Torasemid SANDOZ ® tablets are used for the following indications: edema, high blood pressure in severe renal failure (creatinine clearance less than 20 ml / minute) in the presence of any residual diuresis (200 ml in 24 hours), including in patients on hemodialysis.
Composition
The active substance is torasemide anhydrous (one tablet contains 200 mg of torasemide anhydrous).
Excipients: colloidal anhydrous silicon dioxide, microcrystalline cellulose, magnesium stearate, talc (E 421), copolyvidone, crospovidone, hydrogenated castor oil.
Contraindication
Hypersensitivity to torasemide, to sulfonylurea derivatives or to any of the excipients. Renal failure with anuria, hepatic coma or precoma, arterial hypotension, arrhythmia. Hypovolemia, hyponatremia, hypokalemia. Significant urinary impairment, e.g. due to prostatic hypertrophy. Gout. Concomitant use with aminoglycosides or cephalosporins. Renal failure caused by nephrotoxic substances.
Method of application
The tablets should be taken in the morning, without chewing, with a small amount of liquid.
The duration of treatment depends on the course of the disease; in case of heart failure, treatment should continue until the edema disappears.
Edema. Therapy should be started with a dose of 5 mg per day. This dose is usually considered maintenance. If a daily dose of 5 mg is insufficient, a daily dose of 10 mg should be used, which should be administered daily. Depending on the severity of the patient's condition, the daily dose may be gradually increased to 20 mg of torasemide (once a day).
In chronic renal failure, the dose is determined individually and depends on the degree of renal dysfunction. If the dose of 20 mg is insufficient, it can be increased to 50 mg of torasemide 1 time per day and, if necessary, gradually increased to the maximum - 200 mg 1 time per day. The maximum daily dose of 200 mg should be prescribed only to patients with severe renal dysfunction (creatinine clearance <20 ml / minute) (including during hemodialysis) in the presence of diuresis of at least 200 ml / 24 hours.
Application features
Pregnant women
There are no reliable data on the effect of torasemide on the embryo and fetus in humans. There is information on the reproductive toxicity of torasemide. Torasemide penetrates the placental barrier. In connection with the above, torasemide can be used during pregnancy only for vital indications and in the minimum possible effective dose.
It is not currently known whether torasemide is excreted in animal or human breast milk. A risk to the newborn/infants cannot be excluded. Therefore, the use of the drug during breastfeeding is contraindicated. If it is necessary to use torasemide during this period, breastfeeding should be discontinued.
Children
The drug should not be used in children due to lack of data.
Drivers
Until the individual response to torasemide is determined during treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and quick reactions.
Overdose
Symptoms
Typical symptoms are unknown. In case of overdose, forced diuresis may occur with the risk of excessive loss of fluid and electrolytes. Drowsiness, confusion, hypotension, cardiovascular failure and gastrointestinal disorders may occur.
Treatment
There is no specific antidote. Depending on the symptoms of overdose, a dose reduction or discontinuation of the drug is recommended. Measures are taken to restore water and electrolyte balance. Torasemide is not removed from the blood by hemodialysis. Treatment of hypovolemia: fluid volume replacement. Treatment of hypokalemia: administration of potassium preparations. Treatment of cardiovascular failure: sitting position of the patient and, if necessary, the appointment of symptomatic therapy.
Anaphylactic shock (immediate measures). At the first appearance of skin reactions (such as, for example, urticaria or redness of the skin), the patient's agitated state, headache, sweating, nausea, cyanosis, perform catheterization of the vein; place the patient in a horizontal position, ensure free air flow, and administer oxygen. If necessary, administer adrenaline, solutions that replace fluid volume, and glucocorticoid hormones.
Side effects
Adverse reactions are listed by frequency of occurrence: common ≥ 1/100 and <1/10.
Metabolism: increased metabolic alkalosis; hypokalemia with concomitant low-potassium diet, with vomiting, diarrhea, after excessive use of laxatives, as well as in patients with chronic liver dysfunction.
From the nervous system: headache, dizziness (especially at the beginning of treatment).
Gastrointestinal tract: loss of appetite, nausea, vomiting, stomach pain, indigestion and diarrhea, constipation, flatulence, mainly at the beginning of treatment.
On the part of the hepatobiliary system: increased levels of some liver enzymes (γ-glutamyl transpeptidase) in blood plasma.
Musculoskeletal and connective tissue disorders: muscle spasms (especially at the beginning of treatment).
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
