Consumer medicine information

Urex Forte

Furosemide (frusemide)

BRAND INFORMATION

Brand name

Urex Forte

Active ingredient

Furosemide (frusemide)

Schedule

SUMMARY CMI

UREX FORTE

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using UREX FORTE?

UREX FORTE contains the active ingredient, which belongs to a group of medicines called diuretics. Diuretics are used to help the kidneys remove excess fluid from the body.

For more information, see Section 1. Why am I using UREX FORTE? in the full CMI.

2. What should I know before I use UREX FORTE?

Do not use if you have ever had an allergic reaction to UREX FORTE or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use UREX FORTE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with UREX FORTE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use UREX FORTE?

The dose of UREX FORTE may be different for each person and their medical condition. Your doctor will decide the right dose for you.

UREX Forte is a 500 mg tablet.

More instructions can be found in Section 4. How do I use UREX FORTE? in the full CMI.

5. What should I know while using UREX FORTE?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using this medicine! Make sure you drink enough water during any exercise and during hot weather when you are taking This medicine, especially if you sweat a lot.
Things you should be careful of	If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up. If you are using This medicine for a long period of time, you should check with your doctor to determine whether or not you should eat more potassium-containing foods or take potassium supplements.
Driving or using machines	If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up. If this happens, do not drive or operate machines
Drinking alcohol	It is not recommended that you drink alcohol while taking This medicine.
Looking after your medicine	Keep This medicine in a cool dry place, protected from light, where the temperature stays below 30°C in its original packaging.

For more information, see Section 5. What should I know while using UREX FORTE? in the full CMI.

6. Are there any side effects?

Tell your doctor as soon as possible if you do not feel well while you are taking This medicine.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
You can help by reporting any side affects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

FULL CMI

UREX FORTE

Active ingredient(s): Furosemide

Consumer Medicine Information (CMI)

This leaflet provides important information about using UREX FORTE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using UREX FORTE.

Where to find information in this leaflet:

1. Why am I using UREX FORTE?
2. What should I know before I use UREX FORTE?
3. What if I am taking other medicines?
4. How do I use UREX FORTE?
5. What should I know while using UREX FORTE?
6. Are there any side effects?
7. Product details

1. Why am I using UREX FORTE?

UREX FORTE contains the active ingredient called which belongs to a group of medicines called diuretics. Diuretics are used to help the kidneys remove excess fluid from the body.

UREX FORTE is used to treat several medical conditions, including:

oedema (swelling of the body, ankles, feet, legs or even the brain or lungs due to excess fluid). This problem can also occur in cases of heart, liver or kidney disease.
hypertension (high blood pressure).

This can occur by itself or in severe heart, liver or kidney disease.

Everyone has blood pressure. This pressure helps move your blood around your body. Your blood pressure may vary at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed.

If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure.

UREX FORTE may be taken alone or in combination with other medicines to treat your condition.

Ask your doctor if you have any questions about why UREX FORTE has been prescribed for you.

Your doctor may have prescribed it for another purpose.

This medicine is available only with a doctor's prescription.

This medicine is not addictive.

2. What should I know before I use UREX FORTE?

Warnings

Do not use UREX FORTE if you are allergic to:

this medicine or any of the ingredients listed at the end of this leaflet.
medicines called sulphonamides (e.g. Some types of antibiotics which are also referred to as ‘sulfur antibiotics’) or sulfonylureas which are medicines which can be used to treat diabetes

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not use UREX FORTE if:

have severe kidney and liver disease or have no urine output.
low blood pressure, low sodium levels in your blood, low potassium levels in your blood, dehydration, hepatic coma or precoma
are pregnant.
are breastfeeding or plan to breast feed.
for use for children unless your doctor has prescribed it. If the medicine is for a newborn child, tell your doctor if the baby was jaundiced.
after the expiry date (EXP.) printed on the pack.
the packaging is torn or shows signs of tampering.

Check with your doctor if you have any of the following medical conditions:

Liver problems
Kidney problems
Heart problems
High cholesterol levels
Asthma
Diabetes
Gout, a disease with painful, swollen joints
Passing less urine than is normal for you.
Difficulty passing urine.
No production or no passing of urine
Prostate problems
Systemic Lupus Erythematosus (SLE), a disease affecting the skin, joints and kidneys.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

UREX FORTE passes into breast milk and there is possibility your baby may be affected. Your doctor will discuss the risks and benefits of taking it if you are breast-feeding or planning to breast-feed.

Tell your doctor If you are on a salt restricted diet:

If you have not told your doctor about any of the above, tell them before you start taking UREX FORTE.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines should not be taken with UREX FORTE. This includes large amounts of laxatives.

Some medicines may interfere with UREX FORTE. These include:

certain other fluid tablets or diuretic medicines
medicines used to treat high blood pressure and some other heart conditions, especially ACE inhibitors or angiotensin receptor antagonists
digoxin and other medicines used to treat heart failure.
non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin, medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis
methotrexate, a medicine used to treat arthritis and some types of cancer.
probenecid, a medicine used to treat gout.
medicines used to relax muscles before or during surgery.
lithium, a medicine used to treat mood swings and some types of depression.
medicines used in emergency situations such as adrenaline (epinephrine) and noradrenaline (norepinephrine)
cisplatin, a medicine used to treat cancer.
theophylline, a medicine used to treat asthma.
certain antibiotics, especially cephalosporins and aminoglycosides
amphotericin, a medicine used to treat fungal infections.
barbiturates, medicine used to treat epilepsy, to produce calmness, or to help you sleep.
narcotic/strong pain killers such as codeine and morphine
insulin and tablets used to treat diabetes.
sucralfate, a medicine used to treat stomach ulcers.
anticonvulsant medicines such as chloral hydrate or phenytoin
corticosteroids such as cortisone, prednisone or dexamethasone
medicines used to treat thyroid conditions.
risperidone, an antipsychotic medication used to schizophrenia.
medicines used during scans to see the images of your body.

These medicines may be affected by UREX FORTE or may affect how well it works. You may need to use different amounts of your medicine or take different medicines. Your doctor or pharmacist will advise you.

You should not eat large amounts of liquorice when you are taking UREX FORTE.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect UREX FORTE.

4. How do I use UREX FORTE?

How much to take.

The dose of UREX FORTE may be different for each person and their medical condition. Your doctor will decide the right dose for you.

The recommended doses for:

Oedema

Adults: 20 to 80 mg as a single dose. The dose may be increased in exceptional cases up to 400 mg per day.
Children: 2 mg per kg per day up to a maximum of 6 mg per kg per day or 40 mg per day.

Hypertension

Adults: 20 to 40 mg twice daily.
Only in unusual cases of reduced glomerular filtration (kidney disease) will a high dose using UREX FORTE be required.

How to take this medicine

Swallow the medicine with water.
If the dose is one-half tablet, there is a breakline on the tablet to help you divide it.

When to take this medicine

This medicine should be taken either early in the day or in the morning and no later than 4 hours before retiring if a twice daily dose is required.

How long to take it

Continue taking This medicine as long as your doctor recommends it.

If you forget to use this medicine

If your dosing schedule is one dose a day, take the missed dose as soon as possible, but not later than 4 hours before bedtime. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of you getting an unwanted side effect.

If you use too much UREX FORTE (overdose)

If you think that you have used too much UREX FORTE, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to Accident and Emergency at your nearest hospital.
if you think that you or anyone else may have taken too much UREX FORTE.

You should do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol (including any barbiturates or narcotics) which has been taken.

You may need urgent medical attention.
If you take too much UREX FORTE, you may feel confused, dehydrated, dizzy or you may pass excessive urine.

5. What should I know while using UREX FORTE?

Things you should do

Tell your doctor if, for any reason you have not taken your medicine exactly as directed or if you feel it is not helping your condition.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell all doctors, dentists and pharmacists who are treating you that you are taking UREX FORTE.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking UREX FORTE.

If you plan to have a surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.

Immediately tell your doctor if you become pregnant while you are taking this medicine.

Tell your doctor if you have excessive vomiting or diarrhoea while taking UREX FORTE or if you experience any of the following symptoms:

Dry mouth or thirst
Fainting
Weakness, tiredness or drowsiness
Muscle pain or cramps
Fast heartbeat
passing less urine than normal

If you experience these symptoms, you may be dehydrated because you are losing too much water.

Make sure you drink enough water during any exercise and during hot weather when you are taking UREX FORTE, especially if you sweat a lot.

If you do not drink enough water while taking UREX FORTE, you may feel faint or light-headed or sick. This is because your blood pressure is dropping suddenly, and you are dehydrating. If you continue to feel unwell, tell your doctor.

If you are about to have any blood tests, tell your doctor that you are taking UREX FORTE.

There may be some interference with the results of these tests.

If you are taking UREX FORTE to treat high blood pressure, make sure you have your blood pressure checked when your doctor says to make sure UREX FORTE is working properly.

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to keep taking UREX FORTE.

Things you should not do.

Do not take any other medicines while you are taking UREX FORTE without first telling your doctor.
Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not take UREX FORTE for a longer time than your doctor has prescribed.
Avoid prolonged exposure to direct sunlight.
Do not change your dose without first checking with your doctor.
Do not stop taking UREX FORTE or lower the dose, without first checking with your doctor.

Stopping the medicine suddenly on your own accord may cause some unwanted effects or your condition may reappear.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how UREX FORTE affects you.

If you feel light-headed, dizzy or faint, get up slowly when getting out of bed or standing up.

You may feel light-headed or dizzy when you begin to take UREX FORTE. This is because your blood pressure is falling suddenly. Standing up slowly, especially when you get up from beds or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Be careful driving or operating machinery until you know how UREX FORTE affects you.

Diuretic medicines may cause dizziness or light-headedness in some people. Make sure you know how you react to your medicine before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.

If this occurs do not drive.

Drinking alcohol

If you drink alcohol or take strong painkillers, dizziness or light-headedness may be worse.

The effects of alcohol could be made worse while taking UREX FORTE. It is not recommended that you drink alcohol while taking UREX FORTE.

If you are taking UREX FORTE for a long period of time, you should check with your doctor to determine whether or not you should eat more potassium-containing foods or take potassium supplements. However, increasing the amount of potassium in your diet may not be necessary and could be harmful. Check with your doctor.

UREX FORTE may cause your skin to become more sensitive to the sun. If this happens you should take care to wear protective clothing including a hat and sun block when you are outside.

Things that may help your condition.

Some self-help measures suggested below may help your condition.

Alcohol – your doctor may advise you to limit your alcohol intake.

Diet – eat a healthy diet which includes plenty of fresh vegetables, fruit, bread, cereals and fish. Also eat less fat and sugar.

Exercise – regular exercise helps reduce blood pressure and helps the heart get fitter, but it is important not to overdo it. Walking is a good exercise but try to find a route that is fairly flat. Before starting any exercise, ask your doctor about the best kind of program for you.

Salt – if you have high blood pressure, your doctor may advise you to watch the amount of salt in your diet. To reduce your salt intake, you should avoid using salt in cooking or at the table.

Smoking – your doctor may advise you to stop smoking or at least to cut it down.

Weight – your doctor may suggest that you lose some weight to help lower your blood pressure and help lessen the amount of work your heart has to do. Some people may need a dietician's help to lose weight.

Talk to your doctor or pharmacist about these measures and for more information.

Looking after your medicine

Keep UREX FORTE in a cool dry place, protected from light, where the temperature stays below 30°C; for example, do not store it:

in the bathroom or near a sink, or
in the car or on windowsills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Heat and dampness can destroy some medicines.

When to discard your medicine

If your doctor tells you to stop taking the tablets or they have passed their expiry date, ask your pharmacist what to do with any left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor as soon as possible if you do not feel well while you are taking UREX FORTE.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
Muscle pains or cramps lethargy vomiting or nausea drowsiness or a lack of energy fever loss of appetite dry mouth diarrhoea blurred vision or impaired vision. skin rashes. Confusion Ringing or buzzing in the ears Unusual bleeding or bruising under the skin. restlessness	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

usual bruising
Irregular or fast heartbeat
Passing less urine than is normal for you.
Severe stomach pain, often with nausea or vomiting
Severe dizziness or a spinning sensation
Increased sensitivity to sunlight
Flaking or peeling of the skin
Symptoms of anaemia such as tiredness, being short of breath when exercising, dizziness and looking pale
Frequent infections such as fever, severe chills, sore throat or mouth ulcers
Bleeding or bruising more easily than normal, nose bleeds.
Loss of control of your bladde or bowels (incontinence)
Gout, a disease with painful, swollen joints
Deafness or ringing in the ears.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Serious side effects are uncommon.

Very Serious side effects

Very Serious side effects

What to do

sudden signs of allergy such as rash, itching or hives (pinkish, itchy raised areas) on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
chest pain
fainting or having a rapid, weak pulse
red, often itchy spots similar to the rash seen with measles which starts on the limbs and sometimes on the face and body. The spots may blister and may progress to form raised red, pale-centred marks. Those affected may have fever, sore throat, headache with or without diarrhoea
yellowing of the skin and/or eyes

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of side effects.

You may not experience any of them.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

UREX FORTE 500 mg is a-white round uncoated tablet with one side plain and the other scored with a break line. Available in blister packs of 50 tablets.

What UREX FORTE contains

UREX FORTE

Active ingredient (main ingredient)	Each UREX FORTE tablet contains 500 mg of the active ingredient, furosemide
Other ingredients (inactive ingredients)	It also contains the inactive ingredients lactose monohydrate, maize starch, magnesium stearate, maltodextrin and colloidal anhydrous silica.
Potential allergens	This medicine contains sugars as lactose. It does not contain gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What UREX FORTE looks like

UREX FORTE 500 mg is a-white round uncoated tablet with one side plain and the other scored with a break line. Available in blister packs of 50 tablets.

Who distributes UREX FORTE

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia

www.arrotex.com.au

The Australian Registration Number for UREX FORTE is:

UREX FORTE 500 mg tablet blister pack: AUST R 196972

This leaflet was revised in June 2024.

Published by MIMS August 2024

BRAND INFORMATION

Brand name

Urex Forte

Active ingredient

Furosemide (frusemide)

Schedule

1 Name of Medicine

Furosemide.

2 Qualitative and Quantitative Composition

Furosemide is an anthranilic acid derivative. Furosemide is a sulphonamide-type loop diuretic and occurs as a white to slightly yellow, odourless crystalline powder with a pKa of 3.9. It is only slightly soluble in water, sparingly soluble in alcohol and freely soluble in alkali hydroxides.
Urex tablets are available in 500 mg (Urex Forte).

Excipients with known effect.

Urex Forte contain sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Urex Forte.

Each tablet contains furosemide 500 mg. White round uncoated tablet, one face plain, one face with a break-bar.

4 Clinical Particulars

4.1 Therapeutic Indications

Furosemide in a high dosage formulation such as Urex Forte (500 mg tablets) is intended exclusively for patients with severely impaired renal function. For use under strict medical supervision only within a hospital setting (see Section 4.2 Dose and Method of Administration). High doses of furosemide may be used as an adjuvant treatment of oliguria and in the promotion of diuresis in the treatment of oedema; in selected patients with acute renal failure, e.g. in the postoperative phase and in association with septic infections; in selected patients with chronic renal failure with fluid retention, both in the predialysis phase and when dialysis has become unavoidable, especially in the presence of acute pulmonary oedema; in selected patients with nephrotic syndrome and with severe impairment of renal function, e.g. in chronic glomerulonephritis, lupus erythematosus and Kimmelstiel-Wilson syndrome. If diuresis is less than 2.5 L/day, dialysis has to be used.

4.2 Dose and Method of Administration

Adults: oral.

Oedema.

Therapy should be individualised according to the patient's response. This therapy should be titrated to gain maximal therapeutic response with the minimum dose possible to maintain that diuretic response. The usual initial daily dose is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues and the starting dose can then be maintained or even reduced. If a satisfactory diuresis has not occurred within 6 hours, succeeding doses should be increased by increments of 20 to 40 mg after the previous dose until the desired diuretic effect is obtained. If necessary, this individually determined dose should be given once or twice daily (e.g. at 8 am and 2 pm). The dose of Urex (furosemide) may be carefully titrated up to 400 mg/day (except in advanced renal failure) in those patients with severe clinical oedematous states.
The mobilisation of oedema may be most efficiently accomplished by utilising an intermittent dosage schedule in which furosemide is given for 2 to 4 consecutive days each week. With doses exceeding 80 mg/day, careful clinical and laboratory observations are particularly advisable.

Children.

Doses of 2 mg per kilogram bodyweight per day up to a maximum of 40 mg orally, given as a single dose, are usually indicated. If diuretic response is not satisfactory, the dose may be increased by 1 to 2 mg/kg, no sooner than 6 to 8 hours after the previous dose. Treatment is otherwise as for adults. Doses greater than 6 mg per kilogram bodyweight per day are not recommended.
For maintenance therapy in infants and children, the dose should be adjusted to the minimum effective level.

Hypertension.

Therapy should be individualised according to the patient's response. This therapy should be titrated to gain maximal therapeutic response with the minimum dose possible to maintain that therapeutic response. 20 to 40 mg twice daily. Individualised therapy is of great importance. Careful observations for changes in blood pressure must be made when furosemide is used with other antihypertensive drugs, especially during initial therapy. The dosage of other agents must be reduced by at least 50% as soon as furosemide is added to the regimen to prevent an excessive drop in blood pressure. As the blood pressure falls under furosemide's potentiating effect, a further reduction in dosage, or even discontinuation of other antihypertensive drugs, may be necessary. If 40 mg twice daily does not lead to a clinically satisfactory response, addition of other antihypertensive agents rather than an increase of the dose of furosemide should be considered. Furosemide administration may induce extracellular metabolic alkalosis, primarily by virtue of the disproportionate loss of chloride but also, in part, as a result of the variable depletion of potassium.
The high dosage preparation, Urex Forte tablets, is intended exclusively for administration to patients with greatly reduced glomerular filtration rate (GFR less than 20 mL/minute but greater than 5 mL/minute). Normal dose may be adequate in patients with greatly reduced GFR, mainly if functional oliguria or anuria is observed. Thus, test a normal dose first before administering a high dose.
Before treatment of patients in shock is started, hypovolaemia and hypotension should be dealt with by normal measures. Similarly, disturbed serum electrolytes and acid/ base balance should first be corrected.
When treating patients with conditions likely to interfere with micturition such as prostatic hypertrophy or disturbed consciousness, it is absolutely essential to ensure free urinary drainage. Because of the wide and unpredictable individual variations in responsiveness, it is important to adjust dosage and route of administration to individual needs.
Once the desired rise in urinary output has begun, exact balance of water intake and fluid output must be maintained throughout the course of treatment so as to avoid hypovolaemia or hypotension. Careful electrolyte replacement is also necessary.
The dosage of high strength furosemide, Urex Forte tablets, given below is for adults only. The dosage regimen for children has not yet been determined. The administration of large doses of furosemide in children has been associated with permanent deafness (see Section 4.4 Special Warnings and Precautions for Use). If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, an initial dose of 250 mg may be given, increased, if necessary, in steps of 250 mg every 4 to 6 hours until adequate diuresis of at least 2.5 L/day is achieved. A maximum daily dose of 1000 mg should not be exceeded.

Use in children.

High dose furosemide preparations such as Urex Forte tablets should not be used in children. However, normal doses may be used (see Section 4.2 Dose and Method of Administration, above).

4.3 Contraindications

Known hypersensitivity to furosemide or sulfonamides or to any of the components of Urex (see Section 6.1 List of Excipients). Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross sensitivity to Urex.
Complete renal shutdown, impaired renal function or anuria. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.
In hepatic coma or precoma and conditions producing electrolyte depletion, furosemide therapy should not be instituted until the underlying condition has been corrected or ameliorated.
Severe hypokalaemia, hyponatraemia, hypovolaemia, dehydration or hypotension must be regarded as contraindications until serum electrolytes, fluid balance and blood pressure have been restored to normal levels.
In breastfeeding or pregnant women (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation, Use in pregnancy).
Do not administer furosemide to newborns presenting jaundice or to infants with conditions which might induce hyperbilirubinaemia or kernicterus (Rh incompatibility, familial nonhemolytic jaundice, etc.) because of furosemide's "in vitro" potential to displace bilirubin from albumin.
Normal renal function or impaired renal function with glomerular filtration rates below 5 mL/minute or in excess of 20 mL/minute, due to the possibility of severe fluid and electrolyte loss and renal failure due to poisoning with nephrotoxic or hepatotoxic substances. Hepatic cirrhosis; breastfeeding.

4.4 Special Warnings and Precautions for Use

Furosemide is a potent diuretic, which, if given in excessive amounts, can lead to a profound diuresis.
Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity.
In patients with hepatic cirrhosis and ascites, initiation of therapy with furosemide is best carried out in hospital. In hepatic coma or precoma and states of electrolyte depletion, therapy should not be initiated until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma, therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalaemia and metabolic alkalosis.
Particularly careful monitoring is required in patients with gout, in patients with partial obstruction of urinary outflow, in patients with hypotension or who are at particular risk from a pronounced fall in blood pressure (e.g. patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain), in patients with latent or manifest diabetes mellitus, in patients with hepatorenal syndrome or in patients with hypoproteinaemia (e.g. associated with nephrotic syndrome). Dose titration, especially in this latter case, is required. In premature infants, there is the possible development of nephrocalcinosis/nephrolithiasis and therefore renal function must be monitored and renal ultrasonography must be performed. In premature infants furosemide administered during the first weeks of life may increase the risk of persistence of Botallo's duct.
Patients with known sulphonamide sensitivity may show allergic reactions to furosemide.
Cases of reversible or irreversible tinnitus and deafness have been reported. Usually, reports indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, hypoproteinaemia, doses exceeding several times the usual recommended dose, or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. In patients with hypoproteinaemia, e.g. associated with nephrotic syndrome, the effect of Urex may be weakened and its ototoxicity potentiated. Cautious dose titration is required. There have also been some reports of cases, the majority in children undergoing renal transplantation, in which permanent deafness has occurred. In these latter cases, the onset of deafness is usually insidious and gradually progressive up to 6 months after furosemide therapy.
Caution should be exercised when administering curare or its derivatives to patients undergoing furosemide therapy and it is advisable to discontinue furosemide for one week prior to any elective surgery.
Caution should be exercised and the risks and benefits of combining risperidone with furosemide or other potent diuretics should be considered prior to the decision to treat.
As with any effective diuretic, electrolyte depletion may occur during therapy with furosemide, especially in patients receiving higher doses and a restricted salt intake. All patients receiving Furosemide therapy should be observed for signs of fluid or electrolyte imbalance; namely hyponatraemia, hypochloraemic alkalosis, and hypokalaemia. Thus, strict restriction of sodium intake is not advisable in patients receiving furosemide. Periodic determinations of serum electrolytes to detect possible imbalance, should be performed at appropriate intervals, as well as creatinine and blood urea and CO₂ content.
All patients receiving furosemide therapy should be observed for signs of fluid or electrolyte imbalance: namely hyponatraemia, hypochloraemic alkalosis, hypokalaemia, hypomagnesemia or hypocalcaemia. Serum and urine electrolyte determinations are particularly important when the patient is at high risk of developing electrolyte imbalances (e.g. receiving parental fluids) or in case of significant additional fluid loss, such as vomiting, diarrhea and intense sweating. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, arrhythmia, and gastrointestinal disturbances such as nausea and vomiting. Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected, which may require temporary discontinuation of Urex.
Hypokalaemia may develop with furosemide as with any other potent diuretic, especially with brisk diuresis, when cirrhosis is present, during long-term therapy or during concomitant use of corticosteroids or ACTH. Interference with adequate oral electrolyte intake will also contribute to hypokalaemia. Digitalis therapy may exaggerate metabolic effects of hypokalaemia, especially with reference to myocardial effects. Caution with potassium is necessary for infants and children; a reduction in dose or discontinuation of furosemide therapy may be necessary.
During long-term therapy, a high potassium diet is recommended. Potassium supplements may be required, especially when high doses are used for prolonged periods. Particular caution with potassium is necessary when the patient is on digitalis glycosides, potassium depleting steroids, or in the case of infants and children. Potassium supplementation, diminution in dose, or discontinuation of furosemide therapy may be required.
Since rigid sodium restriction is conductive to both hyponatraemia and hypokalaemia, strict restriction in sodium intake is not advisable in patients receiving furosemide.
Asymptomatic hyperuricaemia can occur and rarely, gout may be precipitated.
Periodic checks on urine and blood glucose should be made in diabetics and even those suspected of latent diabetes when receiving furosemide.
Increases in blood glucose and alterations in glucose tolerance tests with abnormalities of the fasting and 2-hour postprandial sugar have been observed, and rare cases of precipitation of diabetes mellitus have been reported.
Furosemide may lower serum calcium levels, and rare cases of tetany have been reported. Accordingly, periodic serum calcium levels should be obtained.
In children, urge to defecate, complaints of abdominal pain and cramping have been reported after intravenous furosemide. An association of these symptoms with a low serum calcium and/or a low calcium/protein ratio is possible.
Transient rises in creatinine levels have also been observed, reflecting a fall in glomerular filtration rate on a haemodynamic basis. Furosemide increases cholesterol and triglyceride short-term. It is not clear whether this effect persists long-term, however, the current evidence does not indicate this.
In patients with prostatic hypertrophy or if disturbances of micturition exist or are suspected, or where consciousness is impaired, furosemide should be used with care and urinary outflow must be secured. Symptoms of obstructed urine flow (e.g. in hydronephrosis, or ureteric stenosis) may become manifest or intensified in the course of diuretic therapy. In patients with a partial obstruction of urinary outflow (e.g. in patients with bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra), increased production of urine may provoke or aggravate complaints. Thus, these patients require careful monitoring.
Renal calcifications (from barely visible on X-ray to staghorn) have occurred in some premature infants treated with intravenous furosemide for oedema due to patent ductus arteriosus (PDA) and hyaline membrane disease. The concurrent use of chlorothiazides has been reported to decrease hypercalciuria and to dissolve some calculi.
The possibility exists of exacerbation or activation of systemic lupus erythematous.
As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver or kidney damage, or other idiosyncratic reactions.
Some adverse effects associated with the use of furosemide (e.g. an undesirable pronounced fall in blood pressure) may impair the patient's ability to concentrate and react. This constitutes a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).
During therapy with high dose Urex Forte, careful laboratory control is essential and extreme care must always be taken to adjust dosage to individual requirements. Fluid balance and electrolytes should be carefully controlled and, in particular, in patients with shock, measures should be taken to correct blood pressure and blood volume before Urex Forte therapy.

Use in hepatic impairment.

In patients with hepatic cirrhosis and ascites, initiation of therapy with furosemide is best carried out in hospital. In hepatic coma or precoma and states of electrolyte depletion, therapy should not be initiated until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma, therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalaemia and metabolic alkalosis.

Use in renal impairment.

If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, the drug should be discontinued.
Hearing impairment is more likely to occur in patients with severely reduced renal functions who are given large doses of furosemide parenterally, at a rate exceeding 4 mg/min or in patients who are also receiving drugs known to be ototoxic.
Reversible elevations of blood urea may be seen. These have been observed in association with dehydration, which should be avoided, particularly in patients with renal insufficiency.

Use in elderly.

In the risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone compared to treatment with risperidone alone or furosemide alone. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low doses) was not associated with similar mortality findings. No pathophysiological mechanism has been identified to explain this finding and no consistent pattern for cause of death was observed. Nevertheless, caution is advised. Irrespective of treatment, dehydration was an overall risk factor for mortality and should, therefore, be carefully avoided in elderly patients with dementia.
Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse and with the possibility of vascular thrombosis and embolism, particularly in elderly patients.

Paediatric use.

The use of furosemide in children has been established (see Section 4.2 Dose and Method of Administration for details).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Interactions with foods.

The extent to which the absorption of furosemide is affected by taking it with food seems to depend on the pharmaceutical formulation. It is recommended that oral formulations of furosemide, such as Urex, be taken on an empty stomach.

Interactions with other medicines.

Combinations that are not recommended.

Furosemide may increase the ototoxic and nephrotoxic potential of certain antibiotics, for example aminoglycosides (e.g. kanamycin, gentamicin and tobramycin) and certain cephalosporins (e.g. cephaloridine, cephalothin), and other ototoxic drugs, especially in patients with impaired renal function. Except in life-threatening situations, avoid this combination. The simultaneous administration of these drugs is therefore not advisable.
Anticonvulsants may decrease the response to furosemide. A combination of furosemide and chloral hydrate may lead to diaphoresis, sensation of heat, flushes, sweating attacks, restlessness, nausea, tachycardia and elevation of blood pressure. As a result, this combination is not recommended.

Precautions for use.

Furosemide should not be used in combination with ethacrynic acid or cisplatin because of the possibility of ototoxicity. In addition, nephrotoxicity of cisplatin may be enhanced if Urex is not given in sufficiently 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.
Furosemide decreases the excretion of lithium salts and may cause increased serum lithium levels, resulting in increased risk of lithium toxicity, including increased risk of cardiotoxic and neurotoxic effects of lithium. Therefore, it is recommended that lithium levels are carefully monitored in patients receiving this combination.
Simultaneous administration of sucralfate and oral furosemide must not be taken within two hours of each other because sucralfate decreases the absorption of furosemide from the intestine and hence, reduces its effect. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Urex has been achieved.
The action of other antihypertensive drugs may be potentiated by furosemide, especially in combination with angiotensin converting enzyme (ACE) inhibitors. The administration of ACE inhibitors to patients pretreated with furosemide may lead to a deterioration in renal function including renal failure, or may result in severe hypotension, especially when an ACE inhibitor or angiotensin II receptor antagonist is given for the first time, or for the first time at an increased dose. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs. Therefore consideration must be given to interrupting the administration of Urex temporarily or at least reducing the dose of Urex for 3 days before starting treatment with, or increasing the dose of, an ACE inhibitor or angiotensin II receptor antagonist.
Caution should be exercised and the risks and benefits of treating a patient on risperidone with furosemide or 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.
High doses of furosemide may inhibit binding of thyroid hormones to carrier proteins when administered with levothyroxine, and thereby lead to an initial transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels. It is recommended that thyroid hormones be monitored.

To be considered.

The effects of digitalis preparations and drugs inducing QT interval prolongation syndrome may be potentiated by changes in electrolyte concentrations (e.g. hypokalaemia, hypomagnesaemia) due to furosemide. When a cardiac glycoside is administered concurrently, it should be remembered that potassium or magnesium deficiency increases the sensitivity of the myocardium to digitalis and may increase the toxicity of drugs which induce QT interval prolongation syndrome. When a glucocorticoid is administered during diuretic treatment, the potassium lowering effect of the steroid should be borne in mind (see Section 4.4 Special Warnings and Precautions for Use). Carbenoxolone, corticosteroids, prolonged use of laxatives or ingestion of liquorice in large amounts may also predispose a patient to hypokalaemia.
Patients receiving high doses of salicylates, as in rheumatic diseases, in conjunction with furosemide may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
Interactions between furosemide and neuromuscular blocking agents have been reported. The interaction appears to be dependent on the dose of furosemide and the neuromuscular blocking agent involved. Low doses of furosemide (0.1 to 10 microgram/kg) enhance the neuromuscular blockade of tubocurarine and succinylcholine. High doses (1 to 5 mg/kg) of furosemide have a tendency to antagonise the skeletal muscle relaxing effect of tubocurarine but may potentiate the action of succinylcholine. The clinical relevance of these findings is uncertain.
Concomitant use of furosemide and amphotericin may result in an excessive potassium loss.
Furosemide may decrease arterial responsiveness to noradrenaline. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.
If antihypertensive agents, diuretics or other drugs with blood pressure lowering potential are given concomitantly with Urex, a more pronounced fall in blood pressure must be anticipated.
Non-steroidal anti-inflammatory drugs, including acetylsalicylic acid and indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. In patients with dehydration or pre-existing hypovolaemia, non-steroidal anti-inflammatory drugs may cause acute renal failure. Salicylate toxicity may be increased by furosemide.
Phenytoin, methotrexate, probenecid and other drugs which, like furosemide, undergo significant renal tubular secretion, may attenuate the effects of furosemide. Conversely Urex may decrease renal elimination of these drugs. In the case of high dose treatment (in particular of both Urex and the other drugs), this may lead to an increased risk of adverse effects due to Urex or the concomitant medication.
Intravenous furosemide was shown to increase the steady state concentration of theophylline in a small number of asthmatic patients; hence it is appropriate to measure serum theophylline levels when both drugs are given together.
The effects of curare type muscle relaxants or of theophylline may be increased.
It should be borne in mind that the effect of antidiabetics or of pressor amines (e.g. adrenaline (epinephrine), noradrenaline (norepinephrine)) may be attenuated by furosemide (see Section 4.4 Special Warnings and Precautions for Use).
Impairment of renal function may develop in patients receiving concurrent treatment with furosemide and high doses of certain cephalosporins. The harmful effects of nephrotoxic drugs on the kidney may be increased.
Concomitant use of cyclosporine A and furosemide is associated with increased risk of gouty arthritis secondary to furosemide-induced hyperuricaemia and cyclosporine impairment of renal urate excretion.
Patients who are at high risk for radiocontrast nephropathy treated with furosemide experienced a higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Data not available.
(Category C)
Urex must not be given during pregnancy unless there are compelling medical reasons. Treatment during pregnancy requires monitoring of foetal growth.
Thiazides, related diuretics and loop diuretics enter the foetal circulation and may cause electrolyte disturbances. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like furosemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy, products of this type should only be given on sound indications, and then in the lowest effective dose. In pregnancy, furosemide must only be used in patients with a marked reduction in glomerular filtration.
Furosemide passes into the breast milk and inhibits lactation. Women must not breastfeed if being treated with furosemide.

4.7 Effects on Ability to Drive and Use Machines

Due to possible hypotension, the patient's ability to drive or operate machinery may be impaired, especially at the commencement of therapy.

4.8 Adverse Effects (Undesirable Effects)

Metabolism and nutritional disorders.

Disturbances in electrolytes and water balance may occur during furosemide therapy, especially in patients receiving high doses for a prolonged period. The serum potassium concentration may decrease, especially at the commencement of treatment (owing to the earlier onset of action of furosemide).
Excessive diuresis may cause, especially in elderly patients and children, circulatory disturbances such as headache, dizziness, dry mouth or visual impairment, as symptoms of hypovolaemia. In extreme cases, hypovolaemia and dehydration may lead to hypotension, circulatory collapse and, in elderly patients in particular, thrombophilia. Although diuresis occurs rapidly, because of individualised dosage, acute haemodynamic reactions are generally not expected.
All salurectics may cause hypokalaemia, mainly in cases of low potassium diet, vomiting or chronic diarrhea.
Factors such as underlying diseases (liver cirrhosis, cardiac failure), concomitant medication (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions) or nutritional inadequacies (excessive restriction of salt intake) may lead to sodium (hyponatraemia), chloride (hypochloremia), or other electrolyte or fluid deficiencies. This manifests itself by weakness, a fall in orthostatic blood pressure, dizziness, apathy, lethargy, leg cramps, calf muscle spasms, sweating, bladder spasms, anorexia, vomiting and/or mental confusion (see Section 4.4 Special Warnings and Precautions for Use).
Furosemide may lower the serum calcium level, which may trigger a state of increased neuromuscular irritability. In very rare cases, tetany has been observed. In premature infants, calcium salts may be deposited in the renal tissue (nephrocalcinosis/nephrolithiasis).
Furosemide may cause a rise in serum cholesterol and triglyceride.
Hypomagnesaemia and, in rare cases, tetany or cardiac arrhythmias have been observed as a consequence of increased renal magnesium loss.
Pre-existing metabolic alkalosis (e.g. due to decompensated liver cirrhosis) may be aggravated during furosemide treatment. Metabolic alkalosis has been reported with furosemide use.
Furosemide may cause hypokalaemia, mainly in cases of low potassium diet, vomiting or chronic diarrhoea.
Treatment with Urex may lead to transitory increases in urine volume, blood creatinine and urea levels. Serum levels of uric acid may increase and attacks of gout may occur.
Various forms of dermatitis, including urticaria and rare cases of exfoliative dermatitis and pruritus have occurred. Paresthesia, blurring of vision, postural hypotension, nausea, vomiting and diarrhoea have been reported. Anaemia, leucopenia and thrombocytopenia (with purpura) have occurred, as well as rare cases of agranulocytosis, which responded to treatment.
Treatment with furosemide has occasionally caused reduced glucose tolerance and deterioration in cases of manifest diabetes, or made latent diabetes manifest.
Pseudo-Bartter syndrome in the context of misuse and/or long-term use of furosemide has been reported.
Very common: electrolyte disturbances (including symptomatic).
In addition, the following rare adverse reactions have been reported: sweet taste, paradoxical swelling, and emboli: however, relationship to the drug has not been definitely established.
Adverse reactions are categorised below by organ system and listed by decreasing severity.

Gastrointestinal system and hepatic system reactions.

Reactions with normal doses of Urex are uncommon. They include: anorexia, oral and gastric irritation, cramping, diarrhoea, constipation, nausea and vomiting.
In isolated cases, acute pancreatitis and increases in liver transaminases have been observed. Additionally, intrahepatic cholestasis and jaundice have been reported. Furosemide may increase the bile flow and distend the biliary tree which is already obstructed.

Central nervous system reactions.

Reactions such as paresthesia, vertigo, dizziness, headache, blurred vision, and xanthopsia occasionally accompany furosemide induced diuresis.

Ear and labyrinth disorders.

Tinnitus, reversible hearing impairment and, rarely, permanent tinnitus and impairment of hearing have been observed, especially in patients with markedly reduced renal function, or hypoproteinaemia, (e.g. in nephrotic syndrome), or in patients who are also receiving drugs known to be ototoxic.
Cases of deafness, sometimes irreversible, have been reported after oral or intravenous administration of furosemide.

Haematological reactions.

Common: haemoconcentration. Uncommon: thrombocytopenia. The following rare adverse reactions have been reported: aplastic anaemia, agranulocytosis, leucopoenia, anaemia, eosinophilia, thrombophlebitis, haemolytic anaemia.

Dermatologic hypersensitivity reactions.

Allergic reactions may occur in the form of dermatitis, including rash, itching, urticaria, pruritus, and rare cases of necrotising angiitis (vasculitis, cutaneous vasculitis), exfoliative dermatitis, erythema multiforme, purpura, bullous lesions or eruptions, pemphigoid, Steven-Johnson syndrome, and toxic epidermal necrolysis. Also photosensitivity reactions have been reported. AGEP (acute generalized exanthematous pustulosis) and DRESS (drug rash with eosinophilia and systemic symptoms) have been reported with furosemide use.

Cardiovascular reactions.

Very common (especially for intravenous infusion), orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates or narcotics. Ischaemic complications have also been reported in elderly patients. A tendency for thromboses has been reported. If furosemide is administered to premature infants during the first weeks of life, it may increase the risk of persistence of the patent ductus arteriosus.
Rare: vasculitis.
Cases of thrombosis have been reported.

Renal and urinary system disorders.

Excessive diuresis and dehydration could cause transient elevation of serum urea, creatinine and BUN and reduction of GFR. In elderly men with prostatic hypertrophy, acute urinary retention with overflow incontinence may occur. Symptoms of existing conditions of obstructed micturition, such as urethrostenosis or hydronephrosis, may be triggered or aggravated by pronounced diuresis. Interstitial nephritis has also been reported with furosemide use. In patients with a partial obstruction of urinary outflow, acute retention of urine may occur. Increase in sodium and/or chloride urine levels, and renal failure has been reported with furosemide use.

Immune system disorders.

Severe anaphylactic or anaphylactoid reactions (e.g. with shock) is rare, but is acutely life-threatening if it does occur. Cases of exacerbation or activation of systemic lupus erythematosus have been reported.

Nervous system disorders.

Common: hepatic encephalopathy in patients with hepatocellular insufficiency.
Rare: paraesthesia.
Headache, dizziness, fainting or loss of consciousness have been reported.

Musculoskeletal and connective tissue disorders.

Cases of rhabdomyolysis have been reported, often in the context of severe hypokalaemia (see Section 4.3 Contraindications).

Other reactions.

Hyperglycaemia, glycosuria, hyperuricaemia, fever, transient rise in serum cholesterol and triglyceride, muscle weakness, restlessness.
Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or withdrawn.
Reporting suspected adverse reactions after registration of this medicinal product is important. It allows continued monitoring of the benefit-risk balance of this medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

The clinical manifestations of acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss e.g. dehydration, blood volume reduction, hypotension, electrolyte imbalance, cardiac arrhythmias (including A-V block and ventricular fibrillation), hypokalaemia and hypochloraemic alkalosis and extensions of the diuretic action of furosemide. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion. In cirrhotic patients, overdosage may precipitate hepatic coma.
The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD₅₀ exceeded 1000 mg/kg bodyweight. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide in biological fluids associated with death is not known.

Treatment.

No specific antidote to Urex 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 designed to reduce absorption (e.g. activated charcoal).
Treatment of overdosage is supportive. Discontinue the drug. Institute water and electrolyte replacements immediately and adjust in accordance with urine output. Haemodialysis does not accelerate furosemide elimination. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder obstruction (such as prostatic hypertrophy).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Furosemide is a potent diuretic. It inhibits sodium reabsorption in the ascending limb of Henle's loop and in both the proximal and distal tubules. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase or aldosterone. The high degree of efficacy is due to this unique site of action.
Furosemide may promote diuresis in cases which have previously proved resistant to other diuretics.
Furosemide has no significant pharmacological effects other than on renal function.

Clinical trials.

Data not available.

5.2 Pharmacokinetic Properties

Absorption.

Furosemide is rapidly absorbed from the upper gastrointestinal tract. Absorption rates in healthy subjects have been reported from 60-69%; 45% in patients with end stage renal failure; and 34-80 in patients with congestive heart failure.
Bioavailability in healthy subjects is 60-69%.

Distribution.

The mean apparent volume of distribution in the steady state ranges from 0.07 to 0.18 L/kg bodyweight in healthy subjects.

Metabolism.

Recent evidence suggests that furosemide glucuronide is the only, or at least the major, biotransformation product of furosemide in man. Furosemide is extensively bound to plasma proteins, mainly to albumin. Plasma concentrations, ranging from 1 to 400 microgram/mL, are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% of therapeutic concentrations.

Excretion.

Furosemide's diuretic effect is apparent within 1 hour following oral administration and the peak effect occurs in the first or second hour. The duration of action is 4 to 5 hours but may continue up to 8 hours.
At the peak of diuretic response, 30 to 40% of the filtered sodium load may be excreted, along with some potassium and with chloride as the major anion. Furosemide augments the potassium output as a result of increased distal potassium secretion. Its diuretic action is independent of changes in acid/ base balance. Under conditions of acidosis or alkalosis the diuretic produces a chloruresis without augmentation of bicarbonate excretion.
Urinary excretion is accomplished both by glomerular filtration and proximal tubular secretion, which accounts for roughly 66% of the ingested dose, the remainder being excreted in the faeces. A small fraction is metabolised.
Table 1 summarises furosemide's elimination kinetics in both normal subjects and patients with renal insufficiency.

Furosemide administration may induce extracellular metabolic alkalosis, primarily by virtue of the disproportionate loss of chloride, but also, in part, as a result of the variable depletion of potassium.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Urex Forte tablets contain the following excipients; lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate and maltodextrin.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf-life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light.

6.5 Nature and Contents of Container

Urex Forte.

Tablets, 500 mg:

50's in blister pack (PVC/PVDC-Al) and glass bottle*.
*Currently not marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Chemically, furosemide is 4-Chloro-2-[(furan-2-ylmethyl) amino]-5-sulfamoylbenzoic acid.
The chemical structure is below.

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Urex Forte 500 mg