Medicinal Products

ADIXON 50 micrograms

Generic drug of the therapeutic class: Anti-inflammatories
Active ingredients: Fludrocortisone
laboratory: Primus Lab Ltd

Tablet breackable
Box of 60
All forms

Indication

Mineralocorticoid replacement therapy in primary adrenocortical insufficiency of any etiology, or secondary, in combination with a glucocorticoid.

Dosage ADIXON 50 micrograms Breakable tablet Box of 60

Dosage

Newborn and during the first year: 50 to 200 micrograms per day, and exceptionally 200 to 300 micrograms per day.

Adult and child over 2 years old: 50 to 200 micrograms a day.

The dosage of fludrocortisone should be adjusted according to blood pressure, serum potassium, serum sodium and plasma renin activity which should be within the upper limit of normal (see Warnings and Precautions section). ).

The dosage should be regularly reassessed during treatment.

Administration mode

Oral way.

In children less than 6 years old, the tablets will be crushed and dissolved, preferably in fruit juice or in room temperature water, then mixed and administered immediately.

Against indications

Hypersensitivity to fludrocortisone or to any of the excipients.

Adixon Adverse Effects

The undesirable effects observed during treatment with fludrocortisone at the usual therapeutic doses essentially result from its mineralocorticoid activity: water-soluble retention, hypokalemia; they disappear after adjustment of the dosage (search for the lowest effective dose).

Glucocorticoid-related adverse effects are rarely observed during fludrocortisone replacement therapy, because even at the maximum dose of 300 μg per day it is a low equivalent of hydrocortisone in terms of glucocorticoid activity.

Disturbances of the hydro-electrolytic balance

· Hypokalemia, hypokalemic alkalosis.

· Hydrosoduced retention.

These effects are related to the mineralocorticoid action of fludrocortisone; they require dose adjustment or potassium supplementation.

Nervous system disorders

· Headache: Headaches may occur in connection with an increase in blood pressure.

· Neuropsychic effects: euphoria, excitement. These effects have been very rarely observed.

Cardiovascular system disorders

· Heart failure: Heart failure may occur during initiation of glucocorticoid and mineralocorticoid therapy in patients with adrenocortical insufficiency; the mechanisms would be:

o persistence in adrenocortical insufficiency of a renal regulation process to compensate for sodium loss and fluid retention,

o iatrogenic hypertension during the introduction of the exogenous mineralocorticoid.

Heart failure recedes after a decrease in the dose of fludrocortisone, or even its temporary arrest; after normalization, fludrocortisone will be reintroduced in progressively increasing doses.

· Hypertension: Due to the high mineralocorticoid potency of fludrocortisone, decreased sodium excretion and increased extracellular blood volume may occur and lead to high blood pressure. Hypertension can also occur independently of the sodic balance or plasma volume.

· Peripheral edema (lower limbs) and weight gain due to fluid retention.

Osteo-muscular disorders

· Muscle weakness, cramps, myalgia: these effects are the clinical consequence of the hypokalemia which can be induced by the mineralocorticoid action of fludrocortisone.

Gastrointestinal disorders

· Gastrointestinal disorders of moderate intensity very rarely observed (dyspepsia).

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