Toradiv (torasemide) tablets 10 mg. №30

Description

Toradiv (torasemide) tablets 10 mg. №30

Composition

active substance: torasemide;

1 tablet contains torasemide 10 mg;

Excipients: lactose monohydrate, pregelatinized starch, colloidal anhydrous silica, magnesium stearate.

Dosage form

Tablets.

Main physical and chemical properties: white round tablets with one-sided notch for separation.

Pharmacotherapeutic group

Diuretics. Highly active diuretics.
ATX code C0ZS A04.

Pharmacological properties

Torasemide acts as a saluretic, the action is associated with the inhibition of the renal absorption of sodium and chlorine ions in the ascending part of Henle’s loop. In humans, the diuretic effect quickly reaches its maximum within the first 2-3 hours after intravenous and oral administration, respectively, and remains constant for almost 12 hours. In healthy volunteers in the dose range of 5-100 mg, an increase in urine output was observed in proportion to the logarithm of the dose. An increase in diuresis was observed even in cases where other diuretics, for example, 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. After oral administration, the antihypertensive effect of torasemide develops gradually, starting from the first week after starting treatment. The maximum antihypertensive effect is reached no later than 12 weeks. Torasemide lowers blood pressure by reducing the total peripheral vascular resistance. This effect is explained by the normalization of the disturbed electrolyte balance, mainly due to a decrease in the increased activity of free calcium ions in the cells of the muscles of arterial vessels, which was revealed in patients with arterial hypertension. Probably, this effect reduces the increased susceptibility of blood vessels to endogenous vasopressor substances, such as catecholamines.

Indications

Toradiv tablets are indicated for the treatment and prevention of recurrence of edema and / or effusions caused by heart failure.

Contraindications

Hypersensitivity to the active substance, other sulfonylureas or to excipients. Renal failure with anuria. Hepatic coma or precoma. Arterial hypotension. Hypovolemia. Hyponatremia. Hypokalemia. Significant urinary disorders, for example, due to prostatic hypertrophy.

Method of administration and dosage

Treatment should be started with a daily dose of 5 mg torasemide, which corresponds to ½ tablet of Toradiv tablets. Usually this dose is considered maintenance. If the daily dose of 5 mg is insufficient, a daily dose of 10 mg of torasemide should be used, which is prescribed by the doctor daily. Depending on the severity of the patient’s condition, the daily dose can be increased to 20 mg of torasemide. The maximum daily dose is 40 mg. Take the tablets on an empty stomach, do not chew and drink a small amount of liquid. The duration of treatment depends on the course of the disease.

Children

The safety and efficacy of Toradiv tablets in children and adolescents under 18 years of age have not been established. Therefore, torasemide should not be used in patients of this age group).

Overdose

The typical symptoms are unknown. Overdose can cause severe diuresis, including the risk of excessive loss of water and electrolytes, drowsiness, amentive syndrome (a form of impaired consciousness), symptomatic arterial hypotension, cardiovascular failure, and disorders of the digestive tract.
Overdose treatment. The specific antidote is unknown. Symptoms of intoxication disappear, as a rule, when the dose is reduced and the drug is discontinued, as well as with appropriate fluid and electrolyte replacement (control should be carried out). Torasemide is not cleared from the blood by hemodialysis. Treatment for hypovolemia is fluid volume replacement. Treatment in case of hypokalemia is the appointment of potassium preparations. Treatment of cardiovascular insufficiency – give the patient a sitting position and, if necessary, prescribe symptomatic therapy.
Anaphylactic shock (emergency measures). At the first appearance of skin reactions (such as urticaria or redness of the skin), an agitated state of the patient, headache, sweating, nausea, cyanosis, conduct vein catheterization; give the patient a horizontal position, provide free air flow, prescribe oxygen. If necessary, enter epinephrine, solutions that replace the volume of fluid, glucocorticoid hormones.

Side effects:

• Metabolism / electrolytes. Often: intensification of metabolic alkalosis; muscle spasms (especially at the beginning of treatment); indigestion of food, flatulence, urge to urinate, rash; increased concentration of uric acid and glucose in the blood, as well as hyperlipidemia (including increased cholesterol and triglycerides); hypokalemia with 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, disturbances in water and electrolyte balance are possible, for example, hypovolemia, hypokalemia and / or hyponatremia. With significant losses of fluid and electrolytes as a result of increased urination, hypotension, headache, fatigue, thirst, drowsiness may occur, especially at the beginning of treatment and in elderly patients.
• On the part of the cardiovascular system. Very rare: due to possible blood thickening, 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 heart attack myocardium, syncope.
• From 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 rare: pancreatitis.
• From the kidneys and urinary tract. Sometimes: increased concentration of creatinine and blood urea. In patients with urination disorders, increased urine production can lead to urinary retention and overstretching of the bladder.
• From the liver and biliary tract. Often: an increase in the concentration of certain liver enzymes (gamma-glutamyl transpeptidase) in the blood.
• On the part of the skin and the immune system. Very rare: allergic reactions such as pruritus, exanthema, photosensitivity, severe skin reactions.
• From the side of the blood. Very rare: a decrease in the number of platelets, erythrocytes and / or leukocytes, as a result of hemoconcentration.
• General manifestations. Often: headache, dizziness, increased fatigue, general weakness (especially at the beginning of treatment). Sometimes: dry mouth, discomfort in the limbs (paresthesia). Very rare: visual impairment, ringing in the ears, hearing loss.