Торсид® (solution for injections)

General characteristics. Structure:

Active ingredient: torasemide;

1 ml of solution contains a torasemid in terms of 100% dry matter of 5 mg;

excipients: polyethyleneglycol 400, трометамин, sodium hydroxide, water for injections.

Pharmacological properties:

Pharmacodynamics. Torasemid acts as a saluretic, braking the return renal reabsorption of ions of sodium and chlorine in the ascending part of a Henle's loop.

Pharmacokinetics. At the person the diuretic effect after intravenous administration begins quickly, at the same time the maximum action develops in the first 1–3 h and remains during nearly 12 h. The diuresis against the background of use of a torasemid has dozozavisimy character. Increase in a diuresis arises also at a renal failure. Thanks to these qualities торасемид eliminates hypostases. Linkng of a torasemid with proteins of a blood plasma makes 99%, metabolites of M1, M3 and M5 — 86%, 95% and 97% respectively. Final time of semi-removal (t1/2) of a torasemid and its metabolites makes at healthy volunteers of 3-4 h. The general clearance of a torasemid makes 40 ml/min., renal clearance — about 10 ml/min. The main metabolite of M5 of diuretic effect does not render, and about 10% of pharmakodinamichesky action are the share of a share of metabolites of M1 and the M3 taken together. At a renal failure the general clearance and an elimination half-life of a torasemid do not change, and the elimination half-life of M3 and M5 increases. Nevertheless pharmakodinamichesky characteristics remain not changed, severity of a renal failure does not influence duration of effect of drug. At patients with an abnormal liver function or heart failure elimination half-lives of a torasemid and a metabolite of M5 slightly increase. The amount of substance which is removed with urine almost fully corresponds to its quantity at healthy volunteers therefore торасемид and its metabolites do not kumulirut.

Pharmaceutical characteristics.

Main physical and chemical properties: transparent colourless liquid practically without mechanical inclusions.

Indications to use:

Treatment and prevention of the hypostases and/or exudates caused by heart failure in need of intravenous therapy.

Route of administration and doses:

The drug is administered intravenously, slowly. The initial single dose makes 10 mg a day (2 ml of drug Torsid). At insufficient clinical effect the dose can be raised to 20 mg (4 ml of drug Torsid). If the desirable clinical effect is not reached, the dose is raised to

40 mg a day (8 ml of drug Torsid), but apply it no more than 3 days.

Acute fluid lungs. The initial dose makes 20 mg. Depending on a clinical picture it is possible to enter such dose every 30 min., but no more than 100 mg of a torasemid a day.

For further treatment early transition to oral administration is recommended. It is not necessary to use drug intravenously more than 7 days.

The maximum daily dose should not exceed 100 mg.

Patients with a liver failure. Treatment of this category of patients needs to be carried out with care as increase in concentration of a torasemid in a blood plasma is possible.

Patients of advanced age. Treatment of this category of patients does not demand special selection of a dose. Unfortunately, adequate researches concerning comparison of treatment of patients of advanced age and young patients are absent.

Solution for injections is entered intravenously, slowly.

Not to enter vnutriarterialno!

Features of use:

It is not necessary to use drug longer than one week. For further treatment the tableted drug form Torsid is recommended. At long treatment it is regularly necessary to control electrolytic balance, in particular blood serum potassium. It is regularly necessary to check the level of glucose, uric acid, creatinine and lipids of blood, and also a blood picture (erythrocytes, leukocytes, thrombocytes). In some cases it is not excluded that increase in level of glucose in blood at patients is connected with a possible latent or manifest diabetes mellitus therefore at such patients it is necessary to control carefully the content of sugar in blood. There are no data on use of drug for patients with a system lupus erythematosus. In need of an operative measure it is necessary to warn the anesthesiologist about Torsid's use.

After reception of a torasemid ototoxicity manifestations (a sonitus and a hearing loss) which had reversible character were observed, but a feedforward using drug it is not established.

Due to the lack of sufficient clinical experience of use it is not necessary to appoint торасемид at following diseases and states:

gout; arrhythmias, for example, sinuatrial blockade, atrioventricular block ІІ and ІІІ degrees; pathological changes of acid-base metabolism; the accompanying therapy using drugs of lithium, aminoglycosides or cephalosporins; pathological changes of a picture of blood, for example, thrombocytopenia or anemia at patients without renal failure; the renal failure caused by nephrotoxic substances.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

It is not recommended to manage motor transport or other mechanisms during treatment by Torsid, especially at the beginning of therapy.

Side effects:

From cardiovascular system. Disturbance of water and electrolytic balance, in isolated cases - strengthening of a metabolic alkalosis; arterial hypotension, confusion of consciousness, fibrinferment, cardial and cerebral ischemia with possible development of disturbances of a cordial rhythm, stenocardia, acute myocardial infarction, a syncope.

From a nervous system. Sometimes, especially in an initiation of treatment, the headache, dizziness, increased fatigue, myotonia can take place.

From the alimentary system. Lock, lack of appetite, nausea, vomiting, stomach ache, diarrhea; increase in level of liver enzymes (gammaglutamiltranspeptidaza) can be observed.

From an urinary system. At patients with disturbance of an urination intensive urination can lead to its delay and hyperdystension of a bladder. Increase in creatinine and urea in blood is seldom observed.

Metabolism. Sometimes the level of uric acid, glucose, lipids (triglycerides, cholesterol) in blood increases.

From system of blood. Seldom – reduction of quantity of thrombocytes, erythrocytes and/or leukocytes.

From immune system. Seldom – an itch, a dieback, photosensitivity; in some cases after intravenous administration the acute reactions of hypersensitivity demanding the emergency help can develop; heavy skin reactions are sometimes possible.

Others. Seldom meet dryness in a mouth, paresthesia, in some cases - a vision disorder. In isolated cases - a sonitus and hearing losses.

Interaction with other medicines:

Simultaneous therapy by lithium drugs, aminoglycosides or cephalosporins is contraindicated. Torasemid strengthens effect of other anti-hypertensive drugs, in particular inhibitors of an angiotensin-converting enzyme (IAPF). If IAPF is applied in addition during treatment torasemidy or at once after its termination, then perhaps excessive lowering of arterial pressure. At simultaneous use with torasemidy foxglove drugs the deficit of potassium caused torasemidy can lead to strengthening of side effects of both drugs. Torasemid can reduce action of antidiabetic means.

Probenetsid and non-steroidal anti-inflammatory drugs can reduce diuretic and hypotensive action of a torasemid. At therapy by salicylates in high doses торасемид can strengthen their toxic action on the central nervous system. Torasemid, especially in high doses, can strengthen from - and nephrotoxic effect of antibiotics of group of aminoglycosides and the platinum derivatives operating cytotoxically. Torasemid can strengthen effect of theophylline, and also myorelaxation effect of kurarepodobny medicines. Purgatives, and also mineralo-and glucocorticoids can increase the potassium loss caused torasemidy. At simultaneous treatment torasemidy and lithium increase in concentration of lithium in blood serum can take place that can lead to strengthening of action and side effects of lithium. Torasemid can reduce vasoconstrictive effects of catecholamines. There are no data on interaction with Amiodaronum, Amphotericinum In and anticoagulants.

Contraindications:

Hypersensitivity to active ingredient, excipients, and other drugs of sulfanylurea.
Arterial hypotension (the ABP is lower than 90 mm of mercury.).
The renal failure which is followed by an anury.
Heavy abnormal liver functions (prekoma, coma).
Disturbances of water and electrolytic balance (hypovolemia, hyponatremia, hypopotassemia).
The expressed urination disturbances (for example, as a result of a prostatauxe).
Gout.
Disturbances of the carrying-out system of heart of high degree: sinoauricular block, atrioventricular block of II or III degrees.
Pathological changes of an acid-base state.
Pathological changes of a picture of blood (thrombocytopenia or anemia at patients without renal failure).
Renal failure owing to defeat by nephrotoxic substances.
Pregnancy and period of feeding by a breast.

Overdose:

The typical symptomatology is not known. The overdose can cause a severe diuresis, including risk of excessive loss of water and electrolytes, drowsiness, an amental syndrome (a consciousness disturbance form), symptomatic arterial hypotension, cardiovascular insufficiency and frustration from a digestive tract.

Overdose treatment. The specific antidote is not known. Symptoms of intoxication disappear, as a rule, at reduction of a dosage and/or cancellation of medicine, and also at the corresponding completion of liquid and electrolytes (it is necessary to carry out control!). Torasemid not to be brought from blood by means of a hemodialysis.

Treatment in case of a hypovolemia: completion of volume of liquid. Treatment in case of a hypopotassemia: purpose of drugs of potassium.

Treatment of cardiovascular insufficiency: sitting position of the patient and, if necessary, purpose of symptomatic therapy. Acute anaphylaxis (immediate actions). At the first emergence of skin reactions (such as, for example, small tortoiseshell or erubescence), the excited condition of the patient, a headache, perspiration, nausea, cyanosis carry out vein catheterization; the patient is given horizontal position, provide free access of air, appoint oxygen. If necessary, enter Epinephrinum, solutions which fill volume, glucocorticoid hormones.

Use during pregnancy or feeding by a breast.

There is no sufficient experience of use of drug for pregnant women therefore it is not recommended to apply it during pregnancy.

During treatment torasemidy breastfeeding should be stopped as it is not known whether drug gets to breast milk.

Children.

 

Clinical data on efficiency and safety of use of drug for treatment of children are absent therefore patients of this age category are not recommended to appoint drug.

Storage conditions:

Period of validity 2 years. Not to use drug after the termination of the period of validity specified on packaging. To store in the dry, protected from light place at a temperature not above 25 °C. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 2 ml or 4 ml in an ampoule. On 5 ampoules enclosed in a pack.