Consumer medicine information

Glaumox Powder for Injection

Acetazolamide

BRAND INFORMATION

Brand name

Glaumox Powder for Injection

Active ingredient

Acetazolamide

Schedule

What is in this leaflet

This leaflet answers some common questions about Glaumox. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Glaumox against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet. You may need to read it again.

What Glaumox is used for

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 sulphonamides.

Ask your doctor if you have any questions about why Glaumox has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you are given Glaumox

When it must not be given

You should not be given Glaumox if you have an allergy to:

any medicine containing acetazolamide
any of the ingredients listed at the end of this leaflet
any other similar medicines such as sulphonamide medicines.

The active ingredient of Glaumox is a sulphur-containing medicine (a sulphonamide). Therefore, if you are allergic to sulphur medicines, such as some antibiotics, you may be allergic to Glaumox. Check with your doctor if you are not sure whether you are allergic to sulpha medicines.

Some of the symptoms of an allergic reaction may include:

shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.

You should not be given Glaumox if you have:

liver problems
kidney disease
a deficiency of the adrenal gland (eg, Addison’s disease)
a condition which lowers the levels of potassium or sodium in your blood
high levels of chloride in your blood.

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.

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

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

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.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

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

Before you are given Glaumox

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

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

hyperkalemic periodic paralysis, a condition which causes periodic muscle weakness and high potassium levels in the blood
diabetes or impaired glucose tolerance
any breathing difficulties or lung problems
any electrolyte imbalances, a condition which causes an unusual amount of salt in the body
too much or not enough acid in the blood which may cause an increased rate of breathing.

Tell your doctor if you are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor any of the above, tell him/her before you are given Glaumox.

Taking other medicines

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

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 be affected by Glaumox, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given this medicine.

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.

It is injected directly into a vein.

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.

Glaumox must only be used for a short time.

If you are given too much (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.

While you are being given Glaumox

Things you must do

If you are about to be started on any new medicine tell your doctor and pharmacist that you are being given Glaumox.

Tell any other doctors, dentists or pharmacists who are treating you that you are being given this medicine.

If you become pregnant while being given Glaumox tell your doctor immediately.

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.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how Glaumox affects you. This medicine 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.

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.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Glaumox.

This medicine helps most people with high eye pressure and glaucoma, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

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 changes such as depression
pain at the injection site.

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

flushing, skin rash
yellowing of the skin
need to urinate 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 such as fever, sore throat, severe chills or mouth ulcers
breathlessness
blood in the urine, black tar-like stools
confusion, lack of co-ordination, unsteadiness when walking
sensitivity to sunlight.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to the Emergency Department at your nearest hospital:

severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell
bleeding in the lips, eyes, mouth, nose and genitals
sudden life threatening allergic reaction such as swelling of face, lips, tongue, shortness of breath, wheezing or trouble breathing.

The above list includes very serious side effects. You may need urgent medical attention.

Tell your doctor if you notice anything that is making you feel unwell.

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

Some side effects can only be found when your doctor does tests from time to time to check your progress.

After being given Glaumox

Storage

Glaumox will be stored in the surgery, pharmacy or ward of a hospital. It will be kept in a cool dry place where the temperature stays below 25°C.

Glaumox will be opened for use on you. It will be used only once and then it will be discarded. It will never used for more than one person.

After sterile water has been added to Glaumox it may be stored in the fridge for no more than 24 hours.

Product description

What it looks like

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

Glaumox is available in a 10mL vial.

Ingredients

Glaumox contains acetazolamide sodium equivalent to 500mg acetazolamide as the active ingredient.

Sodium hydroxide and hydrochloric acid are added when required for pH adjustment.

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

Supplier

Glaumox is supplied in Australia by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Telephone: 1800 720 020

Glaumox is distributed in New Zealand by:

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

Glaumox Powder for Injection, 500mg acetazolamide (as sodium). 10mL vial.

AUST R 142075

Phebra Product Code- INJ192

Date of most recent amendment: 18^th September 2015

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

Published by MIMS September 2017

BRAND INFORMATION

Brand name

Glaumox Powder for Injection

Active ingredient

Acetazolamide

Schedule

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 lyophilized acetazolamide sodium in a rubber capped vial. The contents of the vial require reconstitution with Water for Injections before use.

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.

Each 500 mg vial containing Glaumox sterile acetazolamide sodium should be reconstituted with at least 5 mL of sterile Water for Injections prior to use. 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. Contains no antimicrobial preservative. The direct intravenous route of administration is preferred. Glaumox is intended for short-term usage only when it is not practicable to use acetazolamide in the oral dosage form.

Glaucoma.

Glaumox should be used as an adjunct to the usual therapy. The dosage employed in the treatment of chronic simple (open-angle) glaucoma ranges from 250 mg to 1 g per 24 hours, usually in divided doses for amounts over 250 mg. It has usually been found that a dosage in excess of 2 g per 24 hours does not produce an increased effect. In all cases, the dosage should be adjusted with careful individual attention both to symptomatology and ocular tension. Continuous supervision by a physician is advisable.
In treatment of secondary glaucoma and in the preoperative treatment of some cases of acute congestive (closed-angle) glaucoma, the preferred dosage is 250 mg every 4 hours, although some cases have responded to 250 mg twice daily on short-term therapy. In some acute cases, it may be more satisfactory to administer an initial dose of 500 mg followed by 125 or 250 mg every 4 hours depending on the individual case.
Intravenous therapy may be used for rapid relief of ocular tension in acute cases. A complementary effect has been noted when Glaumox has been used in conjunction with miotics or mydriatics as the case demanded.

Epilepsy.

It is not clearly known whether the beneficial effects observed in epilepsy are due to direct inhibition of carbonic anhydrase in the central nervous system or whether they are due to the slight degree of acidosis produced by the divided dosage. The best results to date have been seen in petit mal in children. Good results, however, have been seen in both adult and paediatric patients, in other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk pattern etc.
The recommended dose in paediatric patients is 8-30 mg/kg daily in divided doses not to exceed 750 mg/day. In adults the recommended dose is 250-1000 mg daily in divided doses. When Glaumox is given in combination with any other anticonvulsant, it is suggested that the starting dose should be 250 mg once daily in addition to the existing medication. This can be increased to the levels indicated above. The change from other medication to Glaumox should be gradual in accordance with usual practice in epilepsy therapy.

Congestive heart failure.

For diuresis in congestive heart failure, the starting dose is usually 250 to 375 mg once daily in the morning (5 mg/kg). If after an initial response, the patient fails to continue to lose oedema fluid, do not increase the dose but allow for kidney recovery by omitting medication for a day. Glaumox yields best diuretic results when given on alternate days, or for 2 days alternating with a day of rest. Failures in therapy may be due to overdosage or too frequent dosage. The use of Glaumox does not eliminate the need for other therapy such as digitalis, bed rest and salt restriction.

Drug-induced oedema.

Recommended dosage is 250 to 375 mg once daily for 1 to 2 days, alternating with a day of rest.

Note.

The dosage recommendations for glaucoma and epilepsy differ considerably from those for congestive heart failure, since the first two conditions are not dependent upon carbonic anhydrase inhibition in the kidney which requires intermittent dosage if it is to recover from the inhibitory effect of the therapeutic agent.

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.

Pharmacokinetic studies in four volunteers showed that the plasma protein binding and renal clearance of acetazolamide were significantly reduced during chronic salicylate dosing. Salicylate appears to competitively inhibit plasma protein binding of acetazolamide and simultaneously to inhibit acetazolamide renal secretion that may produce serious metabolic acidosis.
When acetazolamide and phenytoin are given together, accelerated development of osteomalacia has been reported. The concurrent use of these two agents should be avoided or else monitoring to detect osteomalacia should be instituted.

Precautions.

Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paraesthesia. Increasing the dose often results in a decrease in diuresis. Under certain circumstances however, very large doses have been given in conjunction with other diuretics in order to secure diuresis in complete refractory failure.
Fatalities have occurred, due to severe reactions to sulfonamides and sulphonamide derivatives, including acetazolamide. Adverse reactions common to all sulfonamide derivatives may occur: fever, rash (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), fulminant hepatic necrosis, crystalluria, renal calculus, bone-marrow depression, thrombocytopenic purpura, haemolytic anaemia, leucopenia, pancytopenia, agranulocytosis, aplastic anaemia and other blood dyscrasias, anaphylaxis, renal and ureteral colic and renal lesions.
There have been reports of increased muscular weakness, occasionally severe, in patients with hyperkalaemic periodic paralysis who have taken acetazolamide.
Serious and occasionally fatal hypersensitivity including shock and anaphylaxis have been reported in patients receiving acetazolamide.
Hypersensitivity reactions may recur if a sulfonamide or sulfonamide derivative is re-administered, irrespective of the route of administration. The drug should be discontinued and appropriate therapy instituted if such reactions are detected. To monitor for haematological reactions common to all sulfonamides, it is recommended that a baseline CBC, platelet count and electrolyte levels be obtained on patients prior to initiating Glaumox therapy and at regular intervals during therapy. If significant changes or toxic skin manifestations occur, early discontinuation and institution of appropriate therapy are important. Fatalities have occurred due to severe adverse reactions to sulfonamides.

Other concomitant conditions.

Both increases and decreases in blood glucose levels have been described in patients treated with acetazolamide. This should be taken into consideration in patients with impaired glucose tolerance or diabetes mellitus.

Acid/base and electrolyte balance.

Acetazolamide treatment may cause electrolyte imbalances, including hyponatraemia and hypokalaemia, as well as metabolic acidosis. Therefore, monitoring of serum electrolytes is recommended. Particular caution is recommended in patients with conditions that are associated with, or predisposed to, electrolyte and acid/base imbalance, such as patients with impaired renal function (including elderly patients, patients with diabetes mellitus, and patients with impaired alveolar ventilation (such as patients with pulmonary obstruction or emphysema)). In patients with moderate to severe renal impairment, the dose should be reduced by half or the dosage interval should be increased to every 12 hours.

Use in hepatic impairment.

See Section 4.3 Contraindications.

Use in renal impairment.

See Acid/base and electrolyte balance.

Use in the elderly.

Metabolic acidosis, which can be severe, may occur in the elderly with reduced renal function.

Patient monitoring.

Monitoring serum electrolyte levels (particularly potassium) and blood pH levels should be considered if overdose with acetazolamide is suspected. In the case of overdosage when complicated by the presence of renal failure, dialysis may be beneficial since acetazolamide is dialyzable.

Paediatric use.

The safety and effectiveness of acetazolamide in paediatric patients have not been established. Growth retardation has been reported in children receiving long-term therapy, believed secondary to chronic acidosis. (See Section 4.2 Dose and Method of Administration.)

Effects on laboratory tests.

Sulfonamides may give false negative or decreased values for urinary phenolsulfonphthalein and phenol red elimination values for urinary protein, serum non-protein and for serum uric acid. Acetazolamide may produce an increased level of crystals in the urine.
Acetazolamide interferes with the HPLC method of assay for theophylline. Interference with the theophylline assay by acetazolamide depends on the solvent used in the extraction; acetazolamide may not interfere with other assay methods for theophylline.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Amphetamines.

By increasing the pH of renal tubular urine, acetazolamide reduces the urinary excretion of amphetamine and so may enhance the magnitude and duration of the effect of amphetamines.

Carbonic anhydrase inhibitors.

Because of possible additive effects with other carbonic anhydrase inhibitors, concomitant use is not advisable.

Cyclosporine.

When given concomitantly, acetazolamide may elevate cyclosporine blood levels. Caution is advised when administering acetazolamide in patients receiving cyclosporine.

Folic acid antagonists.

Acetazolamide may potentiate the effects of other folic acid antagonists.

Hypoglycaemic agents.

Lithium.

Acetazolamide increases lithium excretion due to impaired reabsorption of lithium in the proximal tubule. The effect of lithium carbonate may be decreased.

Methenamine compounds.

By increasing the pH of urine, acetazolamide may prevent the urinary antiseptic effect of methenamine compounds.

Phenytoin.

When given concomitantly, acetazolamide modifies the metabolism of phenytoin, leading to increased serum levels of phenytoin. Acetazolamide may increase the occurrence, or accelerate the manifestation of osteomalacia in some patients receiving chronic phenytoin therapy. Caution is advised in patients receiving chronic concomitant therapy.

Primidone.

By decreasing the gastrointestinal absorption of primidone, acetazolamide may decrease serum concentrations of primidone and its metabolites, with a consequent possible decrease in anticonvulsant effect. Caution is advised when beginning, discontinuing, or changing the dose of acetazolamide in patients receiving primidone.

Quinidine.

By increasing the pH of renal tubular urine, acetazolamide reduces the urinary excretion of quinidine and so may enhance the effect of quinidine.

Salicylates.

Caution is advised for patients receiving concomitant aspirin and acetazolamide, as severe toxicity has been reported. Severe metabolic acidosis has been reported in patients with normal renal function during treatment with acetazolamide and salicylates. Pharmacokinetic studies showed that the plasma protein binding and renal clearance of acetazolamide were significantly reduced during chronic salicylate therapy. Systemic acidosis produced by acetazolamide may increase salicylate toxicity by enhancing salicylate tissue penetration.
Precaution is advised for patients receiving concomitant high-dose aspirin and acetazolamide as anorexia, tachypnoea, lethargy and coma have been reported due to a possible drug interaction. (See Section 4.4 Special Warnings and Precautions for Use, Warnings.) Concomitant administration with high-dose aspirin may potentiate the adverse reactions of Glaumox.

Sodium bicarbonate.

The use of concurrent sodium bicarbonate therapy enhances the risk of renal calculus formation in patients taking acetazolamide.

Cardiovascular agents.

Potentiation of the effects of oral anticoagulants is possible when administered with Glaumox, and may warrant a reduction in the dose of the anticoagulant. Adjustment of dose may be required when Glaumox is given with cardiac glycosides or antihypertensive agents.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Acetazolamide, administered orally or parenterally, has been shown to be teratogenic (defects of the limbs) in mice, rats, hamsters and rabbits, at oral or parenteral doses in excess of ten times those recommended in human beings. There are no adequate and well-controlled studies in pregnant women. Glaumox should not be used in pregnancy, especially during the first trimester.
Australian categorisation definition of Category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Acetazolamide has been detected in low levels in the milk of lactating women who have taken the drug. Therefore the potential exists for adverse reactions in the infant. Extreme caution should be utilized when Glaumox is administered to lactating women.

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.

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.

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.

Acetazolamide is an enzyme inhibitor that acts specifically on carbonic anhydrase, the enzyme that catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid.
In the eye this inhibitory action of acetazolamide decreases the secretion of aqueous humour and results in a drop in intraocular pressure desirable in cases of glaucoma. Evidence indicates that Glaumox is useful as an adjuvant in the treatment of certain dysfunctions of the central nervous system (e.g. epilepsy). Inhibition of carbonic anhydrase in this area appears to retard abnormal, paroxysmal, excessive discharge from central nervous system neurons.
The diuretic effect of acetazolamide is due to its action in the kidney on the reversible reaction involving hydration of carbon dioxide and dehydration of carbonic acid. The result is renal loss of bicarbonate ions. Alkalinisation of the urine and promotion of diuresis are thus affected.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

No data available.

Distribution.

No data available.

Metabolism.

No data available.

Excretion.

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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

Lyophilized powder in a 10 mL vial. Pack of 1. Solvent required.
Phebra product code - INJ 192.

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.

The CAS for acetazolamide is 59-66-5.
The CAS for acetazolamide sodium is 1424-27-7.

7 Medicine Schedule (Poisons Standard)

S4.

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