Furosemide 20mg/2ml Solution For Injection
Patient Information Leaflet:
Furosemide 20mg/2ml Solution for Injection
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Furosemide Injection is and what it is used for
2. Before you are given Furosemide Injection
3. How Furosemide Injection is given
4. Possible side effects
5. How to store Furosemide Injection
6. Further information
1. WHAT FUROSEMIDE INJECTION IS AND WHAT IT IS USED FOR
What Furosemide Injection is
The name of your medicine is Furosemide 20mg/2ml Solution for Injection (called Furosemide Injection throughout this leaflet). Furosemide Injection contains a medicine called furosemide. Furosemide Injection belongs to a group of medicines called diuretics (water tablets).
What Furosemide Injection is used for
Furosemide Injection can be used to help you lose extra water in your body very quickly. It is given when you cannot take a tablet or when you have a lot of extra water in your body. Furosemide Inejction is often used when you have too much water around your heart, lungs, liver or kidneys.
How Furosemide Injection works
Furosemide Injection works by helping you to pass more water (urine) than you usually do. If the extra water in your body is not removed, it can put extra strain on the heart, blood vessels, lungs, kidneys or liver.
2. BEFORE YOU ARE GIVEN FUROSEMIDE INJECTION
Do not have this medicine and tell your doctor if:
• You are allergic (hypersensitive) to furosemide or any of the other ingredients of Furosemide injection (listed in Section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You are allergic to sulphonamideantibiotics such as sulfadiazine or co-trimoxazole.
• You have been told by your doctor that you have kidney failure. In some types of kidney failure, it is still okay to have this medicine. Your doctor will be able to decide.
• You have severe liver problems.
• Your doctor has told you that you have a low blood volume or are dehydrated.
• You are not passing any water (urine).
• You have too little potassium or sodium in your blood (shown in blood tests).
• You are breast-feeding (see “Pregnancy and breast-feeding” section below).
Do not use Furosemide Injection if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Furosemide Injection.
Take special care with Furosemide Injection
Check with your doctor or nurse before you have this medicine if:
• You have difficulty in passing water (urine).
• You are 65 years of age or older.
• You have liver or kidney problems.
• You have diabetes.
• You have low blood pressure or feel dizzy when you stand up.
• You have prostate problems
• You have gout
• You feel dizzy or dehydrated. This can happen if you have lost a lot of water through being sick, having diarrhoea or passing water very often. It can also happen if you are having trouble drinking or eating.
• You are going to have a glucose test.
• The person having the medicine is a premature infant. This is due to the possible formation of kidney stones.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before being given Furosemide Injection.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Furosemide Injection can affect the way some other medicines work.
Also, some medicines can affect the way Furosemide Injection works.
In particular, tell your doctor if you are taking any of the following:
The following medicines can affect the way Furosemide Injection works and increase the chance of you getting side effects:
• Medicines such as ramipril, enalapril, perindopril (called ‘ACE inhibitors’) or losartan, candesartan, irbesartan (called ‘angiotensin II receptor antagonists’). Your doctor may need to change the dose of your tablets or ask you to stop taking them
• Medicines for high blood pressure or heart problems. Your doctor may need to change the dose of your medicine
• Medicines used as a general anaesthetic for relaxing your muscles during surgery
• Medicines for diabetes. These may not work as well when you are using Furosemide Injection
• Theophylline - used for wheezing or difficulty in breathing
• Phenytoin - used for epilepsy. This can lower the effect of Furosemide Injection
The following medicines can increase the chance of side effects when taken with Furosemide Injection:
• Lithium - used for mental illnesses. To help stop side effects your doctor may need to change the dose of your lithium and check the amount of lithium in your blood
• Cisplatin - used for some cancers
• Digoxin - used for heart problems. Your doctor may need to change the dose of your medicine
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, ketoprofen or indometacin
• Carbamazepine - used for epilepsy
• Aminoglutethimide - used for breast cancer
• Ciclosporin - used to stop the rejection of organs after a transplant
• Methotrexate - used for cancers of the skin, joint or bowel diseases
• Carbenoxolone - used for ulcers of the foodpipe (gullet)
• Reboxetine - used for depression
• Amphotericin - used for fungal infections if used for a long time
• Corticosteroids - used for inflammation (such as prednisolone)
• Liquorice - often used in cough medicines if taken in large amounts
• Probenecid (used with another HIV medicine)
• Medicines for infection such as gentamicin, amikacin, neomycin, netilmicin, tobramicin, vancomycin or high doses of cephalosporins
• Medicines used as injections before X-ray examinations
• Medicines used for constipation (laxatives) if used for a long time such as bisacodyl or senna
• Medicines for asthma when given in high doses such as salbutamol, terbutaline sulphate, salmeterol, formoterol or bambuterol
• Other water tablets (diuretics) such as bendroflumethiazide. Your doctor may need to change the dose of your medicine
Pregnancy and Breast-feeding
Do not have Furosemide Injection if you are pregnant.
Talk to your doctor before having this medicine if you are pregnant, might become pregnant, or think you might be pregnant.
Do not breast-feed if you are being given Furosemide Injection. This is because small amounts may pass into the mother’s milk. Talk to your doctor before having this medicine if you are breastfeeding or planning to breast-feed.
Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breast-feeding.
The following information is intended for medical or healthcare professionals only
Furosemide 20mg/2ml Solution for Injection
TECHNICAL LEAFLET
1. NAME OF THE MEDICINAL PRODUCT
Furosemide 20mg/2ml Solution for Injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide 20mg/2ml Solution for Injection contains 20 mg Furosemide (Frusemide) in 2ml aqueous solution.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Furosemide 20mg/2ml Solution for Injection is a diuretic indicated for use when a prompt and effective diuresis is required. The intravenous formulation is appropriate for use in emergencies or when oral therapy is precluded. Indications include cardiac, pulmonary, hepatic and renal oedema.
4.2 Posology and method of administration
Route of administration: intramuscular or intravenous Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded.
In patients with severe impairment of renal function (serum creatinine>5 mg/dl), it is recommended that an infusion rate of 2.5 mg per minute is not exceeded. Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration are feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.
To achieve optimum efficacy and suppress counterregulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections. Where continuous furosemide infusion is not feasible for followup treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx. 4 hours) is to be preferred to a regimen with higher bolus doses at longer intervals.
Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.
Elderly: The dosage recommendations for adults apply, but in the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.
Children: Parenteral doses for children range from 0.5 to
1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
This medical product is for single use only. Discard any contents remaining in the ampoule immediately after use.
4.3 Contraindications
Furosemide 20mg/2ml Solution for Injection is contraindicated in patients with hypovolaemia or dehydration, anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents or renal failure associated with hepatic coma, severe hypokalaemia, severe hyponatraemia, pre-comatose and comatose states associated with hepatic encephalopathy and breast feeding women.
Hypersensitivity to furosemide or any of the excipients of Furosemide 20 mg/2ml Injection. Patients allergic to sulphonamides may show cross-sensitivity to furosemide.
4.4 Special warnings and precautions for use
Urinary output must be secured. Patients with partial obstruction of urinary outflow, for example patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention and require careful monitoring.
Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy.
Particularly careful monitoring is necessary in:
• patients with hypotension.
• patients who are at risk from a pronounced fall in blood pressure.
• patients where latent diabetes may become manifest or the insulin requirements of diabetic patients may increase.
• patients with gout
• patients with hepatorenal syndrome
• patients with hypoproteinaemia, e.g. associated with nephritic syndrome (the effect of furosemide may be weakened and its ototoxicity potentiated). Cautious dose titration is required.
• premature infants (possible development nephrocalcinosis nephrolithiasis; renal function must be monitored and renal ultrasonography performed).
Caution should be observed in patients liable to electrolyte deficiency. Regular monitoring of serum sodium, potassium and creatinine is generally recommended during furosemide therapy; particularly close monitoring is required in patients at high risk of developing electrolyte imbalances or in case of significant additional fluid loss. Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected. This may require temporary discontinuation of furosemide.
In patients who are at high risk for radiocontrast nephropathy, furosemide is not recommended to be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.
4.5 Interaction with other medicinal products and other forms of interaction
The dosage of concurrently administered cardiac glycosides, diuretics, antihypertensive agents, or other drugs with blood-pressure-lowering potential may require adjustment as a more pronounced fall in blood pressure must be anticipated if given concomitantly with furosemide. A marked fall in blood pressure and deterioration in renal function may be seen when ACE inhibitors or angiotensin II receptor antagonists are added to furosemide therapy, or their dose level increased. The dose of furosemide should be reduced far at least three days, or the drug stopped, before initiating the ACE inhibitor or angiotensin II receptor antagonist or increasing their dose.
The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such as furosemide.
Oral furosemide and sucralfate must not be taken within 2 hours of each other because sucralfate decreases the absorption of furosemide from the intestine and so reduces its effect.
In common with other diuretics, serum lithium levels may be increased when lithium is given concomitantly with furosemide, resulting in increased lithium toxicity including increased risk of cardiotoxic and neurotoxic effects of lithium. Therefore, it is recommended that lithium levels are carefully monitored and where necessary the lithium dosage is adjusted in patients receiving this combination.
Certain non-steroidal anti-inflammatory agents (e.g. indomethacin, acetylsalicylic acid) may attenuate the action of furosemide and may cause acute renal failure in
cases of pre-existing hypovolaemia or dehydration. Salicylate toxicity may be increased by furosemide. Furosemide may sometimes attenuate the effects of other drugs (e.g. the effects of anti-diabetics and of pressor amines) and sometimes potentiate them (e.g. the effects of salicylates, theophylline and curare-type muscle relaxants).
Furosemide may potentiate the ototoxicity of aminoglycosides and other ototoxic drugs. Since this may lead to irreversible damage, these drugs must only be used with furosemide if there are compelling medical reasons.
There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of cisplatin may be enhanced if furosemide is not given in low doses (e.g. 40 mg in patients with normal renal function) and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Some electrolyte disturbances (e.g. hypokalaemia, hypomagnesaemia) may increase the toxicity of certain other drugs (e.g. digitalis preparations and drugs inducing QT interval prolongation syndrome).
Attenuation of the effect of furosemide may occur following concurrent administration of phenytoin. Concomitant administration of carbamazepine or aminoglutethimide may increase the risk of hyponatraemia.
Corticosteroids administered concurrently may cause sodium retention.
Corticosteroids, carbenoxolone, liquorice, B2 sympathomimetics in large amounts, prolonged use of laxatives, reboxetine and amphotericin may increase the risk of developing hypokalaemia.
Probenecid, methotrexate and other drugs which, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of these drugs. In case of high-dose treatment (in particular, of both furosemide and the other drugs), this may lead to increased serum levels and an increased risk of adverse effects due to furosemide or the concomitant medication. Impairment of renal function may develop in patients receiving concurrent treatment with furosemide and high doses of certain cephalosporins. Concomitant use of ciclosporin and furosemide is associated with increased risk of gouty arthritis.
Driving and using machines
You may feel dizzy or unwell after having Furosemide Injection. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Furosemide Injection
This injection contains:
• Sodium. There is 7.7mg of sodium in 2ml of injection. This may be harmful to people on a low sodium or low salt diet.
3. HOW FUROSEMIDE INJECTION IS GIVEN
Furosemide Injection is normally given by a doctor or nurse. This is because it needs to be given as an injection into a vein or into a muscle.
How much Furosemide Injection is given
If you are not sure why you are being given Furosemide Injection or have any questions about how much Furosemide Injection is being given to you, speak to your doctor or nurse. The usual doses are:
Adults and the elderly
The initial dose is 20 mg to 50 mg. This will then be gradually increased up to a maximum dose of 1500mg per day. If you are elderly you may be given a lower dose.
Children
The usual dose for children ranges from 0.5 to 1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
If you have more Furosemide Injection than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine. Having too much Furosemide Injection may make you feel confused, unable to focus, show a lack emotion or interest in anything. You may also have dizziness, lightheadedness, fainting (due to low blood pressure), uneven heartbeat, muscle weakness or cramps and blood clots (signs include pain and swelling at the part of body that is affected). You may also have problems with your kidneys or blood.
If you miss a dose of Furosemide Injection
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However if you think you have missed a dose, talk to your doctor or nurse.
If you stop having Furosemide Injection
Keep having Furosemide Injection until your doctor tells you to stop.
Blood tests
Your doctor may carry out blood tests to check that the levels of some salts in the blood are at the correct levels. If you have any further questions on the use of this product, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Furosemide Injection can cause side effects, although not everybody gets them.
Tell your doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment
• If you have an allergic reaction. The signs may include inflammation of the kidney (nephritis), swollen ankles or high blood pressure, skin rashes, change in skin colour, severe blistering of the skin, being more sensitive to the sun than usual, high temperature (fever), and itching
• Severe allergic reactions. The signs may include shock such as difficulty in breathing, cold clammy skin, pale skin colour and racing heart beat
• Severe stomach or back pain. These could be signs of ‘pancreatitis’
• Bruising more easily, getting more infections, feeling weak or tired more than usual. Furosemide Injection can affect the number of blood cells, causing serious blood problems.
• Increased thirst, headache, feeling dizzy or light-headed, fainting, confusion, muscle or joint pains or weakness, cramps or spasms, stomach upsets or uneven heartbeats.
• These could be signs of dehydration or changes in your normal body chemicals. Severe dehydration can lead to blood clots or ‘gout’
Tell your doctor as soon as possible if you have any of the following side effects:
• Problems hearing or ringing in the ears (tinnitus). This especially affects people who already have problems with their kidneys
• Tingling or feeling numb on the skin
• Small changes in your mood such as feeling agitated or anxious
• Headaches, feeling dizzy or light-headed when standing up quickly. Also loss of concentration, slower reactions, feeling sleepy or weak, problems with your sight, dry mouth. This could be due to low blood pressure
• You notice yellowing of your skin or eyes and your urine becomes darker in colour. These could be signs of a liver problem. In patients who already have liver problems, a more serious liver problem known as liver encephalopathy may occur. Symptoms include forgetfulness, fits, mood changes and coma.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet
• Feeling sick (nausea) or a general feeling of being unwell, diarrhoea and being sick (vomiting) and constipation
• People with bladder and prostate problems may notice pain when passing water. This is due to an increase in the amount of water passed
• If you have diabetes you may be less able to control the levels of glucose in your blood
• Passing more water (urine) than you usually do. This normally happens 1 or 2 hours after taking this medicine
• Pain at the site of injection. This occurs when the medicine is injected into the muscle
Blood tests
Furosemide Injection can change the levels of liver enzymes or body fats known as cholesterol and triglycerides. Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yeiiowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FUROSEMIDE INJECTION
• This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it.
• The expiry date is stated on the carton and on the ampoules after EXP. The expiry date refers to the last day of that month.
• Furosemide Injection must be stored protected from light.
• Keep this medicine out of the reach and signt of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Furosemide Injection contains
The active ingredient in this medicine is furosemide 20mg. This is the new name for frusemide 20mg. The ingredient itself has not changed
• Each 2ml of Furosemide Injection contains 20mg furosemide
• The other ingredients are sodium hydroxide, sodium chloride and water for injection
What Furosemide Injection looks like and contents of the pack
Furosemide Injection is a clear, almost colourless solution. It is available in ampoules of 2 ml and in pack sizes of 1, 5 or 10 ampoules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Laboratorio Reig Jofre, S.A. Gran Capitan, 10 - 08970 Sant Joan Despt, Barcelona, Spain
This leaflet does not contain all the information about your medicine.
If you have any questions or are not sure about anything, ask your doctor or nurse.
This leaflet was last revised on June 2015
4.6 Pregnancy and lactation
Results of animal work, in general, show no hazardous effect of furosemide in pregnancy. There is clinical evidence of safety of the drug in the third trimester of human pregnancy; however, furosemide crosses the placental barrier. It must not be given during pregnancy unless there are compelling medical reasons. Treatment during pregnancy requires monitoring of fetal growth. Furosemide passes into breast milk and may inhibit lactation. Women must not breast-feed if they are treated with furosemide.
4.7 Effects on ability to drive and use machines
Reduced mental alertness may impair ability to drive or operate dangerous machinery.
4.8 Undesirable effects
Furosemide 20mg/2ml Solution for Injection is generally well tolerated.
Eosinophilia is rare.
Occasionally, thrombocytopenia may occur. In rare cases, leucopenia and, in isolated cases, agranulocytosis, aplastic anaemia or haemolytic anaemia may develop. Bone marrow depression has been reported as a rare complication and necessitates withdrawal of treatment. Rarely, paraesthesiae may occur.
Hepatic encephalopathy in patients with hepatocellular insufficiency may occur (see Section 4.3).
Serum calcium levels may be reduced; in very rare cases tetany has been observed. Nephrocalcinosis/ Nephrolithiasis has been reported in premature infants. Serum cholesterol and triglyceride levels may rise during furosemide treatment. During long term therapy they will usually return to normal within six months.
Glucose tolerance may decrease with furosemide. In patients with diabetes mellitus this may lead to a deterioration of metabolic control; latent diabetes mellitus may become manifest.
Hearing disorders and tinnitus, although usually transitory, may occur in rare cases, particularly in patients with renal failure, hypoproteinaemia (e.g. in nephritic syndrome) and/or when intravenous furosemide has been given too rapidly.
Furosemide may cause a reduction in blood pressure which, if pronounced may cause signs and symptoms such as impairment of concentration and reactions, lightheadedness, sensations of pressure in the head, headache, dizziness, drowsiness, weakness, disorders of vision, dry mouth, orthostatic intolerance.
In isolated cases, intrahepatic cholestasis, an increase in liver transaminases or acute pancreatitis may develop.
The incidence of allergic reactions, such as skin rashes, photosensitivity, vasculitis, fever, interstitial nephritis or shock is very low, but when these occur treatment should
be withdrawn. Skin and mucous membrane reactions may occasionally occur, e.g. itching, urticaria, other rashes or bullous lesions, erythema multiforme, bullous pemphigod, exfoliative dermatitis, purpura.
As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis after prolonged therapy. Furosemide leads to increased excretion of sodium and chloride and consequently water. In addition excretion of other electrolytes (in particular potassium, calcium and magnesium) is increased. Symptomatic electrolyte disturbances and metabolic alkalosis may develop in the form of a gradually increasing electrolyte deficit or, e.g. where higher furosemide doses are administered to patients with normal renal function, acute severe electrolyte losses. Warning signs of electrolyte disturbances include increased thirst, headache, hypotension, confusion, muscle cramps, tetany, muscle weakness, disorders of cardiac rhythm and gastrointestinal symptoms. Pre-existing metabolic alkalosis (e.g. in decompensated cirrhosis of the liver) may be aggravated by furosemide treatment.
The diuretic action of furosemide may lead to or contribute to hypovolaemia and dehydration, especially in elderly patients. Severe fluid depletion may lead to haemoconcentration with a tendency for thromboses to develop.
Increased production of urine may provoke or aggravate complaints in patients with an obstruction of urinary outflow. Thus, acute retention of urine with possible secondary complications may occur, for example, in patients with bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra.
If furosemide is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.
Severe anaphylactic or anaphylactoid reactions (e.g. with shock) occur rarely.
Side-effects of a minor nature such as nausea, malaise or gastric upset (vomiting or diarrhoea) may occur but are not usually severe enough to necessitate withdrawal of treatment. Following intramuscular injection, local reactions such as pain may occur.
As with other diuretics, treatment with furosemide may lead to transitory increases in blood creatinine and urea levels. Serum levels of uric acid may increase and attacks of gout may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard.
4.9 Overdose
The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias due to excessive diuresis. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.
Treatment should therefore be aimed at fluid replacement and correction of the electrolyte imbalance. Together with the prevention and treatment of serious complications resulting from such disturbances and of other effects on the body, this corrective action may necessitate general and specific intensive medical monitoring and therapeutic measures.
No specific antidote to furosemide is known. If ingestion has only just taken place, attempts may be made to limit further systemic absorption of the active ingredient by measures such as gastric lavage or those designated to reduce absorption (e.g. activated charcoal).
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: C03C A01
The evidence from many experimental studies suggests that furosemide acts along the entire nephron with the exception of the distal exchange site. The main effect is on the ascending limb of the loop of Henle with a complex effect on renal circulation. Blood-flow is diverted from the juxta-medullary region to the outer cortex. The principle renal action of furosemide is to inhibit active chloride transport in the thick ascending limb. Re-absorption of sodium chloride from the nephron is reduced and a hypotonic or isotonic urine produced. It has been established that prostaglandin (PG) biosynthesis and the renin-angiotensin system are affected by furosemide administration and that furosemide alters the renal permeability of the glomerulus to serum proteins.
5.2 Pharmacokinetic properties
Furosemide is a weak carboxylic acid which exists mainly in the dissociated form in the gastrointestinal tract. Furosemide is rapidly but incompletely absorbed (60-70%) on oral administration and its effect is largely over within 4 hours. The optimal absorption site is the upper duodenum at pH 5.0. Regardless of route of administration 69-97% of activity from a radio-labelled dose is excreted in the first 4 hours after the drug is given. Furosemide is bound to plasma albumin and little biotransformation takes place. Furosemide is mainly eliminated via the kidneys (80-90%); a small fraction of the dose undergoes biliary elimination and 10-15% of the activity can be recovered from the faeces.
In renal/ hepatic impairment Where liver disease is present, biliary elimination is reduced up to 50%. Renal impairment has little effect on the elimination rate of Furosemide 20 mg/2ml Injection, but less than 20% residual renal function increases the elimination time.
The elderly
The elimination of furosemide is delayed in the elderly where a certain degree of renal impairment is present.
New born
A sustained diuretic effect is seen in the newborn, possibly due to immature tubular function.
5.3 Preclinical safety data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hydroxide Ph. Eur., Sodium chloride Ph. Eur., Water for Injection Ph. Eur.
6.2 Incompatibilities
Furosemide may precipitate out of solution in fluids of low pH (e.g. dextrose solutions).
6.3 Shelf life
4 years.
6.4 Special precautions for use
Keep the ampoule in the outer carton in order to protect from light.
This medicinal product does not require any further special storage conditions
6.5 Nature and contents of container
Each pack contains Furosemide 20 mg/2ml Injection in a type I topaz glass ampoule.
Furosemide 20mg/2ml Solution for Injection is available in 2 ml ampoules in packs of 1, 5 or 10 ampoules. Not all pack sizes may be marketed.
6.6 Instructions for use and handling
Furosemide 20mg/2ml Solution for Injection solution should not be mixed with any other drugs in the injection bottle.
7 MARKETING AUTHORISATION HOLDER
Laboratorio Reig Jofre, S.A.
Gran Capitan, 10 08970 Sant Joan Despi Barcelona, Spain
8. MARKETING AUTHORISATION NUMBER
PL 25174 /0005
B10802-01
1
REIG JOFRE