the drug indapamide retard, does not lead to a breach of psychomotor reactions. However, some patients in response to a decrease in blood pressure may develop a variety of individual reactions, especially at the beginning of therapy or when added to the therapy of other antihypertensive agents. In this case, the ability to drive vehicles or other mechanisms can be reduced.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Inside, 1 tablet a day, preferably in the morning. Tablets should be swallowed whole without chewing, drinking water.
Increasing the dose does not increase the antihypertensive effect, but strengthens the diuretic effect.
Elderly patients.
Elderly patients should be monitored plasma concentration of creatinine according to the age, weight and gender.
Indapamide retard can be applied to elderly patients with normal or mildly impaired renal function.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist