Torasemide Canon, pills 5mg 20pcs

Composition

1 tablet contains:

Active ingredient:

torasemide 5 mg;

Auxiliary substances:  

pregelatinized corn starch 37 mg,

colloidal silicon dioxide 0.7 mg,

croscarmellose sodium 7 mg,

mannitol 52 mg,

magnesium stearate 0.7 mg,

microcrystalline cellulose 37.6 mg

Pharmacological action

Torasemide is a loop diuretic; in low doses used for antihypertensive treatment, it has a weak diuretic and saluretic effect. At higher doses, torasemide increases diuresis in a dose-dependent manner.

Torasemide exhibits maximum diuretic activity 2-3 hours after oral use.

Pharmacokinetics

After oral use, torasemide is rapidly and almost completely absorbed; Cmax in blood serum is reached 1-2 hours after use. The systemic bioavailability is 80-90%. The binding of torasemide to plasma proteins is >99%, and the binding of metabolites M1, M3, and M5 is 86%,95%, and 97%, respectively.

The estimated volume of distribution is 16 liters. Torasemide is metabolized by oxidation and hydroxylation to form three metabolites: M1, M3, and M5. M5 is pharmacologically inactive, and the M1 and M3 metabolites account for approximately 10% of the pharmacological action of the drug.

T1 / 2 of torasemide and its metabolites is 3-4 hours in healthy volunteers. The total clearance of torasemide is 40 ml / min, and the renal clearance is about 10 ml / min. Approximately 80% of the dose is excreted as unchanged torasemide (24%) and its metabolites: M 1 (12%), M 3 (3%), M 5 (41%).

In renal insufficiency, the T1/2 of torasemide does not change, and the T1 / 2 of the M3 and M5 metabolites is prolonged. Torasemide and its metabolites are practically not eliminated by hemodialysis or hemofiltration.

In patients with hepatic impairment or heart failure, T1 / 2 of torasemide and the M5 metabolite are slightly prolonged, but accumulation of torasemide and its metabolites is unlikely.

Indications

• Edematous syndrome of various origins, including chronic heart failure, liver and kidney diseases.
• Arterial hypertension.

Use during pregnancy and lactation

Torasemide does not have a teratogenic effect and fetotoxicity, penetrates the placental barrier, causing violations of water and electrolyte metabolism and thrombocytopenia in the fetus.

Torasemide Canon can be used during pregnancy only when the intended benefit to the mother exceeds the potential risk to the fetus, under close medical supervision and only in minimal doses.

There are no data on the excretion of torasemide in breast milk, so if it is necessary to use Torasemide Canon during lactation, breastfeeding should be discontinued.

Contraindications

— renal failure with anuria;

— chronic renal failure with increasing azotemia;

acute glomerulonephritis;

— pronounced violations of the outflow of urine of any etiology (including unilateral lesion of the urinary tract);

hepatic coma and precoma;

— severe hypokalemia;

— severe hyponatremia;

— hypovolemia (hypotension with or without it) or dehydration;

— glycoside intoxication;

— sinoatrial block;

— AV-block II-III degree;

— decompensated aortic and mitral stenosis;

— hypertrophic obstructive cardiomyopathy;

— increase of Central venous pressure (over 10 mm Hg. St. )

— arrhythmia;

— age up to 18 years (safety and efficacy in children and adolescents has not been studied);

— lactation period;

— hypersensitivity to torasemid or to any component of the drug;

— patients who are allergic to sulfonamides (sulfa antibiotics or sulfonylureas) may be cross-allergic to torasemid.

With caution should be prescribed when arterial hypotension; constrictive atherosclerosis of cerebral arteries; hypoproteinemia; violation of the outflow of urine (benign prostatic hyperplasia, narrowing of the urethra or hydronephrosis); ventricular arrhythmia in history; acute myocardial infarction (increased risk of developing cardiogenic shock); diarrhea; pancreatitis; hypokalemia, hyponatremia; the liver, liver cirrhosis, renal failure, hepatorenal syndrome; diabetes (reduced tolerance to glucose); gout, hyperuricemia; anemia; concomitant use of cardiac glycosides, aminoglycosides or cephalosporins, corticosteroids or adrenocorticotropic hormone (ACTH); pregnancy.

Side effects

WHO classification of side effects: very common – ≥1/10 prescriptions (>10%), common – ≥1/100 to ><1/10 prescriptions (>1% and <1/10 prescriptions (><10%), uncommon – ≥1/1000 to <1/100 prescriptions (>0.1% and <1/100 prescriptions (><1%), rare – ≥1/10 000 to <1/1000 prescriptions (>0.01% and <1/1000 prescriptions (><0.1%), very rare – <1/10 000 appointments (

From the hematopoietic system:  the frequency is unknown-thrombocytopenia, leukopenia, agranulocytosis, aplastic or hemolytic anemia.

From the side of metabolism and nutrition:  infrequently-polydipsia, hypercholesterolemia, hypertriglyceridemia; frequency unknown-decreased glucose tolerance (possible manifestation of latent diabetes mellitus).

From the side of water-electrolyte and acid-base balance:  the frequency is unknown-hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, hypochloremia, metabolic alkalosis, hypovolemia, dehydration (more often in elderly patients), which can lead to hemoconcentration with a tendency to develop blood clots.

Nervous system disorders:  often – dizziness, headache, drowsiness; frequency unknown-confusion, fainting, paresthesia in the extremities (numbness, “crawling” and tingling).

From the side of the visual organ:  frequency unknown – visual impairment.

From the side of the hearing organ:  frequency unknown-hearing impairment, tinnitus and hearing loss (usually reversible) usually in patients with renal insufficiency or hypoproteinemia (nephrotic syndrome).

From the cardiovascular system:  infrequently – extrasystole, arrhythmia, tachycardia.

Vascular disorders:  the frequency is unknown – excessive decrease in blood pressure, orthostatic hypotension, collapse, deep vein thrombosis, thromboembolism.

Respiratory system disorders:  infrequently-nosebleeds.

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

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

From the genitals and breast:  frequency unknown-decreased potency.

Skin and subcutaneous tissue disorders:  frequency unknown-exfoliative dermatitis, purpura, vasculitis, photosensitization.

Musculoskeletal disorders:  infrequently – muscle cramps of the lower extremities; frequency unknown-muscle weakness.

Allergic reactions:  infrequently – severe anaphylactic reactions up to shock, which have so far been described only after intravenous use; frequency unknown-pruritus, rash, urticaria, erythema multiforme.

From the side of laboratory and instrumental data:  the frequency is unknown-hypercholesterolemia, hypertriglyceridemia, hyperuricemia, a slight increase in the concentration of alkaline phosphatase in the blood, a transient increase in the concentration of creatinine and urea in the blood, an increase in the activity of certain liver enzymes (for example, gamma-glutamyltransferase).

Other services:  infrequently – fever, asthenia, weakness, increased fatigue, hyperactivity, nervousness.

If any of the side effects indicated in the instructions are aggravated or any other side effects are noted that are not specified in the instructions, the patient should inform the doctor.

Interaction

With the simultaneous use of mineral-and glucocorticosteroids, amphotericin B increases the risk of hypokalemia; with cardiac glycosides-increases the risk of glycoside intoxication due to hypokalemia (for high-and low-polar) and elongation of T 1/2 (for low-polar).

The drug Torasemide Canon increases the concentration and risk of developing nephrotoxic and ototoxic effects of chloramphenicol, ethacric acid, antibiotics, salicylates, platinum (Pt) preparations, amphotericin B (due to competitive renal excretion).

Sequential or simultaneous use of Torasemide Canon with ACE inhibitors or angiotensin II receptor antagonists can lead to a sharp drop in blood pressure. This can be avoided by reducing the initial dose of an ACE inhibitor or by reducing the dose of Torasemide Canon (or temporarily discontinuing it).

NSAIDs, sucralfate, methotrexate and probenecid reduce the diuretic effect due to inhibition of prostaglandin synthesis, impaired plasma renin activity and aldosterone excretion.

Torasemide enhances the antihypertensive effect of antihypertensive agents, neuromuscular blockade of depolarizing muscle relaxants (suxamethonium) and weakens the effect of non-depolarizing muscle relaxants (tubocurarin).

Torasemide may increase the toxicity of lithium preparations and the ototoxicity of ethacric acid.

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

Pressor amines and Torasemide Canon mutually reduce the effectiveness.

Drugs that block tubular secretion increase the concentration of Torasemide Canon in the blood serum.

Concomitant use of cyclosporine and Torasemide Canon increases the risk of gouty arthritis due to the fact that cyclosporine can cause impaired urate excretion by the kidneys, and torasemide-hyperuricemia.

It has been reported that patients at high risk of developing nephropathy, taking torasemide orally, with the introduction of radiopaque agents, renal function disorders were observed more often than in patients at high risk of developing nephropathy, who were given intravenous hydration before the introduction of radiopaque agents.

The bioavailability and, as a consequence, the effectiveness of torasemide may be reduced with co-therapy with colestyramine.

How to take, course of use and dosage

The drug is taken orally, at any convenient time, regardless of food intake, preferably at the same time. Tablets should be taken without chewing and washed down with water.

In edematous syndrome with chronic heart failure, the initial dose is 10-20 mg 1 time/day. If necessary, the dose can be doubled until the desired effect is obtained.

In case of edematous syndrome with kidney disease, the initial dose is 20 mg 1 time/day. If necessary, the dose can be doubled until the desired effect is obtained.

In case of edematous syndrome with liver disease, the initial dose is 5-10 mg 1 time/day. If necessary, the dose can be doubled until the desired effect is obtained.

A single dose of more than 40 mg is not recommended, as its effect has not been studied.

The drug Torasemide Canon is prescribed for a long period or until the edema disappears.

In arterial hypertension, the initial dose is 5 mg 1 time/day. In the absence of an adequate reduction in blood pressure for 4-6 weeks, the dose is increased to 10 mg 1 time/day. If this dose does not give the desired effect, an antihypertensive drug of another group should be added to the treatment regimen.

Elderly patients do not need to adjust the dose.

Overdose

Symptoms: increased diuresis, accompanied by a decrease in BCC and electrolyte imbalance, followed by an excessive decrease in blood pressure, drowsiness and confusion, collapse. Gastrointestinal disorders may occur.

Treatment: there is no specific antidote; provocation of vomiting, gastric lavage, activated charcoal. Conducting symptomatic therapy, reducing the dose or discontinuing the drug and simultaneously replenishing the BCC and indicators of water-electrolyte balance and acid-base state under the control of serum electrolyte concentrations, hematocrit.

Hemodialysis is not effective because the elimination of torasemide and its metabolites is not accelerated.

Special instructions

Torasemide Canon should be used strictly as prescribed by your doctor.

Patients with hypersensitivity to sulfonamides and sulfonylureas may have cross-sensitivity to Torasemide Canon.

In patients receiving Torasemide Canon in high doses, it is not advisable to limit the intake of table salt and the use of potassium preparations in order to avoid the development of hyponatremia, hypokalemia and metabolic alkalosis.

The risk of hypokalemia is greatest in patients with cirrhosis of the liver, expressed by diuresis, with insufficient intake of electrolytes with food, as well as with simultaneous treatment with corticosteroids or ACTH.

An increased risk of developing water-electrolyte balance disorders is noted in patients with renal insufficiency. During the course of treatment with Torasemide Canon, it is necessary to periodically monitor the concentration of blood plasma electrolytes (including sodium, calcium, potassium, magnesium), acid-base state, residual nitrogen, creatinine, uric acid and, if necessary, conduct appropriate therapy (with greater frequency in patients with frequent vomiting and against the background of parenterally administered fluids).

In patients with advanced water-electrolyte disorders, hypovolemia, or prerenal azotemia, laboratory test data may include: hyper – or hyponatremia, hyper-or hypochloremia, hyper – or hypokalemia, acid-base balance disorders, and elevated blood urea concentrations.

If these disorders occur, it is necessary to stop taking Torasemide Canon until normal values are restored, and then resume treatment at a lower dose.

If azotemia and oliguria appear or increase in patients with severe progressive kidney disease, it is recommended to suspend treatment with Torasemide Canon.

Selection of the dosage regimen for patients with ascites on the background of cirrhosis of the liver should be carried out in a hospital setting (violations of the water-electrolyte balance can lead to the development of hepatic coma). Regular monitoring of blood plasma electrolytes is indicated for this category of patients.

The use of Torasemide Canon may cause an exacerbation of gout.

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

In patients with prostatic hyperplasia, narrowing of the ureters, monitoring of diuresis is necessary due to the possibility of acute urinary retention.

In patients with cardiovascular diseases, especially those taking cardiac glycosides, diuretic-induced hypokalemia can cause arrhythmias.

Influence on the ability to drive motor vehicles and manage mechanisms

During treatment with Torasemide Canon, patients should refrain from driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

 In a dark place, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Torasemide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Heart Failure