Teva-Indapamide Tab n / a film about 2.5 mg 30 pcs

Description

Composition
Active substance:
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, soya lecithin, xanthan gum).
Description:
Biconvex tablets, film-coated, almost white.
Product form:
Tablets, film-coated 2.5 mg.
10 tablets in blister PVC / aluminum foil; 3 blisters in a cardboard box, together with instructions for use.
Contraindications
Increased sensitivity to the drug and other sulfonamide derivatives, lactose intolerance, galactosemia, syndrome disorders absorption of glucose / galactose; severe renal insufficiency (anuria stage), hypokalemia, severe hepatic (including encephalopathy) failure, age 18 years (effectiveness and safety have been established); simultaneous administration of drugs prolonging the interval QT.
Precautions: assigning the human liver and / or kidney disease, disturbance of water-electrolyte balance, hyperparathyroidism, patients with increased QT interval in the electrocardiogram (ECG) or receiving concomitant therapy with other anti-arrhythmic drugs, diabetes decompensated, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).
Dosage
2.5 mg
Indications
Arterial hypertension.
Interaction with other drugs
With simultaneous use of indapamide with lithium therapy may increase the concentration of lithium in the blood plasma.
Astemizole, erythromycin (w / w), pentamidine, sultopride, vincamine, antiarrhythmics IA (quinidine, disopyramide) and class III (amiodarone, bretilium, sotalol) may increase the risk of heart rhythm disorders of torsades de pointes type (ventricular tachycardia type ” pirouette”).
Nonsteroidal anti-inflammatory drugs, glucocorticoids, tetracosactide, sympathomimetics reduce the hypotensive effect of baclofen increases.
Saluretiki, cardiac glycosides, gluco and mineralokortikosteroidy, tetrakozaktid,
Amphotericin B (w / w), laxatives increase the risk of hypokalemia.
When applied simultaneously with cardiac glycosides increases the likelihood of digitalis intoxication with calcium supplementation – hypercalcemia, metformin – possibly worsening lactic acidosis.
Combination with potassium-sparing diuretics may be effective in some categories of patients, however, this is not completely excluded the likelihood of developing hypo- or hyperkalemia, especially in patients with diabetes and renal failure.
Angiotensin-converting enzyme inhibitors increase the risk of hypotension and / or acute renal failure (especially when existing renal artery stenosis).
Iodine-containing contrast agents in high doses increase the risk of renal dysfunction (dehydration). Before application of iodine-containing contrast agents to patients is necessary to restore lost fluids.
Tricyclic antidepressants and antipsychotic drugs increase the hypotensive effect and increase the risk of orthostatic hypotension.
Cyclosporin increases the risk of hypercreatininemia.
Reduces the effect of anticoagulants (coumarin or indandione derivatives) due to increased concentration of clotting factors by reducing blood volume and increase their production by the liver (the dose may be required correction).
Enhances blockage of neuromuscular transmission, developing under the effect of non-depolarizing muscle relaxants.
Overdose
Symptoms include nausea, vomiting, weakness, impaired function of the gastrointestinal tract, water-electrolyte disorders, lowering blood pressure, respiratory depression. In patients with impaired liver function may develop hepatic coma.
Treatment: gastric lavage and / or administration of activated charcoal, followed by restoration of normal fluid and electrolyte balance, symptomatic therapy.
No specific antidote.
pharmachologic effect
Pharmacological group:
diuretic
Pharmacodynamics:
Hypotensive agent, thiazide diuretic with moderate strength and long duration of action of the benzamide derivatives. It has a moderate salureticheskim and diuretic effects that are associated with the blockade of reabsorption of sodium, chlorine, hydrogen and, to a lesser extent potassium ions in the proximal tubule and cortical segment of the distal tubule of the nephron.
Vasodilatory effects and decrease total peripheral vascular resistance are based on the following mechanisms: reduced vascular reactivity to norepinephrine and angiotensin II; increased synthesis of prostaglandins having vasodilating activity; calcium current inhibition in vascular smooth muscle wall.
It reduces the tone of smooth muscle of arteries decreases total peripheral vascular resistance. It helps to reduce the hypertrophy of the left ventricle of the heart. At therapeutic doses, has no effect on lipid and carbohydrate metabolism (including patients with concomitant diabetes).
The antihypertensive effect develops at the end of the first / second week of the beginning of taking the drug at a constant and maintained for 24 hours on a background of a single dose.
Pharmacokinetics:
Once inside quickly and completely absorbed from the gastrointestinal tract. Bioavailability – high (93%). Eating slows down the speed, but does not affect the absorption of completeness. The maximum blood concentration is achieved 1-2 hours after ingestion. The equilibrium concentration is reached after 7 days of regular reception. The preparation is 70-80% bound to plasma proteins. Has a high volume of distribution, it passes through the blood-tissue (including placental) barriers into breast milk.
It is metabolized in the liver. Indapamide half-life averages 14 to 18 hours. Excreted by the kidneys (80%) is preferably in the form of metabolites through the intestine – 20%. In patients with renal insufficiency The pharmacokinetics does not change. Not accumulates.
Pregnancy and breast-feeding
The drug should not be used during pregnancy as diuretics can cause fetoplacental ischemia with risk of malnutrition of the fetus.
Indapamide is excreted in breast milk. Considering the possibility of the appearance of adverse events in infants, breast-feeding during treatment is not recommended.
Conditions of supply of pharmacies
On prescription.
side effects
With the cardiovascular system: orthostatic hypotension, ECG changes (as a manifestation of hypokalemia), arrhythmia, palpitations.
From the nervous system: headache, dizziness, nervousness, fatigue, drowsiness, vertigo, insomnia, depression, rarely – fatigue, malaise, muscle spasms, tension, irritability, anxiety.
From the digestive system: constipation or diarrhea, dyspepsia (including nausea, vomiting), dry mouth, anorexia, abdominal pain, hepatic encephalopathy (hepatic insufficiency on the background).
With the genitourinary system: infection, nocturia, polyuria.
The respiratory system: cough, pharyngitis, sinusitis, rarely – rhinitis.
Allergic reactions: itching, maculopapular rash, urticaria, hemorrhagic vasculitis.
From the side of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia.
Laboratory findings: hypercalcemia, hyperuricemia, chloropenia, hyponatremia, hyperglycemia, hypokalemia, hypercalciuria, increased blood urea nitrogen, hypercreatininemia, glycosuria.
Other: flu-like symptoms, chest pain, back pain, infection, decreased potency, decreased libido, runny nose, sweating, weight loss, tingling in the extremities, pancreatitis, exacerbation of systemic lupus erythematosus.
special instructions
With prolonged use or when receiving a drug-Indapamide Teva in large dosages may develop electrolyte disturbances such as hyponatremia, hypokalemia, alkalosis hypochloraemic. These disorders are more common in patients with chronic heart failure (II-IV FK, in NYHA classification); liver disease, with vomiting and diarrhea, as well as in those on a low-salt diet.
Simultaneous with the appointment of the drug indapamide-Teva with cardiac glycosides and corticosteroids increases the risk of hypokalemia. Furthermore, selection may increase excretion of magnesium, which can lead to hypomagnesemia.
May cause orthostatic hypotension, which can be provoked by alcohol, barbiturates, narcotic drugs and simultaneous use of other antihypertensive agents.
Patients receiving cardiac glycosides, laxatives, amid hyperaldosteronism, as well as in the elderly shows a close monitoring of potassium and creatinine.
The most careful control shown in patients with liver cirrhosis, coronary heart disease, chronic heart failure.
High-risk group also includes patients with an increased QT interval on the electrocardiogram (congenital or develop on the background of a pathological process). The first measurement of potassium concentration in blood should be carried out within 1 week of treatment.
Hypercalcemia in patients receiving drug-Indapamide Teva may be a consequence of previously undiagnosed hyperparathyroidism.
In patients with diabetes is extremely important to control the level of glucose in the blood, especially in the presence of hypokalemia.
Considerable dehydration may lead to acute renal failure (decreased glomerular filtration). Patients need to compensate for the loss of fluid and at the beginning of treatment carefully monitor renal 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 terminate diuretics (if necessary diuretics can be resumed later) or they are assigned initial low doses of inhibitors of angiotensin-converting enzyme.
Sulfonamide derivatives may aggravate for systemic lupus erythematosus (to be kept in mind while prescribing Indapamide-Teva).
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children!
Dosing and Administration
Inside, preferably in the morning, regardless of the meal 2.5 mg (1 tablet) per day, drinking plenty of fluids.
The maximum daily dose – 1 tablet.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist