DEFLAN ® Deflazacort

DEFLAN ® a drug based on Deflazacort

THERAPEUTIC GROUP: Non-associated systemic corticosteroids

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications DEFLAN ® Deflazacort

DEFLAN ® is indicated in the treatment of all those pathological conditions on an inflammatory basis, for which hormonal therapy with corticosteroids is required.

Classic examples are rheumatic diseases, dermatological diseases, eye diseases, respiratory diseases, gastro-intestinal inflammatory diseases and hematological disorders with malignant evolution.

Mechanism of action DEFLAN ® Deflazacort

DEFLAN ® is a drug based on systemic corticosteroids, and more specifically of deflazacort, a drug that is taken orally and rapidly absorbed at the intestinal level and metabolised to its active metabolites.

The latter, particularly concentrated at the renal and haematological level, in a similar way to prednisolone, but with an efficacy about 10-20 times higher, inhibit the enzyme phospholipase A2, reducing the cellular availability of arachidonic acid and its metabolites. inflammatory drugs such as leukotrienes, prostaglandins and prostacyclines.

Its biological action therefore coincides with an important anti-inflammatory effect, particularly useful in the management and control of the evolution of chronic inflammatory manifestations.

Once the biological activity of these active substances derived from deflazacort has ceased, the relative metabolites are eliminated mainly via the kidneys in about 24 hours.

Studies carried out and clinical efficacy

1. DEFLAZACORT, STATE OF THE ART

The numerous side effects of conventional therapies with systemic corticosteroids have led to the search for new active ingredients. The deflazacort born on this trail, seems to be able to reduce some adverse reactions such as osteoporosis and loss of lean mass, applying to use in pediatric settings. However, a literature limited mainly to experimentation in dystrophic pathologies does not allow us to fully understand the potential of this molecule.

2. STEROIDS AND DEUCHENNE PATHOLOGY

The administration of steroids has proved useful in delaying the natural progression of the disease, safeguarding muscular strength and motor function from the deterioration induced by deuchenne dystrophy.

3. DEFLAZACORT AND GROWTH

This important study shows that deflazacort therapy, rather than methylprednisone therapy, in pediatric patients undergoing kidney transplantation, may favor better growth with a linear increase in lean mass and reducing the risk of bone fractures.

Method of use and dosage

DEFLAN ® tablets of 6 - 30 mg of Deflazacort or oral drops of 22.75 mg of deflazacort per ml of solution:

given the wide range of useful dosages, generally between 6 and 90 mg of daily deflazacort, and the variable need for this medicine, the specific dose should be defined by your doctor after a careful evaluation of the physio-pathological and clinical status of the patient.

During the therapy the dosage could be subject to modifications useful to maintain the initial therapeutic effects.

Warnings DEFLAN ® Deflazacort

Systemic corticosteroid therapy could significantly reduce the efficacy of immunization therapies, making their protective effects practically ineffective and increasing the risk of infections.

The prolonged therapy instead could determine the onset of secondary adrenal insufficiency, manageable through a gradual reduction of deflazacort doses, and a hyperglycemic effect such as to require a further adjustment of the doses of hypoglycemic agents, in the case of diabetic patients.

The psychic and neurological alterations induced by corticosteroid therapy could make the use of machinery and the driving of vehicles dangerous, further aggravating the health conditions of neurological or psychiatric patients.

DEFLAN ® tablets contain lactose, so they should not be taken by patients who are lactose intolerant or have lactase deficiency and glucose-galactasoio malabsorption.

PREGNANCY AND BREASTFEEDING

The lack of statically significant experimental and clinical data does not allow defining the safety profile of deflazacort for fetal and infant health.

Consequently the intake of DEFLAN ® during pregnancy and lactation should be carried out only in case of actual need and under strict medical supervision.

Interactions

Despite the scientific literature does not describe particularly serious pharmacological interactions from the clinical point of view, it is necessary to consider that deflazacort, like other systemic corticosteroids, can interact with various active ingredients such as anticonvulsants, antibiotics, anticoagulants, bronchodilators, antacids and non-systemic anti-inflammatory drugs, determining important variations from the pharmacokinetic point of view.

Medical supervision is therefore also important in predicting such interactions and adjusting the dosage.

Contraindications DEFLAN ® Deflazacort

DEFLAN ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, in case of active tuberculosis, peptic ulcer, simplex ocular herpes, systemic fungal infections and psychosis.

Undesirable effects - Side effects

The side effects of systemic corticosteroid therapy become particularly evident especially after prolonged therapies or the use of high doses.

Despite the reduced mineralocorticoid properties of deflazacort, the administration of DEFLAN ® could be accompanied by alterations of the hydro-electrolyte balance with an increased risk of hypertension and heart failure, alterations of bone and muscle metabolism with relative fragility, peptic ulcers and gastro-intestinal pathologies, endocrine, metabolic and neurological disorders.