Torasemide-SZ, tablets 5 mg 60 pcs

Torasemide-SZ is a “loop” diuretic.

The main mechanism of action is due to the reversible binding of torasemide to the sodium/chlorine/potassium transporter located in the apical membrane of the thick segment of the ascending loop of Genle, resulting in a reduction or complete inhibition of sodium ion reabsorption and a decrease in intracellular fluid osmotic pressure and water reabsorption.

Thorasemide causes hypokalemia to a lesser extent than furosemide, but it is more active and its effect is prolonged.

The diuretic effect develops within about an hour after oral administration, reaching a maximum after 3-6 hours, and lasts for 8 to 10 hours.

Limits systolic and diastolic BP in lying and standing position.

Indications

Arterial hypertension, edema syndrome of different genesis, including chronic heart failure, liver, lung and kidney disease.

Active ingredient

Composition

Tablets

Active ingredient:

torasemide 5 mg;

Associates:

Lactose monohydrate (lactopress) (milk sugar) – 89.3 mg;

Pregelatinized starch (starch 1500) – 24.5 mg;

colloidal silica (aerosil) – 0.6 mg;

magnesium stearate – 0.6 mg

How to take, the dosage

Ingestion, once a day, without chewing, with plenty of water, at any convenient constant time, regardless of meals.

Oedematous syndrome in CHF. The usual starting dose is 10-20 mg once daily. If necessary, the dose may be doubled until the desired effect is achieved.

Oedematous syndrome in kidney disease. The usual starting dose is 20 mg once daily. If necessary, the dose may be doubled until the desired effect is achieved.

Oedematous syndrome in liver disease. The usual starting dose is 5-10 mg once daily. If necessary, the dose may be doubled until the desired effect is obtained. The maximum single dose is 40 mg, it is not recommended to exceed it (no experience of use). The drug is used for a long period or until edema disappears.

Arterial hypertension. The initial dose is 2.5 mg (1/2 tablet of 5 mg) once daily. In case of no therapeutic effect within 4 weeks the dose is increased to 5 mg once a day. In absence of an adequate BP reduction in a dose of 5 mg once a day for 4-6 weeks, the dose is increased to 10 mg once a day. If the use of 10 mg/day does not give the desired effect, a hypotensive drug of another group should be added to the treatment regimen.

Patients of advanced age do not require dose adjustment.

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 efficacy.

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

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 GH synthesis, impaired plasma renin activity and aldosterone excretion.

It enhances the antihypertensive effect of hypotensive agents, neuromuscular blockade of depolarizing myorelaxants (suxamethonium) and weakens the effect of nondepolarizing myorelaxants (tubocurarin).

The simultaneous use of high doses of salicylates 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 strong 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 renal excretion of urate 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 were given IV hydration prior to radiopaque administration.

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

Special Instructions

Use strictly as directed by the physician.

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

Patients receiving high doses of Torasemide-SZ over a long period of time 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 and if necessary provide the appropriate corrective therapy (with higher frequency – in patients with frequent vomiting and with parenteral administration of fluids).

In case of occurrence or worsening of azotemia and oliguria in patients with severe progressive renal disease, it is recommended to suspend treatment.

The dosage regimen of patients with ascites with liver cirrhosis should be chosen under hospital conditions (disorders of water-electrolyte balance 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.

Impact on the ability to drive and operate machinery. During the treatment patients should refrain from driving motor transport and engaging in other potentially dangerous activities requiring high concentration and quick psychomotor reactions (risk of dizziness and somnolence).

Contraindications

Side effects

Nervous system disorders:often – headache, dizziness, somnolence; infrequently – cramps of the muscles 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).

CCS: infrequent – extrasystole, arrhythmia, tachycardia; frequency unknown – excessive decrease in BP, orthostatic hypotension, collapse, deep vein thrombosis, thromboembolism, reduction of the RBC.

In the respiratory system: infrequent – nasal bleeding.

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

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

Musculoskeletal side: frequency unknown – muscle weakness.

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

Concerning the reproductive system: incidence unknown – decreased potency.

Metabolic disorders: 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 concentrations of creatinine and urea, 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.

Overdose

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

Treatment:symptomatic. Induction of vomiting, gastric lavage, prescription of activated charcoal; dose reduction or drug cancellation and simultaneous replacement of the blood circulation and parameters of water-electrolyte balance and acid-base status under control of serum concentrations of electrolytes, hematocrit. There is no specific antidote. Hemodialysis is ineffective.

Similarities