Torasemid-Darnytsia (torasemide) solution for injections 20 mg/4 ml. ampoules 4 ml. №5

Description

Torasemid-Darnytsia (torasemide) solution for injections 20 mg/4 ml. ampoules 4 ml. №5

Composition

active substance: torasemide;

1 ampoule (4 ml) of solution for injection contains 20 mg torasemide;

Excipients: polyethylene glycol 400 (macrogol 400), sodium hydroxide, trometamol, water for injections.

Dosage form

Solution for injection.

Basic physical and chemical properties: transparent colorless liquid that contains virtually no mechanical inclusions.

Pharmacotherapeutic group

Drugs that affect the cardiovascular system. Diuretics. Highly active diuretics. Sulfanilamides are common. Torasemide.
ATX code C0ZS A04.

Pharmacological properties

Torasemide acts as a saluretic, its action is associated with inhibition of the renal absorption of sodium and chlorine ions in the ascending part of the Henle loop. In humans, the diuretic effect quickly reaches its maximum during the first 2-3 hours after parenteral and oral administration, respectively, and remains constant for almost 12 hours. In healthy probands in the dose range of 5–100 mg, an increase in diuresis (loop diuretic activity) proportional to the dose logarithm was observed. An increase in diuresis was observed even in cases where other diuretics, as well as distally acting effective thiazide 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 afterload.

Indications

Treatment of edema and / or effusion caused by heart failure, if intravenous administration of the drug is necessary, for example, in the case of pulmonary edema due to acute heart failure.

Contraindications

Hypersensitivity to the active substance, sulfonylurea preparations and to the excipients of the drug. Renal failure with anuria. Hepatic coma or precoma. Arterial hypotension. Hypovolemia. Hyponatremia. Hypokalemia. Acute violation of urination, for example, as a result of prostatic hypertrophy. Breastfeeding period.

Method of administration and dosage

Treatment should begin with a single dose of 2 ml of the drug Torasemid-Darnytsia solution, which is equivalent to 10 mg of torasemide per day. If the effect is insufficient, then a single dose can be increased to 4 ml of the drug, which is equivalent to 20 mg of torasemide. If the effect in this case is insufficient, you can apply short-term (no more than 3 days) therapy with the introduction of a daily dose of 8 ml of the drug Torasemid-Darnitsa, which is equivalent to 40 mg of torasemide.
Acute pulmonary edema. Treatment should begin with intravenous administration of a single dose of 4 ml of the drug Torasemid-Darnytsia solution, which is equivalent to 20 mg of torasemide.
Depending on the clinical effect obtained, the introduction of this dose can be repeated at intervals of 30 minutes.
It is forbidden to exceed the maximum daily dose of 20 ml of the drug, which is equivalent to 100 mg of torasemide.
Inject solution for injection slowly intravenously. It is forbidden to inject the solution intraarterally! Inject only a clean solution. With prolonged use, intravenous administration should be replaced as soon as possible with oral administration, since intravenous administration of the drug torasemide is not recommended for more than 7 days.

Children

Torasemid-Darnytsia solution should not be used in children and adolescents due to the lack of sufficient clinical experience.

Overdose

The typical symptoms are unknown. Overdose can cause severe diuresis and, as a result, excessive loss of water and electrolytes, drowsiness, amentive syndrome (one of the forms of impaired consciousness), symptomatic arterial hypotension, cardiovascular failure, and disorders of the digestive system.
Overdose treatment. The specific antidote is unknown. Symptoms of intoxication disappear, as a rule, when the dose is reduced or the drug is discontinued and with appropriate fluid and electrolyte replacement (control must be carried out!). Torasemide is not cleared from the blood by hemodialysis. Treatment for hypovolemia is fluid volume replacement. Treatment in case of hypokalemia: administration of potassium supplements. Treatment of cardiovascular failure: transfer the patient to the supine position and, if necessary, prescribe symptomatic therapy.
Anaphylactic shock (immediate action). If skin reactions appear (such as hives or redness of the skin), agitation, headache, sweating, nausea, cyanosis, vein catheterization should be performed; put the patient in a horizontal position, provide free air flow, prescribe oxygen. If necessary, use the introduction of epinephrine, solutions that replace the volume of fluid, glucocorticoid hormones.

Side effects:

• From the gastrointestinal tract. Often: multiple disorders of the digestive system (especially at the beginning of treatment), including lack of appetite, flatulence, stomach pain, nausea, vomiting, diarrhea, constipation. Very rare: pancreatitis.
• From the liver and biliary tract. Often: an increase in the concentration of certain liver enzymes (gamma-glutamyl transpeptidase) in the blood.
• From the kidneys and urinary system. Rarely: increased concentrations of creatinine and urea in the blood, urge to urinate. When there is a significant loss of water and electrolytes caused by excessive urine production, especially at the beginning of treatment and in elderly patients, there may be a decrease in blood pressure, headache, asthenia and drowsiness.
• In patients with urinary disorders (eg, prostatic hypertrophy), increased urine production can lead to urinary retention and excessive distension of the bladder.
• From the side of metabolism, metabolism. Often: increased metabolic alkalosis. Muscle spasms (especially at the beginning of treatment). An increase in the concentration of uric acid and glucose in the blood, as well as cholesterol and triglycerides. Hypokalemia with concomitant potassium-free 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, disturbances in the water-electrolyte balance are possible, for example: hypovolemia, hypokalemia and / or hyponatremia.
• On the part of the cardiovascular system. Very rarely, thromboembolic complications, confusion, arterial hypotension, as well as circulatory and cardiac disorders, including ischemia of the heart and brain, which can lead, for example, to arrhythmias, angina pectoris, acute myocardial infarction, syncope due to possible hemoconcentration.
• On the part of the blood and lymphatic system. Very rare: a decrease in the number of platelets, erythrocytes and / or leukocytes, anemia.
• From the immune system. Very rare: allergic reactions, including pruritus, exanthema, photosensitivity, skin reactions. After intravenous administration, acute, potentially life-threatening hypersensitivity reactions (anaphylactic shock) may occur.
• General disorders and reactions at the injection site. Often: headache, dizziness, increased fatigue, general weakness (especially at the beginning of treatment). Rarely: dry mouth, discomfort in the limbs (paresthesia). Very rare: visual impairment, ringing in the ears, hearing loss. Frequency not known: local reactions after injection.