SUMMARY CMI

FUROSEMIDE-BAXTER

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 Furosemide-Baxter?

Furosemide-Baxter contains the active ingredient Furosemide. Furosemide-Baxter is a diuretic which helps reduce the amount of excess fluid in the body by increasing the amount of urine produced.

For more information, see Section 1. Why am I using Furosemide-Baxter? in the full CMI.

2. What should I know before I use Furosemide-Baxter?

Do not use if you have ever had an allergic reaction to Furosemide-Baxter 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 Furosemide - Baxer? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Furosemide-Baxter 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 Furosemide-Baxter?

• Furosemide-Baxter solution for injections are normally administered to you by doctors or nurses in hospital

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

5. What should I know while using Furosemide-Baxter?

For more information, see Section 5. What should I know while using Furosemide-Baxter? in the full CMI.

6. Are there any side effects?

Some of the common and less serious side effects are dry mouth, blurred vision, spasms, headache, numbness in hands/ feet, light-headedness, diarrhea and unusual bleeding or bruising under the skin. Some of the uncommon/ rare and serious side effects are chest pain, sudden signs of allergy, fainting, lockjaw, yellowing of skin/ eyes, irregular or fast heartbeat, deafness, passing less urine than normal, increased sensitivity to sunlight and loss of control of your bladder or bowels.

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.

FULL CMI

FUROSEMIDE-BAXTER

Active ingredient(s): Furosemide

Consumer Medicine Information (CMI)

This leaflet provides important information about using Furosemide-Baxter. 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 Furosemide-Baxter.

Where to find information in this leaflet:

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

1. Why am I using Furosemide-Baxter?

Furosemide-Baxter contains the active ingredient Furosemide. Furosemide-Baxter is a diuretic. A diuretic helps reduce the amount of excess fluid in the body by increasing the amount of urine produced.

Furosemide-Baxter is used to treat swelling of the ankles, feet, legs or even the brain or lungs. This swelling is called edema and can occur in some heart, lung, liver or kidney conditions.

Furosemide-Baxter may be used in some patients with more serious kidney problems who may have some fluid retention.

Furosemide-Baxter may be given alone or in combination with other medicines to treat your condition.

Your doctor may have prescribed Furosemide-Baxter for another purpose.

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

This medicine is only available with a doctor's prescription. This medicine is not addictive.

2. What should I know before I use Furosemide-Baxter?

Warnings

Do not use Furosemide-Baxter if:

• certain liver and kidney problems
• no production or no passing of urine
• low blood pressure (hypotension)
• low sodium levels in your blood
• low potassium levels in your blood
• dehydration
• jaundice or history of jaundice in newborns or infants
• hepatic coma or precoma

Do not use Furosemide-Baxter if you are allergic to:

• furosemide, or any of the ingredients listed at the end of this leaflet.
• medicines called sulfonamides (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.
  Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Do not use Furosemide-Baxter if you are pregnant.

Do not use Furosemide-Baxter if you are breastfeeding or planning to breast-feed.

The active drug, furosemide, passes into breast milk and there is a possibility your baby may be affected.

Do not use Furosemide-Baxter after the expiry date (EXP) printed on the pack.

If you use it after the expiry date has passed, it may not work as well.

Do not use the medicine if the packaging is torn or shows signs of tampering.

Check with your doctor if you:

• any of the ingredients listed at the end of this leaflet
• any other medicines called sulfonamides or sulfonylureas
• any other substances, such as foods, preservatives or dyes

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

Tell your doctor if you have or have had any medical conditions especially the following:

• 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

Tell your doctor if you are on a salt restricted diet.

Pregnancy and breastfeeding

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

Like most medicines of this kind, Furosemide-Baxter is not recommended to be used during pregnancy. If there is a need to consider Furosemide-Baxter during your pregnancy, your doctor will discuss the risks and benefits of taking it if you are pregnant.

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

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

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 Furosemide-Baxter. This includes large amounts of laxatives.

Some medicines may interfere with Furosemide-Baxter.

These medicines may be affected by Furosemide-Baxter, 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. These medicines 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 B (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

You should not eat large amounts of liquorice when you are using Furosemide-Baxter.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Furosemide-Baxter.

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

4. How do I use Furosemide-Baxter?

How to use

Furosemide-Baxter solution for injections are normally administered to you by doctors or nurses in hospital

When to use Furosemide-Baxter

• Furosemide-Baxter solution for injections are normally given by doctors or nurses in hospital. If you are not sure when to receive it, ask your doctor or pharmacist.

If you use too much Furosemide-Baxter

As Furosemide-Baxter is given to you under the supervision of your doctor, it is unlikely that you will have too much.

However, if you experience any side effects after being given Furosemide-Baxter, you should immediately:

• contact your doctor, or
• go to the Emergency Department at your nearest hospital, or
• phone the Poisons Information Centre (by calling 13 11 26)

You should do this even if there are no signs of discomfort or poisoning.

If you are given too much Furosemide-Baxter, you may feel confused, dehydrated, dizzy or you may pass excessive urine.

5. What should I know while using Furosemide-Baxter?

Things you should do

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Furosemide-Baxter.

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

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

If you become pregnant while you are taking this medicine, tell your doctor or pharmacist immediately.

Tell your doctor if you have excessive vomiting or diarrhea while taking Furosemide-Baxter or if you experience any of the following symptoms:

• dry mouth or thirst
• fainting
• weakness, tiredness or drowsiness
• muscle pain or cramps
• fast heart beat
• 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 using Furosemide-Baxter, especially if you sweat a lot.

If you do not drink enough water while using Furosemide-Baxter, 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 Furosemide-Baxter. There may be some interference with the results of these tests.

Remind any doctor, dentist, or pharmacist you visit that you are using Furosemide-Baxter.

Things you should not do

Women must not breast feed while being treated with furosemide.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Fluconazole - Baxter affects you.

Fluconazole - Baxter 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 lightheaded.

If this occurs, do not drive or operate machines.

Drinking alcohol

Tell your doctor if you drink alcohol.

The effects of alcohol could be made worse while taking Furosemide-Baxter. If you drink alcohol or take strong painkillers, dizziness or lightheadedness may be worse. It is not recommended that you drink alcohol while using Furosemide-Baxter.

Looking after your medicine

• Furosemide-Baxter will be stored in the hospital pharmacy or in the ward. It will be kept in original packaging below 25°C, protected from light.

6. Are there any side effects?

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

Serious side effects

Very serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

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

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

What Furosemide-Baxter contains

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

What Furosemide-Baxter looks like

Furosemide-Baxter is a clear, colorless, sterile aqueous solution available in a 2 mL (AUST R 148003) and 5 mL (AUST R155969) amber glass ampoule.

Who distributes Furosemide-Baxter

Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie
NSW 2146, Australia
Toll Free Number: 1800 229 837
www.baxterhealthcare.com.au

This leaflet was prepared in August 2024.

Published by MIMS October 2024

1 Name of Medicine

Furosemide.

2 Qualitative and Quantitative Composition

Furosemide 20 mg/2 mL and 50 mg/5 mL solution for injection.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection, for Intramuscular (I.M.) or Intravenous (I.V.) use.

4 Clinical Particulars

4.1 Therapeutic Indications

Oedema.

4.2 Dose and Method of Administration

Adults.

Oedema.

Acute pulmonary oedema.

Cerebral oedema.

Infants and children.

4.3 Contraindications

Known hypersensitivity to furosemide or sulfonamides or any of the inactive ingredients. Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to furosemide.
Complete renal shutdown.
If increasing azotaemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.
Severe hypokalaemia, hyponatraemia, hypovolaemia 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 breast-feeding 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 non-haemolytic jaundice etc.) because of furosemide's in vitro potential to displace bilirubin from albumin.
Furosemide-Baxter 250 mg injection must not be used as a bolus injection. It must only be infused using volume or rate controlled infusion pumps to reduce the risk of accidental overdose.

4.4 Special Warnings and Precautions for Use

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.
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.
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. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults with normal renal function, an infusion rate not exceeding 4 mg furosemide per minute must be used; for adults with impaired renal function [creatinine > 5 mg/dL], an infusion rate of no greater than 2.5 mg per minute must be used).
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.
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 urinate 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. These patients require careful monitoring.
Careful monitoring is required in patients with gout, with partial obstruction of urinary outflow, in patients at risk from hypotension (e.g. patients with coronary artery stenosis), 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 vomiting excessively or receiving parenteral fluids. 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 post prandial 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.
The possibility exists of exacerbation or activation of systemic lupus erythematosus.
Asymptomatic hyperuricaemia can occur and rarely, gout may be precipitated.
When furosemide is administered parenterally, a maximum injection rate of 4 mg/minute should be used to minimise the risk of ototoxicity.
Intramuscular administration of furosemide must be limited to exceptional cases where neither oral nor intravenous administration are feasible. Intramuscular administration is not suitable for acute conditions such as pulmonary oedema.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Combinations that are not recommended.

Precautions for use.

To be considered.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

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.
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 or nutritional inadequacies (excessive restriction of salt intake), may lead to sodium 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 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).
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 blood creatinine and urea levels. Serum levels of uric acid 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.

Hepatic system.

Central nervous system.

Dermatologic.

Haematologic.

Urinary system.

Cardiovascular.

Other.

Reporting suspected adverse effects.

4.9 Overdose

The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss; e.g. 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 body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg. 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 toxicity or death is not known.
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 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Inactive ingredients: sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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. Occasionally crystal deposits may be seen when Furosemide-Baxter ampoules are stored at low temperatures. Dissolve crystals by warming to 40°C and injection may be used.
Although the chemical stability of diluted Furosemide-Baxter has been demonstrated for storage at 25°C for 24 hours, the diluted solution should be used as soon as practicable to reduce the risk of microbiological hazard. If storage is necessary, hold the diluted solution at 2-8°C (under refrigeration) for not more than 24 hours.

6.5 Nature and Contents of Container

Furosemide-Baxter ampoules, 20 mg/2 mL (AUST R 148003); 50 mg/5 mL (AUST R 155969): packs of 5 and 25 ampoules.

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 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. Solutions for injection are prepared with sodium hydroxide giving solutions with a pH of 8.0 to 9.3. Furosemide should be protected from light.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes