DECADRON ® Dexamethasone

DECADRON ® a dexamethasone based drug

THERAPEUTIC GROUP: Non-associated corticosteroids

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

Indications DECADRON ® Dexamethasone

DECADRON ® is indicated in the treatment of all those inflammatory and allergic manifestations that require hormone therapy based on corticosteroid hormones.

Particularly intense allergic manifestations, rheumatic, dermatological, ophthalmologic diseases, adrenal endocrine disorders, respiratory diseases, haematological and neoplastic diseases are the main fields of clinical application of dexamethasone.

Mechanism of action DECADRON ® Dexamethasone

Dexamethasone is a synthetic corticosteroid, functionally analogous to endogenous cortisol and cortisone hormones, but characterized by more targeted pharmacokinetic and therapeutic properties, with more modest side effects.

The application in the clinical field of these molecules is justified by the important anti-inflammatory activity that is carried out through the induction of the lipocortin enzyme, capable of inhibiting phospholipase A2 and the downstream cascade that leads, through lipoxygenase enzymes and oxygenase cycle, to production of inflammatory mediators, and to antiallergic activity, probably due to the ability of dexamethasone to inhibit protein synthesis, resulting in a significant decrease in the production of antibodies and the number of lymphocytes, eosinophils and basophils.

The rapid gastro-intestinal absorption, and the relative bio-distribution concentrated above all at the vascular and platelet level, makes the dexamethasone therapy particularly easy and decidedly effective, although responsible for several side effects associated with the complex biological mechanism of action.

Studies carried out and clinical efficacy

1. DESAMETASONE AND RISTENOSIS

Restenosis is a very frequent pathophysiological event, probably due to an exaggerated inflammatory reaction associated with vascular damage, which reduces the effectiveness of coronary interventions. This preliminary study shows that dexamethasone in situ can reduce the inflammatory process, preventing the appearance of restenosis.

2. DESAMETASONE AND INFLAMMATORY MYOSITIS

The use of high-dose dexamethasone therapeutic protocols in the treatment of inflammatory myositis was found to be as effective as conventional therapy but characterized by a reduced number of side effects.

3. DESAMETASONE AND VARIABILITY OF THE THERAPEUTIC SCHEME

Example study showing different dosages and therapeutic schemes based on dexamethasone, may be more or less effective in different clinical conditions. Even from these evidences the need arises to formulate a specific dosage for each case.

Method of use and dosage

DECADRON ® tablets of 0.5 - 0.75 mg of dexamethasone

the definition of the correct dosage is a highly specialized task, which is the responsibility of the physician after carefully evaluating the patient's state of health, his clinical picture, his ability to respond to hormonal therapy and having defined the therapeutic goals.

The range of application is very varied, including dosages ranging from 0.5 mg of dexamethasone per day up to 10 mg / day, and especially variable over time based on the therapeutic response observed in the patient and the possible presence of side effects.

For this reason, medical supervision is essential not only in the initial stages of treatment but throughout the therapeutic process.

Warnings DECADRON ® Dexamethasone

The whole duration of the therapy, from the definition of the dosage to the suspension of the intake, must be carefully monitored by a doctor, in order to minimize the appearance of side effects and safeguard the patient's state of health.

Periodic monitoring of blood pressure, saline concentrations, glucose metabolism, prothrombin time, liver and kidney function and gastro-intestinal health status may be necessary to assess the safety of drug treatment.

Dexamethasone intake could worsen the symptoms of neurological and psychiatric patients, contribute to hyperglycaemia in diabetic patients and reduce the preventive efficacy of immunization protocols.

The numerous adverse reactions affecting the nervous system, such as to significantly reduce the patient's perceptive capacities, could make the use of machinery, the driving of vehicles and all other possible activities that require an intellectual commitment dangerous.

PREGNANCY AND BREASTFEEDING

The absence of studies concerning the potential effects of corticosteroid therapy on the health of the fetus, when taken during pregnancy, does not yet allow us to establish the true risk profile of these medicines.

However, the use of these hormones during pregnancy, which should occur in case of real need and under strict medical control, must necessarily be followed by accurate checks and assessments to exclude hypoadrenalism in the newborn.

Interactions

Various anticonvulsants, antibiotics, anticoagulants, bronchodilators, antacids and non-systemic anti-inflammatory drugs are partly responsible for pharmacokinetic changes in corticosteroid hormones that require an adjustment of the dosage.

Monitoring of blood potassium concentrations instead becomes necessary following the concomitant intake of non-potassium-sparing diuretics.

Contraindications DECADRON ® Dexamethasone

DECADRON ® is indicated 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 dexamethasone, as well as most corticosteroid hormones, are observed following prolonged use over time.

In addition to adrenal insufficiency, which represents the most frequent endocrine aspect among the side effects, the aforementioned hormonal therapy can determine a very wide range of adverse reactions, affecting various systems and devices such as:

The skeletal muscle system, increasing the risk of pathological fractures and muscle injuries;
The gastro-intestinal system, with a significant increase in the risk of ulcers and bleeding;
The nervous system, with the appearance of alterations in behavior and mood as well as headache, nausea, dizziness and restlessness;
The endocrine-metabolic structure, with a negativization of the nitrogen balance and significant alterations of the glycemic balance;
The cardiovascular system, with the appearance of hypertension, heart failure and hypokalemic alkalosis.