Consumer medicine information

Fludrocortisone Medsurge

Fludrocortisone acetate

BRAND INFORMATION

Brand name

Fludrocortisone Medsurge

Active ingredient

Fludrocortisone acetate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fludrocortisone Medsurge.

SUMMARY CMI

Fludrocortisone Medsurge tablets

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 Fludrocortisone?

Fludrocortisone tablet contains fludrocortisone acetate as the active ingredient. It is a type of medicine known as a corticosteroid. Fludrocortisone is used in combination with other medicines to treat Addison's disease. It is also used to treat a disorder (called salt-losing adrenogenital syndrome) which causes too much salt to be lost in the urine.

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

2. What should I know before I use Fludrocortisone?

Do not use if you have ever had an allergic reaction to fludrocortisone 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 Fludrocortisone? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with fludrocortisone 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 Fludrocortisone?

  • The usual dose is one tablet each day, but you may be required to take one tablet on alternate days.
  • Fludrocortisone tablet is taken continuously, your doctor will tell you when to stop taking it.

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

5. What should I know while using Fludrocortisone?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
  • If you think you may have an infection of any kind while you are taking fludrocortisone tablet, you must see your doctor immediately to ensure adequate treatment.
  • Tell your doctor if you notice anything that is making you feel unwell.
  • Ask your doctor to answer any questions you may have.
Driving or using machines
  • Your doctor will tell you when it is safe to drive and operate potentially dangerous machinery.
  • As far as it is known, fludrocortisone has no effect on alertness or concentration.
Looking after your medicine
  • Store below 25°C.
  • The diluted product should be used immediately.

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

6. Are there any side effects?

Like all medicines, Fludrocortisone can cause side effects, but not everyone gets them. Common side effects could be:

  • fluid retention due to an abnormal amount of salt in the body
  • muscle weakness
  • thinning of skin
  • poor healing
  • stomach upsets
  • headache
  • dizziness
  • menstrual irregularities in women
  • eye problems
  • masking of infections.

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

Fludrocortisone Medsurge tablets

Active ingredient(s): fludrocortisone acetate


Consumer Medicine Information (CMI)

This leaflet provides important information about using fludrocortisone. 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 fludrocortisone.

Where to find information in this leaflet:

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

1. Why am I using fludrocortisone?

Fludrocortisone tablet contains fludrocortisone acetate as the active ingredient. It is a type of medicine known as a corticosteroid.

Fludrocortisone is used in combination with other medicines when there is an inadequate production of one type of natural steroid hormone produced by the adrenal glands (Addison's disease).

It is also used to treat a disorder (called salt-losing adrenogenital syndrome) which causes too much salt to be lost in the urine.

Fludrocortisone can help treat this condition by causing the kidneys to retain fluid and salt in the body.

Your doctor will have explained why you are being treated with fludrocortisone.

Ask your doctor if you want any more information about this medicine.

Fludrocortisone is not addictive.

2. What should I know before I use fludrocortisone?

Warnings

Do not use Fludrocortisone if:

  • you are allergic to fludrocortisone acetate, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • 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

Check with your doctor if you:

  • have a current serious or uncontrolled infection including systemic fungal infections. Your doctor will know if this is the case and you will be receiving treatment.
  • have or have had any of the following medical conditions:
    - tuberculosis
    - been immunised or vaccinated recently
    - high blood pressure
    - glaucoma, or other eye problems or an infection in your eye
    - thyroid gland is not working (hypothyroid)
    - cirrhosis of the liver
    - ulcerative colitis
  • have allergies to:
    - any other medicines
    - any other substances, such as foods, preservatives or dyes
  • take any medicines for any other condition

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.

Your doctor will discuss the risks and benefits of using fludrocortisone if you are pregnant or breast-feeding.

If you have not told your doctor about any of the above, tell them before you are given fludrocortisone.

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 may interfere with fludrocortisone and affect how it works.

Tell your doctor if you are taking or have recently taken:

Medicines that may reduce the effect of fludrocortisone include:

  • diabetic medicines e.g. insulin
  • oral anticoagulants
  • CYP3A inhibitors e.g. cobicistat
  • oral contraceptives
  • anti-inflammatory drugs
  • thyroid drugs

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

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

4. How do I use fludrocortisone?

How much to take

  • Your doctor will have prescribed a dose of fludrocortisone tablet suitable for you.
  • The usual dose is one tablet each day, but you may be required to take one tablet on alternate days.

How long to take fludrocortisone

  • Fludrocortisone tablet is taken continuously and your doctor will tell you when to stop taking it.

If you forget a dose

  • Take it as soon as you remember, and then go back to taking it as you would normally.

If you use too much

If you think that you have used too much fludrocoritsone, 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 the Emergency Department at your nearest hospital.

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

5. What should I know while using fludrocortisone?

Things you should do

Tell your doctor:

  • If you think you may have an infection of any kind while you are taking fludrocortisone tablet, you must see your doctor immediately to ensure adequate treatment.

Things you should not do

Driving or using machines

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

As far as it is known, fludrocortisone has no effect on alertness or concentration.

Looking after your medicine

  • Store below 25°C.
  • Follow the instructions in the carton on how to take care of your medicine properly.
  • Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
    - in the bathroom or near a sink, or
    - in the car or on window sills.

Keep it where young children cannot reach it.

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?

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.

Side effects

Side effectsWhat to do
  • fluid retention due to an abnormal amount of salt in the body
  • muscle weakness
  • thinning of skin
  • poor healing
  • stomach upsets
  • headache
  • dizziness
  • menstrual irregularities in women
  • eye problems
  • masking of infections.
Speak to your doctor if you have any of these side effects and they worry you.

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 fludrocortisone contains

Active ingredient
(main ingredient)
Fludrocortisone acetate
Other ingredients
(inactive ingredients)
  • microcrystalline cellulose
  • mannitol
  • hypromellose
  • croscarmellose sodium
  • colloidal anhydrous silica
  • magnesium stearate
Potential allergens
  • none

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

What fludrocortisone looks like

Fludrocortisone 100 microgram tablets are white or off-white, oblong tablets, with a scoring line on one side.

Available as PVC/PVDC/Al blister packs of 100 tablets

AUST R 346713

Who distributes fludrocortisone

Marketed and Distributed by Medsurge Healthcare Pty Ltd.
Telephone: 1300 788 261
Website: www.medsurgehc.com

This leaflet was prepared in January 2025.

Published by MIMS March 2025

BRAND INFORMATION

Brand name

Fludrocortisone Medsurge

Active ingredient

Fludrocortisone acetate

Schedule

S4

 

Notes

Distributed by Medsurge Healthcare Pty Ltd

1 Name of Medicine

Fludrocortisone acetate.

2 Qualitative and Quantitative Composition

Fludrocortisone acetate tablets contain 0.1 mg of fludrocortisone acetate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White or off-white, oblong tablets, with a scoring line on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Partial replacement therapy for primary adrenocortical insufficiency in Addison's disease and for the treatment of salt losing adrenogenital syndrome.

4.2 Dose and Method of Administration

Addison's disease.

The combination of fludrocortisone acetate tablets with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects. The usual dose is 0.1 mg of fludrocortisone acetate tablets daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Fludrocortisone acetate tablets is preferably administered in conjunction with cortisone (10 to 37.5 mg daily in divided doses) or hydrocortisone (10 to 30 mg daily in divided doses).

Salt-losing adrenogenital syndrome.

The recommended dosage is 0.1 to 0.2 mg of fludrocortisone acetate tablets daily.

4.3 Contraindications

Patients with systemic fungal infections.
Patients with suspected or known hypersensitivity to fludrocortisone or any of the inactive ingredients.

4.4 Special Warnings and Precautions for Use

Because of its marked effect on sodium retention, the use of fludrocortisone acetate tablets in the treatment of conditions other than those indicated herein is not advised.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. If an infection occurs during fludrocortisone acetate therapy, it should be promptly controlled by suitable antimicrobial therapy. Chicken pox, measles, herpes zoster, or threadworm infestations for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased potassium excretion. These effects are less likely to occur with the synthetic derivatives except when used in large doses. However, since fludrocortisone acetate is a potent mineralocorticoid, both the dosage and salt intake should be carefully monitored in order to avoid the development of hypertension, oedema or weight gain.
Periodic checking of serum electrolyte levels is advisable during prolonged therapy; dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Patients should not be vaccinated against smallpox while on corticosteroid therapy. Other immunisation procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.
The use of fludrocortisone acetate tablets in patients with active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur. During prolonged corticosteroid therapy these patients should receive chemoprophylaxis.
Adverse reactions to corticosteroids may be produced by too rapid withdrawal or by continued use of large doses.
To avoid drug induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery or severe illness) both during treatment with fludrocortisone acetate and for a year afterwards.
There is an enhanced corticosteroid effect in patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular Herpes simplex because of possible corneal perforation.
The lowest possible dose of corticosteroid should be used to control the condition being treated. A gradual reduction in dosage should be made when possible.
Psychiatric disturbances may appear when corticosteroids are used. These may range from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic tendencies may also be aggravated by corticosteroids.
Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.
The use of antidepressant drugs does not relieve and may exacerbate adreno-corticosteroid induced mental disturbances.
Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection.
Corticosteroids should also be used cautiously in patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, acute glomerulonephritis, vaccinia, varicella, exanthema, Cushing's syndrome, antibiotic resistant infections, diabetes mellitus, congestive heart failure, chronic nephritis, thromboembolic tendencies, thrombophlebitis, convulsive disorders, metastatic carcinoma and myasthenia gravis.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
An adequate protein intake is advised for patients on long-term corticosteroids to counteract any tendency to weight-loss or muscle wasting/weakening associated with negative nitrogen balance.
Patients should be monitored regularly for blood pressure and serum electrolyte levels.

Use in the elderly.

The adverse effects of systemic corticosteroids, such as osteoporosis or hypertension, may be associated with more serious consequences in the elderly. Close clinical supervision is therefore recommended.

Paediatric use.

No data available.

Effects on laboratory tests.

Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection, producing false-negative results.

4.5 Interactions with Other Medicines and Other Forms of Interactions

When administered concurrently, the following drugs may interact with adrenal corticosteroids:

Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide).

Enhanced hypokalemia. Potassium levels should be checked at frequent intervals and potassium supplements used if necessary (see Section 4.4 Special Warnings and Precautions for Use).

Anticholinesterases.

Effects of the anticholinesterase agent may be antagonized.

Anticoagulants oral.

Corticosteroid may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should therefore be closely monitored.

Antidiabetics (oral agents and insulin).

Diminished antidiabetic effect. Patient should be monitored for symptoms of hyperglycemia; dosage of antidiabetic drug should be adjusted if necessary.

Antitubercular drugs.

Isoniazed serum concentrations may be decreased in some patients.

Cyclosporin.

Increased activity of both cyclosporin and corticosteroids may occur when the two are used concurrently.

CYP3A inhibitors.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Digitalis glycosides.

Enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Potassium levels should be monitored and potassium supplements used if necessary.

Estrogens, including oral contraceptives.

Corticosteroid half-life and concentration may be increased and clearance decreased. A reduction in corticosteroid dosage may be required when estrogen therapy is initiated, and an increase required when estrogen is stopped.

Hepatic enzyme inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampin).

Increased metabolic clearance of fludrocortisone. Patients should be observed for possible diminished effect of steroid, and the dosage of fludrocortisone acetate tablets should be adjusted accordingly.

Human growth hormone (e.g. somatrem).

The growth-promoting effect of somatrem may be inhibited.

Ketoconazole.

Corticosteroid clearance may be decreased, resulting in increased therapeutic effect.

Nondepolarizing muscle relaxants.

Corticosteroids may decrease or enhance the neuromuscular blocking action.

Nonsteroidal anti-inflammatory agents (NSAIDs).

Increased ulcerogenic effect; decreased pharmacologic effect of aspirin. Conversely, salicylate toxicity may occur in patients who discontinue steroids with concurrent high-dose aspirin therapy. Corticosteroids should be used cautiously in conjunction with aspirin in patients with hypoprothrombinemia.

Thyroid drugs.

Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid dosage.

Vaccines.

Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
In animal experiments, corticosteroids have been found to cause malformations of various kinds (cleft palate, skeletal malformations) and abortion. These findings do not seem to be relevant to humans. Reduced placental and birth weight have been recorded in animals and humans after long-term treatment. Since the possibility of suppression of the adrenal cortex in the newborn infant after long-term treatment must be considered, the needs of the mother must be carefully weighed against the risk to the foetus when prescribing these drugs. The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the foetus or the newborn infant.
Infants born of mothers who have received substantial doses of fludrocortisone acetate during pregnancy should be carefully observed for signs of hypoadrenalism. Maternal pulmonary oedema has been reported with tocolysis and fluid overload.
The use of this drug in nursing mothers requires that the possible benefits of the drug be weighed against the potential hazards to the child.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.
However, adverse effects of this medicine include blurred vision, convulsions and vertigo which could affect the ability to drive or use machines (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

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 www.tga.gov.au/reporting-problems.
In the recommended small dosages, the side effects seen with cortisone and its derivatives are not usually a problem with fludrocortisone. However, the following untoward effects should be kept in mind, particularly when this agent is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid.

Fluid and electrolyte disturbances.

Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalaemic alkalosis and hypertension.

Musculoskeletal.

Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones and spontaneous fractures.

Gastrointestinal.

Peptic ulcer with possible perforation and haemorrhage, pancreatitis, abdominal distension and ulcerative oesophagitis.

Dermatological.

Impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hirsutism, and acne-form eruptions; reactions to skin tests may be suppressed.

Neurological.

Convulsions, increased intracranial pressure with papilloedema (pseudotumour cerebri) usually after treatment, vertigo, headache and severe mental disturbances.

Endocrine.

Menstrual irregularities, development of the cushingoid state, suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g. trauma, surgery or illness), decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, and increased requirements for insulin or oral hypoglycaemic agents in diabetes.

Ophthalmic.

Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos and blurred vision (see Section 4.4 Special Warnings and Precautions for Use).

Metabolic.

Hyperglycaemia, glycosuria and negative nitrogen balance due to protein catabolism.

Other.

Other adverse reactions that may occur following the administration of a corticosteroid are necrotising angitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes and anaphylactoid reactions.

4.9 Overdose

Chronic.

Development of hypertension, edema, hypokalemia, significant increase in weight, and increase in heart size may be signs of excessive dosage of fludrocortisone acetate tablets. When these are noted, administration of the drug should be discontinued, after which the symptoms will usually subside within several days; subsequent treatment with fludrocortisone acetate tablets, if necessary, should be resumed at a reduced dose. Muscle weakness due to excessive potassium loss may develop and can be treated with potassium supplements. Monitoring of blood pressure and serum electrolytes can reduce the likelihood of consequences of excessive dosage (see Section 4.4 Special Warnings and Precautions for Use).

Acute.

For large, acute overdoses, treat symptomatically and institute usual supportive measures as required.
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.

Fludrocortisone acetate is a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity. It is used for its mineralocorticoid effects.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Metabolism.

The physiological action is similar to that of hydrocortisone. However, the effects of fludrocortisone acetate, particularly on electrolyte balance, but also on carbohydrate metabolism, are considerably heightened and prolonged. In small oral doses, it produces marked sodium retention and increased urinary potassium excretion. It also causes a rise in blood pressure, apparently because of these effects on electrolyte levels.
In larger doses, fludrocortisone acetate inhibits endogenous adrenal cortical secretion, thymic activity, and pituitary corticotropin excretion; promotes the deposition of liver glycogen; and, unless protein intake is adequate, induces negative nitrogen balance. The approximate half-life of fludrocortisone is 18-36 hours.

Excretion.

It is highly protein bound and is eliminated by the kidneys, mostly as inactive metabolites. Duration of action is 1 to 2 days.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, mannitol, hypromellose, croscarmellose sodium, colloidal anhydrous silica, 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.

6.5 Nature and Contents of Container

The tablets are packed in PVDC/PVDC/Alu blister. Pack sizes of 30 and 100 tablets.
(Note: not all pack sizes are marketed.)

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Fludrocortisone acetate. The chemical name is 9-Fluoro-11β,17-dihydroxy -3,20-dioxopregn- 4-en-21-yl acetate.
It is a white to pale yellow, odourless or almost odourless, crystalline powder. Practically insoluble in water; soluble 1 in 50 in alcohol, 1 in 50 in chloroform; slightly soluble in ether.

Chemical structure.


CAS number.

514-36-3.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes