Consumer medicine information

APO-Frusemide

Furosemide (frusemide)

BRAND INFORMATION

Brand name

APO-Frusemide

Active ingredient

Furosemide (frusemide)

Schedule

SUMMARY CMI

APO-Frusemide

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 APO-Frusemide?

APO-Frusemide 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 APO-Frusemide? in the full CMI.

2. What should I know before I use APO-Frusemide?

Do not use if you have ever had an allergic reaction to APO-Frusemide 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 APO-Frusemide? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-Frusemide 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 APO-Frusemide?

The dose of APO-Frusemide may be different for each person and their medical condition. Your doctor will decide the right dose for you. APO-Frusemide is available as either a 20mg or 40mg tablet.

More instructions can be found in Section 4. How do I use APO-Frusemide? in the full CMI.

5. What should I know while using APO-Frusemide?

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 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 25°C in its original packaging.

For more information, see Section 5. What should I know while using APO-Furosemide? 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

APO-Frusemide

Active ingredient(s): Furosemide

Consumer Medicine Information (CMI)

This leaflet provides important information about using APO-Frusemide. 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 APO-Frusemide.

Where to find information in this leaflet:

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

1. Why am I using APO-Frusemide?

APO-Frusemide 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.

APO-Frusemide 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.

APO-Frusemide may be taken alone or in combination with other medicines to treat your condition.

Ask your doctor if you have any questions about why APO-Frusemide 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 APO-Frusemide?

Warnings

Do not use APO-Frusemide 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 APO-Frusemide 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.

APO-Frusemide 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 APO-Frusemide.

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 APO-Frusemide. This includes large amounts of laxatives.

Some medicines may interfere with APO-Frusemide. 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 APO-Frusemide, 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 APO-Frusemide.

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

4. How do I use APO-Frusemide?

How much to take.

The dose of APO-Frusemide 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.
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.

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 APO-Frusemide (overdose)

If you think that you have used too much APO-Frusemide, 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 APO-Frusemide.

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 APO-Frusemide, you may feel confused, dehydrated, dizzy or you may pass excessive urine.

5. What should I know while using APO-Frusemide?

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 APO-Frusemide.

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

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 APO-Frusemide 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 APO-Frusemide, especially if you sweat a lot.

If you do not drink enough water while taking APO-Frusemide, 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 APO-Frusemide.

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

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

Visit your doctor regularly.

Your doctor needs to check your progress and see whether you need to keep taking APO-Frusemide.

Things you should not do.

Do not take any other medicines while you are taking APO-Frusemide without first telling your doctor.
Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not take APO-Frusemide 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 APO-Frusemide 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 APO-Frusemide 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 APO-Frusemide. 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 APO-Frusemide 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 APO-Frusemide. It is not recommended that you drink alcohol while taking APO-Frusemide.

If you are taking APO-Frusemide 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.

APO-Frusemide 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 APO-Frusemide in a cool dry place, protected from light, where the temperature stays below 25°C in original container; 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 APO-Frusemide.

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

What it looks like APO-Frusemide 20 mg is a white to off-white plain round uncoated tablet. Available in bottles of 50 tablets.

APO-Frusemide 40 mg is a white round biconvex tablet, one side plain and the other scored. Available in blister packs of 100 tablets.

What APO-Frusemide contains

APO-Frusemide 20mg Tablet

Active ingredient (main ingredient)	Each tablet contains 20 mg of the active ingredient, furosemide
Other ingredients (inactive ingredients)	It also contains the inactive ingredients lactose monohydrate, maize starch and magnesium stearate.
Potential allergens	This medicine contains sugars as lactose. It does not contain gluten, tartrazine or any other azo dyes.

APO-Frusemide 40mg tablet

Active ingredient (main ingredient)	Each tablet contains 40 mg of the active ingredient, furosemide
Other ingredients (inactive ingredients)	It also contains the inactive ingredients lactose monohydrate, maize starch and magnesium stearate.
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 APO-Frusemide looks like

APO-Frusemide 20 mg is a White to off-white round tablets, debossed with 'F2' on one side and plain on the other side. Available in bottles of 50, 100, 1000 tablets*.

APO-Frusemide 40 mg is a White to off-white round tablets, debossed with 'F4' on one side and break line on the other side.. Packaged in bottles of 30, 50, 60, 100, 250 and 1000 tablets*.

* Not all strengths and/or pack sizes may be available.

Who distributes APO-Frusemide

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

www.arrotex.com.au

The Australian Registration Numbers for APO-Frusemide are:

APO-Frusemide 20 mg tablet bottle:
AUST R 186517
APO-Frusemide 40 mg tablet blister pack:
AUST R 186516

This leaflet was revised in December 2024

Published by MIMS February 2025

BRAND INFORMATION

Brand name

APO-Frusemide

Active ingredient

Furosemide (frusemide)

Schedule

1 Name of Medicine

Furosemide.

2 Qualitative and Quantitative Composition

Each tablet contains 20 mg or 40 mg furosemide, as the active ingredient.

Excipients with known effect.

Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

20 mg tablets.

White to off-white round tablets, debossed with 'F2' on one side and plain on the other side.

40 mg tablets.

White to off-white round tablets, debossed with 'F4' on one side and breakline on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Oedema.

Furosemide is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired.
Parenteral therapy with furosemide should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.

Hypertension.

Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.

4.2 Dose and Method of Administration

APO-Frusemide (furosemide) tablets are intended for oral administration.
It is recommended that oral formulations of furosemide be taken on an empty stomach.

Dosage.

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.

Adults.

The usual initial daily dose of furosemide for oedema is 20 to 80 mg given as a single dose. If the diuretic response to a single dose of 20 to 80 mg is not satisfactory, increase this dose by increments of 20 to 40 mg, not sooner than 6 to 8 hours after the previous dose, until the desired diuretic effect is obtained. This individually determined dose should be given once or twice (e.g. at 8 am and 2 pm) daily. The dose of 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 and safely accomplished by giving furosemide on 2 to 4 consecutive days each week.
When doses exceeding 80 mg/day are given for prolonged periods, careful clinical laboratory observations are particularly advisable.

Infants and children.

The usual initial dose is 2 mg/kg bodyweight given as a single dose. If the 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. Doses of greater than 6 mg/kg bodyweight are not recommended.
For maintenance therapy in infants and children, the dose should be adjusted to the minimum effective level.
Hypertension. Therapy should be individualized 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.

Adults.

The usual initial daily dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
Changes in blood pressure must be carefully monitored when furosemide is used with other antihypertensive drugs, especially during initial therapy.
To prevent an excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50% when furosemide is added to the regimen. As the blood pressure falls under the potentiating effect of furosemide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

4.3 Contraindications

Known hypersensitivity to furosemide, sulfonamides or any of the inactive ingredients (see Section 6.1 List of Excipients). Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross sensitivity to furosemide.
Complete renal shutdown; impaired renal function or anuria. If increasing azotaemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide. Severe hypokalaemia (see Section 4.8 Adverse Effects (Undesirable Effects)), 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 hepatic coma or precoma and conditions producing electrolyte depletion, furosemide therapy should not be instituted until the underlying conditions have been corrected or ameliorated.
In breastfeeding or pregnant women.
Do not administer furosemide to newborns presenting jaundice or to infants with conditions which might induce hyperbilirubinaemia or kernicterus (e.g. Rhesus incompatibility, familial nonhaemolytic jaundice, etc.) because of furosemide's in vitro potential to displace bilirubin from albumin.

4.4 Special Warnings and Precautions for Use

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity.
Cases of reversible or irreversible tinnitus or hearing impairment have been reported. Usually, reports indicate that furosemide ototoxicity is associated with rapid injection or infusion, 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 furosemide may be weakened and its ototoxicity potentiated. Cautious dose titration is required.
Caution should be exercised when administering curare or its derivatives to patients undergoing furosemide therapy. It is also 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 (see Use in the elderly).
Rigid sodium restriction is conducive to both hyponatraemia and hypokalaemia; thus, strict restriction of sodium intake is not advisable in patients receiving furosemide.
Furosemide should be used with care, especially in the initial stages, in patients with impairment of micturition (e.g. prostatic hypertrophy). Urinary outflow must be secured. 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.
Particularly careful monitoring is required in patients with gout, 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.
As with any effective diuretic, electrolyte depletion may occur during therapy, 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. Periodic determinations of serum electrolytes to detect a possible imbalance should be performed at appropriate intervals, as well as creatinine, blood urea and CO₂ content determinations. This is particularly important when the patient is at high risk of developing electrolyte imbalances (e.g. receiving parenteral fluids) or in case of significant additional fluid loss, such as vomiting, diarrhoea and intense sweating. Warning signs of an imbalance, irrespective of cause include 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. This may require temporary discontinuation of furosemide.
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.
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 calcium levels and rare cases of tetany have been reported. Accordingly, periodic serum calcium levels should be obtained.
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.
Furosemide increases cholesterol and triglycerides short-term. It is not clear whether this effect persists long-term; however, the current evidence does not indicate this.
As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver damage or other idiosyncratic reactions.
Renal calcifications (from barely visible on X-ray to staghorn) have occurred in some severely premature infants treated with intravenous furosemide for oedema due to patent ductus arteriosus 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 erythematosus.
Asymptomatic hyperuricaemia can occur and rarely, gout may be precipitated.
Furosemide should be used with care, especially in the initial stages, in patients with impairment of micturition (e.g. prostatic hypertrophy). Urinary outflow must be secured. 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.

Use in renal impairment.

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 hepatic impairment.

In patients with hepatic cirrhosis and ascites, initiation of therapy with furosemide is best carried out in hospital. 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.

Use in the elderly.

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) compared to treatment with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90). 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.

Paediatric use.

In premature infants, there is the possible development of nephrocalcinosis/ nephrolithiasis and therefore renal function must be monitored and renal ultrasonography performed. In premature infants furosemide administered during the first weeks of life may increase the risk of persistence of Botallo's duct.
In children, the urge to defecate, complaints of abdominal pain and cramping have been reported after IV furosemide. An association of these symptoms with a low serum calcium and/or a low calcium/ protein ratio is possible.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Combinations that are not recommended.

Furosemide may increase the ototoxic and nephrotoxic potential of certain antibiotics (e.g. aminoglycosides) and certain cephalosporins (e.g. cephaloridine) and other ototoxic drugs, especially in the presence of impaired renal function; therefore, the simultaneous administration of these drugs is not advisable.
Anticonvulsants may decrease the response to furosemide. In isolated cases intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure and tachycardia. Use of furosemide concomitantly with chloral hydrate is, therefore, not recommended.

Precautions for use.

Furosemide should not be used concomitantly with ethacrynic acid or cisplatin because of the possibility of ototoxicity. In addition, nephrotoxicity of cisplatin may be enhanced if furosemide is not given in low doses (e.g. 40 mg in patients with normal renal function) and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
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.
Oral furosemide and sucralfate 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.
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 in an increased dose. Consideration must be given to interrupting the administration of furosemide temporarily or at least reducing the dose of furosemide 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, Use in the elderly).
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.

Take into account.

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 above). 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 disease, 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. These appear to be dependent on the dose of furosemide and the neuromuscular blocking agent involved. Low doses of furosemide (0.1-10 microgram/kg) enhance the neuromuscular blockade of tubocurarine and succinylcholine. High doses (1-5 mg/kg) of furosemide have a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine but may potentiate the action of succinylcholine. The clinical relevance of these findings is uncertain.
The combination of furosemide and amphotericin may result in an excessive loss of potassium.
Furosemide may decrease arterial responsiveness to noradrenaline (norepinephrine). 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 furosemide, a more pronounced fall in blood pressure must be anticipated.
Nonsteroidal anti-inflammatory drugs including acetylsalicylic acid may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. In patients with dehydration or pre-existing hypovolaemia, nonsteroidal 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 reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of these drugs. In the case of high dose treatment (in particular of both furosemide and the other drugs), this may lead to an increased risk of adverse effects due to furosemide or the concomitant medication.
IV furosemide was shown to increase the steady-state concentration of theophylline by 20% 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 ciclosporin A and furosemide is associated with increased risk of gouty arthritis secondary to furosemide induced hyperuricemia and ciclosporin impairment of renal urate excretion.
Patients who were 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.

Interactions with food.

It is recommended that oral formulations of furosemide be taken on an empty stomach.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Furosemide 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 thrombocytopaenia 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

Some adverse effects (e.g. an undesirable pronounced fall in blood pressure) may impair the patient's ability to concentrate and react and therefore constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).

4.8 Adverse Effects (Undesirable Effects)

Whenever adverse reactions are moderate or severe, furosemide dose should be reduced or therapy withdrawn.

Metabolism and nutritional disorders.

As with other diuretics, electrolytes and water balance may be disturbed during therapy with furosemide, 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 give rise, especially in elderly patients and children, to 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. However, with individualised dosage, acute haemodynamic reactions are generally not to be expected, although diuresis sets in rapidly.
All saluretics may cause hypokalaemia, mainly in cases of low potassium diet, vomiting or chronic diarrhoea.
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 (hyponatremia), chloride (hypochloremia), or other electrolyte or fluid deficiencies which may produce a fall in orthostatic blood pressure, calf muscle spasms, anorexia, weakness, dizziness, drowsiness, apathy, vomiting and confusion.
Furosemide may lower the serum calcium level (hypocalcaemia) which may trigger a state of increased neuromuscular irritability.
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.
Treatment with furosemide may lead to transitory increases in urine volume, blood creatinine and urea levels. Serum levels of uric acid (hyperuricaemia) may increase and attacks of gout may occur.
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.
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), dehydration and hypovolaemia especially in elderly patients, increased blood creatinine, increased blood triglycerides.
Common: hyponatremia, hypochloremia, hypokalaemia, blood cholesterol increased blood uric acid increased and attacks of gout, urine volume increased.
Uncommon: impaired glucose tolerance. Latent diabetes mellitus may manifest.

Gastrointestinal disorders and hepatobiliary disorders.

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

Central nervous system disorders.

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

Ear and labyrinth disorders.

Reversible hearing impairment and tinnitus 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). This occurs particularly when the injectable form of furosemide is used at a recommended rate of injection or infusion of 4 mg per minute (normal renal function) or 2.5 mg per minute (impaired renal function) is exceeded, or in patients who are also receiving drugs known to be ototoxic.
Cases of deafness, sometimes irreversible have been reported after oral administration of furosemide.

Skin and subcutaneous tissue disorders.

Uncommon allergic reactions include dermatitis, dermatitis bullous, rashes, urticaria, pruritus, photosensitivity reactions, pemphigoid, erythema multiforme, purpura and exfoliative dermatitis. Itching may occur and rare cases of necrotising angiitis, Steven-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP), lichenoid reactions, and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported with furosemide use.

Blood and the lymphatic system disorders.

Common: haemoconcentration.
Uncommon: thrombocytopaenia.
Rare: eosinophilia, thrombophlebitis, haemolytic or aplastic anaemia, leukopaenia and agranulocytosis.

Congenital and familial/ genetic disorders.

The persistence of patent ductus arteriosus when furosemide has been administered to a premature infant during the first weeks of life has been reported.

Renal and urinary disorders.

Excessive diuresis and dehydration could cause transient elevation of creatinine and BUN and reduction of GFR. Rare cases of tubulointerstitial nephritis have been reported. In elderly men with prostatic hypertrophy, acute urinary retention with overflow incontinence may occur. Symptoms of existing conditions of obstructed micturition, such as ureterostenosis or hydronephrosis, may be triggered or aggravated by pronounced diuresis. Interstitial nephritis has also been reported with furosemide use. In premature infants, calcium salts may be deposited in the renal tissue (nephrocalcinosis/ nephrolithiasis). 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.

Vascular disorders.

Very common: (especially for intravenous infusion) orthostatic hypotension may occur and may be aggravated by alcohol, narcotics and barbiturates. Due to the possibility of side effects such as hypotension, a patient's ability to drive or operate machinery may be impaired, especially at the commencement of therapy. 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 patent ductus arteriosus.
Rare: vasculitis.
Cases of thrombosis have been reported.

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.

General disorders and administration site conditions.

Rarely, fever may occur. Following intramuscular injection, local reactions such as pain may occur. Restlessness has also 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).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems and contact Arrotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

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. dehydration, blood volume reduction, hypotension, electrolyte imbalance, cardiac arrhythmias (including A-V block and ventricular fibrillation), hypokalaemia and hypochloraemic alkalosis, and extensions of its diuretic action. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.
The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD₅₀ exceeded 1,000 mg/kg bodyweight, while the intravenous LD₅₀ ranged from 300-680 mg/kg. The acute intragastric toxicity in neonatal rats is 7-10x that of adult rats. The concentration of furosemide in biological fluids associated with toxicity or death is not known.

Treatment.

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 activated charcoal.
Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Haemodialysis does not accelerate furosemide elimination.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Furosemide is a potent diuretic. It inhibits sodium and chloride absorption in the ascending limb of Henle's loop and in both the proximal and distal tubules. The high degree of efficacy is due to this unique site of action. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase or aldosterone.
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.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Furosemide is rapidly absorbed from the gastrointestinal tract. Absorption rates in healthy subjects have been reported from 60-69% and from 43-46% in patients with end stage renal failure.
The onset of diuresis following oral administration is within 1 hour. The peak effect occurs within the first or second hour. The duration of diuretic effect is 6 to 8 hours.
The onset of diuresis following intravenous administration is within 5 minutes and somewhat later after intramuscular administration. The peak effect occurs within the first half hour. The duration of diuretic effect is approximately 2 hours.
In fasted normal men, the mean bioavailability of furosemide from tablets is 64% of that from an intravenous injection of the drug. Peak plasma concentrations increase with increasing dose but times to peak do not differ among doses.

Distribution.

Furosemide is extensively bound to plasma proteins, mainly albumin. Plasma concentrations of 1-400 microgram/mL are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic concentrations.

Metabolism.

Recent evidence suggests that furosemide glucuronide is the only, or at least the major, biotransformation product of furosemide in humans.

Excretion.

In patients with normal renal function, approximately 80% of an intravenous or intramuscular dose is excreted in the urine within 24 hours. 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 by cleavage of the side chain.
Significantly more furosemide is excreted in urine following an intravenous injection than after tablet administration.
Furosemide has a biphasic half-life in the plasma with t_1/2 ranging up to 100 minutes; t_1/2 is prolonged by renal and hepatic insufficiency, and in newborn infants.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, maize starch, pregelatinised maize starch, sodium starch glycollate (type A), magnesium stearate.

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 25°C. Protect from light.

6.5 Nature and Contents of Container

APO-Frusemide (furosemide) tablets.

20 mg tablets.

Packaged in bottles of 50, 100 and 1000 tablets (AUST R 186517).

40 mg tablets.

Packaged in bottles of 30, 50, 60, 100, 250 and 1000 tablets (AUST R 186516).
Not all strengths and/or pack sizes may be available.

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

Furosemide is an anthranilic acid derivative. It is a white to off-white odourless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids.

Chemical structure.

Chemical name: 4-chloro-2-(furan-2-ylmethylamino)-5-sulfamoylbenzoic acid.
Molecular formula: C₁₂H₁₁ClN₂O₅S. Molecular weight: 330.744.

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APO-Frusemide Tablets 20 mg

APO-Frusemide Tablets 40 mg