Description
Latin name
TORASEMIDE-SZ
packaging 10 pcs – blister packs (6) – packs of cardboard.
Indications
edematous syndrome of various origins, including in chronic heart failure, diseases of the liver, lungs and kidneys
arterial hypertension.
Contraindications
Hypersensitivity to tosemide or to any of the drug s components in patients with allergies to sulfonamides (sulfonamide antimicrobials or sulfonylureas) renal failure with anuria, hepatic coma and precoma refractory hypokalemia (hyperemia or hyperemia) or dehydration, pronounced violations of the outflow of urine of any etiology (including unilateral damage to the urinary tract) is glycosidic intoxication acute glomerulonephritis decompensated aortic and mitral stenosis, hypertrophic obstructive cardiomyopathy, increased central venous pressure (over 10 mm Hg ) hyperuricemia, the simultaneous use of aminoglycosides and cephalosporins under the age of 18 years of pregnancy, the period of breastfeeding lactose intolerance, lactase deficiency or glucose-galactose malabsobiya.
Precautions
Arterial hypotension, stenosing atherosclerosis of cerebral arteries, hypoproteinemia, predisposition to hyperuricemia, impaired urine outflow (benign prostatic hyperplasia, narrowing of the urethra or hydronephrosis), ventricular cardiac arrhythmia, acute myocardial infarction, acute myocardial infarction diarrhea, pancreatitis, diabetes mellitus (decreased glucose tolerance), hepatorenal syndrome, gout, anemia, simultaneous use of cardiac icosides, corticosteroids and adrenocorticotropic hormone (ACTH).
Composition
active substance: torasemide – 10 mg excipients: lactose monohydrate (lactopress) (milk sugar) – 178.6 mg 1500 starch (starch) – 49.0 mg of silicon colloidal dioxide (Aerosil) – 1.2 mg of magnesium stearate – 1.2 mg.
Description
Tablets are white or almost white in color, round, flat-cylindrical with bevel and notch on one side.
Dosage and administration
The drug is taken orally 1 time / day, at any convenient (but at the same) time, regardless of food intake. The tablets should be swallowed without chewing and drinking plenty of water.
Edema syndrome in chronic heart failure
Recommended starting dose is 10-20 mg 1 time / day. If necessary, the dose can be doubled to obtain the desired effect.
Edema syndrome with kidney disease
Recommended starting dose is 20 mg 1 time / day. If necessary, the dose can be doubled to obtain the desired effect.
Edema syndrome in liver disease
The recommended starting dose is 5-10 mg 1 time / day. If necessary, the dose can be doubled to obtain the desired effect.
It is not recommended to exceed the maximum single dose, which is 40 mg (no experience of use).
The drug is used for a long period or until the edema disappears.
Arterial hypertension
The initial dose is 2.5 mg (1/2 tab. 5 mg) 1 time / day. In the absence of a therapeutic effect within 4 weeks, the dose is increased to 5 mg 1 time / day. In the absence of an adequate decrease in blood pressure when taken at a dose of 5 mg 1 time / day for 4-6 weeks, the dose is increased to 10 mg 1 time / day. If the use of the drug at a dose of 10 mg / day does not give the desired effect, an antihypertensive drug of another group is added to the treatment.
In elderly patients, dose adjustment is not required.
Side effects
The incidence of side effects is classified according to the recommendations of the World Health Organization: very often – 1/10 (> 10%) often – from 1/100 to1% and0.1% and0. 01% and
From the nervous system: often – headache, dizziness, drowsiness infrequently – cramps in the muscles of the lower extremities, frequency unknown – confusion, fainting, paresthesia in the extremities (numbness, crawling and tingling sensations).
On the part of the sensory organs: frequency unknown – visual impairment, hearing impairment, tinnitus and hearing loss (usually reversible) usually in patients with renal failure or hypoproteinemia (nephrotic syndrome).
From the cardiovascular system: infrequently – extrasystole, arrhythmia, tachycardia, frequency is unknown – excessive decrease in blood pressure, orthostatic hypotension, collapse, deep vein thrombosis, thromboembolism, decrease in bcc.
From the respiratory system: infrequently – nosebleeds.
From the digestive system: often – diarrhea infrequently – abdominal pain, flatulence, polydipsia frequency unknown – dry mouth, nausea, vomiting, loss of appetite, pancreatitis, dyspeptic disorders, intrahepatic cholestasis.
From the urinary system: often – an increase in the frequency of urination, polyuria, nocturia infrequently – increased urination frequency is unknown – oliguria, urinary retention (in patients with obstruction of the urinary tract), interstitial nephritis, hematuria.
From the reproductive system: frequency unknown – decreased potency.
From the skin and subcutaneous tissues: frequency unknown – itching, rash, urticaria, polymorphic erythema, exfoliative dermatitis, purpura, vasculitis, photosensitivity.
From the musculoskeletal system: the frequency is unknown – muscle weakness.
From the side of metabolism: the frequency is unknown – hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, hypochloremia, metabolic alkalosis, hypovolemia, dehydration (more often in elderly patients).
On the part of laboratory indicators: infrequently – hypercholesterolemia, hypertriglyceridemia, frequency is unknown – hyperuricemia, a slight increase in the activity of alkaline phosphatase in the blood plasma, an increase in the concentration of creatinine and urea in the blood plasma, an increase in the activity of some liver enzymes in the blood plasma (for example, GGT), thrombocytopenia, leukopenia, , agranulocytosis, hyperglycemia, decreased glucose tolerance (possible manifestation of latent diabetes mellitus).
Other: frequency unknown – aplastic or hemolytic anemia.
Drug Interaction
Increases the concentration and risk of nephro- and ototoxic effects of cephalosporins, aminoglycosides, chloramphenicol, ethacrynic acid, cisplatin, amphotericin B (due to competitive renal excretion).
Increases the efficiency of diazoxide and theophylline, decreases – hypoglycemic agents, allopurinol.
Press amines and torasemide mutually reduce the effectiveness of each other.
Drugs that block canal secretion increase the concentration of torasemide in the serum.
With the use of ACS, amphotericin B increases the risk of hypokalemia, with cardiac glycosides – the risk of developing glycosidic intoxication due to hypokalemia (for high- and low-polar) and lengthening of T1 / 2 (for low-polar) increases.
Reduces the renal clearance of lithium drugs and increases the likelihood of intoxication.
NSAIDs, sucralfate reduce the diuretic effect due to inhibition of prostaglandin synthesis, impaired plasma renin activity, and aldosterone excretion.
Enhances the antihypertensive action of antihypertensives, neuromuscular blockade of depolarizing muscle relaxants (suxamethonium) and attenuates the effect of non-depolarizing muscle relaxants (tubocurarin).
Co-administration of high-dose salicylates against torasemide increases the risk of their toxicity (due to competitive renal excretion).
Sequential or co-administration of torasemide with ACE inhibitors or angiotensin II receptor antagonists can lead to a significant decrease in blood pressure. This can be avoided by lowering the dose of torasemide or temporarily discontinuing it.
Concomitant administration of probenecid or methotrexate may impair the effectiveness of torasemide (the same route of secretion). Torasemide, on the other hand, can reduce the renal elimination of these drugs.
The combined use of cyclosporine and torasemide increases the risk of developing gouty arthritis due to the fact that cyclosporine can cause impaired urinary excretion by the kidneys and torasemide causes hyperuricemia.
It has been reported that patients with a high risk of nephropathy taking torasemide orally, with the introduction of X-ray contrast agents, renal dysfunction was observed more often than in patients with a high risk of nephropathy, who were given hydration prior to the introduction of X-ray contrast agents.
The bioavailability and, as a consequence, the effectiveness of torasemide may be reduced when co-administered with cholestyramine.
Overdose
Symptoms: increased diuresis, accompanied by a decrease in BCC and impaired water-electrolyte balance of blood, followed by excessive decrease in blood pressure, drowsiness and confusion, collapse. Gastrointestinal disorders may occur.
Treatment: There is no specific antidote. Vomiting provocation, gastric lavage, activated carbon. Conducting symptomatic therapy, reducing the dose or discontinuing the drug and simultaneously replenishing BCC and indicators of water-electrolyte balance and acid-base state under the control of serum concentrations of electrolytes, hematocrit. Hemodialysis is ineffective.
Storage conditions
In a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
Expiration
3 years. Do not use after the expiry date stated on the packaging.
Active substance
Torasemide
dosage form
dosage form
tablets
Northern Star, Russia