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Florinef

Florinef

fludrocortisone

Manufacturer:

Aspen Pharmacare Asia

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Fludrocortisone acetate
Indications/Uses
Partial replacement therapy for primary adrenocortical insufficiency in Addison's disease. Treatment of salt-losing adrenogenital syndrome.
Dosage/Direction for Use
Adult 0.05-0.3 mg daily. Paed patient 0.05-0.1 mg daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Systemic infections unless specific anti-infective therapy is employed. Use is not advised in the treatment of conditions other than those indicated.
Special Precautions
Marked effect on Na retention. Periodic checking of serum electrolyte levels is advisable during prolonged therapy. Adrenal cortical atrophy develops during prolonged therapy & may persist for yr after stopping treatment. Gradual w/drawal after prolonged therapy to avoid acute adrenal insufficiency & taper off over wk or mth according to dose & duration of treatment. Suppression of inflammatory response & immune function increases susceptibility to infections & their severity. Caution in the event of exposure to chickenpox, measles or other communicable diseases. Reduced Ab response during therapy. Do not administer live vaccines. Effects may be enhanced in hypothyroid patients or decreased in hyperthyroid patients. Effects may be enhanced in patients w/ cirrhosis. Diabetes may be aggravated. Menstrual irregularities may occur. Risk of visual disturbance. Prolonged use may produce posterior subcapsular cataracts or glaucoma, w/ possible damage to optic nerve, & may enhance likelihood of secondary ocular infections. Caution in patients w/ ocular herpes simplex. Increased Ca excretion, which may predispose to osteoporosis or aggravate pre-existing osteoporosis. Potentially severe psychiatric adverse reactions may occur. Pre-existing emotional instability or psychosis may be aggravated. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Caution in patients w/ nonspecific ulcerative colitis; recent intestinal anastomoses; diverticulitis; thrombophlebitis; existing or previous history of severe affective disorders; exanthematous disease; chronic nephritis or renal insufficiency; metastatic carcinoma; osteoporosis; active or latent, or history of peptic ulcer; myasthenia gravis; latent or healed TB; local or systemic viral infection; systemic fungal infections; active infections not controlled by antibiotics; acute psychoses; acute glomerulonephritis; HTN, CHF; existing or family history of glaucoma; previous steroid myopathy or epilepsy; liver failure. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy or breastfeeding should be carefully observed for signs of hypoadrenalism. Dose-related growth retardation in infancy, childhood & adolescence.
Adverse Reactions
Hypokalaemia; cardiac failure congestive; HTN. Headache; muscular weakness; oedema, swelling.
Drug Interactions
Risk of hypokalemia w/ amphotericin B inj & K-depleting agents. Antagonised effects of anticholinesterase agents; antihypertensives & diuretics. Potentiated or decreased action of anticoagulants. Corticosteroids may increase blood glucose; diabetic control should be monitored. Enhanced hypokalaemic effect of diuretics, including acetazolamide. Decreased serum conc of INH. Increased toxicity of cyclosporine. Increased risk of systemic side effects w/ CYP3A inhibitors, including cobicistat-containing products. Enhanced possibility of arrhythmias or digitalis toxicity associated w/ hypokalemia. Increased conc & decreased clearance w/ oestrogens, including OCs. Increased metabolic clearance w/ hepatic enzyme inducers (eg, aminoglutethimide, barbiturates, carbamazepine, phenytoin, primidone, rifabutin, rifampicin). Inhibited growth-promoting effect of human growth hormone. Decreased clearance w/ ketoconazole. Decreased or enhanced neuromuscular blocking action of nondepolarising muscle relaxants. Increased incidence &/or severity of GI bleeding & ulceration associated w/ NSAIDs. Reduced serum levels of salicylates. Discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction w/ corticosteroids in patients w/ hypoprothrombinaemia. Metabolic clearance is decreased in hypothyroid patients & increased in hyperthyroid patients. Neurological complications & lack of Ab response may occur when patients taking corticosteroids are vaccinated.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AA02 - fludrocortisone ; Belongs to the class of mineralocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Florinef tab 0.1 mg
Packing/Price
100's
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