Britar pills with prolonged action 5mg N30
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Active ingredients
Torasemide
Release form
Pills
Composition
Active ingredient: Torsemide (Torasemide). Concentration of active ingredient (mg): 5
Pharmacological effect
Pharmacological action - diuretic.
Pharmacokinetics
The drug Britomar in the dosage form of pills of prolonged action provides a gradual release of Torsemide, reducing fluctuations in its concentration in the blood, compared with preparations of Torsemide in the dosage form of pills with normal release. Suction. After taking several doses of the drug, the relative bioavailability of the prolonged form, compared with the usual dosage form, is about 102%. The active substance is absorbed in the gastrointestinal tract with a limited effect of the first passage through the liver and Cmax in the blood plasma is reached within 1.5 hours after ingestion. Eating does not have a significant effect on the absorption of the drug. Impaired renal and / or liver function does not affect the absorption of the drug. Distribution. More than 99% of Torsemide binds to plasma proteins. Vd in healthy volunteers and in patients with mild and moderate renal failure or chronic heart failure - from 12 to 15 liters. In patients with cirrhosis, Vd is doubled. Metabolism. It is metabolized by the action of CYP2C9 isoenzyme of cytochrome P450 in the liver to form 3 metabolites. The main metabolite is a carboxylic acid derivative, is pharmacologically inactive. The other two metabolites, which are formed in an insignificant amount in the body, have some diuretic activity, but their concentration is too low to have any significant clinical effect. Inference. T1 / 2 of Torsemide in healthy volunteers is 4 hours. About 80% of the ingested dose is excreted by the kidneys as metabolites and about 20% unchanged (in patients with normal renal function). The total clearance of Torsemide is 41 ml / min and renal clearance is about 10 ml / min, which corresponds to about 25% of the total. Pharmacokinetics in special clinical situations: Patients with chronic heart failure in the stage of decompensation reduced the hepatic and renal clearance of the drug.In such patients, the total clearance of Torsemide is 50% less than in healthy volunteers, and T1 / 2 and overall bioavailability, respectively, are higher. In patients with renal insufficiency, the renal clearance of Torsemide is markedly reduced, but this does not affect the overall clearance of the drug. Diuretic effect in renal failure can be achieved by using large doses of the drug. The total clearance of Torsemide and T1 / 2 remain at the same level in the case of reduced kidney function, due to metabolism in the liver. In patients with cirrhosis of the liver, Vd, T1 / 2 and renal clearance of the drug is increased, but the total clearance remains unchanged. The pharmacokinetic profile of Torsemide in elderly patients is similar to that in young patients, with the exception that there is a decrease in the renal clearance of the drug due to a characteristic age-related impairment in the reduction of renal function in elderly patients. The total clearance and T1 / 2 do not change.
Indications
Edematous syndrome of various genesis, including in chronic heart failure, liver diseases, and kidneys. arterial hypertension.
Contraindications
Hypersensitivity to the components of the drug or to sulfonylurea derivatives. Renal failure, accompanied by anuria, impaired urination, hepatic coma or precoma, arterial hypotension, hypovolemia, hyponatremia, hypokalemia. Rare hereditary intolerance to galactose, lactase deficiency or impaired glucose-galactose absorption.
Precautionary measures
It is recommended to treat with extreme caution in the following situations: Diarrhea, Diabetes mellitus, Anamnesis, Hypovolemia, Pathology of the liver, Low blood pressure, Recently suffered Myocardial infarction and recovery period, Pancreatitis, Anemia, Arrhythmia, Gout.
Use during pregnancy and lactation
Torsemide does not have a teratogenic effect and fetotoxicity, penetrates the placental barrier, causing impaired water-electrolyte metabolism and thrombocytopenia in the fetus. The drug Britomar is not recommended for use during pregnancy. It is not known whether Torsemide penetrates into breast milk. Britomar during lactation (breastfeeding) should be prescribed with caution.
Dosage and administration
InsideTablets are swallowed whole, not liquid, squeezed fluid. Tablets can be taken at any convenient constant time, regardless of the meal. Edematous syndrome in chronic heart failure. The usual initial dose is 10-20 mg by mouth once a day. If necessary, the dose can be doubled to obtain the desired effect. Edematous syndrome with kidney disease. The usual initial dose is 20 mg orally once a day. If necessary, the dose can be doubled to obtain the desired effect. Edematous syndrome with liver disease. The usual initial dose is 5–10 mg orally once a day with drugs, aldosterone antagonists, or potassium-sparing diuretics. If necessary, the dose of Britomar can be doubled to obtain the desired effect. A single dose of more than 40 mg is not recommended, since its action has not been studied. The drug is prescribed for a long period or until the edema disappears. Arterial hypertension. The usual initial dose is 5 mg 1 time per day. In the absence of an adequate reduction in blood pressure for 4–6 weeks, the dose is increased to 10 mg once a day. If this dose does not give the desired effect, the antihypertensive drug of another group should be added to the treatment regimen. Elderly patients dose adjustment is not required. Dose skip: in case of skipping a regular dose, you should not take a double dose of the drug. It should immediately take a forgotten dose. The next dose is taken at the usual time the next day.
Side effects
On the part of metabolism: infrequently - hypercholesterolemia (increase in cholesterol in the blood), hypertriglyceridemia (increase in the level of TG in the blood), polydipsia (increased thirst). From the nervous system: often - dizziness, headache, drowsiness. infrequently - muscle cramps of the lower limbs. the frequency is unknown - confusion, fainting, paresthesia in the limbs (feeling of numbness, crawling and chills). Since the cardiovascular system: infrequently - extrasystole (heart rhythm disorder), tachycardia (increased heart rate), increased heart rate, facial flushing. frequency not known - excessive arterial hypotension, deep vein thrombosis (formation of blood clots), thromboembolism, hypovolemia (decrease in BCC).On the part of the respiratory system: infrequently - nosebleeds. On the part of the digestive system: often - diarrhea. infrequently - abdominal pain, flatulence. frequency is unknown - nausea, vomiting, loss of appetite, pancreatitis, dyspeptic symptoms. On the part of the kidneys and urinary tract: often - an increase in the frequency of urination, polyuria (increased urine formation), nocturia (increased urination at night). infrequently - the increased urge to urinate. frequency is unknown - urinary retention (in patients with obstruction of the urinary tract), increasing the concentration of urea and creatinine in the blood. Laboratory indicators: infrequently - an increase in the number of platelets. frequency is unknown - hyperglycemia, hyperuricemia, hypokalemia, decrease in the number of erythrocytes, leukocytes and platelets, a slight increase in ALP activity in the blood, increased activity of some liver enzymes (for example, GGT), hyponatremia, hypochloremia, metabolic alkalosis. On the part of the senses: the frequency is unknown - visual impairment, tinnitus and hearing loss (as a rule, is reversible). On the part of the skin: the frequency is unknown - pruritus, rash, photosensitivity. Other: infrequently - asthenia (exhaustion), weakness, thirst, hyperactivity, nervousness, fatigue.
Overdose
Symptoms: an excessively elevated diuresis, accompanied by a decrease in BCC and impaired electrolyte balance in the blood, followed by a pronounced decrease in blood pressure, drowsiness and confusion, collapse. Gastrointestinal disturbances may occur. Treatment: there is no specific antidote. Provocation of vomiting, gastric lavage, activated carbon. Treatment is symptomatic, dose reduction or drug withdrawal and simultaneous replenishment of the BCC and correction of water-electrolyte balance and acid-base status under the control of serum electrolyte concentrations, hematocrit. Hemodialysis is ineffective, since the elimination of Torsemide and its metabolites is not accelerated.
Interaction with other drugs
Torsemide increases the toxicity of cardiac glycosides. When taken simultaneously with mineral and glucocorticoids, laxatives, an increase in potassium excretion is possible. Torsemide enhances the action of antihypertensive drugs.Torasemide, especially in high doses, can enhance the nephrotoxic and ototoxic effects of aminoglycosides, antibiotics, platinum drugs (Pt), cephalosporins. Torsemide may enhance the action of curare-like muscle relaxants and theophylline. When using salicylates in high doses, their toxic effects may be enhanced. Torsemide reduces the effects of hypoglycemic drugs. Consistent or simultaneous administration of Torsemide with ACE inhibitors can lead to a short-term drop in blood pressure. This can be avoided by reducing the initial dose of an ACE inhibitor or reducing the dose of Torsemide (or temporarily canceling it). NSAIDs and probenecid may decrease the diuretic and hypotensive effects of Torsemide. Bioavailability and, as a result, the effectiveness of Torsemide can be reduced with co-therapy with colestyramine. Torsemide can increase the toxicity of lithium preparations (Li +) and ototoxicity of ethacrynic acid.
special instructions
Apply strictly on doctor's prescription. Patients with hypersensitivity to sulfonamides and sulfonylurea derivatives may have a cross-sensitivity to Britomar. In patients, especially at the beginning of treatment with Britomar and the elderly, it is recommended to monitor electrolyte balance and BCC. With long-term treatment with Britomar, it is recommended to regularly monitor the electrolyte balance (especially potassium levels), glucose, uric acid, creatinine, lipids, and cellular blood components. Patients receiving high doses of the drug Britomar, in order to avoid the development of hyponatremia and metabolic alkalosis, it is impractical to limit the intake of salt. The risk of hypokalemia is greatest in patients with cirrhosis of the liver, severe diuresis, with insufficient consumption of electrolytes from food, as well as with simultaneous treatment of CS or ACTH. An increased risk of developing disorders of water and electrolyte balance is observed in patients with renal insufficiency. During the course of treatment, it is necessary to periodically monitor the concentration of plasma electrolytes (including sodium, calcium, potassium, magnesium), the acid-base state, the level of residual nitrogen, creatinine, uric acid and, if necessary, carry out appropriate corrective therapy (with a higher frequency in patients with frequent vomiting and on the background of parenterally injected fluids).In patients with advanced water electrolyte disorders, hypovolemia, or prerenal azotemia, laboratory test data may include: hyper or hyponatremia, hyper or hypochloraemia, hyper or hypokalemia, acid-base imbalance, and increased blood urea levels. If these disorders occur, you must stop taking Britomar until normal levels are restored, and then resume treatment with Britomar at a lower dose. With the onset or increase of azotemia and oliguria in patients with severe progressive kidney disease, it is recommended to suspend treatment. Selection of the dosage regimen for patients with ascites on the background of cirrhosis should be carried out in stationary conditions (disturbances of water and electrolyte balance may lead to the development of hepatic coma). This category of patients shows regular monitoring of plasma electrolytes. For the prevention of hypokalemia, the use of potassium and potassium-sparing diuretics (primarily spironolactone) is recommended, as well as a diet rich in potassium. The use of the drug Britomar may cause aggravation of gout. Patients with diabetes mellitus or with reduced glucose tolerance require periodic monitoring of the concentration of glucose in the blood and urine. In patients with prostatic hyperplasia, narrowing of the ureters, it is necessary to control diuresis due to the possibility of acute urinary retention. In patients with cardiovascular diseases, especially those taking cardiac glycosides, hypokalemia caused by diuretics can cause arrhythmias. Influence on ability to drive vehicles and mechanisms. During the period of treatment, you should avoid practicing potentially hazardous activities that require increased attention and quickness of psychomotor reactions.