Indapamide-Teva SR 1.5 mg 30 tablets — Made in Germany — Free Delivery
(Indapamide-Teva SR)
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Description Indapamide-Teva SR 1.5 mg 30 tablets — Made in Germany — Free Delivery
Pharmacological properties
Pharmacodynamics. Mechanism of action. Indapamide is a sulfonamide diuretic with an indole ring, which is pharmacologically related to thiazide diuretics and is prescribed for the treatment of ag. Indapamide acts at the level of the kidneys and blood vessels.
Indapamide inhibits sodium reabsorption in the cortical segment of the kidney. This increases the excretion of sodium and chloride in the urine and, to a lesser extent, potassium and magnesium, thus increasing urine output.
Pharmacodynamic effects. Clinical studies of phase II – III monotherapy with indapamide have demonstrated that the antihypertensive effect of indapamide lasts 24 hours. The diuretic effect of indapamide is moderate. The antihypertensive effect of indapamide is associated with an improvement in the elasticity of the arteries and a decrease in the resistance of arterioles and OPSS. Indapamide reduces left ventricular hypertrophy.
When the recommended dose is exceeded, the therapeutic effect of thiazides and thiazide-like diuretics does not increase, while the number of adverse events increases. If the treatment is not effective enough, it is not recommended to increase the dose.
As shown in studies of various durations (short-term, medium-term and long-term) involving patients with hypertension, indapamide:
does not affect lipid metabolism (TG, cholesterol / LDL and cholesterol / HDL);
does not affect the metabolism of carbohydrates, even in patients with diabetes mellitus and hypertension.
Indapamide acts at the level of the vascular wall by:
a decrease in the contractility of vascular smooth muscles, which is associated with changes in the transmembrane exchange of ions (mainly calcium);
stimulation of the synthesis of prostaglandins PGE2 and prostacyclin PGI2 (vasodilator and inhibitor of platelet aggregation).
Pharmacokinetics. The active ingredient - 1.5 mg of indapamide is contained in a sustained-release tablet based on a matrix. The distribution of indapamide in the matrix system ensures uniform release from the tablet.
Absorption. The released fraction of indapamide is rapidly and completely absorbed in the gastrointestinal tract. Food intake slightly increases the rate of absorption, but does not affect the amount of the preparation absorbed.
Cmax in blood plasma after taking a single dose is reached after about 12 hours, further use of the preparation reduces fluctuations in the level of indapamide in blood plasma in the interdose interval. There are intra-individual fluctuations.
Distribution. Plasma protein binding - 79%. T½ is 14-24 hours (average 18 hours). The stable concentration level is reached after 7 days. Regular use does not cause cumulation.
Excretion. Indapamide is excreted in the urine (70% of the dose) and feces (22%) as inactive metabolites.
High risk patients. Pharmacokinetic parameters do not change in patients with moderate renal impairment.
Indications
Essential hypertension in adults.
Application
Mode of application. for oral administration.
Dosing. 1 tablet daily, preferably in the morning. The tablets should be swallowed whole without chewing with water.
The use of higher doses of the preparation does not lead to an increase in the antihypertensive effect, but the diuretic effect increases.
Special patient groups
Renal failure (see SPECIAL INDICATIONS and CONTRAINDICATIONS). In patients with severe renal impairment (creatinine clearance 30 ml / min), the use of the preparation is contraindicated. Thiazide and thiazide-like diuretics are most effective if renal function is not impaired or if the impairment is minor.
Elderly age (see SPECIAL INSTRUCTIONS). In elderly patients, plasma creatinine levels should be appropriate for age, body weight and gender. Elderly patients Indapamide-Teva SR can be prescribed if renal function is not impaired or if the impairment is minor.
Patients with impaired liver function (see SPECIAL INDICATIONS and CONTRAINDICATIONS). In the case of severe liver dysfunction, treatment is contraindicated.
Contraindications
Hypersensitivity to indapamide, other sulfonamides or any other components of the preparation; severe renal failure; hepatic encephalopathy or severe liver dysfunction; hypokalemia.
Side effects
The most commonly reported occurrence of the following adverse reactions: hypersensitivity reactions, mainly dermatological, in patients prone to the development of allergic and asthmatic reactions, and maculopapular rash.
During clinical studies, hypokalemia (plasma potassium level 3.4 mmol / L) was observed in 10% of patients, in 4% of cases the level of potassium decreased to 3.2 mmol / L after 4-6 weeks of treatment. After 12 weeks of therapy, the average decrease in the level of potassium in the blood plasma was 0.23 mmol / L.
Most of the side effects, both clinical and laboratory parameters, are dose-dependent.
During treatment with indapamide, the following side effects were noted below with such a frequency of occurrence: very often (≥1 / 10), often (from ≥1 / 100 to 1/10), infrequently (from ≥1 / 1000 to 1/100) , rare (≥1 / 10,000), very rare (1 / 10,000), frequency unknown (cannot be determined from available information).
On the part of the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia.
From the nervous system: rarely - dizziness, fatigue, headache, paresthesia; frequency unknown - syncope.
From the side of the organ of vision: the frequency is unknown - myopia, blurred vision, visual impairment.
From the side of the heart: very rarely - arrhythmia; the frequency is unknown - paroxysmal ventricular tachycardia of the pirouette type (torsades de pointes), which can be fatal (see SPECIFIC INSTRUCTIONS, INTERACTIONS).
From the vascular system: very rarely - arterial hypotension.
From the digestive system: infrequently - vomiting; rarely - nausea, constipation, dry mouth; very rarely - pancreatitis.
From the side of the kidneys and urinary tract: very rarely - renal failure.
From the hepatobiliary system: very rarely - liver dysfunction; the frequency is unknown - with hepatic failure, hepatic encephalopathy may occur (see SPECIAL INDICATIONS, CONTRAINDICATIONS), hepatitis.
On the part of the skin and its derivatives. Hypersensitivity reactions, mainly from the skin, in patients with a tendency to allergic and asthmatic reactions: often - maculopapular rash; infrequently, purple; very rarely - angioedema and / or urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome; the frequency is unknown - an exacerbation of the existing acute systemic lupus erythematosus is possible. Cases of photosensitivity reactions have been reported (see SPECIAL INSTRUCTIONS).
From the side of metabolism and metabolism: very rarely - hypercalcemia; the frequency is unknown - a decrease in the level of potassium with the occurrence of hypokalemia, in particular serious, in certain categories of high-risk patients (see SPECIAL INSTRUCTIONS); hyponatremia with hypovolemia can lead to dehydration and orthostatic hypotension; the concomitant loss of chlorine ions can cause secondary compensatory metabolic alkalosis (the frequency and severity of this phenomenon is low).
Research: frequency is unknown - lengthening of the Q – T interval on the ECG (see SPECIAL INSTRUCTIONS, INTERACTIONS); an increase in the level of uric acid and glucose in the blood plasma during treatment with diuretics, the rationale of prescribing which should be carefully weighed before prescribing to patients with gout or diabetes mellitus; increased levels of liver enzymes.
Special instructions
Patients with impaired liver function. in patients with impaired liver function, the use of thiazide diuretics can cause hepatic encephalopathy, especially in case of electrolyte imbalance. in this case, you should immediately stop using diuretics.
Photosensitivity. Cases of photosensitivity reactions have been reported in patients taking thiazide and thiazide-like diuretics (see SIDE EFFECTS). If such reactions occur, diuretic treatment is recommended to be discontinued. If it is necessary to re-prescribe diuretics, you should protect vulnerable areas from the action of the sun or sources of artificial ultraviolet radiation.
Excipients. The preparation contains lactose, so it should not be prescribed to patients with congenital galactose intolerance, glucose and galactose malabsorption syndrome, Lapp lactase deficiency.
Water-electrolyte balance
Plasma sodium level. Before starting treatment, it is necessary to monitor the level of sodium in the blood plasma and subsequently, during treatment, to regularly monitor it. Decreases in plasma sodium levels may initially be asymptomatic and should be monitored regularly. Sodium monitoring should be done more frequently in elderly patients and in patients with cirrhosis. Any diuretic can cause hyponatremia, sometimes with serious consequences.
Hyponatremia with hypovolemia can lead to dehydration and orthostatic hypotension; the concomitant loss of chlorine ions can cause secondary compensatory metabolic alkalosis (the frequency and severity of this phenomenon is low).
Plasma potassium level. A decrease in the level of potassium in the blood plasma with the onset of hypokalemia is the main risk with the use of thiazide and thiazide-like diuretics. The likelihood of developing hypokalemia (3.4 mmol / L) must be prevented in certain high-risk categories of patients, such as elderly patients, patients with insufficient nutrition and / or taking many preparationы, patients with cirrhosis of the liver, especially with edema or ascites, patients with ischemic heart disease and heart failure. In such cases, hypokalemia leads to increased cardiotoxicity of cardiac glycosides and the risk of arrhythmias.
The risk group also includes patients with an extended Q – T interval of congenital or iatrogenic genesis. In such patients, hypokalemia, like bradycardia, can contribute to the development of severe cardiac arrhythmias, in particular paroxysmal ventricular tachycardia of the pirouette type (torsades de pointes), which can be fatal.
Regular monitoring of the level of potassium in the blood is necessary in all cases mentioned above. The first analysis should be carried out within the 1st week of treatment. If hypokalemia is determined, it should be corrected.
Plasma calcium level. Thiazide and thiazide-like diuretics can reduce urinary calcium excretion and lead to a slight and temporary increase in its level in blood plasma. Severe hypercalcemia may be due to previously undiagnosed hyperparathyroidism. In this case, treatment should be discontinued and a study of the function of the parathyroid glands should be carried out.
Blood glucose level. Monitoring of blood glucose levels in diabetic patients is necessary, especially in the presence of hypokalemia.
Uric acid. Patients with elevated uric acid levels may tend to have more gout attacks.
Kidney function and diuretics. Thiazide and thiazide-like diuretics are most effective if renal function is not impaired or if the impairment is insignificant (plasma creatinine is 25 mg / l, that is, 220 μmol / l in adults). In elderly patients, plasma creatinine levels should be appropriate for age, body weight and gender. Hypovolemia associated with the loss of water and sodium due to the use of diuretics at the beginning of treatment leads to a decrease in glomerular filtration rate. This can lead to an increase in blood urea and creatinine levels. This transient functional renal failure is of no consequence in individuals with normal renal function, but may worsen existing renal failure.
In athletes, indapamide can cause a positive reaction during doping control.
Use during pregnancy and lactation. Pregnancy. Data on the use of indapamide in pregnant women are absent or limited (less than 300 cases). The consequence of long-term use of thiazide diuretics during the third trimester of pregnancy may be a decrease in the BCC in a pregnant woman and uteroplacental blood filling, which can lead to placental ischemia and fetal growth retardation. Animal studies have not revealed direct or indirect toxic effects on reproductive health. As a preventive measure, the use of indapamide during pregnancy should be avoided.
Lactation. There is insufficient data on the penetration of indapamide / metabolites into breast milk. Hypersensitivity to sulfonamide derivatives and hypokalemia may occur. The risk to newborns / babies cannot be excluded. Indapamide belongs to thiazide-like diuretics, the use of which during breastfeeding is associated with a decrease or even suppression of lactation. Indapamide is contraindicated during breastfeeding.
Fertility Reproductive toxicity studies have shown no effect on fertility in male and female rats. No effect on human fertility is expected.
Children. The safety and efficacy of Indapamide-Teva SR in children have not been established. No data available.
The ability to influence the reaction rate when driving or working with other mechanisms. Indapamide does not affect alertness. But in the event of adverse reactions (see SIDE EFFECTS), including symptoms associated with a decrease in blood pressure, especially at the beginning of treatment or when used in combination with another antihypertensive preparation, the ability to drive or operate machinery may be impaired.
Interactions
Combinations not recommended
Lithium: Plasma lithium levels may increase due to decreased excretion of lithium (as with a salt-free diet). If the appointment of a diuretic is required, it is necessary to carefully monitor the level of lithium in the blood plasma and adapt its dose.
Combinations to be used with caution
Preparations that can cause pirouette-type paroxysmal ventricular tachycardia:
class Ia antiarrhythmic preparations (quinidine, hydroquinidine, disopyramide);
class III antiarrhythmic preparations (amiodarone, sotalol, dofetilide, ibutilide);
some antipsychotic preparations: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine); benzamides (amisulpride, sulpiride, sultopride, tiapride); butyrophenones (droperidol, haloperidol);
other preparations: bepridil, cisapride, diphemanil, erythromycin i.v., halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine i.v.
When using indapamide with the aforementioned preparations, the risk of ventricular arrhythmias increases, in particular torsades de pointes - paroxysmal ventricular tachycardia of the pirouette type (hypokalemia is a risk factor).
Before prescribing such a combination, the potassium level is checked and, if necessary, corrected. The clinical condition of patients, plasma electrolytes and ECG should be monitored. In the presence of hypokalemia, preparations should be prescribed that do not lead to the occurrence of torsade de pointes.
NSAIDs (for systemic use), including selective COX-2 inhibitors, high doses of salicylates (≥3 g / day): may reduce the hypotensive effect of indapamide. Patients with dehydration are at increased risk of acute renal failure (due to decreased glomerular filtration). Before starting treatment, it is necessary to restore water balance and check kidney function.
ACE inhibitors: sudden arterial hypotension and / or ARF may occur in patients with hyponatremia (especially in patients with renal artery stenosis).
AG. In patients with hypertension, in whom the previous use of a diuretic has led to hyponatremia, it is necessary to stop the use of diuretics 3 days before starting treatment with ACE inhibitors and then, if necessary, restore diuretic therapy or start prescribing an ACE inhibitor with a low initial dose, followed by a gradual increase.
In patients with congestive heart failure, the use of an ACE inhibitor should be started at the lowest dose and, possibly, after a reduction in the dose of a concomitant diuretic. In all cases, close monitoring of renal function (plasma creatinine level) is necessary during the first weeks of treatment with ACE inhibitors.
Preparations, simultaneous administration with which can cause hypokalemia: gluco- and mineralocorticoids (for systemic use), amphotericin B (iv), tetracosactide, laxatives that stimulate peristalsis. The risk of hypokalemia increases (additive effect). It is necessary to monitor and, if necessary, correct the level of potassium in the blood plasma, special attention should be paid to simultaneous therapy with cardiac glycosides. It is recommended to prescribe laxatives that do not stimulate peristalsis.
Cardiac glycosides: The presence of hypokalemia increases the cardiotoxicity of cardiac glycosides. It is necessary to monitor the level of potassium in the blood plasma, ECG control and, if necessary, adjust the therapy.
Baclofen: enhances the hypotensive effect of the preparation. At the beginning of therapy, it is necessary to restore the water-electrolyte balance and control the renal function.
Combinations requiring attention
Potassium-sparing diuretics (amiloride, spironolactone, triamterene): this combination does not exclude the possibility of hypokalemia or hyperkalemia (especially in patients with diabetes mellitus or with renal failure). Plasma potassium levels and ECG monitoring should be monitored and therapy adjusted if necessary.
Metformin: the risk of lactic acidosis increases in the case of functional renal failure due to the use of diuretics and especially loop diuretics. Metformin should not be prescribed if the blood creatinine level exceeds 15 mg / L (135 μmol / L) in men and 12 mg / L (110 μmol / L) in women.
Iodine contrast agents: if dehydration occurs due to diuretics, the risk of developing acute renal failure increases, especially with the use of high doses of iodine contrast agents. It is necessary to restore the water balance before prescribing iodine contrast agents.
Imipramine-like antidepressants, antipsychotics: the risk of orthostatic hypotension increases (additive effect).
Calcium salts: hypercalcemia may occur due to a decrease in the elimination of calcium in the urine.
Cyclosporine, tacrolimus: the risk of an increase in plasma creatinine without affecting the level of circulating cyclosporine, even if there is no water and sodium deficiency.
Corticosteroids, tetracosactide (systemic action): a decrease in the hypotensive effect of indapamide due to the retention of water and sodium ions under the influence of corticosteroids.
Overdose
Indapamide does not show toxicity at a dose of 40 mg, that is, at a dose that exceeds the therapeutic dose by 27 times.
Overdose symptoms are primarily manifested by water-electrolyte disturbances (hyponatremia, hypokalemia). Clinically possible: nausea, vomiting, hypotension, convulsions, drowsiness, dizziness (vertigo), confusion, polyuria or oliguria up to anuria (due to hypovolemia).
Treatment. First aid measures include the rapid elimination of the preparation by gastric lavage and / or the appointment of activated charcoal, followed by the restoration of water and electrolyte balance in a hospital setting.
Storage conditions
At a temperature not exceeding 30 ° c.
Tags: Indapamide
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