Indapamid-Teva
Indapamid-Teva: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Indapamide-Teva
ATX code: C03BA11
Active ingredient: indapamide (Indapamide)
Manufacturer: Balkanpharma-Dupnitsa, AD (Balkanpharma-Dupnitsa, AD) (Bulgaria); Balkanpharma-Razgrad AD (Bulgaria); Merkle, GmbH (Germany)
Description and photo update: 2019-11-07
Prices in pharmacies: from 49 rubles.
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Indapamide-Teva is an antihypertensive drug that has a diuretic effect.
Release form and composition
Dosage forms of Indapamide-Teva:
- film-coated tablets: biconvex, almost white (10 pcs. in a blister made of aluminum foil / polyvinyl chloride, in a cardboard box 3 blisters; 30 pcs. in a polyethylene bottle);
- capsules: opaque, hard gelatinous, size 4, brown cap, pink body; content - almost white or white powder (10 pcs. in a blister of aluminum foil / polyvinyl chloride, in a cardboard box of 3, 5 or 10 blisters).
Each pack also contains instructions for the use of Indapamid-Teva.
1 tablet contains:
- active substance: indapamide hemihydrate - 2.5 mg;
- additional components: corn starch, lactose monohydrate, povidone, magnesium stearate, calcium phosphate dihydrate, talc;
- film coating: Opadry (Opadry OY-B-28920) - titanium dioxide (E171), polyvinyl alcohol, soy lecithin, talc, xanthan gum.
1 capsule contains:
- active substance: indapamide hemihydrate - 2.44 mg, which is equivalent to anhydrous indapamide in the amount of 2.5 mg;
- additional components: sodium carboxymethyl starch, corn starch, magnesium stearate, lactose monohydrate;
- capsule shell: titanium dioxide, gelatin, iron dyes, oxides yellow, red and black.
Pharmacological properties
Pharmacodynamics
Indapamide is an antihypertensive agent that belongs to the group of sulfonamide derivatives, which is similar in pharmacological properties to thiazide diuretics. It exhibits moderate saluretic and diuretic effects due to the suppression of the reabsorption of chlorine, sodium, hydrogen and, to a lesser extent, magnesium and potassium ions in the cortical segment of the distal nephron tubule and in the proximal renal tubules.
The active substance Indapamide-Teva lowers the tone of the smooth muscles of the arterial walls and has a vasodilating effect, weakens the total peripheral vascular resistance (OPSS). These effects are mediated by a decrease in the reactivity of the vascular wall to angiotensin II and norepinephrine, an increase in the production of prostaglandins, showing vasodilating activity, and blockage of calcium flow in vascular smooth muscle cells.
Indapamide helps to reduce left ventricular hypertrophy, and also has an antihypertensive effect in doses that do not have a pronounced diuretic effect. When used in therapeutic doses, its effect on the course of carbohydrate and lipid metabolism is not observed (including in patients with diabetes mellitus).
Thiazide-like and thiazide diuretics in doses exceeding those required to provide the required therapeutic effect are characterized by the formation of a plateau of the therapeutic effect, while the severity of adverse reactions continues to increase. As a consequence, it is impossible to increase the dose of indapamide in the case when using the recommended dose fails to achieve a therapeutic effect.
When taking pills, the antihypertensive effect is noted at the end of the first or the beginning of the second week of the course with constant intake of Indapamide-Teva and lasts for 24 hours against the background of a single dose.
Pharmacokinetics
After oral administration, indapamide is rapidly and completely absorbed in the gastrointestinal tract (GIT), the bioavailability of the drug is 93%. Food intake slows down the rate of absorption of indapamide, but does not affect the dose of the absorbed active substance. After taking a single dose in the blood plasma, the maximum concentration (C max) of indapamide is reached in about 0.5–2 hours.
Its steady-state concentration (Css) in the blood is recorded 7 days after the start of regular use of Indapamide-Teva. The substance binds to blood plasma proteins by an average of 70–80%. As a result of the presence of a high affinity for elastin, indapamide accumulates in the smooth muscles of the vascular walls, and also combines with carbonic anhydrase of erythrocytes, without inhibiting the activity of this enzyme.
Metabolic transformation takes place in the liver, repeated use does not lead to cumulation. Indapamide is characterized by a large volume of distribution, it passes through the histohematological barriers (including the placental one) and is excreted in breast milk. It is eliminated mainly by the kidneys (60–70% of the administered dose) and with feces (16–20%) in the form of inactive metabolites, approximately 7% - unchanged. The half-life (T 1/2) from blood plasma is approximately 14-18 hours.
Indications for use
Indapamide-Teva is recommended for the treatment of arterial hypertension.
Contraindications
Absolute:
- hypokalemia;
- severe renal failure, anuria;
- severe violations of the liver, including hepatic encephalopathy;
- lactase deficiency, lactose intolerance, glucose / galactose malabsorption syndrome;
- age up to 18 years;
- pregnancy and lactation;
- combined use with drugs that prolong the QT interval (for tablets);
- hypersensitivity to any component of the drug and other sulfonamide derivatives.
Relative (Indapamide-Teva should be used with caution):
- hepatic and / or renal failure of moderate severity;
- disorders of water and electrolyte balance (including hyponatremia);
- hyperuricemia, especially with gout and urate nephrolithiasis (the risk of exacerbation of gout increases);
- diabetes mellitus, for tablets - in the stage of decompensation (it is required to control the glucose content in the blood, especially with established hypokalemia);
- increased on the electrocardiogram (ECG) QT interval (regardless of whether this increase is caused by congenital causes or the effect of drugs);
- combination therapy with other antiarrhythmic drugs;
- hyperparathyroidism (hypercalcemia detected during admission may be the result of undiagnosed hyperparathyroidism).
Additional relative contraindications for Indapamide-Teva capsules: chronic heart failure (CHF), ischemic heart disease, combined administration with drugs that prolong the QT interval, ascites, old age, weakened state.
Indapamid-Teva, instructions for use: method and dosage
Indapamide-Teva capsules and tablets are taken orally with a sufficient amount of liquid, they should be swallowed whole without opening or chewing.
The recommended dose of the drug is 1 capsule / tablet (2.5 mg) once a day, preferably in the morning, regardless of the meal time.
The maximum daily dose of Indapamide-Teva is 2.5 mg (1 tablet / capsule).
Side effects
- cardiovascular system: extremely rarely - palpitations, orthostatic hypotension, arrhythmia, marked decrease in blood pressure; with an unknown frequency - changes in the ECG (increase in the QT interval) in the form of manifestations of hypokalemia; for capsules - pirouette-type arrhythmia (with the threat of death);
- nervous system: dizziness, headache, nervousness, lethargy; for tablets - insomnia / drowsiness, vertigo, asthenia, depression; rarely - malaise, increased fatigue, tension, muscle spasm, anxiety, irritability; with an unknown frequency (for capsules) - fainting;
- digestive system: infrequently - vomiting; rarely - dryness of the oral mucosa, constipation / diarrhea, nausea; for pills - abdominal pain, anorexia; extremely rare - liver dysfunction, pancreatitis; with an unknown frequency - hepatic encephalopathy against the background of hepatic failure;
- urinary system: for tablets - nocturia, urinary tract infections, polyuria; extremely rare (for capsules) - renal failure;
- respiratory system (for tablets): cough, pharyngitis, sinusitis, rarely rhinitis;
- blood and lymphatic system: leukopenia, thrombocytopenia, agranulocytosis, hemolytic anemia, bone marrow aplasia;
- immune system (hypersensitivity reactions, mainly dermatological, in patients with a predisposition to allergic / asthmatic reactions): often - maculopapular rash (capsules), pruritus, maculopapular rash (tablets); infrequently - hemorrhagic vasculitis; extremely rare - urticaria; for capsules - angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis; isolated cases - photosensitivity reactions; with an unknown frequency - with the concomitant acute form of systemic lupus erythematosus, aggravation of the course of this disease;
- others (for pills): sweating, weight loss, back / chest pain, rhinorrhea, flu-like syndrome, infections, decreased potency / libido, tingling in the extremities;
- laboratory parameters: hyperuricemia, hypercalcemia, hypochloremia, hyperglycemia, hyponatremia, hypokalemia, increased blood urea nitrogen, hypercalciuria, glucosuria, hypercreatininemia.
Overdose
Symptoms of Indapamide-Teva overdose include nausea, vomiting, water-electrolyte disturbances (hyponatremia, hypokalemia), weakness, drowsiness, marked decrease in blood pressure, respiratory depression; in patients with cirrhosis of the liver - the occurrence of hepatic coma; additionally for capsules - polyuria / oliguria up to anuria (as a result of hypovolemia), dizziness, lethargy, convulsions, confusion.
With the development of symptoms of an overdose, gastric lavage and / or intake of activated carbon, restoration of water and electrolyte balance, and symptomatic treatment are prescribed. The specific antidote for indapamide is unknown.
special instructions
Against the background of long-term use of Indapamide-Teva or its use in high doses, electrolyte disturbances may occur. These side effects are more often observed in persons with CHF II – IV functional class according to the classification of the New York Heart Association (NYHA), with liver damage, diarrhea and vomiting, as well as in patients adhering to a salt-free diet.
In patients with functional liver pathologies, Indapamide-Teva therapy can cause the development of hepatic encephalopathy, especially against the background of concomitant violations of the water-electrolyte balance. If this complication occurs, the drug should be stopped immediately.
Plasma blood sodium levels should be established before starting treatment with the drug, which may result in hyponatremia, in some cases with very serious consequences. Decreases in plasma sodium may initially be asymptomatic and should be monitored regularly. In elderly patients or with liver cirrhosis, the sodium concentration in the blood should be determined more often.
In patients with liver cirrhosis, ascites and peripheral edema, patients with coronary artery disease, CHF, as well as debilitated and elderly patients, it is necessary to prevent hypokalemia. In this risk group, hypokalemia can provoke an aggravation of the toxic effect of cardiac glycosides, as well as increase the risk of cardiac arrhythmias. During therapy, regular monitoring of the plasma potassium concentration is necessary. The initial measurement of its content is recommended to be made during the first week of the course and, if hypokalemia is detected, an appropriate correction should be made.
In the presence of arterial hypertension and possible hyponatremia (as a result of taking diuretics), it is necessary to stop using Indapamide-Teva 3 days before starting treatment with angiotensin-converting enzyme (ACE) inhibitors and switch to potassium-sparing diuretics, or start treatment with ACE inhibitors with low doses, with their further gradual raising if necessary. During the first 7 days of ACE inhibitors therapy, the plasma concentration of blood creatinine should be monitored.
If photosensitivity reactions develop during the use of Indapamide-Teva, you should stop taking it. If it is necessary to continue treatment with indapamide hemihydrate, it is required to protect the skin from exposure to sunlight or artificial ultraviolet rays.
It should be borne in mind that if a doping control is required, indapamide can give a positive doping test result.
Influence on the ability to drive vehicles and complex mechanisms
Patients who drive vehicles or work with complex mechanisms are advised to be careful during therapy.
Application during pregnancy and lactation
Indapamide-Teva should not be taken during pregnancy, since diuretics can lead to placental ischemia with the threat of slowing fetal development.
The drug is excreted in breast milk. Given the risk of adverse reactions in infants, breastfeeding is not recommended while taking Indapamide-Teva.
Pediatric use
Indapamide-Tev is contraindicated in patients under 18 years of age, since the safety and effectiveness of its use in children and adolescents have not been established.
With impaired renal function
Pharmacokinetic characteristics of indapamide in renal failure do not change.
In the presence of severe renal failure, creatinine clearance (CC) below 30 ml / min, as well as acute renal failure of the oligoanuric stage, the drug is contraindicated. In patients with moderate renal insufficiency, drug therapy should be carried out with caution, carefully monitoring the activity of the kidneys at the beginning of the course.
For violations of liver function
In the presence of severe hepatic impairment, Indapamide-Teva is contraindicated.
Patients with moderate renal impairment should use an antihypertensive drug with caution.
Use in the elderly
Elderly patients Indapamide-Teva in the form of capsules should be taken only with normal renal function or with minor renal impairment.
During the period of therapy with Indapamide-Teva, careful monitoring of the concentration of potassium and creatinine in the blood is required.
Drug interactions
- hydroquinidine, quinidine, disopyramide (class IA antiarrhythmics); bretilium tosylate, dofetilide, amiodarone, ibutilide (class III antiarrhythmics); sulpiride, amisulpride, tiapride, sultopride (benzamides); haloperidol, droperidol (butyrophenones); cyamemazine, chlorpromazine, thioridazine, levomepromazine, trifluoperazine (phenothiazines); diphemanil, sotalol, cisapride, bepridil, erythromycin with intravenous administration (i.v.), astemizole, pentamidine, halofantrine, sparfloxacin, mizolastine, vincamine (i.v.), moxifloxacin: the risk of developing ventricular arrhythmias is aggravated, especially against the background hypokalemia; it is required to monitor the content of potassium in the blood, to monitor the clinical condition, ECG and the level of electrolytes in plasma;
- lithium preparations: the plasma concentration of lithium in the blood increases as a result of a decrease in its elimination by the kidneys from the body, which is accompanied by the appearance of signs of an overdose; the simultaneous use of indapamide and lithium preparations is not recommended;
- glucocorticosteroids, non-steroidal anti-inflammatory drugs (NPS), including selective inhibitors of cyclooxygenase-2 (COX-2) and salicylic acid in high doses (from 3 g per day); sympathomimetics, tetracosactide: the hypotensive effect is weakened, against the background of dehydration there is a risk of developing acute renal failure (due to a decrease in the glomerular filtration rate). At the beginning of the combined treatment, it is necessary to normalize the water-electrolyte balance and control the activity of the kidneys;
- ACE inhibitors (captopril, enalapril, ramipril, perindopril, lisinopril, fosinopril, etc.): the risk of arterial hypotension and / or acute renal failure increases, in most cases in the presence of renal artery stenosis;
- baclofen: an increase in the hypotensive effect is recorded;
- amphotericin B (i / v), tetracosactide, systemic gluco- and mineralocorticosteroids, laxatives that activate intestinal motility: the threat of hypokalemia (additive effect) increases. It is required to monitor the content of potassium in plasma and, if necessary, adjust its level;
- calcium supplements: the likelihood of hypercalcemia increases due to a decrease in calcium excretion by the kidneys;
- cardiac glycosides: the toxic effect of these drugs increases with hypokalemia (glycosidic intoxication); monitor the concentration of potassium in the blood, ECG and, if necessary, adjust the treatment;
- antipsychotics, tricyclic antidepressants (imipramine-like): the antihypertensive effect increases and the threat of orthostatic hypotension increases (due to the additive effect);
- triamterene, spironolactone, amiloride (potassium-sparing diuretics): hypokalemia may develop; patients with diabetes mellitus or renal failure are at risk of developing hyperkalemia. Plasma potassium and ECG values should be monitored;
- metformin: the threat of lactic acidosis is aggravated, since during the period of combination therapy, renal failure may occur;
- tacrolimus, cyclosporine: increases the likelihood of an increase in plasma creatinine levels in the blood without affecting the level of circulating cyclosporine;
- indirect anticoagulants (coumarin or indandione derivatives): the effect of these drugs decreases, due to an increase in the concentration of coagulation factors due to a decrease in the volume of circulating blood and an increase in their production by the liver; it may be necessary to change the dose;
- contrast iodine-containing agents (in high doses): the risk of acute renal failure is aggravated; it is necessary to carry out measures to restore the water-electrolyte balance of the blood before the start of the course;
- non-depolarizing muscle relaxants: the blockade of neuromuscular transmission that develops under the influence of these agents is enhanced.
Analogs
The analogues of Indapamid-Teva are Akuter-Sanovel, Akripamid, Indap, Lorvas SR, Arifon Retard, Indapamid, Vero-Indapamid, Ipres Long, Retapres, Ionik, etc.
Terms and conditions of storage
Store out of the reach of children at a temperature not exceeding 25 ° C
Shelf life for tablets is 2 years, for capsules - 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Indapamide-Teva
According to most reviews, Indapamide-Teva is an effective drug that lowers high blood pressure and has a slight diuretic effect. Patients note that it acts gently and quickly, and when taken regularly, it helps to keep blood pressure readings normal for a long time. The advantages of the drug also include its low cost and convenient dosing regimen.
Taking an antihypertensive agent, however, is recommended only as prescribed by a specialist, since it has a large number of contraindications and side effects, and does not help all patients to the same extent.
Price for Indapamid-Teva in pharmacies
The price of Indapamide-Teva 2.5 mg can be per package containing 30 pieces: film-coated tablets - 55–75 rubles; capsules - 70–100 rubles.
Indapamid-Teva: prices in online pharmacies
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Drug name Price Pharmacy |
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Indapamide-Teva 2.5 mg film-coated tablets 30 pcs. RUB 49 Buy |
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Indapamide-Teva tablets p.o. 2.5mg 30 pcs. 82 RUB Buy |
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Indapamide-Teva 2.5 mg capsules 30 pcs. RUB 87 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
