Florinef Special Precautions

Fludrocortisone acetate is a potent mineralocorticoid and is used predominantly for replacement therapy. Although glucocorticoid side effects may occur, these can be reduced by reducing the dosage.
Undesirable effects may be minimised using the lowest effective dose for the minimum period. Frequent patient review is required to titrate the dose appropriately against disease activity (see Dosage & Administration).
Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. Patients on long-term systemic therapy with Fludrocortisone acetate may require supportive corticosteroid therapy in times of stress (such as trauma, surgery or severe illness) both during the treatment period and up to a year afterwards. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.
Patients should carry steroid treatment cards which give clear guidance on the precautions to be taken to minimise risk and which provides details of prescriber, drug, dosage and the duration of treatment.
Anti-inflammatory/immunosuppressive effects: Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.
Chickenpox, shingles and measles are of particular concern since these illnesses may be fatal in immunosuppressed patients. Patients should be advised to avoid exposure to these diseases, and to seek medical advice without delay if exposure occurs.
Chickenpox: Unless they have had chickenpox, patients receiving oral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should preferably be given within 3 days of exposure, and not later than 10 days after exposure to chickenpox. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.
Measles: Prophylaxis with normal immunoglobulin may be needed.
During corticosteroid therapy antibody response will be reduced and therefore affect the patient's response to vaccines. Live vaccines should not be administered.
Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection, producing false negative results.
Tuberculosis: Those with a previous history of, or X-ray changes characteristic of, tuberculosis. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of anti-tuberculosis therapy.
Chemoprophylaxis should be used in patients with latent tuberculosis or tuberculin reactivity who are taking corticosteroids.
Corticosteroids should be used with caution in patients with the following conditions: nonspecific ulcerative colitis (if there is a probability of perforation, abscess, or other pyogenic infection); recent intestinal anastomoses; diverticulitis; thrombophlebitis; existing or previous history of severe affective disorders (especially previous steroid psychosis); exanthematous disease; chronic nephritis or renal insufficiency; metastatic carcinoma; osteoporosis (post-menopausal females are particularly at risk); in patients with an active or latent peptic ulcer (or a history of peptic ulcer); myasthenia gravis; latent or healed tuberculosis, in the presence of local or systemic viral infection, systemic fungal infections or in active infections not controlled by antibiotics; in acute psychoses, in acute glomerulonephritis; hypertension, congestive heart failure; glaucoma (or a family history of glaucoma), previous steroid myopathy or epilepsy. Liver failure.
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.
Corticosteroid effects may be enhanced in patients with hypothyroidism or decreased in hyperthyroid patients.
Corticosteroid effects may be enhanced in patients with cirrhosis.
Diabetes may be aggravated, necessitating a higher insulin dosage. Latent diabetes mellitus may be precipitated.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Menstrual irregularities may occur, and this possibility should be mentioned to female patients.
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of drug allergies.
Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts or glaucoma, with possible damage to the optic nerve. Prolonged use may also enhance the likelihood of secondary ocular infections.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
All corticosteroids increase calcium excretion, which may predispose to osteoporosis or aggravate pre-existing osteoporosis.
Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see Adverse Reactions). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure, although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Pre-existing emotional instability or psychosis may also be aggravated by corticosteroids. Fludrocortisone should be used with caution in patients with, or with a previous history of, severe affective disorders. Fludrocortisone should also be used with caution in patients who have a first degree relative(s) with any existing, or previous history of, severe affective disorders. Specifically, these include depressive or maniac-depressive illness and previous steroid psychosis. The use of antidepressant drugs does not relieve and may exacerbate adrenocorticoid-induced mental disturbances.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.
Effects on ability to drive and use machines: Not relevant.
Use in Children: Because corticosteroids can suppress growth, the growth and development of infants, children and adolescents on prolonged corticosteroid therapy should be carefully monitored. Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible.
Use in the Elderly: The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.