Lasix Neo 10 mg / ml pp d / in. 2 ml ampoule №10

Author Ольга Кияница

2017-05-11

Amount in a package 10
Product form Ampoules Solution
Manufacturer Zentiva (Romania)
Registration certificate UA/13555/01/01
The main medicament Lasix
morion code 280793

Lasix Neo (FUROSEMIDUM) Instructions for use

Stayed up

active ingredient: furosemide;

1 ml of furosemide 10 mg

Auxiliary substances: sodium hydroxide, sodium chloride, water for injection.

Dosage form. Solution for injection.

Basic physical and chemical properties: clear, colorless solution, which does not contain visible particles.

Pharmacological group. Highly active diuretics. Sulfamide preparations. Code ATX C0ZS A01

Pharmacological properties

Pharmacological.

Furosemide is a fast-acting loop diuretic having a relatively strong and short-term diuretic effect. Furosemide blocks the Na + K + 2Cl catheter located in the basal membranes of the thick cell segment of the ascending part of the Henle loop: the effectiveness of the saluretic action of furosemide, therefore, depends on whether the drug in the canals passes through the lumen of the anion-transport mechanism. The diuretic effect occurs as a result of inhibiting the reabsorption of sodium chloride in this segment of the Henle loop. As a result, the fractional excretion of sodium can reach 35% glomerular filtration of sodium. The secondary effects of increased sodium excretion include increased urine excretion (due to osmotically bound water) and increased distal tubular secretion of potassium. Also excretion of calcium and magnesium ions increases. Furosemide induces dose-dependent stimulation of renin-angiotensin-aldosterone. In case of heart failure, furosemide results in acute decrease in cardiac preload (by narrowing the capacitive venous vessels).This early vascular effect is prostaglandin-mediated and suggests an adequate renal function with the activation of renin-angiotensin and unprotected synthesis of prostaglandins. In addition, due to its inherent natriuretic effect, furosemide reduces vascular reactivity relative to catecholamines, increased in patients with arterial hypertension.

The antihypertensive effect of furosemide is due to increased sodium excretion, reduced blood volume and reduced response of smooth muscle vessels to stimulation by vasoconstrictors or vasoconstrictors.

A dose-dependent increase in diuresis and sodium urea was observed in healthy volunteers receiving furosemide at a dose of 10-100 mg. The duration of action in healthy volunteers is approximately 3 hours after the intravenous administration of 20 mg furosemide.

In patients, the relationship between the concentrations of unbound (free) furosemide within the tubular organs (determined on the basis of the rate of excretion of furosemide with urine) and the sodium-urethic effect is expressed in the form of a sigmoid curve with a minimum effective furosemide excretion rate of about 10 micrograms per minute.Thus, continuous infusion of furosemide is more effective than repeated bolus injections. Moreover, apart from a certain bolus dose of the drug, there is no significant increase in the effect. The effect of furosemide is reduced if the underlying tubular secretion or binding of the drug to the albumin inside the tubules occurs.

Pharmacokinetics.

The volume of distribution of furosemide ranges from 0.1 to 0.2 liters per 1 kg of body weight. The volume of distribution may be higher depending on the disease.

Furosemide (over 98%) forms strong compounds with plasma protein proteins, especially albumin.

Furosemide is excreted primarily as an unmodified drug by secretion into the proximal tubule. After an intravenous administration, from 60 to 70% of the administered dose of furosemide is displayed in this way. Metabolite furosemide - glucuronide - accounts for 10-20% of substances contained in the urine. The residual dose is excreted with faeces, probably by biliary secretion.

The terminal half-life of furosemide after intravenous administration is approximately 1 to 1.5 hours.

Furosemide penetrates into breast milk: through the placental barrier and slowly gets to the fetus. Furosemide is determined either in the fetus or in the newborn in the same concentrations as the mother's child.

Kidney Diseases. In case of renal failure, the inhibition of furosemide is delayed, and the half-life is prolonged; The terminal half-life may last up to 24 hours in patients with severe renal insufficiency.

In nephrotic syndrome, reduced concentrations of plasma protein proteins lead to an increase in the concentration of unbound (free) furosemide. On the other hand, the efficacy of furosemide in these patients has been reduced by binding to intratubular albumin and understated tubular secretion.

Furosemide is poorly digested in patients undergoing hemodialysis, peritoneal dialysis and chronic peritoneal dialysis in outpatient settings.

Hepatic failure . In case of hepatic failure, the half-life of furosemide is increased by 30-90%, mainly due to the larger volume of distribution. It should also be noted that a wide variety of all pharmacokinetic parameters is observed in this group of patients.

Congestive heart failure, severe arterial hypertension, elderly patients. Furosemide withdrawal is delayed due to decreased renal function in patients with congestive heart failure, severe arterial hypertension, and in elderly patients.

Premature and infant infants . Depending on the level of kidney formation, the inactivation of furosemide may be delayed. Metabolism of the drug is also reduced if the infant's ability to glucuronide is impaired. The terminal half-life is less than 12 hours in the fetus from 33 weeks after fertilization of the egg. In infants aged 2 months, the final clearance is similar to that of clearance in adult patients.

Indications

Chronic congestive heart failure (if diuretic treatment is necessary).

Fungi with Acute Congestive Heart Failure.

Fungi with chronic renal failure.

Acute renal failure, including pregnant women or during childbirth.

Fungi in liver disease (if necessary, to complement the treatment with the use of aldosterone antagonists).

Hypertensive crisis (as a supportive agent).

Support for forced diuresis.

Contraindications

Hypersensitivity to furosemide or other components included in the drug.

Patients with an allergy to sulfanilamides (for example, sulfonamide antibiotics or sulfonylurea) may experience cross-sensitivity to furosemide.

Hypovolemia or dehydration of the body.

Renal insufficiency in the form of anuria if there is no therapeutic response to furosemide.

Renal failure due to poisoning with nephrotoxic or hepatotoxic drugs.

Severe hypokalemia.

Preecomatous or comatose states associated with hepatic encephalopathy.

Interaction with other drugs and other types of interactions

Unsolicited combinations.

In some cases, taking furosemide within 24 hours after chloral hydrate may cause blood flushing, increased sweating, excited state, nausea, arterial pressure and tachycardia. So, simultaneous use of furosemide and chloral hydrate is not recommended.

Furosemide can increase the ototoxicity of aminoglycosides and other ototoxic drugs. This can lead to damage that is irreversible, these drugs should not be used concurrently with furosemide.

Combinations requiring action.

In the case of co-administration of cisplatin and furosemide, there is a risk

occurrence of ototoxic effects. In addition, cisplatin nephrotoxicity may be enhanced if furosemide is not prescribed in low doses (for example, 40 mg in patients with normal renal function) and with a positive fluid balance when the drug is used to achieve the effect of forced diuresis during cisplatin therapy.

Furosemide reduces lithium salting and may lead to increased levels of lithium in the serum, resulting in an increased risk of lithium toxicity, including a higher risk of developing cardiotoxic and neurotoxic effects of lithium. Therefore, it is recommended to carefully monitor the level of lithium in patients receiving such combination therapy.

Patients receiving diuretics may suffer from severe arterial hypotension and deterioration of renal function, including renal failure, especially when first using an ACE inhibitor (ACE inhibitor) or an angiotensin II receptor antagonist, or at the first dose of an increased dose. It is necessary to decide whether the use of furosemide should be suspended temporarily, or at least reduce the dose of furosemide 3 days before the start of treatment, or to increase the dose of an ACE inhibitor or angiotensin II receptor antagonist.

Risperidone: Caution should be exercised and careful weighing the risk and benefit before deciding whether to use combination therapy or simultaneous use with furosemide or other potent diuretics.

Combinations, there are fears.

Simultaneous use of non-steroidal anti-inflammatory drugs,

including acetylsalicylic acid, may reduce the action of furosemide. In patients with dehydration or hypovolaemia, non-steroidal anti-inflammatory drugs can lead to acute heart failure. The effect of furosemide may increase the toxicity of salicylate.

Reducing the effectiveness of furosemide may occur after the combined use of phenytoin.

The use of corticosteroids, carboksosolone, licorice root in large doses, and prolonged use of laxatives may increase the risk of hypokalemia.

Some electrolyte imbalances (such as hypokalemia, hypomagnesaemia) may increase the toxicity of certain other drugs (for example, digitalis drugs and drugs that cause QT prolongation syndrome).

If antihypertensive drugs, diuretics or other drugs that have the ability to lower blood pressure, should be administered concurrently with furosemide, an even greater reduction in blood pressure should be expected.

Probenecid, methotrexate, and other drugs that, like furosemide, are subject to significant tubular secretion in the kidneys, can reduce the effectiveness of furosemide. Conversely, furosemide can reduce the withdrawal of these drugs by the kidneys. Conducting treatment with high doses (in particular furosemide and other drugs) may increase their serum levels and increase the risk of side effects caused by furosemide or the use of concomitant therapy.

The effectiveness of anti-diabetic drugs and sympathomimetics, which have the property of raising blood pressure (eg epinephrine, norepinephrine), may decrease. The action of curare-like muscle relaxants or Teflon may be intensified.

It is possible to increase the harmful effect of nephrotoxic drugs on the kidneys.

Renal impairment may develop in patients receiving furosemide therapy and high doses of certain cephalosporins.

Simultaneous administration of cyclosporin A and furosemide is associated with an increased risk of gouty arthritis, secondary to hyperuricemia caused by furosemide, and impaired renal excretion of urates caused by cyclosporine.

Patients belonging to the high-risk group of nephropathy due to radiocontrast therapy received high rates of deterioration of renal function after receiving radiocontrast substances in patients treated with furosemide compared with those in high-risk patients who only received intravenous hydration prior to the administration of radiocontrast substances.

Application features

During the treatment of lasix® Neo, continuous urine output should be provided. Patients with partial urinary drainage obstruction require close attention, especially in the initial stages of treatment.

The treatment with the lasix ® Neo drug requires constant medical supervision of the patient. A particularly careful monitoring of the condition is required:

  • patients with arterial hypotension;
  • of patients who are in a special risk group due to a significant reduction in blood pressure, for example, in patients with severe stenosis of the coronary arteries or blood vessels feeding the brain
  • patients with latent or severe form of diabetes mellitus with gout;
  • patients with hepatorenal syndrome, that is, with functional renal failure, is associated with severe liver disease
  • patients with hypoproteinemia, which, in particular, is associated with nephrotic syndrome (the effect of furosemide may be attenuated simultaneously with the potentiation of ototoxicity). Careful titration of the dose is required
  • Premature infants (possibly developing nephrocalcinosis / nephrolithiasis) should monitor kidney function and perform ultrasonography of the kidneys.

Monitoring of sodium, potassium and serum creatinine is generally recommended during treatment with furosemide.Particularly careful monitoring is needed by patients at high risk of developing electrolyte imbalances or in case of significant additional fluid loss (eg, emesis, diarrhea, or intense sweat). Hypovolemia or dehydration of the body, as well as any significant violations of electrolyte and acid-base balance should be corrected. This may require a temporary cessation of treatment with furosemide.

The development of electrolyte imbalance affects factors such as existing diseases (eg cirrhosis of the liver, heart failure), simultaneous use of drugs and nutrition. For example, as a result of vomiting or diarrhea, there may be a lack of potassium.

When using lasix ® Neo, it is advisable to recommend high quality potassium (baked potatoes, bananas, tomatoes, spinach, dried fruit) to the patient. It should be remembered that the use of Lasix ® Neo preparation may require a medication to compensate for potassium deficiency.

In placebo-controlled studies of risperidone with elderly patients with dementia, a higher mortality rate was observed in patients receiving furosemide concurrently with risperidone compared with patients receiving risperidone alone or furosemide alone.

Caution should be exercised and carefully weighing the risks and benefits before deciding to use such a combination of simultaneous treatment with other powerful diuretics. It is necessary to avoid dehydration.

You should avoid simultaneous use of alcohol and preparation lasix® Neo.

Use during pregnancy or breastfeeding.

Pregnancy Furosemide penetrates through the placental barrier. It should not be prescribed during pregnancy, except for cases of treatment with vital signs. Treatment with a drug during pregnancy needs to be monitored for the growth and development of the fetus.

Breast feeding period. Furosemide penetrates into breast milk and can suppress lactation. Women should stop breast-feeding during treatment with furosemide.

Ability to influence the reaction speed when driving or operating with other mechanisms. When using Lazix® Neo, some side effects (such as an unexpected significant decrease in blood pressure) may interfere with the patient's ability to concentrate and rate of response.

Therefore, during the treatment period, you should refrain from driving a car or working with mechanisms.

Method of administration and dose

The dosage regime is set individually by the physician, depending on the severity of the water-electrolyte balance disorders, the size of the glomerular filtration, the severity of the patient's condition. In the course of application of the preparation, the indicators of water-electrolyte balance should be adjusted taking into account diuresis and dynamics of the general condition of the patient.

Furosemide is administered intravenously only when intake is inappropriate or ineffective (eg in the case of intestinal absorption) or in case of need for a rapid effect. In the case of intravenous therapy, it is recommended that the drug be used as an oral route as soon as possible.

For optymalnoy achievements of the effectiveness and oppression vstrechnoy rehulyatsyy a whole otdaetsya Preferences neprerыvnoy infusion of furosemide compared with povtornыmy bolyusnыmy ynъektsyyamy.

In technical cases, when CONTINUOUS infusion of furosemide netselesoobrazna for dalneysheho of treatment after One or Several of administering a dose boleznennыh, otdaetsya Preferences dalnejshem scheme of treatment with the appointment of a number of doses vvodymыh through korotkye vremennыe yntervalы (prymerno 4:00) compared to Big bolyusnыmy doses through vvodyatsya bolshye promezhutky time.

For Adults rekomenduemaya Maximum sutochnaya furosemide dose of 1500 mg.

For children rekomenduemaya furosemide dose parenteral sostavljaet of administering a 1 mg / kg Fire-proof compounds pulmonary embolism, but sutochnaya Maximum dose not dolzhna prevыshat 20 mg.

Special Recommendations on dosage.

Generally dosage for Adults on Using bazyruetsya follows recommendations.

Hronycheskoy zastoynoy edema with cardiac failure . Rekomendovannaya nachalnaya dose oral dasg sredstva pryema sostavljaet from 20 mg to 50 mg per day. In cases Need rehulyrovat dose can be in accordance with the terapevtycheskoho response patsyenta.Rekomenduetsya prynymat sutochnuyu dose raspredelennuyu 2 or 3 reception.

Zastoynoy edema with acute cardiac failure. Rekomendovannaya nachalnaya dose dasg sredstva sostavljaet from 20 to 40 mg and naznachaetsya a video boljusnoe ynъektsyy. In cases Need rehulyrovat dose can be in accordance with the terapevtycheskoho patsyenta response.

Hronycheskoy edema with renal failure. Natryyuretycheskoe action as furosemide dependent factors definitely Quantity, vkljuchaja gravity degree of renal insufficiency and sodium balance. Thus, impossible to accurately predict Efficiency dozы. Patsyentam with renal insufficiency hronycheskoy It should be wary titrate the dose required to implement postepennoy primary loss of fluid. For Adults patsyentov This oznachaet Application for such dozы lead sutochnoho Reduction Fire-proof compounds PE prymerno 2 kg (prymerno 280 mM Na +).

In cases of administering a dose of furosemide can be opredelyat image as follows: Treatment with nachynaetsya of administering a neprerыvnoy infusion of 0.1 mg techenye 1 mynutы, zatem Speed uvelychyvaetsya Each infusion of administering a polchasa in dependence from patsyenta response.

In acute renal failure Before, How Start Application furosemide, sleduet kompensyrovat hypovolemia, hypotension and arteryalnoy Significant electrolyte and acid-alkaline imbalance.

How can skoree recommended to switch from oral to vnutryvennoho of administering a technique.

Rekomendovannaya nachalnaya sostavljaet dose of 40 mg and intravenous naznachaetsya a video ynъektsyy. If the appointment is not эtoy dozы lead for zhelaemomu Increase fluid withdrawal, furosemide is possible to assign a video neprerыvnoy infusion, since as of administering a 50 mg to 100 mg dasg sredstva by 1:00.

Edema disease in the liver . Furosemide prescribe dopolnenye As for aldosterone antagonist therapy in technical cases, when aldosterone antagonists Application Only enough. For predotvraschenyya complications such As orthostatic hypotension or violations electrolyte and acid balance schelochnoho dose titrate It should be cautious, Avto obespechyt postepennuyu nachalnuyu loss of fluid. For Adults patsyentov Introduction This oznachaet such dozы lead sutochnoho Reduction Fire-proof compounds for pulmonary embolism prymerno 0.5 kg. If javljaetsja Introduction absolutely neobhodymыm, nachalnaya razovaya sostavljaet dose of 20-40 mg.

Hypertensive crisis . Rekomendovannuyu nachalnuyu dose from 20 mg to 40 mg prescribe a video boljusnoe ynъektsyy. Need in cases can be rehulyrovat dose dependence from terapevtycheskoho patsyenta response.

Support forsyrovannoho sluchae diuresis in poisoning . Furosemide prescribe vnutryvenno Advanced Introduction for infusions electrolyte solutions. Dose dependent from terapevtycheskoho response to furosemide. Loss of fluid and эlektrolytov It should rehulyrovat ynytsyyrovat IN TIME and treatment. In cases of poisoning or kyslotnыmy O schelochnыmy substance fluid can be uskoryt putem alkalyzatsyy oxidation or urine, respectively.

Rekomendovannaya nachalnaya sostavljaet dose from 20 mg to 40 mg and naznachaetsya vnutryvenno.

Special recommendations for application.

Vnutryvennaya ynъektsyya / infusion : a sluchae of administering a furosemide It should assign a video medlennoy ynъektsyy or infusion co skorostyu no more than 4 mg in 1 minute. Patsyentam with vыrazhennыmy abuse liver function (creatinine blood sera> 5 mg / dL) recommended introducing co skorostyu infusion of no more than 2.5 mg in 1 minute.

Ynъektsyya: appointment of the drug in the video ynъektsyy It should ohranychyvat Only ysklyuchytelnыmy cases, when netselesoobrazen pryem inside and intravenous Introduction. It should Accept t WARNING, something Method of administering a dasg sredstva a video ynъektsyy not shown ostrыh sostoyanyy of treatment for such As edema of the lungs.

Laziksa drug infusion ® Neo It should not osuschestvlyat Together with the second lekarstvennыmy funds!

Lasix ® Neo submityaet is urovnem Solution with pH prymerno 9, no blog bufernoy emkosty. Thus, aktyvnыy Can vыpast component in sediment at Value urovnja pH below 7. It should sluchae razvedenyya rastvora choose to Wikipedia Provision urovnja razbavlennoho pH of the solution as a poorly schelochnoho Limit for neutral.

Solution 0.9% sodium chloride can be rastvorytel How to Apply. Apply recommended razbavlennыe rastvorы can be faster.

Where are you. For children the dose neobhodimo umenshat in accordance with the massoy pulmonary embolism (see. Section "Method and Application dozы").

Overdose

Symptoms: Clinical picture of acute or hronycheskoy peredozyrovky Chief dependent manner and degree from the consequences of the loss of fluid and эlektrolytov and vkljuchaet Such signs, How hypovolemia, dehydration of the organism, hemokontsentratsyya, serdechnыe arrhythmia (including AV-blockade and fibrillation ventricles). K эtyh symptoms violations otnosjatsja tyazhelaya hypotension (shock to progressive), Acute Renal failure, thrombosis, delirium, peryferycheskyy paralysis, apathy and sputannost consciousness.

Treatment: spetsyfycheskyh antydotov furosemide no. OSOBЫE.

Side reactions

Nutritional and metabolic violations.

Furosemide lead for uvelychennoy IZ excretion of sodium and chlorine organism and, As consequence, vodы.Krome эtoho, usylyvaetsya excretion second эlektrolytov (in particular potassium, calcium and magnesium) .Symptomatycheskye violations electrolyte balance and metabolic alkalosis mogut move into shape gradually rastuscheho electrolyte deficit. Patsyentam purpose in cases with normal liver function more than the High doses of furosemide Can voznyknut acute uhudshenye STATUS patsyenta as a result of the loss of the Bolshoi эlektrolytov.

K predupredytelnыh symptomov violations electrolyte balance otnosjatsja usylennoe oschuschenye zhazhdы, Headache pain, sputannost consciousness, cramps, tetany, muscle weakness, violations heart rhythm and symptoms of CO storony pyschevarytelnoho tract.

Can diuretic furosemide effect or cause dehydration and hypovolemia sposobstvovat organism, especially in patsyentov pozhyloho age. Suschestvennoe Reduction Quantity fluid in the body can u bring GAIN processes for svertыvanyya blood with development trends for trombozov.

Treatment for furosemide Can cause prehodyascheho GROWTH urovnja blood creatinine level and mochevynы, as well as for Increase urovnja cholesterol and triglycerides in blood whey. Mogut povыsytsya mochevoj acid level in the blood and whey voznyknut prystupы podahrы.

Can umenshatsya glucose tolerance as a result of Application furosemide. In patsyentov with saharnыm This Could diabetes result for uhudshenyyu metabolic control; saharnыy diabetes can u go IZ latentnoy forms in the form vыrazhennuyu techenyya disease.

Can umenshatsya glucose tolerance as a result of Application furosemide.

Co storony pyschevarytelnoho tract . Mogut voznykat reaction rarely co storony pyschevarytelnoho tract, such As nausea, vomiting, diarrhea or Acute pancreatitis.

Co storony pyschevarytelnoy system. In cases otdelnыh Can razvytsya intrahepatic cholestasis voznyknut Increase transaminase activity pechenochnыh.

Co storony organs of hearing and labyrynta. Mogut rarely be observed violation hearing and zvon ears, although îíè Usually javljajutsja prehodyaschymy disorders, especially in patsyentov with renal insufficiency, gipoproteinemija (for example, when nephrotic syndrome) and / or in sluchae Too Quick of administering a furosemide.

Co storony kozhy and podkozhnoy kletchatky . In otdelnыh cases mogut voznykat reaction co storony kozhy and slyzystыh membranes, for example itch, krapyvnytsa, Other types vыsыpanyy on kozhe or bulleznaya sыp, multyformnaya эrytema, bulleznыy pemfyhoyd syndrome Stevens-Johnson, toxic epidermal nekrolyz, эksfolyatyvnыy dermatitis, purpura in otdelnыh cases - peak times for chuvstvytelnost Light (photosensitivity).

Co storony ymmunnoy system. Heavy anafylaktycheskye or anafylaktoydnыe reactions (for example, soprovozhdayuschyesya shock) proyavlyayutsya rare.

Co storony cardiovascular system . Hypotension in volume including orthostatic hypotension. Trends for the emergence trombozov nablyudalas in otdelnыh cases. Can Vaskulyt.Furosemyd vыzvat hypotension, something in turn, can u cause for occurrence of symptomov, violation How concentrations and reaction, delusion, feeling of pressure in the head, pain Headache, dizziness, drowsiness, weakness, disorders of view, dry t RTU, orthostatic hypotension.

Co storony mochevыvodyaschyh and renal tract. Acute withdrawal Delay in urine patsyentov with chastychnoy obstruktsyey mochevыvodyaschyh tract Can sluchatsya in otdelnыh cases. Interstitial nefryt.U nedonoshennыh infants furosemide Can vыzvat nephrocalcinosis / nefrolytyaz. Uvelychennoe Education Can vыzvat urine or Zoom Quantity complaints, such postupayuschyh patsyentov with obstruktsyey ottoka urine. In this way, can voznyknut Acute Delay urine vtorychnыmy not possible with complications, for example in patsyentov with abuse emptying mochevoho bubbles, hyperplasia or prostatы suzhenyem uretrы.

Co storony nervous system. Sometimes mogut voznykat paresthesia, pechenochnaya encephalopathies in patsyentov with hepatocellular insufficiency or pancreatitis ostrыm.

Co storony blood and lymfatycheskoy system. Sometimes Can voznykat thrombocytopenia, eosinophilia, leukopenia. In cases otdelnыh Can razvytsya agranulocytosis, aplastic or hemolytic anemia.

Vrozhdennыe and nasledstvennыe / henetycheskye violations. If furosemide prymenyayut nedonoshennыh of treatment for infants in techenye First weeks of life, uvelychyvaet This risk occurrence constantly to open the arterial duct.

Sharing violations. Fever. In the Introduction Can voznyknut pain in ynъektsyy meste.

Shelf life

3 years.

Storage conditions

Hranyt in oryhynalnoy packaging at temperatures Above 25 ° C

Hranyt out of reach of children place.

Packaging

10 number 2 ml of the solution in the vials; 10 vials in kartonnoy box.

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