Furosemide tab. 0.04 g N 50(B)#

Furosemide tab. 0.04 g N 50(B)#

Product Code: 12416
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Composition

active substance:furosemide;

1 tablet contains furosemide in terms of 100% dry matter-40 mg

excipients:corn starch, microcrystalline cellulose, magnesium stearate, povidone, polyethylene glycol (macrogols), lactose.

The

Dosage form

Pills.

Basic physical and chemical properties:tablets, round in shape, white with a yellowish sheen color, with a chamfer.

The

drug description

highly Active diuretics. TheCode ATXС0ЗС A01.

The

Pharmacological properties

Pharmacological.

Furosemide is a loop diuretic that inhibits the absorption of sodium and chlorine ions in the ascending portion of the loop of Henle, proximal and distal tubules of the nephron. The effect in the distal tubules does not depend on the inhibitory effect of carbonic anhydrase or aldosterone effect. Pharmacological action of furosemide is limited only by the kidneys.

Pharmacokinetics.

the beginning of diuretic action occurs approximately within 1:00 after oral administration. The diuretic duration of action is 3-6 hours.

in oral administration, the drug is rapidly absorbed from the gastrointestinal tract, bioavailability averages 50-70%.

Distribution.is Characterized by a high degree of binding to plasma proteins, mainly albumin. In healthy subjects the concentration in plasma range from 1 to 400 mcg/ml, and 91-99% of furosemide is associated with blood plasma proteins. Furosemide crosses the placental barrier and slowly falls into a fetus.

Metabolism.furosemide Glucuronides is one or less of the main metabolites of its biotransformation in humans. A small amount is metabolized by breaking off the side chain.

Output.urinary Excretion (glomerular filtration and proximal tubular secretion) is about 66% of the dose, and the remaining amount is excreted with feces. A much larger amount of furosemide is excreted after administration compared with oral administration (tablets or solution). Furosemide passes into breast milk.

half-life Period.Furosemide has a two-phase half-life of approximately 2 hours. In patients with renal or hepatic insufficiency, the magnitude of the half-life period increases.

Reading

The
    The
  • Edema in chronic congestive heart failure (if necessary treatment with the use of diuretics).
  • The
  • Swelling in chronic renal failure.
  • Acute renal failure, including in pregnant women or during childbirth.
  • Swelling in nephrotic syndrome (if necessary, treatment with diuretics).
  • The
  • Swelling in diseases of the liver (if necessary to complement the treatment with the use of aldosterone antagonists).
  • Arterial hypertension.

Contra

The
  • Hypersensitivity to furosemide or other components of the drug.
  • The
  • Hypersensitivity to sulfonamides (eg, sulfonamide antibiotics or sulfonylureas) for possible cross-sensitivity to furosemide.
  • The
  • Hypovolaemia or dehydration.
  • Anuria or renal failure with anuria, in which there is no therapeutic response to furosemide.
  • Renal failure due to poisoning with nephrotoxic or hepatotoxic drugs or renal failure associated with hepatic coma.
  • The
  • Severe degree of hypokalemia.
  • The
  • Severe degree of hyponatremia.
  • The
  • Prekomatosnoe and comatose state associated with hepatic encephalopathy.
The

Interaction with other medicinal products and other forms of interaction

Deprecated combinations.

chloral Hydrate.IN some cases, the intake of furosemide within 24 hours after the application of chloral hydrate can cause hot flashes, sweating, restlessness, nausea, increase in blood pressure and tachycardia. Simultaneous use of furosemide and chloral hydrate is not recommended.

Drugs with increased risk of ototoxicity: aminoglycosides (eg, kanamycin, gentamicin, tobramycin), vancomycin, - teicoplanin.Furosemide may increase the ototoxicity of the latter. This can lead to irreversible hearing damage, these drugs must not be used simultaneously with furosemide.

Combinations that require action.

Cisplatin.there is a risk of ototoxic effects when applied with furosemide. It also increases the risk of nephrotoxic effect if furosemide is not used at low doses (eg, 40 mg with normal kidney function) and a positive fluid balance with forced diuresis during therapy with cisplatin.

Risperidone.care should be taken to carefully weigh the risks and benefits before deciding on combination therapy with furosemide or other potent diuretics.

Lithium.Furosemide, like other diuretics, may lead to an increase in serum lithium levels (due to a decrease in its excretion) and to an increase in its toxicity with signs of overdose, including an increased risk of cardiotoxicity and neurotoxicity. If this combination can not be avoided, you should carefully monitor the level of lithium in the blood and, if necessary, adjust the dose.

Sucralfate, cholestyramine, colestipol.gastrointestinal absorption of furosemide, concentration of furosemide in the blood Decreases and, accordingly, its effect decreases. Therefore, these drugs and furosemide should be used at intervals of at least 2-3 hours.

ACE Inhibitors/antagonists of angiotensin II receptors.patients receiving diuretics may suffer from sudden severe arterial hypotension and impaired renal function, including cases of renal failure, especially with the first application/first dose increase ofACE inhibitors/angiotensin II receptor antagonists. It is necessary to decide whether the use of furosemide should be temporarily discontinued or at least reduced the dose of furosemide 3 days prior to treatment/dose increaseACE inhibitors/angiotensin II receptor antagonists.

Combinations that require special attention.

Ifantihypertensive drugs, diureticsorother drugs that have the property to lower blood pressure, used in conjunction with furosemide, should be expected to further reduce blood pressure. The dosage of these drugs may require adjustment with concomitant use with furosemide.

alpha blockers (e.g. prazosin, doxazosin, terazosin, tamsulosin). Increased antihypertensive effect, the risk of hypotension of the first dose when used with furosemide. Increased risk of orthostatic hypotension.

Inhibitors of renin. Aliskirenreduces the concentration of furosemide in blood plasma.

Vasodilators.Enhanced hypotensive effect, includingmoxisylyte (thymoxamine),hydralazine,nitrate.

other diuretics.Possible a significant increase in diuresis when used withmetolazone, increasing the risk of hypokalemia when combined withthiazide -, increasing the risk of hyperkalemia withpotassium-sparing diuretics (eg, amiloride,spironolactone).

Drugs that lengthen the QT interval (including antiarrhythmic drugs, antihistamines), cardiac glycosides, and antipsychotic drugs (e.g. pimozide, amisulpride, sertindole, phenothiazines).Diuretic - induced electrolyte disorders, including hypokalemia, hypomagnesemia, increase the risk of toxic, including cardiotoxic effects of these drugs, the risk of cardiac arrhythmias, including the type of "torsades de pointes". Effects oflidocaine,tocainide,mexiletincan counteract furosemide effects. A combination withpimozideshould be avoided . Enhanced hypotensive effect when combined withphenothiazine. Should be applied drugs that do not have properties to provoke the type of arrhythmia "torsades de pointes" in hypokalemia.

non-Steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.furosemide action Decreases, increased risk of nephrotoxicity (especially in hypovolemia). In patients with dehydration/hypovolemia, NSAIDs can lead to acute renal failure. Furosemide may increase the toxicity of salicylates.IndomethacinandKetorolaccan counteract furosemide effects (it is advisable to avoid, if possible, such a combination).

Nephrotoxic drugs (aminoglycosides, some cephalosporins in high doses, polymyxins).the Toxic effect of these drugs may be increased by the joint use of potent diuretics, such as furosemidebuying risk of hypokalemia and nephrotoxicity is possible when combined withamphotericin b.

Antidepressants.Enhanced hypotensive effect when used withMAOIs. Increased risk of orthostatic hypotension withtricyclic antidepressants. Increased risk of hypokalemia withreboxetin.

Antidiabetic drugs (including insulin), Pressor amines (e.g. epinephrine, norepinephrine), allopurinol.Furosemide may reduce the effects of these drugs.

anti-epileptic drugs.increased risk of hyponatremia when used withcarbamazepine. A diuretic effect of furosemide reduced to 50% in combination withphenytoin(higher doses of diuretics may be needed).

Aminoglutethimide.increase the risk of hyponatremia.

Carbenoxolone, licorice root preparations at high doses, beta2-sympathomimetics, long-term use of stimulating laxatives.Increases the risk of hypokalemia (additive effect), requires control. Do not use stimulating laxatives.

Corticosteroids, tetracosactide (systemic action).sodium, body fluids and antihypertensive effects may be delayed. The risk of hypokalemia.

Probenecid, methotrexate and other drugs which, like furosemide, are subject to significant tubular secretion in the kidneys.it is possible to reduce the efficiency of furosemide. Conversely, furosemide can reduce the excretion of these drugs by the kidneys. The use of high doses (furosemide, and of these drugs) can lead to an increase in their levels in serum and increased risk of side effects of furosemide and related drug.

Immunomodulators. Cyclosporine,tacrolimusincrease the risk of hyperkalemia. The simultaneous use ofcyclosporineis associated with an increased risk of gouty arthritis secondary to hyperuricemia caused by furosemide and impaired renal excretion of urate caused by cyclosporine. Strengthening the hypotensive action of furosemide withaldesleukin.

Antiviral drugs.Plasma diuretic concentrations may increase in combination withnelfinavir,saquinavir,ritonavir.

muscle Relaxants (e.g. baclofen, tizanidine), General anesthetics, theophylline, levodopa, amifostine, anxiolytics and hypnotics, prostaglandins (for example alprostadil), alcohol.the hypotensive effect of furosemide Increases. Increased effects ofcurated muscle relaxants, theophylline.

Estrogens.it is Possible to reduce the diuretic effect of furosemide due to fluid retention in the body.

Progestagens (drospirenone).an Increased risk of hyperkalemia.

Warfarin, klofibrat.Compete with furosemide in conjunction with serum albumin. It may be important for hypoalbuminemia (for example, nephrotic syndrome).

Metformin.the Development of lactic acidosis due to possible renal failure associated with diuretics and more particularly with loop diuretics. Metformin should not be used when blood creatinine levels exceed 15 mg/l (135 µmol/l) in men and 12 mg/l (110 µmol/l) in women.

Radiocontrast substances.Patients at high risk of the development of radiocontrolledrobot nephropathy treated with furosemide, the use ofRadiocontrast substancesAhead without rehydration increased the frequency of worsening of kidney function compared with patients from risk groups who underwent intravenous hydration before the introduction of Radiocontrast substances.

application Features

during treatment it is necessary to provide a constant outflow of the Sich. Patients with partial obstruction of urine outflow require close attention, especially at the initial stages of treatment.

the use of furosemide requires regular medical and laboratory control.

the condition And/or doses should be monitored very carefully:

The

    elderly patients especially prone to develop side effects. Treatment should start with low doses;

  • to patients with arterial hypotension;
  • patients at risk due to a particular tendency to a sharp decrease in blood pressure, for example, patients with severe coronary artery stenosis or vessels feeding the brain
  • patients with latent or manifest form of diabetes mellitus. Patients with diabetes may result in poor glycemic control; diabetes can go from latent to expressed: you may need to increase insulin dose. Blood sugar levels should be monitored regularly. Before testing for glucose tolerance the use of furosemide should be discontinued;
  • The
  • patients with gout. The use of furosemide slows the excretion of uric acid i can provoke an attack of gout some diuretics are considered dangerous in acute porphyria;
  • The
  • patients with impaired hepatic function. Liver failure, particularly liver cirrhosis may trigger the development of hypokalemia and hypomagnesemia;
  • The
  • patients with hepatorenal syndrome is functional renal failure associated with severe liver disease
  • to patients with hypoproteinemia due to nephrotic syndrome or cirrhosis of liver (reduction of furosemide effects with simultaneous potentiation of its ototoxicity). Careful dose titration is required
  • premature infants (possible development nephrocalcinosis/nephrolithiasis) should monitor the kidney function and to conduct ultrasonography of the kidneys.

in the presence of dropsy without peripheral edema, the drug is recommended to be used in doses that provide additional diuresis in the amount of no more than 700-900 ml/day, which does not cause significant changes in the parameters of blood plasma ions, residual nitrogen, helps prevent oliguria.

if you maintain oliguria for 24 hours of treatment should be discontinued.

in the treatment of arterial hypertension daily dose should be distributed in 2-3 doses, which allows to avoid the phenomenon of "recoil".

during therapy with furosemide, especially long-term, it is recommended that periodic measurement of blood pressure, regular monitoring of levels of sodium, potassium, calcium, chloride, magnesium, uric acid and creatinine of blood serum, especially in patients with high risk of developing electrolyte imbalances or in case of significant fluid loss (e.g., vomiting, diarrhoea or intense sweating). Hypovolemia or dehydration of the body, a violation of the electrolyte and acid-base balance should be corrected; possible temporary cessation of the use of furosemide.

with the development of electrolyte balance is influenced by such factors as underlying disease (e.g. liver cirrhosis, cardiac failure), concomitant use of drugs and especially food. For example, as a result of vomiting or diarrhoea may cause potassium deficiency.

when using furosemide, patients should be recommended foods high in potassium (baked potatoes, bananas, tomatoes, spinach, dried fruits). It should be remembered that when using furosemide may need medical compensation for the lack of potassium.

In placebo-controlled studies,risperidoneinvolving elderly patients with dementia a higher level of mortality was observed in patients receiving furosemide concurrently with risperidone compared to patients receiving only risperidone or furosemide. Care should be taken to carefully weigh the risks and benefits before deciding to use risperidone with furosemide or other potent diuretics. Dehydration should be avoided.

simultaneous use of alcohol and furosemide should be avoided.

cases of photosensitization reactions with furosemide were Reported. In case of their occurrence it is recommended to cancel the drug. If it is necessary to re-use furosemide, should protect exposed areas of the skin from the sun or artificial UV radiation.

Athletes need to keep in mind that the use of furosemide can lead to positive results when conducting doping control.

the Drug contains lactose, so patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use it.

use during pregnancy or lactation.

Furosemide penetrates through the placental barrier, therefore, should not be administered during pregnancy except in cases of application for health reasons. Treatment with the drug during pregnancy needs to monitor the growth and development of the fetus.

Furosemide passes into breast milk and may suppress lactation. For the period of treatment breastfeeding should be discontinued.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms.

Some side effects (for example, a sudden significant decrease in blood pressure) may impair the ability of the patient to concentrate and the speed of his reactions, so during treatment should refrain from driving vehicles or other mechanisms.

Method of application and doses

Furosemide is usually taken orally on an empty stomach. The dosage is determined by the doctor individually according to the severity of fluid and electrolyte imbalance, the magnitude of glomerular filtration, the severity of the patient's condition. In the course of treatment it is necessary to correct indicators of water-electrolyte balance taking into account diuresis and dynamics of the General condition of the patient.

the most effective doses should be used. Furosemide has a wide therapeutic range, its effects are proportional to the dose.

Adults.the maximum daily dose of furosemide is 1500 mg.

Children.the Drug in this dosage form should be prescribed to children weighing more than 10 kg. Children recommended dose of furosemide for oral administration is 2 mg/kg body weight, but the maximum daily dose should not exceed 40 mg.

Special recommendations for adult dosing.

Edema in chronic congestive heart failure.the Recommended starting dose is 20-40 mg per day. If necessary, the dose can be adjusted depending on the therapeutic response of the patient. It is recommended to divide the daily dose into 2-3 doses.

Swelling in chronic renal failure.the Natriuretic effect of furosemide depends on a number of factors, including the severity of renal failure and sodium balance. Thus, it is impossible to accurately predict the effectiveness of the dose. The dose should be carefully titrated to ensure a gradual initial loss of fluid. For adult patients, this means taking such a dose results in a daily weight loss of approximately 2 kg (approximately 280 mmol Na+).

the Recommended starting dose for oral administration is 40-80 mg per day. If necessary, you can adjust the dose depending on the therapeutic response of the patient. The daily dose can be taken once or divided into 2 doses.

for hemodialysis patients, the total daily oral dose is 250-1500 mg.

Acute renal failure.Before starting the use of Furosemide, should be compensated hypovolemia, arterial hypotension and significant electrolyte and acid-base imbalance. It is recommended as soon as possible to make the transition from administration to oral administration of the drug.

Swelling in nephrotic syndrome.the Recommended starting dose for oral administration is 40-80 mg per day. If necessary, the dose can be adjusted depending on the therapeutic response of the patient. The daily dose can be taken once or divided into several methods.

Swelling in liver disease.furosemide administered as a Supplement to the treatment of aldosterone antagonists in cases where the use of aldosterone antagonists only is insufficient. To prevent complications, such as orthostatic hypotension or electrolyte disorders and acid-base balance, the dose should be carefully titrate to provide the gradual primary loss of fluid. For adult patients this means application of this dose leads to a daily reduction of body weight by approximately 0.5 kg. Recommended initial oral dose 20-40-80 mg per day. If necessary, the dose can be adjusted depending on the therapeutic response of the patient. The daily dose can be prescribed once or divided into several methods.

if the administration is absolutely necessary, the initial single dose is 20-40 mg.

elderly Patients.Should be used with caution since the elimination of furosemide is slowed down in these patients. Treatment should start with 20 mg and if necessary, increase the dose.

if it is necessary to prescribe the drug at a dose of 20 mg should be used drugs furosemide with the possibility of such dosing.

Children.

the Drug is not be taken by children weighing less than 10 kg. Children the recommended dose of furosemide for oral administration is 2 mg/kg of body weight, the maximum daily dose should not exceed 40 mg.

Children who are unable to use the tablet form (for example, premature babies, newborns) should consider applying the form for parenteral administration.

Overdose

the Clinical picture of acute or chronic overdose depends mainly on the degree and effects of loss of electrolytes and fluid.

Symptoms:hypovolaemia, dehydration, haemoconcentration, electrolyte imbalance (including hypokalemia and gipohloremichesky alkalosis) due to a diuretic effect; cardiac arrhythmias (including AV blockade and ventricular fibrillation), severe hypotension (may progress to shock), orthostatic collapse , acute renal failure, thrombosis, delirium, flaccid paralysis, apathy and confusion.

Treatment:withdrawal of the drug, at a recent reception - the stimulation of vomiting, gastric lavage, administration of activated charcoal to limit further absorption, correction of fluid and electrolyte balance, recovery of BCC, symptomatic therapy. There is no specific antidote.

Side effects

Metabolic disorders.

The
  • Electrolyte disorders (including symptomatic), especially in patients receiving high doses of furosemide over a long period: hyponatremia, hypochloremia, hypokalemia, hypocalcemia, hypomagnesemia, metabolic alkalosis. Symptomatic disorders of electrolyte balance and metabolic alkalosis can lead to a gradual increase in electrolyte deficiency or, if higher doses are applied to patients with normal renal function, to an acute significant loss of electrolytes and a sharp deterioration in the state.
  • Excessive diuresis can lead to dehydration and hypovolemia, especially in elderly patients and children.
  • increased levels of creatinine, urea, triglycerides in the blood, hypercholesterinemia.
  • increased levels of uric acid in the blood and the risk of exacerbation of gout.
  • The
  • Hyperglycemia, impaired glucose tolerance, which can lead to the deterioration of glycemic control in patients with diabetes mellitus; may manifestaban latent diabetes. Long-term use of diuretics may develop hyperosmolar coma.
  • The
  • the Syndrome of the pseudo-Bartter when excessive doses for a long period of time.

Blood and the lymphatic system.

The
    The
  • Significant loss of fluid may lead to haemoconcentration with a tendency to increased blood clotting and thrombosis, especially in elderly patients.
  • Thrombocytopenia with a potentially increased tendency to bleeding.
  • The
  • Leukopenia, eosinophilia.
  • bone marrow Depression, aplastic anemia, hemolytic anemia, agranulocytosis with an increased tendency to infections. This should include monitoring of hematopoietic status.

the Immune system.

Allergic reactions, severe anaphylaxis, including anaphylactic shock and anaphylactoid reactions.

the Skin and subcutaneous tissue.

Itching, urticaria, bullous reactions, including bullous pemphigoid, other types of rashes, exudative erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis and Stevens-Johnson syndrome, purpura, AGEP syndrome (acute generalized exanthematous pustules), DRESS syndrome (drug hypersensitivity syndrome with systemic symptoms), in some cases - photosensitization.

Cardiovascular system.

Arrhythmias, hypotension, including orthostatic hypotension, vasculitis, including necrotizing vasculitis, thrombosis.

Urinary system.

The
    The
  • increase the formation of urine may provoke or exacerbate any obstruction of urinary outflow (including prostatic hyperplasia or narrowing of the urethra, with bladder pathology), acute urinary retention in patients with partial urinary tract obstruction.
  • tubulo-Interstitial nephritis, renal failure. Possible decrease in diuresis, urinary incontinence. Potassium deficiency can occur in renal symptoms such as polyuria and polydipsia.
  • nephrocalcinosis/nephrolithiasis may develop in premature infants.
  • The
  • increasing the level of sodium chloride in the urine.

Digestive system.

decreased appetite/anorexia, irritation of oral mucosa and stomach, dry mouth, thirst, flatulence, colic, intestinal motility/intestinal obstruction (in severe hypokalemia), nausea, vomiting, diarrhea/constipation, acute pancreatitis.

the Hepatobiliary system.

Intrahepatic cholestasis, jaundice, increased levels of hepatic transaminases in the blood, hepatic encephalopathy in patients with hepatocellular insufficiency.

the Nervous system.

Headache/feeling of pressure in the head, dizziness, depression, paresthesia, decreased concentration, confusion, drowsiness, weakness, delirium.

sense Organs.

The
  • Transient short-term hearing impairment, tinnitus, especially in patients with renal insufficiency, hypoproteinemia (e.g. nephrotic syndrome) and/or in the case of too rapid administration of furosemide (parenteral). Cases of deafness, sometimes irreversible, have been reported.
  • The
  • impaired vision, including blurred vision, xanthopsia.

musculoskeletal system.

Muscle weakness, possible incomplete or complete paralysis, muscle spasms/cramps, tetany.

General disorders.

the Feeling of fatigue, malaise, fever.

Congenital, hereditary and genetic disorders.

nezareatmene Increased risk of patent ductus arteriosus in premature infants with respiratory distress syndrome by the administration of furosemide during the first weeks of life.

The

shelf Life

4 years.

do not use after the expiry date indicated on the package

storage Conditions

in its original packaging at temperatures not exceeding 25 ° C.

keep out of reach of children.

The

Packaging

there are 10 tablets in blister, 5 blisters in a pack.

The

Category vacation

According to the recipe.

The

Manufacturers

Public joint stock company "Scientific and industrial centre" borshchahivskiy chemical pharmaceutical plant ".

the limited liability company "AgroFarm".

the Location of manufacturers and their addresses designated implementation activities

Ukraine, 03134, g.. Kyiv, Mira str., 17.

Ukraine, 08200, Kyiv region, g. . Irpen, Central str, 113-A.

FLOXIN CAPSULE 0.4 MG

Flosin capsules 0.4 mg No. 30 is a complex drug that reduces the tone of the smooth muscle layer in the prostate gland, as well as in the urinary tract. Tamsulosin is the main active ingredient of the drug. The component selectively blocks adrenoreceptors, which helps to reduce tone in smooth muscles.

Assignment

the Drug is prescribed in the treatment of:

    The
  • prostatic Hyperplasia (benign).
  • The
  • of the Lower urinary tract.

as a result of taking the drug improves urine outflow, relieves spasms from the smooth muscles of the urinary canal and prostate gland. In addition, the patency of the urinary tract is restored. The composition of the drug include: hydrochloride tamsulosin, microcrystalline cellulose, ethylacrylate, red iron oxide and Indigo Carmine. The therapeutic effect of the remedy occurs after the first use of the tablet after 6 hours.

Dosage and mode of use

the Drug is designed for oral administration. Men are advised to use 1 capsule once a day. Medication is advisable to drink after the first eating, do not chew.the Medicine is not intended to treat women, children and adolescents.

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