Thorading 5 mg / ml 4 ml solution vials №5
Author Ольга Кияница
|Amount in a package||-|
|Manufacturer||Pharmex Group LLC (Ukraine, Borispol)|
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Toradiv (TORADIV) instructions for use
active ingredient: 1 ml of solution for injection contains torasemide 5 mg
auxiliary substances: polyethylene glycol 400, tromethamine, sodium hydroxide, water for injection.
Diuretic preparations . Highly active diuretics. The code of the automatic telephone exchange is С0ЗС А04.
Treatment of edema and effusions caused by heart failure, if necessary intravenous use of the drug, for example, in case of pulmonary edema due to acute heart failure.
Hypersensitivity to the active substance, sulfonylurea preparations and excipients of the drug. Renal failure with anuria.Hepatic coma or precoma. Arterial hypotension. Hypovolemia. Hyponatremia. Hypokalemia. Significant impairment of urination, for example, as a result of prostatic hypertrophy.
Dosing and Administration
Adults. Treatment begins with taking a single dose of 2 ml of the preparation of the torad, which is equivalent to 10 mg of torasemide per day. If the effect is insufficient, the single dose can be increased to 4 ml of the preparation of the torad, which is equivalent to 20 mg of torasemide. If the effect is insufficient in this case, short-term therapy can be applied within 3 days with the introduction of a daily dose of 8 ml of the torad preparation, which is equivalent to 40 mg of torasemide.
Acute pulmonary edema. Treatment should begin with the introduction of a single dose of 4 ml of the preparation of the torad, which is equivalent to 20 mg of torasemide. Depending on the effect, the dose can be repeated with an interval of 30 minutes. Do not exceed the daily maximum dose of 20 ml of the preparation of the torad, which is equivalent to 100 mg of torasemide.
Solution for injection is introduced slowly. Do not administer the solution intraarterially. With long-term use, the introduction should soon be replaced by oral administration, since intravenous use of the drug is not recommended for more than 7 days.
Patients with hepatic insufficiency. Treatment of this category of patients should be carried out with caution, since an increase in the concentration of torasemide in plasma is possible.
Patients of advanced age. Treatment of this category of patients does not require a special dose selection.
To assess the side effects, such a classification of frequency of their manifestations was used: very often - ≥ 10%; often - ≥ 1% - <10%; sometimes - ≥ 0.1% - <1%; rarely - ≥ 0.01% - <0.1%; very rarely - <0.01%, including isolated cases.
Metabolism / electrolytes. Often the intensification of metabolic alkalosis. Spasms of muscles (especially at the beginning of treatment). Increased concentrations of uric acid and glucose in the blood, as well as cholesterol and triglycerides. Hypokalemia with a concomitant low-calorie diet, with vomiting, diarrhea, after excessive use of laxatives, as well as in patients with chronic liver dysfunction. Depending on the dosage and duration of treatment, there may be abnormalities in the water and electrolyte balance, for example, hypovolemia, hypokalemia and / or hyponatremia.
The cardiovascular system. Very rarely due to possible thickening of blood, thromboembolic complications, confusion, arterial hypotension, as well as circulatory and cardiac disorders, including ischemia of the heart and brain, can occur, which can lead, for example, to arrhythmias, angina pectoris, acute myocardial infarction, syncope.
The digestive tract. Often disorders of the digestive tract (especially at the beginning of treatment), including lack of appetite, stomach pain, nausea, vomiting, diarrhea, constipation. Very rarely pancreatitis.
Kidneys and urinary tract. Sometimes: increasing the concentration of creatinine and urea. In patients with urinary disorders, increased urine production can lead to delay and excessive stretching of the bladder.
Liver. Often: increase in the concentration of certain hepatic enzymes (gamma-glutamyl-transpeptidase) in the blood.
Skin and allergic reactions. Very rarely: allergic reactions, for example, itching, exanthema, photosensitivity, skin reactions. After intravenous administration, acute, potentially life-threatening hypersensitivity reactions (anaphylactic shock) can occur.
Blood and hematopoietic system. Very rarely: a decrease in the number of platelets, red blood cells and / or leukocytes.
General manifestations. Often: headache, dizziness, fatigue, general weakness (especially at the beginning of treatment). Sometimes dry mouth, unpleasant sensations in the extremities (paresthesia). Very rarely: visual disturbances, ringing in the ears, hearing loss.
The typical symptomatology is unknown. Overdosing can cause a strong diuresis, including the risk of excessive loss of water and electrolytes, drowsiness, anemic syndrome (a form of impaired consciousness), symptomatic arterial hypotension, cardiovascular failure and disorders of the digestive tract.
Treatment of overdose. The specific antidote is unknown. Symptoms of intoxication disappear, usually when the dose is reduced and the drug is withdrawn, and when the fluid and electrolytes are appropriately replaced (control should be carried out). Torasemide is not excreted from the blood by hemodialysis. Treatment in the case of hypovolemia: replacement of the volume of fluid. Treatment in case of hypokalemia: administration of potassium preparations.Treatment of cardiovascular failure: transfer of the patient to a sitting position and, if necessary, the appointment of symptomatic therapy.
Anaphylactic shock (emergency measures). At the first appearance of skin reactions (such as, for example, urticaria or reddening of the skin), the excited state of the patient, headache, sweating, nausea, cyanosis, catheterization of the vein is performed; the patient is given a horizontal position, provides a free intake of air, and assigns oxygen. If necessary, enter epinephrine, solutions that replace the volume of fluid, glucocorticoid hormones.
Use during pregnancy and lactation
Pregnancy. There are no reliable data on the effect of torasemide on the embryo and human fetus. Experiments on animals have shown the reproductive toxicity of torasemide. Torasemide penetrates the placental barrier. In connection with the above, torasemide is used during pregnancy only for vital indications and in the lowest possible effective dose.Diuretics are unsuitable for a standard treatment of hypertension or edema in pregnant women, as they can reduce the perfusion of the placental barrier and cause toxic effects on the fetal development of the fetus. If torasemide is used to treat pregnant women with heart failure or renal insufficiency, careful monitoring of electrolytes and hematocrit as well as fetal development is necessary.
Lactation period. The use is contraindicated. If torasemide should be used during this period, then breast-feeding is stopped.
The drug is not used in children due to lack of sufficient clinical experience.
With prolonged use of torasemide, regular monitoring of the electrolyte balance, in particular potassium in the blood serum, is necessary. In addition, it is necessary to regularly monitor the glucose, uric acid, creatinine and lipid levels in the blood. Due to the fact that in the treatment with a diuretic, an increase in the blood glucose level can be observed, in patients with latent and overt diabetes it is necessary to strictly control the metabolism of carbohydrates. Also, regular monitoring of the blood picture (red blood cells, white blood cells, platelets) is necessary. Especially at the beginning of treatment of elderly patients it is necessary to pay special attention to the appearance of symptoms of electrolyte loss and blood thickening.
Through the lack of sufficient clinical experience of use, torasemide should not be prescribed for such diseases and conditions: gout; arrhythmias, for example, sinoatrial block, blockade of II and III degrees; pathological changes in acid-base metabolism; concomitant therapy with lithium, aminoglycoside or cephalosporins; pathological changes in the blood picture, such as thrombocytopenia or anemia in patients without renal failure, renal dysfunction caused by nephrotoxic substances.
The ability to influence the reaction rate when driving vehicles or other mechanisms
Even with proper use, torasemide can affect the reaction of the patient to such an extent that this will have a significant negative impact on the ability to drive vehicles or work with other mechanisms. This in many respects concerns such cases as the initiation of treatment, an increase in the dose of the drug, the replacement of the drug or the administration of concomitant therapy, and the concomitant use of alcohol. Therefore, during the use of the drug should be very careful when driving or working with other mechanisms.
Interaction with other drugs and other interactions
Torasemide enhances the effect of other antihypertensive agents, in particular ACE inhibitors, which can lead to an excessive decrease in blood pressure during their simultaneous use. With the simultaneous use of torasemide with digitalis preparations, a potassium deficiency caused by the use of a diuretic can lead to an increase in the side effects of both drugs. Torasemide may reduce the effectiveness of antidiabetics. Probenecid and non-steroidal anti-inflammatory drugs can inhibit the diuretic and hypotensive effect of torasemide. When treating salicylates in high doses, torasemide can increase their toxic effect on the central nervous system. Torasemide, especially in high doses, can enhance the nephrotoxic effect of aminoglycoside antibiotics, for example, kanamycin, gentamicin, tobramycin and cytostatics-platinum derivatives, as well as the nephrotoxic effect of cephalosporins. Torasemide can enhance the effect of theophylline, as well as the effect of curare-like drugs on muscle relaxation. Laxatives, as well as mineral and glucocorticoids, can enhance potassium loss due to torasemide. With the simultaneous use of torasemide and lithium preparations, an increase in the concentration of lithium in the plasma is possible, which may lead to increased influence and action of lithium. Torasemide can reduce the vasoconstrictive action of catecholamines, for example epinephrine and norepinephrine.
Pharmacodynamics. Torasemide acts as a saluretic, the action is associated with the inhibition of renal absorption of sodium and chlorine ions in the ascending part of the Henle loop. In humans, the diuretic effect quickly reaches its maximum within the first 2 or 3:00 after intravenous and oral administration respectively and remains constant for almost 12:00. In healthy volunteers in a dose range of 5-100 mg, a dose-proportional increase in diuresis was observed. An increase in diuresis was observed even in cases when other diuretics, for example, distally acting effective thiazide series diuretics, no longer had the desired effect, for example, in renal failure. Due to this mechanism of action, torasemide leads to a decrease in edema. In the case of heart failure, torasemide reduces the manifestations of the disease and improves the functioning of the myocardium by reducing pre- and postnagruzku. After ingestion, the antihypertensive effect of torasemide develops gradually, starting from the first week after the start of treatment.Maximum antihypertensive action is achieved no later than 12 weeks. Torasemide reduces blood pressure by reducing the overall peripheral resistance of blood vessels. This influence is explained by the normalization of the disturbed electrolyte balance, mainly due to a decrease in the increased activity of free calcium ions in muscle cells of arterial vessels, was found in patients suffering from arterial hypertension. This influence probably reduces the increased susceptibility of the vessels to endogenous vasopressor substances, for example catecholamines.
Pharmacokinetics. The binding of torasemide to plasma proteins is 99%, the metabolites M 1, M 3, and M 5 are 86%, 95% and 97%, respectively. In humans, torasemide is metabolized with the formation of three metabolites M 1, M 2 and M 5. Evidence of the existence of other metabolites is absent. Metabolites M 1 and M 5 are formed as a result of oxidation of the propellant group, located on the phenolic ring, to the carboxylic acid. Metabolite M 3 is formed as a result of hydroxylation of the ring. The kinetics of torasemide and its metabolites is characterized by linear dependence.This means that the maximum serum concentration and the area under the serum concentration curve increase in proportion to the dosage. The final half-life (t 1/2) of torasemide and its metabolites in healthy volunteers is 3-4 hours.The total clearance of torasemide is 40 ml / min, the renal clearance is about 10 ml / min. The main metabolite M 5 does not have a diuretic effect, and the metabolites M 1 and M 3, taken together, account for about 10% of the pharmacodynamic effect. With renal failure, the total clearance and half-life of torasemide do not change, and the half-life of M 3 and M 5 increases. However, the pharmacodynamic characteristics remain unchanged, and the severity of renal failure for duration of action is not affected. In patients with impaired hepatic function or heart failure, the half-life of torasemide and metabolite M 5 slightly increase, and the amount of urinary excreted material corresponds to the amount withdrawn from healthy volunteers, so the cumulation of torasemide and its metabolites should not be expected.Torasemide and its metabolites are practically not excreted in hemodialysis and haemofiltration.
Basic physical and chemical properties
clear, colorless solution.
The drug torad should not be mixed with other drugs for intravenous injection and / or infusion.
Store in the original packaging at a temperature not higher than 25 ° C. Keep out of the reach of children.
For 4 ml in a vial. For 5 vials in the outline cell packing; 1 contour pack in the package (manufacturer FARMEX GROUP LLC, Ukraine).
To 4 ml in the ampoule. 5 ampoules per pack (manufacturer LLC "Pharmaceutical company" Zdorovie ", Ukraine).
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