
Incepta Pharmaceuticals Ltd. · Tablet
/ Piece
Detailed scientific information regarding the indications, dosage, potential side effects, and guidelines for use during pregnancy of Aldocort or the Fludrocortisone Acetate group is provided below. Always consult a specialist physician before taking any medication.
Fludrocortisone Acetate is used for oral mineralocorticoid replacement therapy in:
Primary and secondary adrenocortical insufficiency in Addison’s disease
Salt losing adrenogenital syndrome
Postural hypotension
Fludrocortisone binds the mineralocorticoid receptor (aldosterone receptor). This binding (or activation of the mineralocorticoid receptor by fludrocortisone) in turn causes an increase in ion and water transport and thus raises extracellular fluid volume and blood pressure and lowers potassium levels.
Primary and secondary Adrenocortical Insufficiency in Addison’s disease: Usual dose may range from 0.2 mg 3 times weekly to 0.2 mg daily. If hypertension occurs, reduce dosage to 0.05 mg daily. Administer concomitantly with Cortisone or hydrocortisone.Salt-Losing Adrenogenital Syndrome: 0.1 to 0.2 mg/day.Postural Hypotension: 0.1-0.4 mg daily to diabetic patients with postural hypotension; 0.05-0.2 mg daily to patients with postural hypotension secondary to Levodopa therapy.
Interactions can occur with following drugs: Amphotericin B, potassium depleting diuretics, anticholinesterases, anticoagulants, antidiabetics. Antitubercular drugs, cyclosporine, digitalis glycosides, oral contraceptives and ketoconazole .
Most adverse reactions are caused by the drug’s mineralocorticoid activity (retention of sodium andwater) include erythema, purpura, vertigo, pancreatitis, increased intraocular pressure, muscular weakness, hypertension, edema, cardiac enlargement, congestive heart failure, steroid myopathy, peptic ulcer, osteoporosis, convulsions, menstrual irregularities, potassium loss, hypokalemic alkalosis, allergic and anaphylactic reaction etc. When Fludrocortisones is used in the small dosages recommended, side effects are not usually a problem; however the above mentioned unwanted effects should be kept in mind, particularly when Fludrocortisones is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid.
Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fludrocortisone is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.Lactation: There are no data on the excretion of fludrocortisone into human milk. However, corticosteroids (systemic therapy) are distributed into breast milk and could cause growth suppression and/or other adverse effects in nursing infants. The manufacturer recommends that caution be used when administering Fludrocortisone to nursing women.
Because of its marked effect on sodium retention, the use of Fludrocortisone in the treatment of conditions other than those indicated herein is not advised. Fludrocortisone should be used with caution in patients suffering from different infections (like tuberculosis, measles, chicken pox, herpes zoster or threadworm infestation), congestive cardiac failure, hypertension, renal insufficiency, osteoporosis, drug-induced secondary adrenocortical insufficiency, peptic ulcer, intestinal anastomosis and ulcerative colitis.
Corticosteroid
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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