Indapamide Tab n / a film about 2.5 mg 30 pcs Hemofarm

Description

Composition
Active substance:
Indapamide – 2.5 mg ;.
Excipients:
Lactose monohydrate – 76.96 mg, povidone QSO – 2.82 mg Crospovidone – 0.88 mg magnesium stearate – 0.88 mg Sodium lauryl sulfate – 0.44 mg talc – 3.52 mg; sheath: hypromellose – 1.7222 mg macrogol 6000 – 0.3445 mg talc – 1.9030 mg of titanium dioxide, E 171 S.1.77891 – 0.4303 mg.
Description:
Round biconvex tablets, film-coated white. The cross-sectional core of a white or nearly white.
Product form:
Tablets, film-coated, 2.5 mg.
10 tablets in a blister (contour cell packing) made of aluminum foil and polyvinylchloride varnished printed film.
3 blisters (blisters), together with instructions for use of the drug in a pile of cardboard.
Contraindications
Hypersensitivity to indapamide, other derivatives of the sulfonamide or other components of the formulation; anuria, refractory hypokalemia, hepatic encephalopathy, or severe hepatic impairment, severe renal impairment (creatinine clearance less than 30 mL / min), pregnancy, breast-feeding, age of 18 years (insufficient data on the efficacy and safety); lactose intolerance, lactase deficiency, glucose-galactose malabsorption (formulation contains lactose).
Dosage
2.5 mg
Indications
Arterial hypertension.
Interaction with other drugs
Not recommended drug combination
lithium Formulations: the 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 lithium overdose. If necessary, diuretic drugs can be used in combination with drugs lithium, it should be carefully selected dose preparations regularly monitoring plasma lithium concentrations.
Combinations of drugs that require special attention
Drugs that can cause arrhythmia type “pirouette”:
Class IA antiarrhythmic agents (quinidine, gidrohinidin, disopyramide); Class III antiarrhythmics (amiodarone, dofetilide, ibutilide) and sotalol; some neuroleptics: phenothiazines (Chlorpromazine, tsiamemazin, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol); others: bepridil, cisapride, difemanil, erythromycin (intravenous (i / v)), 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, correct it before the combination therapy indapamide with the above drugs. Necessary to monitor the patient’s clinical status, control of the content of plasma electrolytes, blood, ECG.
In patients with hypokalemia is necessary to use drugs, do not cause arrhythmia type “pirouette”.
Nestepoidnye antiinflammatory drugs> NSAIDs] (when the system designation: including selective inhibitors niklooksigenazy-2 ‘FOOT-2) saliiilatov high doses (> 3 g / day) may be reduced antihypertensive effect of indapamide.
With substantial fluid loss may develop acute renal failure (due to a decrease in glomerular filtration rate (GFR). Patients must compensate for the loss of fluids and regular monitoring of renal function at the beginning of treatment and during treatment.
Inhibitors of angiotensin converting enzyme (ACE) inhibitors: ACE inhibitors assignment patients with hyponatremia (especially patients with renal artery stenosis) is accompanied by the risk of sudden hypotension and / or acute renal failure.
Patients with hypertension and possibly reduced due diuretics, sodium content in the blood plasma must:
3 days prior to initiation of treatment with an ACE inhibitor stop taking diuretics. Subsequently, if necessary, diuretics can be resumed; or begin therapy with an ACE inhibitor with a low dose, followed by 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, in the first weeks of ACE inhibitors in patients need to monitor renal function (creatinine concentration in blood plasma).
Other drugs that can cause hypokalemia: amfotepiiin B (w / w), gluco- and mineraloko tikosteroidy (ISPs systemic administration tetrakozaktid, laxatives, intestinal motility stimuliruyuishe:. Increased risk of hypokalaemia (additive effect) need for regular monitoring of potassium in the blood plasma if necessary -. its correction Particular attention should be given to patients while receiving cardiac glycosides is recommended to use laxatives, do not stimulate bowel motility..
Baclofen: may increase antihypertensive action. Patients should compensate for the loss of fluid and at the beginning of treatment carefully monitor renal function.
Sepdechnye 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 that require attention
Potassium-sparing diuretics (amiloride, spironolactone, tpiamteren, eplerenone): co-administration of indapamide with potassium-sparing diuretics advisable in some patients, but it does not exclude the possibility of hypokalemia (especially in patients with diabetes and renal failure) 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 patients receiving diuretics, particularly “loop”, while the appointment of metformin increases the risk of lactic acidosis. Metformin should not be used if the creatinine concentration exceeds 15 mg / L (135 pmol / l) in men and 12 mg / L (110 pmol / l) in women.
Iodinated 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.
Tricyclic antidepressants, antipsychotic drugs (neuroleptics):
drugs of these classes increase the antihypertensive effect of indapamide and increase the risk of orthostatic hypotension (additive effect).
Calcium salts: while the appointment may develop hypercalcemia due to decreased renal excretion of calcium ions.
Cyclosporine, tacrolimus: possible to increase the concentration of creatinine in the blood plasma concentration of unchanged circulating cyclosporine, even with normal fluid and sodium ions.
Corticosteroids (minerala- glyukokortiko and steroids), tetracosactide (at system assignment): reduced antihypertensive effect (fluid retention and sodium ions by the action of corticosteroids).
Overdose
Symptoms: marked decrease in blood pressure, water-electrolyte disturbances (hyponatremia, hypokalemia), nausea, vomiting, cramps, dizziness, drowsiness, lethargy, confusion, respiratory depression, polyuria, oliguria or anuria until (due to hypovolemia). Patients with cirrhosis may develop hepatic coma.
Treatment: gastric lavage and / or administration of activated charcoal, vodnoelektrolitnogo balance correction, symptomatic therapy. No specific antidote.
pharmachologic effect
Pharmacological group:
Diuretic.
Pharmacodynamics:
Antihypertensives (diuretic, vasodilator). By pharmacological properties similar to the thiazide diuretics (gives the reabsorption of sodium ions in the loop of Henle cortical segment). Increases urinary excretion of sodium, chlorine and to a lesser extent of potassium and magnesium ions, which is accompanied by increased diuresis. With the ability to selectively block the “slow” calcium channels, increases the elasticity of the artery walls and decreases total peripheral vascular resistance. It helps to reduce the hypertrophy of the left ventricle of the heart. No effect on lipid content in the blood plasma (triglycerides, low density lipoprotein, high density lipoprotein); It has no effect on carbohydrate metabolism (including patients with concomitant diabetes). Reduces the sensitivity of the vascular wall to norepinephrine and angiotensin II, stimulates the synthesis of prostaglandin E2 and prostacyclin PGI2, reduces the production of free and stable oxygen radicals.
The hypotensive effect develops by the end of the first week, it lasts for 24 hours on a background of a single dose. Indapamide has a hypotensive action at doses that do not have a pronounced diuretic effect.
Pharmacokinetics:
Once inside quickly and completely absorbed in the gastrointestinal tract; Bioavailability – high (93%). Eating slows down the rate of absorption, but does not affect the amount of the absorbed compound. Maximum plasma concentration is achieved 1-2 hours after ingestion. Repeated receptions fluctuations in plasma concentrations of drug in the interval between receptions of two reduced doses. The equilibrium concentration is established after 7 days of regular reception. Half-life is 14-24 hours (mean 18 hours), the connection with plasma proteins 79%. Also binds with elastin smooth muscles of the vascular wall. Has a high volume of distribution, passes through the blood-tissue barriers (including placental) passes into breast milk. It is metabolized in the liver. Kidneys displayed 60-80% as metabolites (unchanged output of about 5%), through the intestine – 20%. In patients with renal insufficiency The pharmacokinetics does not change. Not accumulates.
Pregnancy and breast-feeding
Indapamide is not recommended during pregnancy. Diuretics can cause fetoplacental ischemia and lead to disturbance of development of the fetus. Indapamide is excreted in breast milk, therefore the use of the drug during breast feeding is not recommended. If necessary, use during lactation, breast-feeding should be discontinued.
Conditions of supply of pharmacies
Prescription.
side effects
The frequency of possible side effects listed in accordance with the World Health Organization classification: very common – more than 10%; often – more than 1% and less than 10%; infrequently – more than 0.1% and less than 1%; rarely – more than 0.01% and less than 0.1%; very rarely – less than 0.01% (including events); frequency not known – can not be determined from the available data.
From the blood and lymphatic system: very rarely – thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia.
From the nervous system, it is rare – vertigo, fatigue, headache, paresthesia; the frequency is unknown – swoon.
On the part of the cardiovascular system, it is very rare – arrhythmia, hypotension; frequency is unknown – increase QT interval on the ECG, arrhythmias such as “pirouette» ( «torsade de pointes») (possibly fatal).
From the digestive system: rarely – vomiting; rarely – nausea, constipation, dry mouth; very rarely – pancreatitis.
On the part of the kidney and urinary tract: rarely – renal failure.
Of the liver and biliary tract: rarely – liver dysfunction; frequency not known – in hepatic failure may cause hepatic encephalopathy, hepatitis.
Immune System: hypersensitivity reactions, mainly dermatological, in patients with a predisposition to allergic and asthmatic reactions: often – maculopapular rash; rarely – hemorrhagic vasculitis; very rarely – angioedema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome; the frequency is unknown – in patients with acute systemic lupus erythematosus possible worsening of the disease course.
Cases of photosensitivity reactions.
Laboratory findings: very rarely – hypercalcemia; frequency is unknown – increasing concentration of uric acid in blood glucose (thiazide and thiazide diuretics should be used with caution in patients with gout and diabetes mellitus); increased activity of “liver” transaminases; decrease in potassium and hypokalemia, especially significant for patients at risk (see section “Special Instructions”.); hyponatremia, accompanied by hypovolemia, dehydration and otrostaticheskoy hypotension. Simultaneous chloropenia can cause metabolic alkalosis compensatory character (the probability and severity of this effect is low).
special instructions
In the appointment of thiazide and thiazide diuretics in patients with impaired hepatic function may develop hepatic encephalopathy, particularly in case of violation of water-electrolyte balance. In this case, the diuretic should be stopped immediately.
Fotochuvstvitelnost
In patients receiving thiazide and thiazide diuretics reported cases of photosensitivity reactions. In the case of photosensitivity reactions in patients receiving the drug should be discontinued treatment. If necessary, continue the diuretic therapy is recommended to protect the skin from exposure to sunlight or artificial UV rays.
Water and electrolyte balance
The content of sodium ions in plasma
Prior to treatment is necessary to determine the sodium content 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 sodium content, 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 content is required in patients with cirrhosis and elderly patients. The content of 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 (potassium content of less than 3.4 mmol / l) in the following groups of patients: patients are elderly or debilitated patients, patients receiving concomitant drug therapy with other anti-arrhythmic drugs and drugs that may increase the interval QT, patients with cirrhosis liver, peripheral edema or ascites, coronary artery disease, heart failure. Hypokalemia in these patients groups enhances the toxic effects of cardiac glycosides and increased risk of arrhythmia.
In addition, the high-risk group includes patients with increased QT interval, while it does not matter due to the increase or congenital causes of action of drugs. Hypokalemia, as well as bradycardia, a condition conducive to the development of severe arrhythmia, and particularly arrhythmias such as “pirouette” which 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 the content of potassium in the blood must be held during the first week of starting treatment. When hypokalemia should be assigned the appropriate treatment.
The content of calcium ions in the blood plasma
Thiazide and thiazide diuretics reduce calcium excretion by the kidneys, thereby causing a mild and transient hypercalcemia. Hypercalcemia in patients receiving indapamide may be a consequence of previously undiagnosed hyperparathyroidism.
Should stop taking diuretic medications before the test function of the parathyroid glands.
The concentration of plasma glucose
In patients with diabetes is extremely important to control the blood glucose concentration, especially in the presence of hypokalemia.
Uric acid
Patients with gout may increase the incidence of seizures or worsen gout. diuretics 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 patients below 25 mg / l or 220 mmol / l). Elderly patients in plasma creatinine concentration is calculated based on 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 fluid and sodium 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
Indapamide may give a positive result in doping control. Sulfonamide derivative can exacerbate during systemic lupus erythematosus (must be borne in mind when assigning indapamide).
In some patients, especially at the beginning of the treatment or adding another antihypertensive agent, there may be various responses associated with decreased blood pressure. If this happens, you must be careful when driving and operating machinery.
Storage conditions
Stored in a dry place, protected from light, at a temperature from 15 to 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Inside, 1 tablet per day (preferably in the morning). The drug is taken without food, drinking plenty of fluids.
If after 4-8 weeks of treatment, desired therapeutic effect, the dose of the drug is not recommended to increase can not be achieved (risk of side effects without increasing angigipertenzivnogo effect increases). Instead, the drug regimen is recommended to include other agents that is not a diuretic. In cases where treatment should begin with the reception of the two drugs, the dose of the drug remains at indapamide 2.5mg in the morning once a day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist