FUROSEMIDE 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: FUROSEMIDE

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1033805-425092_- 28/09/2012 15:37 Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUROSEMIDE 10MG/ML SOLUTION FOR INJECTION OR INFUSION
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again while you are receiving your treatment.
- If you have any further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
The active ingredient in this medicine is furosemide. This is the new name for frusemide. The ingredient itself has not
changed.
The name of your medicine is furosemide 10mg/ml solution for injection or infusion. In the rest of this leaflet it is
called furosemide injection.
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 should be 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

Furosemide belongs to a group of medicines called loop diuretics which are used to get rid of excess water from the
body.
Furosemide injection is used to get rid of excess fluid from the body, which has accumulated due to problems with
the heart, lungs, liver or kidneys. It is used in emergency situations or in situations when you are unable to take
medicines by mouth.
2.

BEFORE YOU ARE GIVEN FUROSEMIDE INJECTION

Furosemide injection should not be given if:
• you have been told you are allergic to furosemide or any of the other ingredients in the injection (see ‘What
furosemide injection contains’ below)
• you have been told you are allergic to certain antibiotics, called sulphonamides
• you are suffering from dehydration or have lost a lot of blood
• you have kidney failure caused by certain drugs
• you have reduced consciousness due to liver disease
• you have stopped producing urine (water) in spite of treatment with furosemide
• you have very low levels of potassium or sodium in your blood.
Consult your doctor if any of the above warnings applies to you or has applied to you in the past.
Take special care with furosemide injection if:
• you are going to have, or have recently had an X ray with contrast media (dye)
• you are taking risperidone
• the patient is a premature baby
• you have problems with your prostate gland or difficulty in passing water
• you have, or are liable to, very low blood pressure
• you have diabetes mellitus or gout
• you have liver or kidney problems

• you have low levels of protein in your blood
• you are liable to low levels of salts in your blood, particularly if you are elderly. You will need blood tests to check
these.
• you have pancreatitis or a history of pancreatitis
• you have systemic lupus erythematosus or a history of systemic lupus erythematosus
If you have any doubts about whether furosemide injection is right for you then discuss things more fully with your
doctor or nurse.
Taking other medicines
Taking other medicines while you are being given furosemide injection can affect how it or the other medicine
works. Please inform your doctor or nurse if you are taking or have recently taken any other medicines, even those
you have bought yourself without a prescription. Please check with your doctor if you are taking any of the following
(or any other medication):
• Other drugs taken for high blood pressure, especially ACE inhibitors such as captopril, but also alpha-blockers
such as prazosin, beta-blockers, calcium channel blockers and hydralazine.
• Certain antibiotics including some cephalosporins, aminoglycosides (examples include amikacin, gentamicin,
netilmicin) and vancomycin.
• Phenothiazines, lithium, and certain other drugs taken for mental problems, such as reboxetine, primozide,
sertindole and risperidone.
• Drugs used to reduce inflammation (NSAIDs) such as ibuprofen, indometacin and ketoralac.
• Drugs used for diabetes such as glibenclamide.
• Dopamine and similar drugs, used to increase blood pressure.
• Certain drugs used to treat asthma, including theophylline and beta-agonists such as salbutamol.
• Medicines used as a general anaesthetic during surgery and muscle relaxant drugs, such as atracurium,
vecuronium and tizanidine.
• Some medicines used for heart problems including sotalol, disopyramide, flecainide, quinidine, lidocaine, mexilitine,
digoxin, digitoxin and amiodarone.
• Cisplatin aminoglutethimide and aldesleukin, used in cancer therapy.
• Colestyramine and colestipol, used to treat high levels of cholesterol in the blood.
• Medicines used for heart problems including sotalol, disopyramide, flecainide, quinidine, lidocaine, mexilitine,
digoxin, digitoxin and amiodarone.
• Anticoagulants such as warfarin.
• Sedatives such as chloral hydrate.
• Levodopa, used to treat Parkinson’s disease.
• Nitrates, used to treat chest pain associated with angina.
• Carbamazepine and phenytoin which are taken for epilepsy.
• Steroids such as cortisone and hydrocortisone.
• Carbenoxolone, and liquorice, used to treat stomach ulcers.
• Laxatives.
• Amphotericin, used to treat fungal infections.
• Probenecid, a drug used for the prevention of gout.
• Terfenadine, taken for allergies.
Alcohol should be avoided when taking this medicine.
Important information about some of the ingredients of furosemide injection:
Each 2ml ampoule contains 0.26mmol of sodium and each 25ml vial contains 3.25mmol of sodium. This should be
taken into consideration if you are on a controlled sodium diet.
Pregnancy and breast-feeding
Furosemide injection should not be given to you if you are pregnant unless your doctor considers it essential. You
should let your doctor know if you think you may be pregnant or are trying for a baby.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 10mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10mg of furosemide.
Each 2ml ampoule contains 20mg of furosemide.
Each 25ml vial contains 250mg of furosemide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
The solution is colourless or almost colourless.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Furosemide 10mg/ml 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 use.
Adults
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 counter-regulation, a continuous furosemide infusion is generally to be
preferred to repeated bolus injections. Where continuous furosemide infusion is not feasible for follow-up treatment after
one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approximately four 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 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.
4.3 Contraindications
Furosemide 10mg/ml Injection is contra-indicated 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 and pre-comatose and
comatose states associated with hepatic encephalopathy.
Hypersensitivity to furosemide or any of the excipients of Furosemide 10mg/ml 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.
Steps should be taken to correct hypovolaemia before commencing therapy in oliguria.
Caution is required in patients with liver failure, porphyria, pancreatitis or a history of pancreatitis, systemic lupus
erythematosus or a history of systemic lupus erythematosus or severe asthma (hypokalaemia associated with beta2agonist therapy can be potentiated by the concurrent use of diuretics). The insulin requirements of diabetic patients may
increase on treatment with furosemide and latent diabetes may become manifest.
Particularly careful monitoring is necessary in:
• patients with hypotension – correct before use
• patients who are at risk from a pronounced fall in blood pressure
• patients with gout
• patients with hepatorenal syndrome
• patients with hypoproteinaemia, e.g. associated with nephrotic syndrome (the effect of furosemide may be weakened
and its ototoxicity potentiated). Cautious dose titration is required.
• premature infants and neonates (possible development of nephrocalcinosis/nephrolithiasis in association with
increased calcium excretion during long-term furosemide treatment; renal function must be monitored and renal
ultrasonography performed)
Caution should be observed in patients liable to electrolyte deficiency such as the elderly. The risk of hypokalaemia is
increased in patients with severe or congestive heart failure, hepatic cirrhosis or hyperaldosteronism. 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. Possibility of hypocalcaemic tetany in hypoparathyroid patients.
Prolonged treatment with furosemide can lead to thiamine deficiency, particularly in congestive heart failure or the elderly.
This medicinal product contains 0.26mmol of sodium in a 2ml ampoule and 3.25mmol of sodium in a 25ml vial. To be
taken into consideration by patients on a controlled sodium diet.
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.
Concomitant use with risperidone:
In risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in
patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97 years) when compared to
patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96 years) or furosemide alone (4.1%; mean

age 80 years, range 67-90 years). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in
low dose) was not associated with similar findings.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death
observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with
other potent diuretics should be considered prior to the decision to use. There was no increased incidence of mortality
among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration
was an overall risk factor for mortality and should therefore be avoided in elderly patients with dementia.
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol: Enhanced hypotensive effect. Orthostatic hypotension, associated with diuretics, may be enhanced.
Aldesleukin: Enhanced hypotensive effect.
Anaesthetics, general: Enhanced hypotensive effects.
Anion-exchange resins: Colestyramine and colestipol markedly reduce the absorption of furosemide. Administer two to
three hours apart.
Anti-arrhythmics: Toxicity of amiodarone, disopyramide, flecainide and quinidine is increased if hypokalaemia occurs.
Action of lidocaine and mexilitine is antagonised by hypokalaemia. Hypokalaemia increases risk of ventricular arrhythmias
with sotalol, a beta-blocker.
Antibacterials: Furosemide may enhance the toxicity of nephrotoxic antibiotics including some cephalosporins. It can
enhance the ototoxicity of aminoglycoside antibiotics, vancomycin and other ototoxic agents. Since this may lead to
permanent damage, these drugs must only be used with furosemide if there are compelling medical reasons.
Anticoagulants: Reduced anticoagulant effect when furosemide used concomitantly with warfarin.
Antidepressants: Increased risk of postural hypotension with tricyclic antidepressants. Enhanced hypotensive effect with
monoamine oxidase inhibitors (MAOIs). Increase risk of hypokalaemia when furosemide and reboxetine are used
concomitantly.
Antidiabetics: The hypoglycaemic effect is antagonised by loop diuretics.
Antiepileptics: Increased risk of hyponatraemia with concomitant carbamazepine. The diuretic effect of furosemide has
been shown to be substantially reduced by concomitant phenytoin therapy.
Antifungals: Increased risk of hypokalaemia with loop diuretics and amphotericin.
Anti-gout: Probenecid has been shown to reduce the renal clearance of furosemide and may increase, decrease or have
no effect on the overall diuresis. Furosemide may reduce the renal clearance of probenecid. In case of high-dose
treatment (with furosemide and probenecid), this may lead to increased serum levels and an increased risk of adverse
effects.
Antihistamines: Hypokalaemia increases risk of ventricular arrhythmias with terfenadine.
Antihypertensives: Furosemide enhances the hypotensive action of other antihypertensive drugs, including beta-blockers,
calcium-channel blockers and hydralazine. The dosage of currently administered antihypertensive agents may require
adjustment. There is an increase risk of first-dose hypotension with alpha blockers such as prazosin or angiotensinconverting enzyme (ACE) inhibitors such as captopril. Particular care should be taken with ACE inhibitors and
angiotensin-II antagonists when initiating or increasing their dose in concomitant therapy with furosemide, since
combination can result in marked reduction in blood pressure and deterioration in renal function. The dose of furosemide
should be reduced for at least three days, or the drug stopped, before initiating or increasing the dose of an ACE inhibitor
or angiotensin II receptor antagonist. Long term intensive treatment with captopril can enhance the natriuretic response to
furosemide.
Antipsychotics: Hypokalaemia increases risk of ventricular arrhythmias with primozide and sertindole, concurrent use
should be avoided. Enhanced hypotensive effect with phenothiazines. Risperidone: Caution should be exercised and the
risks and benefits of the combination or co-treatment with furosemide or with other potent diuretics should be considered
prior to the decision to use. See section 4.4 Special warnings and precautions for use regarding increased mortality in
elderly patients with dementia concomitantly receiving risperidone
Anxiolytics and hypnotics: Administration of chloral hydrate followed by intravenous furosemide may result in a syndrome
of hot flushes, sweating, tachycardia and hypertension.
Cardiac Glycosides: Increased risk of toxicity if hypokalaemia or hypomagnesaemia occurs. The cardiac glycoside dosage
may require adjustment as a more pronounced fall in blood pressure must be anticipated if given concomitantly with
furosemide.
Corticosteroids: The increased risk of hypokalaemia occurs particularly with the naturally occurring corticosteroids such
as cortisone and hydrocortisone. The synthetic corticosteroids have a much less marked potassium-losing effect. Fluid
retention associated with corticosteroid use may cause antagonism of diuretic/antihypertensive effect. Concomitant
administration of corticosteroids may cause sodium retention.
Cytotoxics: 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. 40mg in patients with normal renal function) and
with positive fluid balance when used to achieve forced dieresis during cisplatin treatment.
Diuretics: Increased risk of hypokalaemia with other loop diuretics and other diuretics, including acetazolamide and
thiazides. Severe electrolyte disturbances may occur in patients given metolazone concurrently with furosemide. The
dosage of concurrently administered diuretics may require adjustment as a more pronounced fall in blood pressure must
be anticipated if given concomitantly with furosemide
Dompaminergics: Enhanced hypotensive effect with levodopa.
Immunosuppressants: Ciclosporin: concomitant use of ciclosporin and furosemide is associated with increased risk of
gouty arthritis.
Laxatives: Prolonged use may increase the risk of developing hypokalaemia.
Lithium: 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. It is
recommended that lithium levels are carefully monitored and where necessary the lithium dosage is adjusted in patients
receiving this combination.
Muscle relaxants: Enhanced hypotensive effect may occur with tizanidine; effects of curare-type muscle relaxants may be
potentiated.
Nicotine: Nicotine inhibits diuresis and diminishes the diuretic effect of furosemide.
Nitrates: Enhanced hypotensive effect.

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Women who are breast-feeding should not be given furosemide. If you are breast-feeding you should discuss this
with your doctor before being given furosemide.
Driving and using machines
Furosemide can affect your ability to drive or use machines. If you are affected, do not drive or operate machinery.
3. HOW FUROSEMIDE INJECTION SHOULD BE GIVEN
Your injection will be given to you by a doctor or nurse. The solution can be injected directly into a muscle
(intramuscularly), be given by a slow injection into a vein (intravenously) over several minutes or diluted with
another fluid and given by a drip over a longer period of time.
Adults and the elderly
In adults and the elderly, the usual dose is 20 to 50mg, increasing by 20mg every two hours if necessary. The
maximum daily dose should not be more than 1,500mg.
Children
In children the dose will range from 0.5 to 1.5mg/kg of bodyweight daily. The maximum daily dose should not be
more than 20mg.
Your doctor will decide the dose which is best for you. If you do not understand, or are in any doubt, ask your
doctor or nurse.
If you think you have been given too much furosemide injection
Your doctor will decide which dose is best for you. If you think too much medicine has been given to you contact
your doctor, nurse, pharmacist or nearest hospital.
If you think you have missed a dose of furosemide injection
If you think you have missed a dose of furosemide injection, inform your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the
following, tell your doctor immediately:
• If you develop a fever, pain in the loins, wheezing, difficulty breathing, a skin rash, itching, or swelling of your
lips, eyes or tongue, become sensitive to sunlight or collapse
• Liver problems including raised liver enzymes and jaundice can develop (e.g. yellowing of the skin and/or whites
of the eyes)
• Blood disorders (you may develop mouth ulcers, a sore throat, nose bleeds or infections)
• There may be an increased tendency to thrombosis (clots in the blood vessels), especially in elderly patients.
Other side-effects that have been reported are:
• The most common side-effects that some other patients have had (as well as the expected effect of passing a
lot of water) are low blood pressure and a low body level of salts such as sodium, potassium or calcium
(symptoms of these include dry mouth, thirst, weakness, confusion, drowsiness, headache, weakness, muscle
cramps or spasms, and irregular heart beat).
• Other side effects that have been reported are an upset stomach, nausea, vomiting and diarrhoea, feeling
unwell, “pins and needles”, difficulty concentrating, slow reactions, dizziness (including dizziness or lightheadedness on standing), fainting, numbness, mental confusion, and blurred vision.
• Furosemide may cause raised blood levels of cholesterol, triglycerides and sugar, can make diabetes worse,
and can cause gout.
• Patients with prostate problems may develop retention of urine.
• Premature infants may develop kidney stones or problems with the circulation of the blood within the heart.
• An inflamed pancreas can occur (which may result in nausea and vomiting with pain in the abdomen and back).
• Very rarely furosemide can cause hearing disturbances including ringing in the ears.
• Occasionally the area around where the needle is injected can become sore, red and itchy.

If you notice any side-effects not mentioned in this leaflet, or feel that the medicine is affecting you badly, please tell
your doctor or nurse.
5.

HOW TO STORE FUROSEMIDE INJECTION

• This medicine should not be used after the expiry date shown on the label. The expiry date refers to the last day
of the month.
• Furosemide injection should not be given if it shows signs of deterioration such as discoloration.
• Store in the original packaging in order to protect the product from light.
• For single use. Discard any unused product immediately after use.
Keep this medicine out of the reach and sight 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 substance in the injection is furosemide.
Other ingredients are sodium chloride, sodium hydroxide and water for injections.
What furosemide injection looks like and contents of the pack
Furosemide injection is a colourless or almost colourless solution for injection or infusion. It is available in two
presentations: a 2ml amber glass ampoule containing 20mg of furosemide and a 25ml amber glass vial containing
250mg of furosemide.
Both presentations are available in packs of 1, 5 or 10. Not all pack sizes may be marketed.

X-PIL Information
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name
Furosemide 10mg/ml solution for injection
or infusion (20mg in 2ml)
Furosemide 10mg/ml solution for injection
or infusion (250mg in 25ml)

Reference Number
29831/0098
29831/0201

This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: Laboratorio Reig Jofré, Gran Capitán, nº 10, 08970 Sant Joan Despí, Barcelona, Spain.
Leaflet prepared October 2012

103380/5

Non-steroidal anti-inflammatory agents (NSAIDs): Certain non-steroidal anti-inflammatory agents (e.g. indometacin,
ketorolac, acetylsalicylic acid) may attenuate the diuretic effect of furosemide and may cause acute renal failure in cases
of pre-existing hypovolaemia or dehydration. Enhanced salicylate toxicity or nephrotoxicity of NSAIDs.
Prostaglandins: Hypotensive effect may be potentiated by alprostadil.
Sympathomimetics: There is an increased risk of hypokalaemia with high doses of β2-sympathomimetics-. Effects of
pressor amines may be attenuated.
Theophylline: Risk of hypokalaemia may be increased; effects of theophylline may be potentiated
Ulcer healing drugs: carbenoxolone and liquorice may increase risk of hypokalaemia. Fluid retention associated with
carbenoxolone may cause antagonism of diuretic/antihypertensive effect. Ranitidine causes a moderate increase in the
bioavailability of furosemide.
4.6 Pregnancy and lactation
Animal teratology studies indicate that furosemide may cause foetal abnormalities. There is clinical evidence of safety of the
drug in the third trimester of human pregnancy; however, furosemide crosses the placental barrier. As furosemide is a potent
diuretic, reduction in maternal blood volume following administration could compromise placental perfusion. It must not be
given during pregnancy unless there are compelling medical reasons. Treatment during pregnancy requires monitoring of
foetal growth.
Furosemide passes into breast milk and may inhibit lactation. Furosemide is not recommended in nursing mothers.
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 10mg/ml Injection is generally well tolerated.
Metabolism and nutrition disorders: The most common side-effect is fluid and electrolyte imbalance including
hyponatraemia, hypokalaemia, hypochloraemic alkalosis, hypotension and increased calcium excretion.
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, dry mouth, headache, hypotension, drowsiness, confusion, muscle
cramps, tetany, muscle weakness, disorders of cardiac rhythm and gastrointestinal symptoms.
Increased calcium excretion in infants and new-borns has been associated with reports of decreased bone mineral
content, rickets, fractures and renal calcification. Hypocalcaemic tetany has also been reported in hypoparathyroid
patients. Nephrocalcinosis / Nephrolithiasis may develop in premature infants.
Pre-existing metabolic alkalosis (e.g. in decompensated cirrhosis of the liver) may be aggravated by furosemide
treatment.
Thiamine deficiency with prolonged treatment, particularly in congestive heart failure and the elderly.
Furosemide may cause hyperuricaemia and precipitate attacks of gout in some patients.
Serum cholesterol and triglyceride levels may rise during furosemide treatment. During long term therapy they will usually
return to normal within six months.
Nervous system disorders: Syncope, rarely, paraesthesiae may occur.
Ear and labyrinth disorders: tinnitus and deafness, although usually transitory, may occur in rare cases, (usually with
large parenteral doses and rapid administration or in patients with hypoproteinaemia or renal impairment). Rarely
deafness may be permanent, particularly if furosemide has been given to patients taking other ototoxic drugs.
Eye disorders: Blurred vision, yellow vision.
Vascular disorders: Furosemide may cause a reduction in blood pressure which, if pronounced, may cause signs and
symptoms such as impairment of concentration and reactions, light-headedness, sensations of pressure in the head,
headache, dizziness, drowsiness, weakness, disorders of vision, dry mouth, orthostatic hypotension. 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.
Immune system disorders: Hypersensitivity reactions, that may include skin rashes, photosensitivity, vasculitis, fever,
urticaria and interstitial nephritis occur rarely but when these occur treatment should be withdrawn. Severe anaphylaxis or
anaphylactoid reactions (e.g with shock) may also occur rarely and necessitate immediate withdrawal of furosemide
treatment.
Endocrine disorders: Glucose tolerance may decrease with furosemide. In patients with diabetes mellitus this may lead to
a deterioration of metabolic control with hyperglycaemia and glycosuria; latent diabetes mellitus may also become
manifest.
Gastrointestinal disorders: side-effects of a minor nature such as nausea, or gastric upset (vomiting and diarrhoea) may
occur but are not usually severe enough to necessitate withdrawal or treatment. Pancreatitis is more common at high
doses.
Blood and lymphatic system disorders: In rare cases, thrombocytopenia, leucopenia, agranulocytosis, eosinophilia,
aplastic anaemia or haemolytic anaemia may develop. Bone marrow depression necessitates withdrawal of treatment.
Hepatobiliary disorders: In isolated cases, intrahepatic cholestasis, an increase in liver transaminases, or cholestatic
jaundice has been reported. Hepatic encephalopathy in patients with hepatocellular insufficiency may occur.
Pregnancy, puerperium and perinatal conditions: If furosemide is administered to premature infants during the first weeks
of life, it may increase the risk of persistence of patent ductus arteriosus.
Renal/and urinary disorders: 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. As with other
diuretics, treatment with furosemide may lead to transitory increases in blood creatinine and urea levels.
Skin and subcutaneous tissue disorders: Skin and mucous membrane reactions may occasionally occur, e.g. itching,
urticaria, and other rashes. Rarely these may be severe and may include purpura and exfoliative dermatitis and bullous
lesions such as erythema multiforme and pemphigoid.
General disorders and administration site conditions: malaise. Following intramuscular injection, local reactions such as
pain may occur.

4.9 Overdose
Symptoms:
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:
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 those designed to reduce absorption (e.g. activated
charcoal).
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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, 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 chloride
Sodium hydroxide
Water for injections
6.2 Incompatibilities
Furosemide may precipitate out of solution in fluids of low pH (e.g. dextrose solutions).
6.3 Shelf life
Three years
6.4 Special precautions for storage
Store in the original package
6.5 Nature and contents of container
20mg in 2ml
Type I amber coloured glass ampoule of 3ml capacity. Each pack contains 1, 5 or 10 ampoules*.
250mg in 25ml
Type I amber coloured glass vial (25ml capacity) sealed with a bromobutyl stopper, aluminium overseal and polypropylene
flip-off cap. Each pack contains 1, 5 or 10 vials*.
*Not all pack sizes may be marketed
6.6 Instructions for use and handling
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the
product should be used immediately.
For single use only.
Furosemide 10mg/ml Injection solution should not be mixed with any other drugs in the injection bottle.
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.
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Limited
Ash Road North
Wrexham
LL13 9UF
UK
8 MARKETING AUTHORISATION NUMBER(S)
20mg in 2ml: PL 29831/0098
250mg in 25ml: PL 29831/0201
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/05/2007
10DATE OF REVISION OF THE TEXT
01/10/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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