Instructions for Toricard tablets 10 mg blister No. 30
Composition
active ingredient: torasemide;
1 tablet contains: torasemide 5 mg or 10 mg;
Excipients: lactose monohydrate; microcrystalline cellulose; crospovidone; povidone; magnesium stearate; purified water.
Dosage form
Pills.
Main physicochemical properties:
Toricard, 5 mg tablets: white to off-white, oval-shaped tablets with a score line and embossed "5" and "6" on one side, embossed "H" on the other.
Toricard, 10 mg tablets: white to off-white, oval-shaped tablets with a score line and embossed "5" and "7" on one side, embossed "H" on the other.
Pharmacotherapeutic group
Diuretics. Highly active diuretics.
ATX code C03C A04.
Pharmacological properties
Pharmacodynamics.
Torasemide is a loop diuretic; at low doses used for antihypertensive treatment, it exhibits a weak diuretic and saluretic effect. At higher doses, torasemide causes increased diuresis, which is dose-dependent. Torasemide exhibits maximum diuretic activity 2-3 hours after oral administration, which remains constant for almost 12 hours.
Pharmacokinetics.
After oral administration, torasemide is rapidly and almost completely absorbed; maximum serum levels are reached 1-2 hours after administration. Systemic bioavailability is 80-90% and is independent of food intake. Binding of torasemide to plasma proteins is more than 99%, metabolites M1, M3 and M5 - 86%, 95% and 97%, respectively. The volume of distribution is 16 l. Torasemide is metabolized by oxidation and hydroxylation with the formation of three metabolites: M1, M3 and M5.
M5 is pharmacologically inactive, and metabolites M1 and M3 account for approximately 10% of the pharmacological action of the drug. The terminal half-life (t1/2) of torasemide and its metabolites is 3-4 hours in healthy volunteers. The total clearance of torasemide is 40 ml/min, renal clearance is approximately 10 ml/min. About 80% of the dose is excreted in the form of unchanged torasemide (24%) and its metabolites: M1 (12%), M3 (3%), M5 (41%). In renal failure, the half-life of torasemide does not change, and the half-life of metabolites M3 and M5 is prolonged. Torasemide and its metabolites are practically not excreted by hemodialysis or hemofiltration. In patients with impaired liver function or heart failure, the half-lives of torasemide and the metabolite M5 are slightly prolonged, but no accumulation of torasemide and its metabolites is observed.
Indication
Essential hypertension, as monotherapy or in combination with other antihypertensive agents.
Treatment of edema caused by congestive heart failure, kidney or liver disease.
Contraindication
· Hypersensitivity to the active substance, other sulfonylurea drugs and excipients of the drug.
· Renal failure with anuria.
· Hepatic coma or precoma.
· Arterial hypotension.
· Hypovolemia. Hyponatremia. Hypokalemia.
· Significant urinary incontinence, for example due to prostatic hypertrophy.
· Breastfeeding period.
· Children's age (up to 18 years).
Interaction with other medicinal products and other types of interactions
When using torasemide with cardiac glycosides, the sensitivity of the heart muscle to these drugs may increase due to potassium or magnesium deficiency. When used simultaneously with mineralocorticoids, glucocorticoids, and laxatives, the risk of potassium deficiency increases.
Torasemide enhances the effect of other antihypertensive drugs, in particular angiotensin-converting enzyme (ACE) inhibitors. Concomitant use with ACE inhibitors may lead to severe hypotension. This can be prevented by reducing the initial dose of the ACE inhibitor or reducing the dose of torasemide 2-3 days before starting ACE inhibitors.
Torasemide may weaken the vasoconstrictor effect of adrenaline and noradrenaline.
Torasemide weakens the effect of antidiabetic drugs.
Torasemide, especially in high doses, may potentiate the nephrotoxic and ototoxic effects of aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin), the toxic effects of platinum drugs and the nephrotoxic effects of cephalosporins.
Torasemide enhances the effect of theophylline and curare-like muscle relaxants.
Probenecid and non-steroidal anti-inflammatory drugs (e.g. indomethacin, propionic acid derivatives) weaken the diuretic and hypotensive effects of torasemide.
The simultaneous use of torasemide and lithium preparations may increase the concentration of lithium in the blood and increase the cardio- and neurotoxicity of the latter.
During therapy with salicylates in high doses, torasemide may enhance their toxic effect on the central nervous system.
When used simultaneously with cholestyramine, the absorption of torasemide may decrease, resulting in a weakening of its effect.
Application features
During long-term treatment with torasemide, it is recommended to regularly monitor electrolyte balance (especially in patients who are simultaneously using digitalis glycosides, glucocorticosteroids, mineralocorticosteroids or laxatives), glucose, uric acid, creatinine and blood lipid levels.
Patients with a tendency to develop hyperuricemia and gout require special supervision.
Patients with overt or latent diabetes mellitus need to monitor carbohydrate metabolism.
Due to the lack of sufficient clinical experience, it is not recommended to prescribe torasemide in pathological changes in acid-base balance; in pathological changes in the blood picture, such as thrombocytopenia or anemia in patients without renal failure; simultaneously with lithium, aminoglycosides, cephalosporins; in renal dysfunction caused by nephrotoxic substances; in children; in elderly patients (no dosage recommendations are available).
Torasemide should be used with extreme caution in patients with liver disease accompanied by cirrhosis and ascites, as sudden changes in water and electrolyte balance can lead to hepatic coma. Therapy with torasemide (as well as other diuretics) in patients of this group should be carried out in a hospital setting. To prevent hypokalemia and metabolic acidosis, the drug should be prescribed with aldosterone antagonists or drugs that promote potassium retention in the body.
After taking torasemide, ototoxicity (tinnitus and hearing loss) was observed, which were reversible, but a direct relationship with the use of the drug has not been established.
When prescribing diuretics, it is necessary to carefully monitor clinical symptoms of electrolyte imbalance, hypovolemia, extrarenal azotemia and other disorders, which may manifest as dry mouth, thirst, weakness, lethargy, drowsiness, agitation, muscle pain or cramps, myasthenia gravis, hypotension, oliguria, tachycardia, nausea, vomiting. Excessive diuresis can cause dehydration, lead to a decrease in circulating blood volume, thrombosis and embolism of blood vessels, especially in elderly patients.
Patients with water and electrolyte imbalance should discontinue use of the drug and resume therapy, starting with lower doses, after the undesirable effects have resolved.
When prescribing the drug, it is necessary to conduct regular laboratory monitoring of potassium and other electrolytes in the blood serum.
Information on dosing in patients with renal or hepatic impairment is limited. Patients with hepatic impairment should be administered the drug with caution as increased plasma concentrations of torasemide may occur.
The drug contains lactose, so it should not be prescribed to patients with hereditary lactase deficiency, galactose intolerance or glucose/galactose metabolism disorders.
Use during pregnancy or breastfeeding
There is no sufficient clinical experience with torasemide during pregnancy, so the drug can be prescribed during pregnancy only if the expected benefit to the pregnant woman outweighs the potential risk to the fetus (for vital indications and in the minimum possible effective dose). It is not known whether torasemide penetrates into breast milk, so breastfeeding should be discontinued during treatment with the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may change the speed of a person's reaction, reducing it when driving vehicles or working with other mechanisms. Therefore, during treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
The tablets should be taken in the morning, regardless of meals, without chewing, with a small amount of liquid.
The duration of treatment depends on the course of the disease.
Essential hypertension. The recommended dose for adults is 2.5 mg per day. If after two months of therapy with torasemide at a dose of 2.5 mg per day, normalization of blood pressure is not achieved, the dose can be increased to 5 mg (once a day). The maximum effect is usually observed 3 months after the start of treatment. The use of doses above 5 mg does not lead to an increase in the antihypertensive effect.
Edema. Therapy should be initiated 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 prescribed, which should be administered daily. Depending on the severity of the patient's condition, the daily dose can be gradually increased to 20 mg of torasemide (once a day).
Patients with cirrhosis of the liver. The total initial dose is 5-10 mg 1 time per day when used together with aldosterone antagonists or potassium-sparing diuretics. In the absence of the necessary diuretic effect, the dose should be doubled (10-20 mg per day) until the desired effect is achieved.
Patients with renal insufficiency: The total starting dose is 20 mg once daily.
In the absence of the necessary diuretic effect, the dose should be doubled (40 mg per day) until the desired effect is achieved.
Elderly patients: No special dose adjustment is required.
Children.
There are no clinical data on the efficacy and safety of the drug for the treatment of children, therefore it is not recommended to prescribe the drug to patients of this age category.
Overdose
Typical symptoms are unknown. Overdose may cause excessive diuresis, including the risk of excessive loss of water and electrolytes, drowsiness, amentia (a form of impaired consciousness), symptomatic hypotension, cardiovascular failure and gastrointestinal disorders.
Treatment. Specific antidote is unknown. Symptoms of intoxication usually disappear when the dosage is reduced, the drug is discontinued, and appropriate fluid and electrolyte replacement is carried out (monitoring is required!). Torasemide is not excreted from the blood by
by hemodialysis. Treatment for hypovolemia: fluid replacement. Treatment for hypokalemia: potassium supplements.
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, a vein catheterization is performed; the patient is placed in a horizontal position, free air intake is ensured, oxygen is prescribed. If necessary, epinephrine, solutions that replace the volume of fluid, glucocorticoid hormones are administered.
Adverse reactions
Metabolism: increased metabolic alkalosis; muscle spasms (especially at the beginning of treatment); increased concentration of uric acid, glucose and lipids (cholesterol, triglycerides) in blood plasma; hypokalemia with concomitant diet low in potassium, 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 of water and electrolyte balance may develop, for example hypovolemia, hypokalemia, hyponatremia. With significant losses of fluid and electrolytes due to increased urination, arterial hypotension, headache, asthenia, drowsiness are possible, especially at the beginning of treatment and in elderly patients.
From the cardiovascular system: thrombosis, arterial hypotension, cardiac and cerebral ischemia with the possible development of cardiac arrhythmias, angina pectoris, acute myocardial infarction, syncope.
On the part of the digestive tract: loss of appetite, nausea, vomiting, stomach pain, indigestion and diarrhea, constipation, flatulence, pancreatitis.
On the part of the urinary system: possible increase in serum creatinine and urea levels; in patients with urination disorders, for example, with prostatic hypertrophy, urinary retention and excessive bladder distension are possible; urge to urinate.
On the part of the hepatobiliary system: increased levels of some liver enzymes (γ-glutamyl transpeptidase) in blood plasma.
Blood and lymphatic system disorders: decreased platelets, erythrocytes and/or leukocytes.
Skin and subcutaneous tissue disorders: allergic reactions (e.g. itching, rash, exanthema, photosensitivity).
General disorders: headache, dizziness, confusion, increased fatigue, general weakness (especially at the beginning of treatment), dry mouth, paresthesia of the extremities, visual disturbances, tinnitus, hearing loss.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister; 3 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Hetero Labs Limited.
Location of the manufacturer and its business address
Unit-III, Formulations, Plot No. 22-110 IDA, Jhidimetla, Hyderabad 500 055, (Andhra Pradesh), India.
Registration certificate holder: Ananta Medicare Ltd.
Location of the registration certificate holder
Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, United Kingdom.
