Indications: For partial replacement therapy for primary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenogenital syndrome. Dosage and method of administration: Daily dosage range of 0.05-0.3mg orally. Supplementary parenteral administration of sodium-retaining hormones is not necessary. When an enhanced glucocorticoid effect is desirable, cortisone or hydrocortisone by mouth should be given concomitantly. Paediatric population: One tablet (0.05 mg) to two tablets (0.1 mg) daily. Contraindications: Hypersensitivity to active substance or excipients. Systemic infections unless specific anti-infective therapy is employed. Use in treatment of conditions other than those indicated is not advised due to effect on sodium retention. Fludrocortisone acetate is a potent mineralocorticoid, dosage and salt intake should be monitored to avoid development of hypertension, oedema or weight gain. Periodic checking of serum electrolyte levels is advisable during prolonged therapy. Special warnings and precautions for use: Undesirable effects may be minimised by using the lowest effective dose for the minimum period. Frequent review is required to titrate the dose against disease activity. Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Taper withdrawal of corticosteroids after prolonged therapy over weeks or months to avoid acute adrenal insufficiency. Patients on long-term systemic therapy may require supportive corticosteroid therapy in times of stress during treatment and up to a year afterwards. If corticosteroids are stopped following prolonged therapy they may need reintroducing temporarily. Patients should carry treatment cards which give clear guidance on precautions to be taken and provides details of prescriber, drug, dosage and the duration of treatment. Suppression of inflammatory response and immune function increases susceptibility and severity of infections. Presentation may be atypical, serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised. Chickenpox, shingles and measles may be fatal in immunosuppressed patients. Advise patients to avoid exposure and to seek medical advice without delay if exposure occurs. Unless they have had chickenpox, patients receiving oral corticosteroids for purposes other than replacement are at risk of severe chickenpox. Manifestations include pneumonia, hepatitis and disseminated intravascular coagulation; rash may not be prominent. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 3 to 10 days of exposure. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped, and the dose may need increasing. Measles: Prophylaxis with normal immunoglobulin may be needed. Reduced antibody response affects response to vaccines. Live vaccines should not be administered. Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection, producing false negative results. Those with a history of, or X-ray changes characteristic of, tuberculosis. Emergence of active tuberculosis can be prevented by prophylactic use of anti-tuberculosis therapy. Chemoprophylaxis should be used in patients with latent tuberculosis or tuberculin reactivity who are taking corticosteroids. Caution in patients with nonspecific ulcerative colitis (with 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 may be reported. Blurred vision or other visual disturbances, may need referral to an ophthalmologist for evaluation of causes, including cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported. Effects may be enhanced in patients with hypothyroidism or cirrhosis or decreased in hyperthyroid patients. Diabetes may be aggravated, necessitating a higher insulin dosage. Latent diabetes mellitus may be precipitated. Menstrual irregularities may occur, mention this to female patients. Anaphylactoid reactions have occurred in patients receiving corticosteroids, especially those with a history of drug allergies. Aspirin should be used cautiously in patients with hypoprothrombinaemia. Prolonged use may produce posterior subcapsular cataracts or glaucoma, with possible damage to the optic nerve and may enhance the likelihood of secondary ocular infections. Caution in patients with ocular herpes simplex due to possible corneal perforation. Increased calcium excretion may predispose to, or aggravate pre-existing, osteoporosis. Warn patients/carers of potential severe psychiatric adverse reactions, typically emerging within days or weeks of starting treatment. Risk may increase with high doses/systemic exposure. Most reactions recover after dose reduction/withdrawal, specific treatment may be necessary. Encourage patient/carers to seek medical advice if psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected, and to be alert to psychiatric disturbances that may occur during or after dose tapering/withdrawal. Pre-existing emotional instability or psychosis may be aggravated. Use with caution in patients with, or with a history of, severe affective disorders, or who have a first-degree relative(s) with existing, or a history of, severe affective disorders, including depressive or maniac-depressive illness and previous steroid psychosis. Antidepressant drugs do not relieve and may exacerbate adrenocorticoid-induced mental disturbances. This product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This product contains sodium, 0.06 mg per tablet. Paediatric population: Corticosteroids can suppress growth. Growth and development should be carefully monitored. Dose-related growth retardation may be irreversible. Elderly: common adverse effects 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. Interactions: Amphotericin B injection and potassium-depleting agents, observe for hypokalemia. Effects of anticholinesterase agents may be antagonised. Corticosteroids may potentiate or decrease anticoagulant action and required monitoring. Corticosteroids antagonise the effects of antihypertensives and diuretics, enhancing the hypokalaemic effect of diuretics, including acetazolamide. Anti-tubercular drugs: Isoniazid serum concentrations may be decreased. Cyclosporin: Monitor for increased toxicity of cyclosporin when used concurrently. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, increases the risk of systemic side-effects and should be avoided unless the benefit outweighs the risk. Digitalis glycosides: Enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Oestrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased. A reduction in corticosteroid dosage may be required when oestrogen therapy is initiated, and an increase required when stopped. Hepatic Enzyme Inducers (e.g. aminoglutethemide, barbiturates, carbamazepine, phenytoin, primidone, rifabutin, rifampicin): possible increased metabolic clearance of Fludrocortisone acetate. Observe for diminished effect of steroid, adjust dosage accordingly. Human growth hormone: growth-promoting effect may be inhibited. Ketoconazole: Corticosteroid clearance may be decreased, resulting in increased effects. Corticosteroids may decrease or enhance the neuromuscular blocking action of non-depolarising muscle relaxants. Corticosteroids may increase the incidence/severity of GI bleeding and ulceration associated with Nonsteroidal anti-inflammatory agents (NSAIDS). Corticosteroids can reduce serum salicylate levels and therefore their effectiveness. Discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status may necessitate adjustment in adrenocorticoid dosage. Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated. Ability to drive/use machines: Not relevant. Fertility, pregnancy and lactation: It may be decided to continue a pregnancy in a woman requiring replacement mineralocorticoid therapy, despite the risk to the foetus. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Evidence of harmful effects in pregnancy in animals. Risk of cleft palate, intra-uterine growth retardation and hypoadrenalism in the neonate. Patients with pre-eclampsia or fluid retention require close monitoring. Breast-feeding: Corticosteroids are found in breast milk. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy or breast feeding should be observed for signs of hypoadrenalism. Document maternal treatment in the infant’s medical records to assist follow up. Undesirable effects: For full list of side effects consult SmPC. Very common (≥ 1/10): Hypokalaemia, cardiac failure congestive, hypertension. Common (≥ 1/100 to < 1/10): Headache, muscular weakness, oedema, swelling. Overdose: Hypertension, oedema, hypokalaemia, significant increase in weight, and increase in heart size may be signs of excessive dosage. Muscle weakness due to excessive potassium loss may develop and can be treated with potassium supplements. In case of symptoms of excessive dosage, discontinue administration of the drug. Symptoms usually subside within several days; subsequent treatment should be resumed at a reduced dose. Large, acute overdoses: treatment includes gastric lavage or emesis and usual supportive measures. A single large dose should be treated with plenty of water by mouth. Careful monitoring of serum electrolytes is essential, with particular consideration being given to the need for administration of potassium chloride and restriction of dietary sodium intake. MA number: PL 35533/0197. Cost: £13.60 for 0.05mg x 30. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG. Legal Category: POM. Date last reviewed: May 2024. Version number:  10106022309 v 1.0