Consumer medicine information

Florinef

Fludrocortisone acetate

BRAND INFORMATION

Brand name

Florinef

Active ingredient

Fludrocortisone acetate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Florinef.

What is in this leaflet

This leaflet answers some common questions about Florinef. It does not contain all of the available information. It does not take the place of talking with your doctor or pharmacist.

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

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Florinef is used for

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

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

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

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

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take Florinef if you have ever had an allergy to fludrocortisone acetate or any ingredient listed at the end of this leaflet.

Symptoms of an allergic reaction to Florinef 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.

Do not take Florinef 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.

Do not take Florinef after the expiry date printed on the bottle.

Do not take this medicine to treat any other complaints unless your doctor has instructed you to do so.

Do not give this medicine to anyone else.

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor if you 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.

Taking other medicines

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

Some medicines may interfere with Florinef. These 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 Florinef.

How to take it

How much to take

Your doctor will have prescribed a dose of Florinef 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 it

Florinef 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 take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Florinef. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking it

Things to be aware of

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

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Florinef.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

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

  • 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.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking it

Storage

Florinef should be stored in a refrigerator between 2-8°C.

Alternatively, and for a period of 3 months only, Florinef can also be stored in a cool dry place where the temperature stays below 25°C.

After this time, discard all Florinef tablets that have not been refrigerated.

Keep this medicine out of the reach of children.

Product description

What it looks like

Florinef are small, round, white, biconvex tablets marked with 'FT01' on one side and scored on the other. Available in bottles of 100 tablets.

Ingredients

Active ingredients:

Florinef tablets contain fludrocortisone acetate 0.1 mg.

Inactive ingredients:

  • lactose
  • lactose monohydrate
  • calcium hydrogen phosphate dihydrate
  • maize starch
  • magnesium stearate
  • purified talc
  • sodium benzoate.

Florinef tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Australian Registration Number:
AUST R 54688

This leaflet was revised in January 2019.

Published by MIMS March 2019

BRAND INFORMATION

Brand name

Florinef

Active ingredient

Fludrocortisone acetate

Schedule

S4

 

1 Name of Medicine

Fludrocortisone acetate.

2 Qualitative and Quantitative Composition

Florinef tablets contain 0.1 mg of fludrocortisone acetate.

Excipients with known effect.

Lactose, lactose monohydrate and sodium benzoate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White tablet, scored on one side and debossed 'FT 01' on the other 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 Florinef 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 Florinef 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. Florinef 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 Florinef 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 Florinef 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 nonimmune 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 Florinef 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, adrenocorticosteroid 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 hyperglycaemia; dosage of the antidiabetic drug should be adjusted if necessary.

Antitubercular drugs.

Isoniazid 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 hypokalaemia. 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 Florinef 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.

Nondepolarising muscle relaxants.

Corticosteroids may decrease or enhance the neuromuscular blocking action.

Nonsteroidal anti-inflammatory agents (NSAIDs).

Increased ulcerogenic effect; decreased pharmacological 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 hypoprothrombinaemia.

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 acneiform 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 angiitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes and anaphylactoid reactions.

4.9 Overdose

Chronic.

Development of hypertension, edema, hypokalaemia, significant increase in weight, and increase in heart size may be signs of excessive dosage of Florinef. When these are noted, administration of the drug should be discontinued, after which the symptoms will usually subside within several days; subsequent treatment with Florinef, 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

Lactose, calcium hydrogen phosphate dihydrate, maize starch, purified talc, lactose monohydrate, magnesium stearate and sodium benzoate.

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 at 2-8°C.

Storage instruction at time of dispensing.

On dispensing, the product can also be stored within the bottle below 25°C for a maximum of 3 months. The Start date (below 25°C) and Expiry date (below 25°C) sections on the product label must be filled in at the time of dispensing as a record for the patient. After this time discard all tablets that have not been refrigerated.

6.5 Nature and Contents of Container

The tablets are packed in an amber glass bottle, polypropylene cap with induction seal and cotton coiler. 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)

S4.

Summary Table of Changes