Lotonel tabs 10mg #60

Instruction for Lotonel

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Lotonel is a diuretic drug.

Release form and composition

Lotonel is available in the form of tablets: white or almost white, flat-cylindrical, round, with a dividing risk and a chamfer (in blister packs: 10 pcs., 2, 3 or 6 packs in a carton pack; 15 pcs., in a carton pack 2 or 4 packs; 20 pcs., in a carton pack 1 or 3 packs; 30 pcs., in a carton pack 1 or 2 packs; in polyethylene cans: 20 or 60 pcs., 1 can in a carton pack; in each the pack also contains instructions for the use of Lotonel).
1 tablet contains:
    active ingredient: torasemide - 5 mg or 10 mg;
    auxiliary components: corn starch, lactose monohydrate, colloidal silicon dioxide, sodium carboxymethyl starch (sodium starch glycolate, type A), magnesium stearate.

Pharmacodynamics

Lotonel is a "loop" diuretic, the active substance of which is torasemide. Its main mechanism of action is due to the ability of torasemide to reversibly bind to the sodium, chloride and potassium ion transporter located in the apical membrane of the thick segment of the ascending loop of Henle. This leads to a decrease or complete inhibition of the reabsorption of sodium ions, a decrease in the osmotic pressure of the intracellular fluid and the reabsorption of water. As a result of blocking myocardial aldosterone receptors, fibrosis decreases and diastolic myocardial function improves.
The antialdosterone action of torasemide, showing high activity and a longer effect, makes it possible to cause the development of hypokalemia to a lesser extent, compared with furosemide.
The diuretic effect appears after approximately 1 hour, and reaches its maximum 2-3 hours after ingestion. The action of Lotonel lasts for 18 hours, which allows not to limit the activity of patients by the need for very frequent urination after taking the drug and to facilitate the tolerability of therapy.
Lotonel causes a decrease in systolic and diastolic blood pressure (BP) in the supine and standing positions. Its appointment is considered the most reasonable choice in case of need for long-term treatment.

Pharmacokinetics

After ingestion, there is a rapid and almost complete absorption of torasemide in the gastrointestinal tract. Simultaneous food intake does not significantly affect the absorption of the drug. The maximum concentration (Cmax) of torasemide in plasma is reached after 1-2 hours. Bioavailability of Lotonel is 80-90%.
Plasma protein binding - more than 99%.
The volume of distribution (Vd) is 12–16 liters, including in mild to moderate renal insufficiency or chronic heart failure. Vd in liver cirrhosis doubles.
Torasemide is metabolized in the liver under the influence of isoenzymes of the cytochrome P450 system. As a result of sequential reactions of oxidation and ring hydroxylation, 3 metabolites are formed - M1, M3 and M5, the activity of which to bind to blood plasma proteins corresponds to 86%, 95% and 97%.
The half-life (T1 / 2) is 3-4 hours. The total clearance is 40 ml/min, the renal clearance is 10 ml/min.
Excretion to a large extent (about 83% of the dose taken) occurs through the kidneys, 24% - unchanged, the rest - in the form of inactive metabolites.
In renal failure, T1 / 2 of the metabolites M3 and M5 increases, T1 / 2 of the active substance does not change. With hemodialysis and hemofiltration, there is a slight excretion of torasemide and its metabolites.
In hepatic insufficiency, the level of drug concentration in blood plasma increases.
With heart or liver failure, T1 / 2 of torasemide and the M5 metabolite increases slightly, cumulation is unlikely.
In elderly patients, the pharmacokinetic profile, total clearance and T1 / 2 do not change. A decrease in the renal clearance of Lotonel, due to age-related impaired renal function, was noted.

Indications for use

    arterial hypertension;
    edematous syndrome of various origins, including those caused by chronic heart failure, diseases of the kidneys, liver, lungs.

Contraindications

    hepatic coma, precoma;
    allergy to sulfanilamide antimicrobials and sulfonylurea drugs;
    refractory hyponatremia;
    refractory hypokalemia;
    glycoside intoxication;
    decompensated aortic and mitral stenosis;
    sinoatrial and atrioventricular block II-III degree;
    hypertrophic obstructive cardiomyopathy;
    arrhythmia;
    an increase of more than 10 mm Hg in central venous pressure;
    acute glomerulonephritis;
    violations of the outflow of urine of any etiology in a pronounced form, including against the background of a unilateral lesion of the urinary tract;
    chronic renal failure with increasing azotemia;
    renal failure with anuria;
    hyperuricemia;
    dehydration, hypovolemia with or without arterial hypotension;
    concomitant therapy with aminoglycosides and cephalosporins;
    syndrome of glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
    age up to 18 years;
    period of pregnancy;
    breast-feeding;
    hypersensitivity to the components of the drug.
With caution, Lotonel tablets should be prescribed for arterial hypotension, stenosing atherosclerosis of the cerebral arteries, a history of ventricular arrhythmia, acute myocardial infarction, hypoproteinemia, anemia, diarrhea, pancreatitis, hyponatremia, hypokalemia, impaired liver function, liver cirrhosis, hepatorenal syndrome, gout, diabetes mellitus , predisposition to hyperuricemia, renal failure, impaired urinary outflow (caused by benign prostatic hyperplasia, narrowing of the urethra or hydronephrosis), the simultaneous use of corticosteroids, cardiac glycosides and adrenocorticotropic hormone (ACTH).

Lotonel, instructions for use: method and dosage

Lotonel tablets are taken orally, swallowed whole and washed down with water, regardless of the meal.
Reception should be made 1 time per day always at the same time of day, convenient for the patient.
The recommended daily dosage for arterial hypertension: the initial dose is 2.5 mg or 1/2 tablet of 5 mg. In the absence of a sufficient therapeutic effect, the dose after 28 days of taking Lotonel should be increased to 5 mg. If the first dose increase did not lead to an adequate decrease in blood pressure after 28-42 days of therapy, it is increased to 10 mg. In the absence of the desired effect from taking 10 mg of torasemide per day, the treatment regimen must be supplemented with the appointment of an antihypertensive agent of another group.
Recommended daily dosage for edematous syndrome:
    edematous syndrome due to chronic heart failure: initial dose - 10-20 mg, in the future, to achieve the desired therapeutic effect, it can be increased to 40 mg;
    edematous syndrome due to kidney disease: the initial dose is 20 mg, in the absence of sufficient clinical action, it can be doubled to obtain the desired effect;
    edematous syndrome in liver pathologies: the initial dose is 5-10 mg, if necessary, it can be increased by 2 times in order to achieve the desired effect.
The maximum single dose is 40 mg (it is not recommended to exceed, since there is no experience with higher doses).
Lotonel is used until the edema disappears or for a long period.
Elderly patients are shown the use of conventional doses of the drug.

Side effects

    from the nervous system: often - drowsiness, dizziness, headache; infrequently - cramps of the muscles of the lower extremities; frequency not established - confusion, fainting, paresthesia in the limbs (tingling sensation, "crawling" or numbness);
    from the digestive system: often - diarrhea; infrequently - flatulence, abdominal pain, polydipsia; frequency not established - dry mouth, loss of appetite, nausea, vomiting, dyspeptic disorders, pancreatitis, intrahepatic cholestasis;
    from the urinary system: often - polyuria, nocturia, increased frequency of urination; infrequently - frequent urge to urinate; frequency not established - urinary retention with urinary tract obstruction, oliguria, hematuria, interstitial nephritis;
    from the side of the cardiovascular system: infrequently - arrhythmia, tachycardia, extrasystole; the frequency has not been established - an excessive decrease in blood pressure, orthostatic hypotension, thromboembolism, deep vein thrombosis, a decrease in circulating blood volume, collapse;
    from the respiratory system: infrequently - nosebleeds;
    on the part of the senses: the frequency is not established - tinnitus, hearing impairment, hearing loss [usually transient; more often with renal failure or hypoproteinemia (nephrotic syndrome)], visual impairment;
    dermatological reactions: frequency not established - pruritus, rash, photosensitivity, urticaria, exfoliative dermatitis, erythema multiforme, purpura, vasculitis;
    from the musculoskeletal system: the frequency is not established - muscle weakness;
    on the part of metabolism: the frequency has not been established - hypokalemia, hyponatremia, hypocalcemia, hypomagnesemia, hypochloremia, hypovolemia, metabolic alkalosis, dehydration (more often in old age);
    from the reproductive system: the frequency is not established - a decrease in potency;
    laboratory parameters: infrequently - hypertriglyceridemia, hypercholesterolemia; frequency not established - hyperuricemia, increased plasma alkaline phosphatase activity (slight), some liver enzymes (including gamma-glutamyl transferase), creatinine and urea concentrations, leukopenia, thrombocytopenia, agranulocytosis, decreased glucose tolerance (including manifestation of latent diabetes mellitus), hyperglycemia;
    other: frequency not established - aplastic anemia, hemolytic anemia.

Overdose

Symptoms: increased diuresis, causing a violation of the water and electrolyte balance of the blood and a decrease in the volume of circulating blood, a pronounced decrease in blood pressure, drowsiness, confusion, collapse. Gastrointestinal disorders are possible.
Treatment: immediate gastric lavage, artificial vomiting, taking activated charcoal, prescribing symptomatic treatment, taking measures to replenish the volume of circulating blood, correcting water and electrolyte balance and acid-base status, canceling or lowering the dose of Lotonel. Close monitoring of plasma electrolytes and hematocrit levels is necessary. There is no specific antidote.
The appointment of a hemodialysis session is ineffective, as this will not accelerate the excretion of Lotonel.

Special instructions

The use of Lotonel is shown strictly according to the doctor's prescription.
If long-term use of Lotonel in high doses is necessary, patients should be given potassium supplements and recommended to follow a diet containing a sufficient amount of sodium chloride. This will reduce the risk of developing hypokalemia, hyponatremia, metabolic alkalosis.
The highest probability of developing hypokalemia with cirrhosis of the liver, increased diuresis, concomitant therapy with corticosteroids or ACTH, insufficient intake of electrolytes from food.
In renal failure, it is necessary to periodically conduct control studies for the content of electrolytes in the blood plasma (including sodium, calcium, potassium, magnesium), acid-base state, the concentration of residual nitrogen, uric acid and creatinine. In case of violation of the water-electrolyte balance, it is necessary to carry out appropriate therapy.
If the results of laboratory tests indicate that the patient has hyper- or hyponatremia, hyper- or hypokalemia, hyper- or hypochloremia, acid-base balance disorders and an increased level of urea concentration in the blood plasma, it is necessary to temporarily stop taking Lotonel. After the restoration of laboratory parameters to normal values, treatment can be resumed at a lower dose of the drug.
The appearance or intensification of azotemia and oliguria in severe progressive kidney disease is the basis for discontinuation of therapy.
With ascites against the background of cirrhosis of the liver, dose selection is recommended in a hospital, this is associated with a high risk of developing hepatic coma in patients due to a violation of water and electrolyte balance.
Patients with reduced glucose tolerance or diabetes mellitus require regular monitoring of glucose levels in the blood and urine.
Patients in an unconscious state, with narrowing of the ureters, benign prostatic hyperplasia need to ensure careful control of diuresis to prevent acute urinary retention.
In diseases of the cardiovascular system, especially in patients taking cardiac glycosides, the development of hypokalemia can cause arrhythmias.

Influence on the ability to drive vehicles and complex mechanisms

In connection with the existing risk of developing dizziness or drowsiness during the period of treatment, it is necessary to avoid performing potentially hazardous activities that require concentration of attention and a high speed of psychomotor reactions, including driving.

Use during pregnancy and lactation

Lotonel, overcoming the placental barrier, causes a violation of water-electrolyte metabolism and thrombocytopenia in the fetus, so its use is contraindicated during the gestation period.
It is not recommended to take Lotonel while breastfeeding.
If it is necessary to prescribe torasemide during lactation, breastfeeding should be discontinued.

Application in childhood

The appointment of Lotonel is contraindicated in patients under the age of 18 due to the lack of information on the safety and efficacy of torasemide in this category of patients.

For impaired renal function

The use of Lotonel is contraindicated for the treatment of patients with acute glomerulonephritis, a pronounced violation of the outflow of urine of any etiology (including unilateral lesions of the urinary tract), increasing azotemia against the background of chronic renal failure, renal failure with anuria.
It can be used with caution in renal failure, hepatorenal syndrome, urinary outflow disorders (caused by benign prostatic hyperplasia, narrowing of the urethra or hydronephrosis).

For impaired liver function

The appointment of Lotonel is contraindicated in hepatic coma and precoma.
With caution, it is recommended to take tablets for patients with impaired liver function, cirrhosis of the liver.

Use in the elderly

The use of the usual dosing regimen of Lotonel for the treatment of elderly patients is shown.

Drug interaction

With the simultaneous use of Lotonel:
    mineralocorticosteroids, glucocorticosteroids, amphotericin B: increase the risk of hypokalemia;
    cardiac glycosides: when interacting with torasemide, low-polarity and high-polarity cardiac glycosides can cause hypokalemia, low-polarity cardiac glycosides - prolong the half-life, resulting in an increased risk of glycoside intoxication;
    antibiotics, salicylates, cisplatin, cephalosporin, aminoglycosides, chloramphenicol, ethacrynic acid, platinum preparations, amphotericin B: increase their concentration and the risk of developing nephro- and ototoxic effects due to competitive renal excretion;
    angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists: contribute to a sharp decrease in blood pressure;
    sucralfate, non-steroidal anti-inflammatory drugs: cause inhibition of prostaglandin synthesis, impaired plasma renin activity and excretion of aldosterone, which leads to a decrease in the diuretic effect of torasemide;
    antihypertensive drugs: enhance antihypertensive activity;
    suxamethonium (depolarizing muscle relaxants): enhances neuromuscular blockade;
    tubocurarine: under the influence of torasemide, non-depolarizing muscle relaxants weaken their effect;
    lithium preparations: there is a decrease in the renal clearance of lithium preparations, which increases the risk of developing intoxication;
    diazoxide, theophylline: increase their activity;
    hypoglycemic agents, allopurinol: torasemide helps to reduce their therapeutic effect;
    pressor amines: there is a decrease in the clinical effect of each of the drugs;
    means that block tubular secretion: cause an increase in the level of concentration of torasemide in the blood plasma;
    cyclosporine: due to a possible violation of renal excretion of urates under the influence of cyclosporine and the development of hyperuricemia under the influence of torasemide, the risk of developing gouty arthritis increases;
    probenecid, methotrexate: the likelihood of a decrease in the effectiveness of torasemide and renal elimination of probenecid and methotrexate increases;
    cholestyramine: a decrease in the bioavailability of torasemide is possible;
    radiocontrast agents: In patients at high risk of developing nephropathy, intravenous hydration is recommended before the introduction of radiopaque agents, this will reduce the likelihood of impaired renal function.

Terms and conditions of storage

Keep away from children.
Store at temperatures up to 25 ° C in a place protected from light.
Shelf life - 3 years.

Reviews about Lotonel

Reviews about Lotonel are positive. They note the high efficacy of the drug in the treatment of edematous syndrome and arterial hypertension. Among the indications of a good diuretic effect of Lotonel, there are reports from patients that its appointment after surgery on the kidney allows you to potentiate the work of the second kidney.

Terms of sell

You can buy Lotonel without a doctor's prescription.