Indapamide-Teva tablets coated. 2.5 mg 30 pcs. (indapamide)

release form

tablets

Packing

30 pcs

Indications

Arterial hypertension.

Contraindications

Hypersensitivity to indapamide, other sulfonamide derivatives or other components of the drug, decompensation of renal function (anuria) and / or liver (including encephalopathy), hypokalemia, concomitant use of drugs that extend the QT interval, pregnancy lactation age up to 18 years (efficacy and safety not established).

Special instructions

In patients taking cardiac glycosides, laxatives, against the background of hyperaldosteronism, as well as in the elderly, regular monitoring of the content of K + ions and creatinine is indicated.

While taking indapamide, the concentration of K +, Na +, Mg 2+ ions in the blood plasma (electrolyte disturbances), pH, the concentration of glucose, uric acid and residual nitrogen should be systematically monitored.

The most careful control is shown in patients with cirrhosis of the liver (especially with edema or ascites - the risk of developing metabolic alkalosis, which increases the manifestations of hepatic encephalopathy), coronary heart disease, heart failure, as well as in the elderly.

The high-risk group also includes patients with an increased QT interval on the electrocardiogram (congenital or developing against the background of any pathological process).

The first measurement of the concentration of K + in the blood should be carried out during the first week of treatment.

Hypercalcemia with indapamide may be due to previously undiagnosed hyperparathyroidism.

In patients with diabetes, it is extremely important to control the level of glucose in the blood, especially in the presence of hypokalemia.

Significant dehydration can lead to the development of acute renal failure (decreased glomerular filtration). Patients need to compensate for water loss and carefully monitor renal function at the beginning of treatment.

Indapamide can give a positive result when conducting a doping control.

Patients with arterial hypertension and hyponatremia (due to taking diuretics) need to stop taking diuretics 3 days before taking angiotensin-converting enzyme inhibitors (if necessary, diuretics can be resumed somewhat later), or they are prescribed initial low doses of angiotensin-converting enzyme inhibitors.

Derivatives of sulfonamides can exacerbate the course of systemic lupus erythematosus (must be borne in mind when prescribing indapamide).

Pediatric use: efficacy and safety in children not established.

Composition

1 tablet contains:

Active ingredient: indapamide hemihydrate 2.5 mg

Excipients: lactose monohydrate 63.5 mg, corn starch 20.0 mg, povidone 7.0 mg, calcium phosphate dihydrate 3.0 mg, magnesium stearate 1.5 mg, talc 2.5 mg film coating: opadry (Opadry® OY-B-28920) 2.5 mg (polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum).

Dosage and administration

Inside, preferably in the morning, regardless of food intake, 2.5 mg (1 tablet) per day, with plenty of fluids.

The maximum daily dose is 1 tablet.

Side effects

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

From the nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression rarely - increased fatigue, general weakness, malaise, muscle spasm, tension, irritability, anxiety.

On the part of the sensory organs: conjunctivitis, visual impairment.

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, urticaria, pruritus, hemorrhagic vasculitis.

Laboratory indicators: hyperuricemia, hyperglycemia, hypokalemia, hypochloremia, hyponatremia, hypercalcemia, increased plasma urea nitrogen, hypercreatininemia, glucosuria.

Other: flu-like syndrome, chest pain, back pain, infection, decreased potency, decreased libido, rhinorrhea, sweating, weight loss, tingling of limbs, pancreatitis, exacerbation of systemic lupus erythematosus.

Drug interactions

Saluretics, cardiac glycosides, gluco- and mineralocorticoids, tetracosactide, amphotericin B (iv), laxatives increase the risk of hypokalemia.

With concomitant use with cardiac glycosides, the likelihood of developing digitalis intoxication with Ca 2+ drugs — hypercalcemia with metformin — may aggravate lactic acidosis. Increases the concentration of Li + ions in blood plasma (decreased excretion in the urine), lithium has a nephrotoxic effect.

Astemizole, iv erythromycin, pentamidine, sultopride, terfenadine, vincamine, antiarrhythmic drugs of class Ia (quinidine, disopyramide) and class III (amiodarone, bretilium, sotalol) can lead to the development of arrhythmias of the "torsades de pointes" type.

Nonsteroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactides, sympathomimetics reduce the hypotensive effect, baclofen enhances.

Combination with potassium-sparing diuretics may be effective in some patients however, the possibility of developing hypo- or hyperkalemia, especially in patients with diabetes mellitus and renal failure, is not completely ruled out.

Angiotensin-converting enzyme inhibitors increase the risk of hypotension and / or acute renal failure (especially with existing renal artery stenosis).

Increases the risk of impaired renal function when using iodine-containing contrast agents in high doses (dehydration).

Patients need to restore fluid loss before iodine-containing contrast agents are used.

Imipramine (tricyclic) antidepressants and antipsychotics increase the hypotensive effect and increase the risk of orthostatic hypotension. Cyclosporine increases the risk of developing hypercreatininemia.

Reduces the effect of indirect anticoagulants (coumarin or indandion derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in the volume of circulating blood and an increase in their production by the liver (dose adjustment may be required).

Enhances neuromuscular transmission blockade that develops under the influence of non-depolarizing muscle relaxants.

Overdose

Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water-electrolyte disorders, in some cases - excessive decrease in blood pressure, respiratory depression. Patients with cirrhosis may develop liver coma.

Treatment: gastric lavage, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 ° C.

Active ingredient

Indapamide

tablet dosage form of tablets



Possible product names

INDAPAMID-TEVA 0.0025 N30 CAPS

INDAPAMID-TEVA 0.0025 N30 TABLE P / O

Indapamide-Teva tab p / o 2.5mg x 30

INDAPAMID-TEVA. P / O CAPTURE. 2.5 MG No. 30

Indapamide-Teva tablets p.p.o. 2. 5 mg N30 Bulgaria

Balkanfarma, Bulgaria



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