FLANTADIN ® Deflazacort

FLANTADIN ® a drug based on Deflazacort

THERAPEUTIC GROUP: Unassociated systemic corticosteroids


Indications FLANTADIN ® Deflazacort

FLANTADIN ® is used in the treatment of dermatological, systemic, respiratory, ocular, haematological and gastro-intestinal inflammatory pathologies.
FLANTADIN ® can also be used in the treatment of allergic diseases and in case of primary or secondary adrenal insufficiency, in conjunction with mineralocorticoids.

FLANTADIN ® Deflazacort mechanism of action

Defazacort, the active ingredient of FLANTADIN ®, is a synthetic corticosteroid characterized by a much higher therapeutic efficacy than cortisol or prednisolone with a lower incidence and severity of side effects.
Taken orally, it is rapidly absorbed in the gastrointestinal tract and metabolized into its active metabolites, which are concentrated mainly in blood and vascular cells, inhibiting the enzyme phospholipase A2.
The therapeutic efficacy of this active principle is to be traced back to the aforementioned activity, useful for reducing the availability of arachidonic acid and the synthesis of inflammatory mediators such as leukotrienes, prostaglandins and prostacyclines, thus preventing both vascular modifications and the recruitment of cells. inflammatory.
The upstream inhibition of the inflammatory chain sustained by arachidonic acid derivatives prevents the important tissue damaging effects of the massive activation of the inflammatory process.
Once the biological activity is over, the metabolites are eliminated, in the 24 hours following the oral assumption, by the kidney.

Studies carried out and clinical efficacy

1. DEFLAZACORT AND DEUCHENNE DYSTROPHY

J Child Neurol. 2010 Sep; 25: 1116-29. Epub 2010 Jun 25.

Change in natural history of Duchenne muscular dystrophy with long-term corticosteroid treatment: implications for management.

Moxley RT 3rd, Pandya S, Ciafaloni E, Fox DJ, Campbell K.


Long-term administration of corticosteroids in Deuchenne disease has been shown to be useful in: prolonging walking for 2 to 5 years, reducing the need for surgery, improving cardiovascular function and improving the quality of life of affected patients.


2. DEFLAZACORT AND EPILEPSY

Epilepsy Res. 2008 Sep; 81: 80-5. Epub 2008 Jun 3.

A comparative study of hydrocortisone versus deflazacort in drug-resistant epilepsy of childhood.

Grosso S, Farnetani M, Mostardini R, Cordelli D, Berardi R, Balestri P.


Defazacort was as effective as other corticosteroids in the treatment of intractable epilepsy, but with a significant reduction in the incidence of side effects. This medicine should be considered as a possible therapeutic approach.


3. DEFLAZACORT AND HEPATITIS

J Korean Med Sci. 2006 Aug; 21: 758-60.

Deflazacort for type-1 autoimmune hepatitis in a Korean girl.

Bae SH, Kim JS, Kim DH.


Experimental study that has shown how the treatment of autoimmune hepatitis with deflazacort, can lead, in quite long periods of treatment, to a complete histological remission of the pathological picture.

Method of use and dosage

FLANTADIN ® Deflazacort 6 - 30 mg tablets or deflazacort 22.75 mg oral drops per ml of solution:
although it is possible to indicate a range of application, between 6 and 90 mg of deflazacort per day, the formulation of the specific dosage is the exclusive competence of the doctor, who should establish this value only after a "careful evaluation of the patient's physical condition and its clinical picture.
Medical supervision throughout the therapeutic treatment is also important in the eventual need to vary the doses used, in order to keep the anti-inflammatory effect active.

FLANTADIN ® Deflazacort warnings

To avoid the onset of important side effects it is advisable for the doctor to carefully evaluate all potential risk factors, providing for any corrections to the normal therapeutic procedure.
Striking examples are represented by diabetic patients, for whom corticosteroid therapy should be accompanied by an adjustment of the dosage of hypoglycemic agents, to cope with the hyperglycemic effect of these hormones, or by patients suffering from neurological or psychiatric pathologies, for which therapy with FLANTADIN ® could aggravate the clinical picture, or in patients undergoing immunizing therapy, who would see the protective effect vanish following the intake of corticosteroids.
Furthermore, prolonged intake over time could lead to secondary adrenal insufficiency, or peptic ulcers.
Dizziness, headache, altered perceptive abilities are just some of the neurological symptoms associated with deflazacort therapy, which could make the use of machinery and driving vehicles dangerous.


PREGNANCY AND BREASTFEEDING

The use of FLANTADIN ® during pregnancy and breastfeeding should be avoided or in any case limited to cases of real need, under the strict supervision of a doctor.
The absence of studies at the moment does not allow to predict the potential side effects on the health of the unborn child and infant.

Interactions

The concomitant intake of anticonvulsants, antibiotics, anticoagulants, bronchodilators, antacids and non-systemic anti-inflammatory drugs, could lead to the appearance of pharmacokinetically important alterations, such as to require a possible adjustment of the dosage.
Fortunately, no interactions are described that would lead to clinically relevant effects.

Contraindications FLANTADIN ® Deflazacort

FLANTADIN ® contraindicated in case of hypersensitivity to the active substance or to one of its excipients, in case of active tuberculosis, peptic ulcer, ocular herpes simplex, systemic mycotic infections and psychosis.

Undesirable Effects - Side Effects

Although deflazacort was born with the main objective of reducing side effects on the osteo-muscular system, prolonged therapies over time and at high doses can be associated with hydro-electrolytic alterations with an increased risk of hypertension and heart failure, with insufficiency adrenal and endocrine alterations of various kinds, neurological and psychiatric decompensation, negative nitrogen balance and bone and muscle fragility.

Note

FLANTADIN ® sold only under medical prescription.

The use of FLANTADIN ® without therapeutic need during sports competitions constitutes doping.


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