DESCRIPTION

Presentation

Aldocort tablet: Each tablet contains Fludrocortisone Acetate USP 0.10 mg.

Description

Fludrocortisone acetate is a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity.

Indications

Used for oral mineralocorticoid replacement therapy in:

– Primary and secondary adrenocortical insufficiency in Addison’s disease

– Salt losing adrenogenital syndrome

– Postural hypotension

Dosage & Administration

– 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.

Side Effects

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.

Precautions

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.

Use in Pregnancy & Lactation

Pregnancy: 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.

Drug Interaction

Interactions can occur with following drugs: Amphotericin B, potassium-depleting diuretics, anticholinesterases, anticoagulants, antidiabetics. Antitubercular drugs, cyclosporine, digitalis glycosides, oral contraceptives and ketoconazole .

Over Dose

Overdose is unlikely; however, treatment of overdose is by supportive and symptomatic therapy.

Storage

Store in a cool and dry place, protected from light.

Commercial Pack

Aldocort Tablet: Each box contains 3 blister strips of 10 tablets.