Mineralocorticoid therapy, substitution in primary adrenocortical insufficiency, primary or secondary etiology, in association with glucocorticoid
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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 of age, 50 to 200 micrograms per 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 section 4.4). And precautions for use).

The dosage should be regularly re-evaluated in the course of treatment.

Mode of administration

Oral use.

In children under 6 years of age, the tablets will be crushed and dissolved, preferably in fruit juice or water, at room temperature and then mixed and administered immediately.

Scored tablet.

Oblong tablet with a bar of fracture on each side and engraved with two hearts on one single side

The tablet can be divided into two equal half-doses.

Class: Pharmacotherapeutic: MINERALOCORTICOIDS, Code: ATC: H02AA02 (fludrocortisone)
(H: systemic hormones, except for sex hormones and insulins)

Fludrocortisone has an important mineralocorticoidal activity and a non-negligible glucocorticoidal activity greater than that of cortisol. However, the glucocorticoid effects of fludrocortisone are not sufficient at therapeutic doses to be administered alone in the adrenal cortex. A glucocorticoid must always be associated.

Orally, at therapeutic doses, fludrocortisone is at the origin, a sodium retention and an increase in urinary excretion of potassium and ions, hydrogen, it causes a rise in blood pressure And weight gain.

At supratherapeutic doses, fludrocortisone inhibits adrenal gland secretions, pituitary corticotropin excretion and thymus activity. It causes an accumulation of hepatic glycogen and a negative nitrogen balance.

Not applicable.

Hypersensitivity to fludrocortisone or any of the excipients

In the case of secondary adrenocortical insufficiency, mineralocorticoid substitution is not systematic and its usefulness is assessed on clinical and biological data

At the recommended doses for fludrocortisone, warnings and precautions for use of corticosteroids are not justified.
Because of the mineralocorticoid effect of fludrocortisone, salt intake should be adapted to the dosage.


Potassium supplementation may be necessary. Regular monitoring of electrolytes, serum and plasma renin activity, as well as clinical monitoring (blood pressure, edema, weight gain, muscle fatigue) are required to periodically reassess the dosage. >

The presence of hypertension and / or edema, tachycardia, or a significant decrease in plasma renin activity are all signs that may result in an overdose of fludrocortisone which should lead to a decrease in dose.

Fludrocortisone should be used with caution in patients with severe arterial hypertension, poorly balanced, and severe heart failure.
Replacement therapy with fludrocortisone should not be interrupted.

Fludrocortisone should be used with caution in the case of concomitant drug therapy with anticonvulsants, enzymatic inducers, digitalis, rifampicin, medicines capable of giving torsades de pointes, or causing hypokalaemia (see section Interactions with Other drugs and other forms of interactions)

Athletes: attention will be drawn to the fact that this specialty contains an active ingredient which can induce a positive reaction of the tests performed during the antidoping tests
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Associations subject to precautions for use

+ Anticonvulsants inducers, enzymatic (carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone)

Decreased plasma concentrations and the effectiveness of corticosteroids by increasing their hepatic metabolism by the inducer: the consequences are particularly important in the addisonians treated with hydrocortisone and in the case of transplantation. Br>

Clinical and biological monitoring and adaptation of dosage of corticosteroids during inducer treatment and after discontinuation

+ Rifampicin

Decreased plasma concentrations and corticosteroid efficacy by increasing their hepatic metabolism by rifampicin: the consequences are particularly important in the addisonians treated with hydrocortisone and in the case of transplantation. >

Clinical and biological monitoring and adaptation of dosage of corticosteroids during treatment with rifampicin and after discontinuation

Associations to be taken into account

+ Antihypertensive drugs

Decreased antihypertensive effect (hydrosodic retention of corticosteroids).

Not applicable.

In the event of a massive overdose, symptomatic treatment should be instituted, in particular to correct the hydroelectrolytic disorders, water and potassium administration, restriction, sodium, monitoring the plasma ionogram and blood pressure for at least 48 hours is recommended.

Pregnancy

Clinically, there is currently no adequate data to evaluate a possible malformative or foetotoxic effect of fludrocortisone when administered during pregnancy. Animal studies have shown reproductive toxicity.

However, given the indication, fludrocortisone may be prescribed during pregnancy if necessary. Maternal adrenocortical insufficiency should be treated, during pregnancy, by adjusting the dosage of fludrocortisone, if necessary (see Warnings and Precautions for Use). Treatment with fludrocortisone should be stopped in case of toxemia gravidae

A period of clinical monitoring (weight, diuresis) and biological (ionogramme, plasma) of the newborn should be put in place.
Breastfeeding

In the absence of data on the passage through the milk of this medicament, it is preferable to avoid breastfeeding, in case of breastfeeding, regular monitoring of the newborn should be started. Code>
The adverse reactions observed during treatment with fludrocortisone at the usual therapeutic doses mainly result from its mineralocorticoid activity, hydrosodic retention, hypokalaemia, and disappear after dose adjustment (search for the lowest effective dose).

Glucocorticoid-type adverse reactions are rarely observed in fludrocortisone replacement therapy because even at the maximum dosage of 300 μg per day it is a low equivalent of hydrocortisone in term, Glucocorticoid activity.

Disturbance of the balance sheet, hydro-electrolyte

· Hypokalemia, hypokalemic alkalosis.

· Hydrosoded retention.

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


Headache: headache may occur in connection with increased arterial tension

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

Cardiovascular system disorders

Heart failure: Heart failure may occur at initiation of glucocorticoid and mineralocorticoid therapy in patients with insufficient adrenal cortex, the mechanisms would be
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O persistence in the inadequate, corticosurrenal of a regulatory process, renal to compensate for sodium loss and fluid retention

O iatrogenic hypertension when introducing the exogenous mineralocorticoid

After reduction of the fludrocortisone dose, or even its temporary discontinuation, after normalization, fludrocortisone will be reintroduced at progressively increasing doses.
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· High blood pressure: Due to the high mineralocorticoid potency of fludrocortisone, decreased sodium excretion and increased extracellular blood volume can occur and lead to high blood pressure. Hypertension may also occur independently of the sodium balance or the plasma volume.
Peripheral edema (limbs) and weight gain due to hydrosodic retention

Osteo-muscular disorders

· Muscle weakness, cramps, myalgia: these effects are the clinical consequence of hypokalaemia which may be induced by the mineralocorticoid action of fludrocortisone.
Gastrointestinal disorders

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

Mineralocorticoid therapy, substitution in primary adrenocortical insufficiency, primary or secondary etiology, in association with glucocorticoid
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