Diuver, 10 mg tablets 60 pcs

Pharmacodynamics

It reduces or completely inhibits sodium ion reabsorption and reduces intracellular fluid osmotic pressure and water reabsorption. Blocks aldosterone receptors in the myocardium, reduces fibrosis and improves diastolic function of the myocardium.

Pharmacokinetics

Intake

After oral administration, thoracemide is rapidly and almost completely absorbed from the GI tract. Cmax of thoracemide in plasma is reached 1-2 hours after oral administration after a meal. Bioavailability is about 80% with slight individual variations.

Distribution

Binding to plasma proteins is more than 99%. The apparent Vd is 16 liters.

Metabolism and excretion

Metabolized in the liver with the participation of cytochrome P450 system isoenzymes. As a result of sequential reactions of oxidation, hydroxylation or ring hydroxylation 3 metabolites are formed (M1, M3 and M5), whose binding to plasma proteins is 86%, 95% and 97% respectively. T1/2 of torasemide and its metabolites in healthy volunteers is 3-4 hours. Total clearance is 40 ml/min, renal clearance is 10 ml/min.

Pharmacokinetics in special clinical cases

The T1/2 of torasemide does not change in renal failure, the T1/2 of M3 and M5 metabolites is increased. Torasemide and its metabolites are slightly excreted by hemodialysis and hemofiltration.

In case of hepatic insufficiency, plasma concentrations of thoracemide are increased due to decreased metabolism of the drug in the liver. In patients with cardiac or hepatic insufficiency T1/2 of thorasemide and M5 metabolite is slightly increased, cumulation of the drug is unlikely.

Indications

Hypertension (high blood pressure), Edema, Heart failure, liver damage

• Oedematous syndrome of various genesis, including chronic heart failure, liver, lung and kidney disease
• arterial hypertension.
  

Active ingredient

Torasemide

Composition

1 tablet contains:

Thorasemide 10 mg.

Auxiliary substances:

lactose monohydrate,

corn starch,

sodium starch glycolate,

anhydrous colloidal silica,

magnesium stearate.

How to take, the dosage

Orally, once a day after breakfast with small amount of water.

Edema syndrome of various genesis. including chronic heart failure, liver and kidney diseases

The usual therapeutic dose is 5 mg orally once a day. If necessary, the dose should be gradually increased to 20-40 mg once a day, in some cases up to 200 mg per day. The drug is prescribed for a long period or until edema disappears.

Arterial hypertension.

The initial dose is 2.5 mg (1/2 tablet of 5 mg) once a day. If necessary, the dose may be increased to 5 mg once a day.
In elderly patients the dose adjustment is not required.

Interaction

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

Torasemide increases the efficacy of diazoxide and theophylline and decreases the effectiveness of hypoglycemic agents, allopurinol.

Presor amines and thorasemide mutually reduce efficacy.

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

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

Thorasemide decreases renal clearance of lithium preparations and increases the likelihood of intoxication.

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

Torasemide increases the hypotensive effect of hypotensive agents, neuromuscular blockade of depolarizing myorelaxants (suxamethonium) and weakens the effect of nondepolarizing myorelaxants (tubocurarin).

The simultaneous use of salicylates in high doses during therapy with thorasemide 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.

Concomitant use with probenecid or methotrexate may decrease the effectiveness of thoracemide (same secretion pathway). On the other hand, thorasemide may lead to decreased renal excretion 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 who receive oral thoracemide have more renal dysfunction when given radiopaque agents than patients at high risk of nephropathy who were given IV hydration before radiopaque agents were administered.

Special Instructions

During long-term treatment with Diuvera it is recommended to monitor electrolyte balance, glucose, uric acid, creatinine and blood lipids.

Prior to prescribing Diuvera, the water-electrolyte balance should be corrected.

With caution, take if you have gout or are prone to elevated uric acid levels.

In the presence of type 1 or 2 diabetes, blood glucose levels should be monitored.

Impact on the ability to drive and operate dangerous machinery

Patients should refrain from driving and engaging in activities that require concentration during treatment with Diuver.

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Contraindications

• High sensitivity to thoracemide and sulfonamides; anuria;
• hepatic coma and precoma;
• renal failure with increasing azotemia;
• arterial hypotension;
• arrhythmia;
• pregnancy;
• lactation period (no data on use during lactation);
• age under 18 years of age (efficacy and safety not established)

With caution: In predisposition to hyperuricemia, gout, in latent and severe diabetes mellitus.

Side effects

Blood disorders: in some cases, changes in the blood picture may be noted: decrease in the number of red blood cells, leukopenia, thrombocytopenia.

Cardiovascular system disorders: in some cases, due to blood clotting, circulatory disorders and thromboembolism, decreased blood pressure may occur.

Gastrointestinal tract disorders: various digestive tract dysfunction, loss of appetite, dry mouth; rarely – pancreatitis.

Renal and urinary tract disorders: in patients with urinary tract obstruction may cause urinary retention; sometimes – increase in urea and creatinine levels.

Central nervous system disorders: headache, dizziness, weakness, drowsiness, confusion, convulsions, and paresthesias of the extremities.

Liver disorders: increased activity of “liver” enzymes may be observed.

Changes of laboratory parameters: hypovolemia, disorders of fluid and electrolyte balance, hypokalemia, increased level of uric acid in serum, hyperglycemia and hyperlipidemia.

Allergic reactions: skin itching, rashes and photosensitization.

Sensory organs: visual disturbances, tinnitus, deafness.

Overdose

Symptoms: excessive increased diuresis accompanied by a decrease in the BOD and electrolyte balance of the blood, followed by a pronounced decrease in BP, drowsiness, confusion, collapse; gastrointestinal disorders are possible.

Treatment: there is no specific antidote. Vomiting should be induced, gastric lavage should be performed, and activated charcoal should be prescribed. Dose reduction or discontinuation of the drug and simultaneous replacement of the blood circulation volume and parameters of water-electrolyte balance and acid-base balance under control of serum concentrations of electrolytes, hematocrit, symptomatic treatment. Hemodialysis is ineffective.

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Pregnancy use

The drug Diuver is contraindicated during pregnancy (can be used only when the potential benefit to the mother exceeds the possible risk to the fetus, only under medical supervision and only in the minimum dose), during lactation, under the age of 18 (effectiveness and safety are not established).

Similarities

Trigrim, Torasemide-SZ, Lotonel, Torasemide