Indapamid-Teva - instructions for use, dose, side effects, contraindications

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: fall off (Opadry® OY-B-28920) 2.5 mg (polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum).

Description:

Biconvex tablets covered with a film coat, almost white.

Pharmacotherapeutic group:Diuretics

ATX: & nbsp

C.03.B.A.11 Indapamide

Pharmacodynamics:

A hypotensive agent, a thiazide-like diuretic with a moderate in strength and long duration of action, a benzamide derivative.Has moderate saluretic and diuretic effects, which are associated with the blockade of the reabsorption of sodium, chlorine, hydrogen ions and, to a lesser extent, potassium ions in the proximal tubules and the cortical segment of the distal tubule of the nephron. The vasodilator effects and the reduction of the overall peripheral vascular resistance are based on the following mechanisms: a decrease in the reactivity of the vascular wall to norepinephrine and angiotensin II; enlargement synthesis of prostaglandins with vasodilator activity; oppression of calcium current in the smooth-muscle walls of blood vessels.

Reduces the tone of the smooth muscles of the arteries, reduces the overall peripheral resistance of the vessels. Helps reduce hypertrophy of the left ventricle of the heart. In therapeutic doses does not affect lipid and carbohydrate metabolism (including in patients with concomitant diabetes mellitus).

Antihypertensive effect develops at the end of the first / beginning of the second week with a constant intake of the drug and persists for 24 hours against a background of a single dose.

Pharmacokinetics:

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract.Bioavailability is high (93%). Eating somewhat slows down the speed, but does not affect the completeness of absorption. The maximum concentration in the blood is achieved 1-2 hours after ingestion. Equilibrium concentration is achieved after 7 days of regular intake. The preparation binds to blood plasma proteins by 70-80%. Has a high volume of distribution, passes through the histohematological (including placental) barriers, penetrates into breast milk. Metabolised in the liver. The half-life of indapamide is on average 14-18 hours. It is excreted from the body by the kidneys (up to 80%) mainly in the form of metabolites, through the intestine - 20%.

In patients with renal insufficiency, pharmacokinetics does not change.

Do not cumulate.

Indications:

Arterial hypertension.

Contraindications:

Hypersensitivity to the drug and other sulfonamide derivatives, lactose intolerance, galactosemia, glucose / galactose absorption disorder syndrome; severe renal failure (anuria stage), hypokalemia, expressed hepatic (including with encephalopathy) insufficiency, age under 18 years (efficacy and safety not established); simultaneous reception of drugs that extend the interval QT.

Carefully:

In case of violations of the liver and / or kidney function, violation of water-electrolyte balance, hyperparathyroidism, patients with an increased interval QT on an electrocardiogram (ECG) or receiving a combination therapy with other antiarrhythmic drugs, diabetes mellitus in decompensation stage, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).

Pregnancy and lactation:

The drug is not used during pregnancy, since diuretics can cause fetoplacental ischemia with a risk of fetal hypotrophy.

Indapamide is excreted in breast milk. Given the potential for adverse events in infants, breastfeeding during treatment is not recommended.

Dosing and Administration:

Inside, preferably in the morning, regardless of food intake of 2.5 mg (1 tablet) per day, squeezed a sufficient amount of liquid.

The maximum daily dose is 1 tablet.

Side effects:

From the cardiovascular system: orthostatic hypotension, changes in the ECG (as manifestations of hypokalemia), arrhythmia, palpitations.

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

From the digestive system: constipation or diarrhea, dyspepsia (including nausea, vomiting), dry mouth, anorexia, abdominal pain, hepatic encephalopathy (against liver failure).

From the genitourinary system: infection, nocturia, polyuria.

From the respiratory system: cough, pharyngitis, sinusitis, rarely - rhinitis.

Allergic reactions: pruritus, patchy-papular rash, hives, hemorrhagic vasculitis.

On the part of the organs of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia.

Laboratory indicators: hypercalcemia, hyperuricemia, hypochloraemia, hyponatremia, hyperglycemia, hypokalemia, hypercalciuria, increased blood urea nitrogen, hypercreatininaemia, glucosuria.

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

Overdose:

Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water-electrolyte disorders, lowering of blood pressure, respiratory depression. In patients with impaired liver function, hepatic coma may develop.

Treatment: gastric lavage and / or the appointment of activated charcoal, followed by the restoration of normal water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction:

With the simultaneous use of indapamide with lithium preparations, an increase in the concentration of lithium in the blood plasma is possible.

Astemizole, erythromycin (w / w), pentamidine, sultopride, wincamine, antiarrhythmic drugs IA (quinidine, disopyramide) and III class (amiodarone, brethility, sotalol) may increase the likelihood of heart rhythm disorders by type torsades de pointes (ventricular tachycardia of the "pirouette" type).

Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, sympathomimetics reduce hypotensive effect, baclofen increases.

Saluretics, cardiac glycosides, gluco- and mineralocorticosteroids, tetracosactide, amphotericin B (IV), laxatives increase the risk of hypokalemia. With simultaneous use with cardiac glycosides, the likelihood of developing digitalis intoxication increases, with calcium preparations - hypercalcemia, with metformin - possibly aggravation of lactic acidosis.

Combination with potassium-sparing diuretics can be effective in some patients, however, the possibility of hypo- or hyperkalemia, in patients with diabetes mellitus and kidney failure, is not completely excluded.

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

Contrasting iodine-containing drugs in high doses increase the risk of kidney dysfunction (dehydration). Before using contrast iodine-containing drugs, patients need to restore fluid loss.

Tricyclic antidepressants and antipsychotic drugs increase the hypotensive effect and increase the risk of orthostatic hypotension.

Cyclosporine increases the risk of hypercreatininaemia.

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

Strengthens the blockade of the neuromuscular transmission, which develops under the action of nondepolarizing muscle relaxants.

Special instructions:

With long-term use or with the use of the drug Indapamide-Teva in large doses, electrolyte disorders such as hyponatremia, hypokalemia, hypochloraemic alkalosis can develop. These disorders are more often observed in patients with chronic heart failure (II-IV f.k. by classification NYHA); liver diseases, with vomiting and diarrhea, as well as in people on a salt-free diet. Simultaneous administration of the drug Indapamid-Teva with cardiac glycosides and corticosteroids increases the risk of hypokalemia. In addition, the release of magnesium in the urine may increase, which can lead to hypomagnesemia.

Perhaps the appearance of orthostatic hypotension, which can be provoked by drinking alcohol, barbiturates, narcotic drugs and simultaneous reception of other antihypertensive drugs.

In patients taking cardiac glycosides, laxatives, against hyperaldosteronism, as well as in the elderly, careful monitoring of the potassium and creatinine content is shown. The most thorough control is indicated in patients with cirrhosis of the liver, ischemic heart disease, chronic heart failure.

The group with increased risk also includes patients with an increase in the interval QT on an electrocardiogram (congenital or developed against a background of a pathological process). The first measurement of the potassium concentration in the blood should be performed within 1 week of treatment.

Hypercalcemia with the use of the drug Indapamida-Teva may be a consequence of previously not diagnosed hyperparathyroidism.

In patients with diabetes, it is extremely important to monitor blood glucose levels, especially when hypokalemia is present.

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

Drug indapamide-Teva can give a positive result in doping control.

Patients with hypertension and hyponatremia (due diuretics) necessary 3 days prior to initiation of angiotensin converting enzyme inhibitors, diuretics stop (if necessary diuretics can be resumed later) or they are assigned the initial low dose of angiotensin converting enzyme inhibitors.

Sulfonamide derivatives may aggravate for systemic lupus erythematosus (to be kept in mind while prescribing Indapamide-Teva).

Form release / dosage:

Tablets, film-coated, 2.5 mg.

Packaging:

For 10 tablets in a PVC blister / aluminum foil; 3 blisters per cardboard pack together with instructions for use.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006069/08

Date of registration:31.07.2008 / 04.08.2016

Expiration Date:Unlimited

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

BALKANPHARMA-DUPNITSA, AD Bulgaria

Representation: & nbspTeva Teva Israel

Information update date: & nbsp02.11.2017

Illustrated instructions

Instructions

Indapamid-Teva (Indapamide-Teva)