Florinef (fludrocortisone)

How does it work?

Florinef tablets contain the active fludrocortisone, which is a type of medicine known as a corticosteroid. Corticosteroid medicines are derivatives of the corticosteroid hormones cortisol and aldosterone that are produced naturally by the adrenal glands. They are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.

Corticosteroids have many important functions on every organ system. They affect the strength of heart muscle and its response to natural chemicals affecting heart rate. They affect the water and salt balance in the body and also enable the body to cope with stress. Stress includes changes in temperature, pain, fear, anxiety and illness. This can be hazardous if the body is not equipped to cope due to low levels of corticosteroids. Corticosteroids allow us to respond to stress by increasing the rate and force of the heartbeat, increasing blood supply to essential tissues (muscle, heart, brain), increasing the body's supply of energy by raising blood sugar and by several other effects on body systems.

If the body's natural level of steroid hormones is too low because the adrenal glands are not producing enough hormones (a condition called adrenal insufficiency), this can cause various symptoms, such as dizziness, fatigue, weakness, gut symptoms, depression and joint and muscle pain. It can also lead to collapse and death if the body is put under stress. Low blood levels of corticosteroids must be treated with replacement therapy to allow the body to function normally.

Fludrocortisone is used as replacement therapy. It's action in the body is most similar to the natural steroid hormone aldosterone. It is normally used in combination with hydrocortisone tablets for complete replacement therapy. Hydrocortisone is used to replace the natural steroid hormone cortisol.

Fludrocortisone is also used to treat a disorder called salt-losing adrenogenital syndrome. In this syndrome there is abnormal production of natural steroid hormones by the adrenal glands and as a result, decreased production of natural aldosterone. Aldosterone is involved in regulating the salt and fluid balance in the body. If too little aldosterone is produced, this can cause too much salt (sodium) to be lost in the urine. Since fludrocortisone is similar to aldosterone, it can be used to treat this condition. It causes the kidneys to retain fluid and salt in the body.

Steroid replacement treatment is almost always lifelong.

What is it used for?

Inadequate production of natural steroid hormones by the adrenal glands (Addison's disease).

Hormonal disorder resulting from abnormal steroid production by the adrenal glands and associated with loss of salt in the urine (salt-losing adrenogenital syndrome).

Warning!

Florinef tablets should be stored at 2°C to 8°C in a refrigerator. Keep the container tightly closed and make sure it is out of the reach of children.

Florinef tablets should be taken in the morning to mimic the natural production of corticosteroids by the body. They should be taken after food to minimise irritation to the stomach.

You should not stop taking this medicine suddenly, particularly if you have been taking it for longer than three weeks, unless your doctor tells you otherwise. This is because your body becomes dependent on the medicine.

You will be given a steroid card with your medicine. The card contains details of your prescriber, type of steroid, dose taken and the duration of treatment. It's purpose is to act as a reminder that your medicine should not be stopped suddenly, and to provide information of your treatment to other people treating you. In case of an accident it explains that you are dependent on adrenal replacement, which is information that could save your life. You should carry the card with you at all times and show it to anyone who treats you (eg doctor, nurse, pharmacist, dentist, anaesthetist).

During times of physical stress, for example illnesses, trauma or surgery, your body would normally produce more steroid hormones to cope. This means that when you are having replacement therapy your steroid dose will normally need to be increased temporarily during these kind of events. Discuss this with your doctor.

Corticosteroids decrease the body's natural immune and inflammatory responses. They may increase your susceptibility to infections and can also mask the symptoms of infections, making you think they are less serious than they are. For this reason, it is important to consult your doctor if you get any signs of infection during treatment.

If you have never had chickenpox and are taking this medicine for purposes other than replacement therapy, you could be at risk of severe chicken pox and should avoid close personal contact with people who have chickenpox or shingles (herpes zoster). You should also avoid contact with people who have measles. If you are exposed you should consult your doctor urgently, as these diseases can be life-threatening in people who are taking long-term corticosteroids.

Corticosteroid treatment, especially with high doses, can alter mood and behaviour early in treatment. For this reason, it is important to let your doctor know if you notice any change in your mood or behaviour during treatment, particularly if you begin to feel depressed, or have any disturbing thoughts or feelings.

It is recommended that you have regular blood tests to monitor the levels of salts (electrolytes such as sodium) in your blood while you are taking this medicine.

Children having long-term treatment with this medicine should have their growth regularly monitored.

Use with caution in

Elderly people.

Children.

Kidney disease.

Liver failure.

Liver cirrhosis.

Recent surgical procedure involving the joining together of ends of the intestine after a section has been removed (intestinal anastomosis).

Painful inflammation of small sacs or pouches in the wall of the gut (diverticulitis).

Active peptic ulcer or history of peptic ulcer.

Inflammation of a vein associated with blood clot formation (thrombophlebitis).

Cancer that has spread from its original site to somewhere else in the body (metastatic carcinoma).

Abnormal muscle weakness .

Current severe psychiatric illness, or a personal or family history of psychiatric illness.

History of psychiatric illness caused by the use of a corticosteroid.

Osteoporosis.

Women who have passed the menopause.

Infections.

Dormant (currently inactive) tuberculosis infection.

Congestive heart failure.

High blood pressure .

Diabetes.

Underactive thyroid gland .

Increased pressure in the eye (glaucoma) or family history of the condition.

History of epilepsy.

History of muscle disorders (myopathy) caused by steroids.

History of allergies to medicines.

Low level of potassium in the blood (hypokalaemia).

Not to be used in

Untreated infection.

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Florinef tablets contain lactose).

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

Women taking this medicine for replacement therapy will need to continue treatment if they become pregnant, as the medicine is essential for the health of the mother. However, the medicine may slow the growth of the baby in the womb, or cause its adrenal glands to be underactive. The baby may need extra monitoring during the pregnancy and after birth. Women who develop pre-eclampsia or fluid retention during their pregnancy will need also extra monitoring. It is important to seek medical advice from your doctor before becoming pregnant if you need to keep taking this medicine.

Corticosteroids pass into breast milk. You should seek medical advice from your doctor before breastfeeding while taking this medicine. The presence of the corticosteroid in the milk could cause a decrease in the natural production of steroid hormones by the infant's adrenal glands.

Label warnings

Follow the printed instructions you have been given with this medication.

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