Consumer medicine information

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.

5. What should I know while using Fludrocortisone?

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.

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

4.9 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

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFLUACE.gif CAS number. 514-36-3.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/FLUMEDST.gif