FLUDROCORTISONE ACETATE Tablet Ref.[6846] Active ingredients: Fludrocortisone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Therapeutic indications

For partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenogenital syndrome.

Posology and method of administration

Adults

A daily dosage range of 0.05-0.3mg Fludrocortisone Acetate tablets 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 with Fludrocortisone Acetate tablets.

Elderly

No specific dosage recommendations (See 4.4 Precautions).

Children

May be used adjusted to the age and weight of the child according to the severity of the condition. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases. (See 4.3 Contraindications).

Overdose

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.

Shelf life

24 months.

Special precautions for storage

Store below 30°C. Store in the original package in order to protect from light.

Nature and contents of container

PVC/PVdC/Al blisters. Available in pack sizes of 30, 50 and 100 tablets.

Special precautions for disposal and other handling

No special requirement.

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