TOPSTER ® Beclometasone dipropionate

TOPSTER ® is a drug based on beclometasone dipropionate

THERAPEUTIC GROUP: Steroid anti-inflammatory intestinal - Glucorticoid

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

Indications TOPSTER ® Beclometasone dipropionate

TOPSTER ® is indicated for the treatment of colitis and ulcerative proctosigmoiditis, both in the acute phase and in the course of exacerbation.

Mechanism of action TOPSTER ® Beclometasone dipropionate

The topical anti-inflammatory action of beclometasone dipropionate that evidently manifests itself at the intestinal level, is guaranteed by the pharmacokinetic characteristics of this active ingredient, which determine a reduced systemic absorption and a significant accumulation at the intestinal level both following oral intake and rectal.

Here the active ingredients of TOPSTER ® belonging to the corticosteroid family can interact with a specific nuclear receptor, modulating the expression of some genes involved in the genesis of the inflammatory process.

More precisely, beclomethasone selectively inhibits the expression of the enzyme phospholipase A2, which is important in generating arachidonic acid from membrane phospholipids, therefore all chemical mediators derived from it, such as leukotrienes, thromboxanes and prostaglandins, responsible for the inflammatory process that determines the typical symptomatology in the course of ulcerative colitis and chronic intestinal diseases on an inflammatory basis.

Studies carried out and clinical efficacy

1. COMPETITIVE INTESTINAL FLAMMERS

In this meta-analysis, it was observed that the intake of beclomethasone dipropionate in enemas can be compared in terms of efficacy and safety with the administration of salicyl amino. In both cases a significant reduction in symptoms was observed, without the appearance of clinically significant side effects.

2. BECLOMETASONE DEPROPONATED IN HOSPITAL PRACTICE

Interesting retrospective study that demonstrates how the efficacy of hospital treatment for inflammatory bowel diseases such as Crohn's disease and ulcerative colitis can significantly reduce relapses and increase the patient's feeling of confidence in the doctor. Among the most used drugs in the hospital environment beclomethasone dipropionate was found.

3. CLISTERS OF BECLOMETASONE DIPROPIONATOATO AND HORMONAL AXIS

This study demonstrates the importance of a correct therapeutic indication and a strict medical control regarding the intake of beclometasone dipropionate in the form of enema, in order to avoid obvious imbalances of the hypothalamic-pituitary axis, involved in rare cases in the onset of hypoadrenalism once therapy has been suspended.

Method of use and dosage

TOPSTER ® rectal suspension and suppositories from 3 mg of beclomethasone dipropionate: the most widely used treatment involves the administration of a 3 mg suppository twice a day, preferably in the morning after evacuation and in the evening before bedtime, or a dose of rectal suspension in the evening before bedtime.

In any case the treatment should not exceed 4 weeks, and the correct dosage and the timing of the intake should be established by the doctor, only after a careful evaluation of the patient's clinical picture.

Warnings TOPSTER ® Beclometasone dipropionate

The absence of data on the effects of long-term intake of beclomethasone in patients with hepatic, renal, arterial hypertension, diabetes mellitus, hypoadrenalism, osteoporosis and gastro-duodenal ulcer, pushes the doctor to periodically monitor the state of health of the patient undergoing TOPSTER ® therapy

The combination of this medicine with antibiotics may be necessary in the treatment of contextual infections of the gastrointestinal tract.

The presence of parhydroxy benzoates in the suspension and rectal foam formulation could be responsible for the appearance of delayed allergic reactions such as dermatitis or hives.

PREGNANCY AND BREASTFEEDING

The general indications strongly advise against the use of TOPSTER ® during the first trimester of pregnancy, whereas the evaluation of the risks / benefits that would derive from the use of beclometasone in the following months or during breastfeeding is sent back to the competent doctor.

Unfortunately the scientific literature does not help given the absence of significant clinical trials that clarify the safety profile of this active principle for fetal health.

Interactions

At the moment there are no known active ingredients capable of significantly altering the therapeutic activity of TOPSTER ® with the exception of other medicinal products containing corticosteroids, for which biological effects could be enhanced.

Contraindications TOPSTER ® Beclometasone dipropionate

TOPSTER ® is contraindicated in case of hypersensitivity to its active ingredient or one of its excipients and during the period of pregnancy and lactation.

TOPSTER ® should not be administered in patients with local tuberculosis, fungal and viral infections as well as perforations, obstructions or intestinal abscesses.

Undesirable effects - Side effects

The low systemic absorption and the good tolerability of the active principle make TOPSTER ® a safe drug and free of clinically significant side effects.

However, local side effects have been described such as sensation of heat and anal burning and difficulty in retaining the preparation in case of foam and rectal suspension.