URBASON ® Methylprednisolone

URBASON ® is a drug based on Methylprednisolone

THERAPEUTIC GROUP: Non-associated systemic corticosteroids

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

Indications URBASON ® Methylprednisolone

URBASON ® is indicated in the treatment of allergic and inflammatory pathologies, both acute and chronic, for which it is necessary to resort to the use of corticosteroid drugs.

Mechanism of action URBASON ® Methylprednisolone

Methylprednisolone contained in URBASON ® is a synthetic derivative of cortisone with which it shares the important anti-inflammatory activity, without however significantly interfering with the glucose and protein metabolic characteristics and the hydro-electrolytic balance.

The use in the clinical setting is therefore justified by the ability of this active principle to block the inflammatory process upstream, inducing the expression of a protein known as lipocortin, capable of inhibiting the enzyme phospholipase A2 and reducing the availability of arachidonic acid .

The reduced presence of the initial substrate results in a lack of synthesis of inflammatory mediators such as leukotrienes, prostaglandins and prostacyclins, responsible for vascular modifications and the recruitment of immune cells, thus safeguarding the tissue from the inflammatory insult induced by the same elements.

From the pharmacokinetic point of view URBASON ® can guarantee, thanks to its formulation, a prolonged release of methylprednisolone, distributed 1/3 to the gastric level and for the remaining part to the intestinal level.

This peculiarity represents an important advantage for long-term therapies, making it possible to take the drug in a single daily dose.

Studies carried out and clinical efficacy

1. METHYLPREDNISOLONE AND PULMONARY ARTERIAL HYPERTENSION

Pulmonary arterial hypertension is a life-threatening complication for patients with connective tissue disorders. Pulsed therapy with methylprednisolone for short periods has been shown to be effective and free of any particular side effects.

2. METHYLPREDNSIOLONE AND CHRONIC RENOSINUSITIS IN PEDIATRIC PATIENTS

Treatment with methylprednisolone at low doses combined with antibiotic therapy has been shown to be effective in reducing nasal obstruction and discharge as well as the complex symptoms in pediatric patients with chronic rhinosinusitis.

3. METHYLPREDNISOLONE AND ATOPIC DERMATIE

Atopic dermatitis is a chronic inflammatory skin disorder characterized by recurrent itching and scratching lesions. The onset of this pathology, generally early, is accompanied by the gradual definition of therapeutic approaches that are increasingly important. Of all the corticosteroids used, methylprednisolone appears to be the one with the greatest therapeutic effects and reduced side effects.

Method of use and dosage

URBASON ® prolonged-release tablets of 4-8 mg of methylprednisolone:

the therapeutic need of methylprednisolone varies from patient to patient based on what are his clinical conditions, the type of pathology and the related therapeutic goals.

It is also useful to remember that the dosage of this active ingredient may vary considerably during the course of the work based on the effective clinical effectiveness of the therapy; for this reason, due to the intrinsic complexity in the formulation of the correct dosage and to the potential side effects it is of fundamental importance that one's doctor monitors the entire therapeutic process.

Warnings URBASON ® Methylprednisolone

The complexity of the formulation of the dosage, the potential side effects, the need for a continuous adjustment of the doses even to therapy started require that the whole therapeutic range be supervised by an expert doctor.

Particular attention should be paid to patients suffering from hepatic, renal, cardiovascular, metabolic, neurological and psychiatric diseases due to the ability of this active ingredient to aggravate the symptoms.

At the same time, patients undergoing immunization therapy or suffering from latent infectious diseases could completely lose their immune coverage following methylprednisolone intake.

Nervous symptoms associated with URBASON ® therapy could make all those activities that require an intellectual commitment, such as the use of machinery and driving vehicles, dangerous.

PREGNANCY AND BREASTFEEDING

The use of methylprednisolone in pregnancy is generally not recommended and at most indicated in cases of real need and under strict medical supervision.

These important indications derive from the absence of clinical evidence able to define the safety profile of this active principle and from the presence of pharmacokinetic studies that demonstrate the ability of methylprednisolone to cross both the blood-placental barrier and the breast filter.

Interactions

Rifampicin, antiepileptics and barbiturates are able to significantly reduce the therapeutic efficacy of methylprednisolone while erythromycin, ketoconazole and troleandromycin can increase their biological effects.

In contrast, methylprednisolone can reduce the therapeutic activity of oral anticoagulants, salicylates, hypoglycemics, psychotropic drugs such as anxiolytics and sympathetic mimetics, thus requiring a further adjustment of the dosage.

Contraindications URBASON ® Methylprednisolone

URBASON ® is contraindicated in case of systemic fungal infections and in case of hypersensitivity to its active ingredient and its excipients.

The administration of corticosteroids could aggravate the clinical picture of diabetic, hypertensive patients suffering from neurological and psychiatric diseases.

Undesirable effects - Side effects

The side effects of cortisone therapy, significantly reduced by the marketing of structurally defined synthetic analogues, occur with greater frequency and greater clinical relevance following prolonged therapies or conducted at high doses.

The apparatuses and the interesting organs are multiple and among the most at risk there are:

- the skeletal muscle apparatus, subjected to demineralization processes and fractures and myopathies;

- the nervous system with both neurological and psychiatric alterations;

- the gastrointestinal system characterized by the increased risk of peptic ulcers;

- the endocrine-metabolic structure with alterations of the hypothalamic-pituitary axis, negativization of the nitrogen balance and alterations of the carbohydrate metabolism;

- the kidney and the cardiovascular system subjected respectively to alterations of the hydro-electrolyte balance and hypertension with an increased risk of heart failure.