DIUVER
Active material: Torasemide
When ATH: C03CA04
CCF: Diuretic
ICD-10 codes (testimony): I50.0, J81, K74, N04
When CSF: 01.08.01.01
Manufacturer: PLIVA HRVATSKA d.o.o. (Croatia)
DOSAGE FORM, COMPOSITION AND PACKAGING
Pills white or nearly white, round, lenticular, with a break line on one side and engraved “915” on the other side.
| 1 tab. | |
| Torasemide | 5 mg |
Excipients: lactose monohydrate, corn starch, sodium starch glycolate, silica colloidal anhydrous, magnesium stearate.
10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (6) – packs cardboard.
Pills white or nearly white, round, lenticular, with a break line on one side and engraved “916” on the other side.
| 1 tab. | |
| Torasemide | 10 mg |
Excipients: lactose monohydrate, corn starch, sodium starch glycolate, silica colloidal anhydrous, magnesium stearate.
10 PC. – blisters (2) – packs cardboard.
10 PC. – blisters (6) – packs cardboard.
Pharmacological action
“Loop” diuretic. The main mechanism of action of the drug due to a reversible binding with torasemide kontransporterom Na+/2Cl–/K+, located in the apical membrane of the thick segment of the ascending portion of the loop of Henle, resulting in reduced or completely inhibited by the reabsorption of sodium ions and decreases the osmotic pressure of the intracellular fluid and water reabsorption.
Torasemide less, than furosemide, cause hypokalemia, thus it exhibits greater activity and its action for a longer time.
Pharmacokinetics
Absorption
After oral torasemide rapidly and almost completely absorbed from the gastrointestinal tract. Cmax torasemide plasma achieved through 1-2 hours after oral administration after a meal. Bioavailability – about 80% with slight individual variations.
Distribution
Plasma protein binding – more 99%. In Кажущийсяd is 16 l.
Metabolism and excretion
It is metabolized in the liver with the participation of cytochrome P450 isozymes to form 3 metabolites (M1 , M3 and M5). T1/2 torasemide and its metabolites in healthy volunteers is 3-4 no. On average, about 83% of the dose is excreted via the renal tubules: in unchanged form (24%) and preferably in the form of inactive metabolites (M1 – 12%, M3 – 3%, M5 – 41%).
Pharmacokinetics in special clinical situations
In renal insufficiency T1/2 torasemide unchanged.
Testimony
- Swelling, caused by heart failure, liver disease, kidneys and lungs.
Dosage regimen
The drug is taken orally 1 times / day after meals.
Average therapeutic dose is 5 mg / day. If necessary, may increase the dose to 20 mg / day, and in some cases - to 40 mg / day.
Elderly patients special dose adjustment is not required.
Side effect
From the hematopoietic system: in some cases – reduction in the number of red blood cells, leukopenia, thrombocytopenia.
With the cardiovascular system: in some cases – decrease in blood pressure, due to blood clots – circulatory disorders and thromboembolism.
From the digestive system: dyspepsia, loss of appetite, dry mouth, increase in liver enzymes; rarely – pancreatitis.
From the urinary system: in patients with obstruction of the urinary tract – urinary retention; sometimes – increased levels of urea and creatinine.
With CNS and peripheral nervous system: headache, dizziness, weakness, drowsiness, confusion, convulsions, limb paresthesia.
From the laboratory parameters: gipovolemiя, violations of water-electrolyte balance, kaliopenia, increased uric acid in blood serum, giperglikemiâ, hyperlipidemia.
From the senses: visual impairment, noise in ears, deafness.
Allergic reactions: itching, rash, photosensitivity.
Contraindications
- Anurija;
- Hepatic coma and prekomatosnoe state;
- Renal insufficiency with progressive azotemia;
- Hypotension;
- Arrhythmia;
- Pregnancy;
- Lactation (No data on the use during lactation);
- Up to 18 years (efficacy and safety have not been established);
- Hypersensitivity to torasemide and sulfonamides.
FROM caution should be used when a predisposition to hyperuricemia, podagre, when hidden and expressed diabetes.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation.
Cautions
Prior to his appointment Diuvera should carry out the correction of water and electrolyte balance.
Monitoring of laboratory parameters
Long-term treatment is recommended Diuverom control electrolyte balance, Glucose, Uric acid, creatinine and blood lipids.
In patients with diabetes mellitus type 1 or 2 should regularly monitor blood glucose levels.
Effects on ability to drive vehicles and management mechanisms
During treatment, patients should avoid driving vehicles and other activities, require high concentration and speed of psychomotor reactions.
Overdose
Symptoms: perhaps – forced urination, accompanied by hypovolemia, electrolyte imbalance, followed by a drop in blood pressure, drowsiness and confusion, collapse. There may be disorders of the gastrointestinal tract.
Treatment: dose reduction or withdrawal of the drug; simultaneous replenishment of fluid and electrolyte loss. No specific antidote.
Drug Interactions
Torasemide increases myocardial sensitivity to cardiac glycosides (due to the possible development of hypokalemia and hypomagnesemia).
In an application with mineralogical torasemide- and glucocorticoids, laxatives may increase the excretion of potassium.
Torasemide enhances the effect of antihypertensive drugs.
Torasemide, especially in high doses, can enhance nephrotoxicity- and ototoxic effects of antibiotics group aminoglikozidov, toxicity of cisplatin, nefrotoksicskie effects of cephalosporins and cardio- and neurotoxicity drugs lithium effects.
Torasemid may exacerbate the effects of peripheral muscle relaxant (kurarina derivatives) and theophylline.
If you are applying with salicilatami torasemida (high dose) their toxic effect can be reinforced.
Torasemid may reduce the effectiveness of gipoglikemicakih (protivodiabeticakih) means.
The sequential or simultaneous administration of torasemide with ACE inhibitors may transient drop in blood pressure. If necessary, use of such a combination should reduce the initial dose or an ACE inhibitor, or reduce the dose of torasemide (or temporarily cancel it).
NSAIDs and probenecid may reduce the diuretic and hypotensive effect of torasemide.
Cholestyramine may decrease absorption from the gastrointestinal tract of torasemide (According to preclinical study in animals).
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children and temperatures not above 30 ° C. Shelf life – 2 year.
