Torasemide-SZ, 10 mg tablets 60 pcs

Interaction

Increases the concentration and risk of nephro- and ototoxic effects of cephalosporins, aminoglycosides, chloramphenicol, etacrynic acid, cisplatin, amphotericin B (due to competitive renal excretion).

Effectiveness of diazoxide and theophylline increases, decreases effectiveness of hypoglycemic agents, allopurinol.

Presor amines and thorasemide mutually reduce the effectiveness of each other.

Drugs that block tubular secretion increase the serum concentration of thoracemide.

The simultaneous use of GCS, amphotericin B increases the risk of hypokalemia; with cardiac glycosides – the risk of glycoside intoxication due to hypokalemia (for high- and low-polar) and prolongation of T1/2 (for low-polar) increases.

Decreases renal clearance of lithium preparations and increases the likelihood of intoxication.

The NSAIDs, sucralfate decrease diuretic effect due to inhibition of prostaglandin synthesis, impairment of plasma renin activity and aldosterone excretion.

It increases the antihypertensive effect of hypotensive drugs, neuromuscular blockade of depolarizing myorelaxants (suxamethonium) and weakens the effect of nondepolarizing myorelaxants (tubocurarine).

The simultaneous use of salicylates in high doses with torasemide therapy increases the risk of their toxicity (due to competitive renal excretion).

The sequential or simultaneous use of thorasemide with ACE inhibitors or angiotensin II receptor antagonists may lead to a significant decrease in BP. This can be avoided by reducing the dose of thorasemide or temporarily cancelling it.

The concomitant use of probenecid or methotrexate may decrease the effectiveness of thorasemide (same secretion pathway). On the other hand, thorasemide may lead to decreased renal elimination of these drugs.

The simultaneous use of cyclosporine and thorasemide increases the risk of gouty arthritis due to the fact that cyclosporine may cause impaired urate excretion by the kidneys and thorasemide may cause hyperuricemia.

It has been reported that patients at high risk of nephropathy taking oral thoracemide were more likely to have impaired renal function when given radiopaque agents than patients at high risk of nephropathy who underwent IV hydration before radiopaque agent administration.

The bioavailability and, consequently, the effectiveness of thoracemide may be reduced by co-therapy with colestyramine.

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Special Instructions

The drug should be used strictly on prescription.

Patients with hypersensitivity to sulfonamides and sulfonylurea derivatives may have cross-sensitivity to Torasemide-SZ.

Patients receiving Toracemide-SZ at high doses for a prolonged period are recommended a diet with sufficient content of table salt and use of potassium preparations to avoid development of hyponatremia, metabolic alkalosis and hypokalemia.

The increased risk of water-electrolyte balance disorders is noted in patients with renal insufficiency. During the course of treatment it is necessary to monitor the concentration of plasma electrolytes (including sodium, calcium, potassium, magnesium), acid-base status, residual nitrogen, creatinine, uric acid periodically and provide the appropriate corrective therapy if necessary (with higher frequency in patients with frequent vomiting and with parenterally administered fluids).

If azotemia and oliguria appear or worsen in patients with severe progressive renal disease, it is recommended to suspend treatment.

Patients with ascites against liver cirrhosis should be dosed under hospital conditions (electrolyte-water balance disorders may lead to hepatic coma). Regular monitoring of blood plasma electrolytes is indicated for this category of patients.

In patients with diabetes mellitus or with reduced glucose tolerance, periodic monitoring of blood and urine glucose concentrations is required.

In unconscious patients with prostatic hyperplasia, ureteral narrowing, diuresis control is necessary due to the possibility of acute urinary retention.

Influence on driving and operating machinery

Patients must refrain from driving and engaging in other potentially dangerous activities that require increased concentration and quick psychomotor reactions (risk of dizziness and somnolence) during treatment.

In renal failure

The drug is contraindicated in renal failure with anuria, acute glomerulonephritis, acute urinary outflow disorders of any etiology (including unilateral urinary tract involvement).

With cautiousness the drug should be used in case of urine outflow disorders (benign prostatic hyperplasia, narrowing of the urethra or hydronephrosis), hepatorenal syndrome.

In case of liver dysfunction

The drug is contraindicated in hepatic coma and precoma.

The drug should be prescribed with cautious in hepatorenal syndrome.

Children

In older patients no dose adjustment is required.

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Contraindications

renal failure with anuria;
hepatic coma and precoma;
refractory hypokalemia/refractory hyponatremia;
hypovolemia (with or without arterial hypotension) or dehydration;
severe urinary outflow disorders of any etiology (including unilateral urinary tract involvement);
glycoside intoxication;
acute glomerulonephritis;
decompensated aortic and mitral stenosis, hypertrophic obstructive cardiomyopathy;
increased central venous pressure (over 10 mm Hg).stenosis);
hyperuric aneurysm.);
hyperuricemia;
concomitant use of aminoglycosides and cephalosporins;
pregnancy;
breast-feeding;
under 18 years of age;
lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
allergic reaction to sulfonamides (sulfonamide antimicrobials or sulfonylureas);
hypersensitivity to thorasemide or to any of the drug components.

Side effects

The incidence of side effects is classified according to World Health Organization recommendations: very frequently, ≥1/10 (>10%); frequently, ≥1/100 to <1/10 (>1% and <10%); infrequently, ≥1/1000 to <1/100 (>01% and <1%); infrequent – ≥1/10,000 to <1/1000 (>0.01% and <0.1%); very rare – <1/10,000 (<0.01%); frequency unknown – cannot be estimated from available data.

Nervous system disorders:often – headache, dizziness, somnolence; infrequent – muscle cramps of the lower extremities; frequency unknown – confusion, fainting, paresthesias in the extremities (feeling of numbness, “creeping” and tingling).

Senses: frequency unknown – visual impairment, hearing impairment, tinnitus and hearing loss (usually reversible) usually in patients with renal failure or hypoproteinemia (nephrotic syndrome).

Cardiovascular disorders: infrequent – extrasystole, arrhythmia, tachycardia; frequency unknown – excessive BP decrease, orthostatic hypotension, collapse, deep vein thrombosis, thromboembolism, reduction of BOD.

In the respiratory system: infrequent – nasal bleeding.

From the digestive system: frequent – diarrhea; infrequent – abdominal pain, flatulence, polydipsia; frequency unknown – dry mouth, nausea, vomiting, loss of appetite, pancreatitis, dyspeptic disorders, intrahepatic cholestasis.

Urinary system disorders:often – increased frequency of urination, polyuria, nycturia; infrequently – frequent urge to urinate; frequency unknown – oliguria, urinary retention (in patients with urinary tract obstruction), interstitial nephritis, hematuria.

Concerning the reproductive system: incidence unknown – decreased potency.

Skin and subcutaneous tissue disorders: frequency unknown – skin itching, rash, urticaria, erythema polymorphic, exfoliative dermatitis, purpura, vasculitis, photosensitization.

Muscular system disorders: frequency unknown – muscle weakness.

Metabolism: incidence unknown – hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, hypochloremia, metabolic alkalosis, hypovolemia, dehydration (more often in elderly patients).

Laboratory parameters: infrequent – hypercholesterolemia, hypertriglyceridemia; infrequent unknown – hyperuricemia, slightly increased plasma ALP activity, increased plasma creatinine and urea concentrations, increased plasma activity of some liver enzymes (e.g., GGT), thrombocytopenia, leukopenia, agranulocytosis, hyperglycemia, decreased glucose tolerance (possible manifestation of latent diabetes).

Others: frequency unknown – aplastic or hemolytic anemia.

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Overdose

Symptoms:Elevated diuresis accompanied by a decrease of the CIC and disturbed water-electrolyte balance of the blood, followed by an excessive decrease in BP, drowsiness and confusion, collapse. Gastrointestinal disorders may be observed.

Treatment:There is no specific antidote. Provocation of vomiting, gastric lavage, activated charcoal. Symptomatic therapy, dose lowering or drug withdrawal and simultaneous refilling of the blood circulation and parameters of water-electrolyte balance and acid-base status under control of serum concentrations of electrolytes, hematocrit. Hemodialysis is ineffective.

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Similarities

Diuver, Trigrim, Torasemide-SZ, Lotonel, Torasemide