SUMMARY CMI

Glaumox Powder for Injection

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 being given Glaumox?

Glaumox contains the active ingredient acetazolamide. Glaumox is used to lower raised pressure in the eye and to treat glaucoma. It is also used to treat some other conditions such as epilepsy and fluid build up due to heart failure or medicines. For more information, see Section 1. Why am I being given Glaumox? in the full CMI.

2. What should I know before I am given Glaumox?

Do not use if you have ever had an allergic reaction to 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 am given Glaumox? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Glaumox 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 is Glaumox given?

• Glaumox Powder for Injection will be injected by your doctor into a vein.
• More instructions can be found in Section 4. How is Glaumox given? in the full CMI.

5. What should I know while being given Glaumox?

For more information, see Section 5. What should I know while being given Glaumox? in the full CMI.

6. Are there any side effects?

Glaumox may cause short sightedness, headache, nausea, vomiting, diarrhoea, dizziness, tiredness, numbness or tingling in the fingers or toes, face or mouth, changes in sensation of taste or smell, ringing or buzzing in the ears, loss of appetite, loss of weight, excessive thirst, mood change such as depression, pain at the injection site, flushing, skin rash, yellowing of the skin, need to urinated more often than usual, sudden severe back pain, which may be caused by kidney stones, bruising or bleeding more easily than normal, nosebleeds, signs of frequent or worrying infections, breathlessness, blood in urine, black tar like stools, confusion, lack of co-ordination, unsteadiness when walking, sensitivity to sunlight.

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

Glaumox Powder for Injection

Active ingredient(s): Acetazolamide (as sodium) 500 mg

Consumer Medicine Information (CMI)

This leaflet provides important information about using Glaumox. 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 Glaumox.

Where to find information in this leaflet:

1. Why am I being given Glaumox?
2. What should I know before I am given Glaumox?
3. What if I am taking other medicines?
4. How is Glaumox given?
5. What should I know while being given Glaumox?
6. Are there any side effects?
7. Product details

1. Why am I being given Glaumox?

Glaumox contains the active ingredients acetazolamide.

Glaumox is used to lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure.

Glaucoma is usually caused by a build up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in.

Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye.

There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems, including total blindness. In fact, untreated glaucoma is one of the most common causes of blindness.

Glaumox is used, either alone or in combination with other eye drops/medicines, to lower raised pressure within your eyes.

Glaumox lowers the pressure in the eye by decreasing the fluid produced and helping the flow of fluid out of the eye chamber.

Glaumox is also used to treat some other conditions such as epilepsy and fluid build up due to heart failure or medicines.

Glaumox belongs to a family of medicines called sulfonamides.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

2. What should I know before I am given Glaumox?

Warnings

Do not use Glaumox if you are allergic to:

• acetazolamide
• the active ingredient of Glaumox is a sulfur containing medicine (a sulfonamide). Therefore, if you are allergic to sulfur medicines, such as some antibiotics, you may be allergic to Glaumox.
• any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

If you have an allergic reaction, you may get a skin rash, hay fever or an asthma attack.

You should not be given Glaumox Injection if, when dissolved in sterile water, it causes the solution to become discoloured, cloudy, turbid, or particles or a precipitate is present.

The solution is normally a clear, colourless to slight yellow liquid.

Check with your doctor if you have:

• problems with your liver.
• kidney disease.
• a deficiency of the adrenal gland (eg. Addison's disease).
• hyperkalemic periodic paralysis, a condition which causes periodic muscle weakness and high potassium levels in the blood.
• any electrolyte imbalances, a condition which causes an unusual amount of salt in the body and lowers the levels of the potassium or sodium in your blood.
• high levels of chloride in your blood.
• too much or not enough acid in the blood which may cause an increased rate of breathing.
• any breathing difficulties or lung problems.
• diabetes or impaired glucose tolerance.
• Glaumox should not be given for long term use in patients with chronic noncongestive angle-closure glaucoma. Glaumox is only to be used for a short term.

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

You should not be given this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy. 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.

Glaumox should not be given to children. Safety and effectiveness in children have not been established.

If you are not sure whether you should be given this medicine talk to your doctor.

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 and Glaumox may interfere with each other. These include:

• amphetamine, a stimulant
• cyclosporine, a medicine used after an organ transplant to prevent rejection
• folic acid antagonists, medicines used during cancer chemotherapy
• tablets used to treat diabetes
• lithium, a medicine used to treat emotional disorders
• methenamine compounds used to treat urinary tract infections
• phenytoin and primidone medicines used to treat epilepsy
• quinidine, a medicine used to treat heart problems
• aspirin, in high doses
• salicylate-containing medicines which are used to relieve pain
• sodium bicarbonate
• digoxin, a medicine used to treat heart failure
• warfarin, a medicine used to prevent blood clots
• medicines to treat high blood pressure
• medicines used to treat glaucoma.

These medicines may affect the way Glaumox works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

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

4. How is Glaumox given?

How much is given

Your doctor will decide what dose of Glaumox you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight.

How Glaumox is given

Glaumox must only be given by a doctor or nurse.

Glaumox must be dissolved in sterile water before it is used. It should be used as soon as possible after the water has been added.

Glaumox is injected directly into a vein. Glaumox must only be used for a short time.

If you are given too much Glaumox (overdose)

Glaumox must only be given by a doctor or nurse so an overdose is not likely to occur.

Symptoms of an overdose are similar to side effects and are listed under the Side effects section below.

5. What should I know while being given Glaumox?

Things you should do

Tell your doctor or nurse if you do not feel well while or after you have been given Glaumox.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem gets worse or continues, talk to your doctor.

If you are about to have any blood tests, tell your doctor that you are being given this medicine. It may interfere with the results of some tests

Driving or using machines

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

Glaumox may cause drowsiness, tiredness and short sightedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol can make you more dizzy or drowsy.

Looking after your medicine

Glaumox will be stored by your doctor or pharmacist under the recommended conditions.

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.

If you are over 65 years of age you may have an increased chance of getting some side effects.

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

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

Glaumox is a prescription medicine and is only administered under a doctor's supervision.

What Glaumox contains

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

This medicine does not contain lactose, sucrose, gluten, alcohol, tartrazine, dyes or preservatives.

What Glaumox looks like

Glaumox is a white to a yellowish white powder in a clear glass vial with a plastic top.

Who distributes Glaumox

Glaumox is supplied in Australia by:

Phebra Pty Ltd
19 Orion Road,
Lane Cove West, NSW 2066,
Australia

Glaumox is supplied in New Zealand by:

AFT Pharmaceutical Ltd
PO Box 33-203, Auckland
Telephone: +64 9 4880232

Glaumox Powder for Injection, 500 mg acetazolamide (as sodium).

AUST R 142075

Date of most recent amendment: 18 December 2024

Glaumox, Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS March 2025

1 Name of Medicine

Acetazolamide sodium.

2 Qualitative and Quantitative Composition

Each vial contains acetazolamide sodium, equivalent to 500 mg acetazolamide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Glaumox is sterile lyophilised powder of acetazolamide sodium in a rubber capped vial. The sterile lyophilised powder is white to faintly yellowish white, crystalline, and odourless. The contents of the vial require reconstitution with water for injections for intravenous administration. The final solution is adjusted to pH 9.6 prior to lyophilisation.

4 Clinical Particulars

4.1 Therapeutic Indications

For adjunctive treatment of oedema: due to congestive heart failure; drug-induced oedema; centrencephalic epilepsies (petit mal, unlocalised seizures); chronic simple (open-angle) glaucoma, secondary glaucoma and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.

4.2 Dose and Method of Administration

Preparation and storage of parenteral solution.

Glaucoma.

Epilepsy.

Congestive heart failure.

Drug-induced oedema.

Note.

4.3 Contraindications

Situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, suprarenal gland failure, hyperchloraemic acidosis and hypersensitivity to acetazolamide, sulfonamides, or sulfonamide derivatives, or any excipients in the formulation. Cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible.
Acetazolamide is contraindicated in patients with marked liver disease or impairment of liver function, including cirrhosis because of the risk of development of hepatic encephalopathy. Acetazolamide decreases ammonia clearance.
Long-term administration in patients with chronic noncongestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

4.4 Special Warnings and Precautions for Use

Warnings.

Precautions.

Other concomitant conditions.

Acid/base and electrolyte balance.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Patient monitoring.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Amphetamines.

Carbonic anhydrase inhibitors.

Cyclosporine.

Folic acid antagonists.

Hypoglycaemic agents.

Lithium.

Methenamine compounds.

Phenytoin.

Primidone.

Quinidine.

Salicylates.

Sodium bicarbonate.

Cardiovascular agents.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Some adverse reactions to acetazolamide, such as drowsiness, fatigue and myopia, may impair the ability to drive and operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions during short-term therapy are minimal.
Effects that have been noted include: paraesthesia, particularly a tingling feeling in the extremities and face, some loss of appetite, polyuria, polydipsia, flushing, thirst, headaches, dizziness, fatigue, irritability and occasional instances of drowsiness and confusion.
Rarely, photosensitivity has been reported.
General reactions such as malaise, pain at injection site, fever, growth retardation in children and anaphylactic/anaphylactoid reactions, including shock and fatalities have been reported.
Gastrointestinal reactions such as abnormal liver function including cholestatic jaundice, gastrointestinal disturbances such as nausea, vomiting and diarrhoea have been reported.
Haematological and lymphatic reactions reported include blood dyscrasias such as aplastic anaemia, agranulocytosis, leucopenia, thrombocytopenia, and thrombocytopenic purpura.
Metabolic/nutritional adverse reactions have included electrolyte imbalance, hyponatraemia, osteomalacia with long-term therapy, taste alteration and hyper/hypoglycaemia.
During long-term therapy, metabolic acidosis and hypokalaemia may occur. This can usually be corrected by the administration of bicarbonate and/or potassium.
Adverse reactions in the nervous system include reports of, depression, excitement, ataxia and confusion.
Skin reactions reported with the use of acetazolamide include allergic skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Hearing disturbances and tinnitus have been reported.
Transient myopia is rare and invariably subsides upon diminution or discontinuation of the medication.
Adverse reactions in the urogenital system with long-term therapy include crystalluria, renal calculi, renal colic, increased risk of nephrolithiasis and renal failure.
Other occasional adverse reactions include urticaria, melaena, haematuria, glycosuria, hepatic insufficiency, flaccid paralysis and convulsions.

Reporting suspected adverse effects.

4.9 Overdose

No specific antidote is known. Treatment should be symptomatic and supportive, with correction of electrolyte and fluid balance. Electrolyte imbalance, development of an acidotic state, and central nervous effects might be expected to occur.
Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Glaumox (acetazolamide sodium) is a carbonic anhydrase inhibitor, effective in the control of fluid secretion (e.g. some types of glaucoma), in the treatment of certain convulsive disorders (e.g. epilepsy) and in the promotion of diuresis in instances of abnormal fluid retention (e.g. cardiac oedema).

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

Each vial contains the excipients hydrochloric acid and sodium hydroxide for pH adjustment.
Contains no antimicrobial preservative.

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)¹. The expiry date can be found on the packaging.
¹AUST R 142075.

6.4 Special Precautions for Storage

Store below 25°C.
Product is for single use in one patient only. Discard any residue. To reduce microbiological hazard, use as soon as practicable after reconstitution. If storage is necessary, hold at 2°-8°C for not more than 24 hours.

6.5 Nature and Contents of Container

Lyophilised powder supplied in a carton containing 1 glass vial.

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

The active ingredient of Glaumox is the acetazolamide sodium, or the sodium salt of N-(5-sulphamoyl-1,3,4-thiadiazol-2-yl) acetamide. Acetazolamide has a molecular weight of 222.25 (C₄H₆N₄O₃S₂).
Acetazolamide sodium is a white or almost white crystalline powder, soluble in water.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes