CLIPPER ® Beclomethasone dipropionate

CLIPPER ® is a beclomethasone dipropionate drug

THERAPEUTIC GROUP: Steroid intestinal anti-inflammatory - Glucorticoids

Indications CLIPPER ® Beclomethasone dipropionate

CLIPPER ® is useful in the treatment of inflammatory bowel diseases such as mild or moderate ulcerative colitis.

CLIPPER ® mechanism of action Beclomethasone dipropionate

CLIPPER ® is a steroidal anti-inflammatory drug based on beclomethasone dipropionate, a powerful corticosteroid which, taken orally, passes the gastric barrier unscathed, concentrating on the intestinal level, where it performs its biological function.
The low systemic absorption and the important topical effect allow this active ingredient to act selectively on the intestinal mucosa, binding a specific nuclear receptor capable of modulating the expression of genes involved in the regulation of the activation of the inflammatory process, and more precisely to inhibit the enzyme phospholipase A2, necessary for the synthesis of inflammatory mediators belonging to the category of arachidonic acid metabolites such as prostaglandins, prostacyclines and leukotrienes.
Furthermore, the same active principle seems to be able to increase the expression of proteins with anti-edema activity.
Given the low systemic absorption of beclomethasone, the metabolic effects of this active ingredient are minimal and unable to vary normal blood parameters.

Studies carried out and clinical efficacy

1. UTILITY OF BECLOMETHASONE IN CLINICAL PRACTICE

J Crohn colitis. 2010 Dec, 4: 629-36.

Utility of oral beclomethasone dipropionate in the treatment of active ulcerative colitis in clinical practice: the RECLICU study.

T Nunes, Barreiro M-de Acosta et al. RECLICU GETECCU Study Group.

Beclomethasone dipropionate is one of the oral steroidal anti-inflammatory drugs used in clinical practice for the treatment of inflammatory diseases of the intestinal tract. This multicenter study has shown that the administration of 5 mg of this active ingredient can guarantee a remission of symptoms in about two thirds of treated patients, with a good safety profile.

2. BECLOMETASONE DIPROPIONATE IN ULCERATIVE COLITIS

Dig Dis Sci. 2010 Jul; 55: 2002-7. Epub 2009 Sep 5.

Oral beclomethasone dipropionate as an alternative to systemic steroids in mild to moderate ulcerative colitis not responding to aminosalicylates.

Papi C, Aratari A, Moretti A, Mangone M, Margagnoni G, Koch M, Capurso L.

This study, conducted on 64 patients with ulcerative colitis, demonstrated how oral treatment with beclomethasone dipropionate may be useful in improving symptoms in patients who are not responsive to mesalamine. The possibility of being able to opt for another drug other than mesalazine but equally effective, allows the doctor to be able to act even in the most difficult cases.

3. BECLOMETASONE DIPROPIONATE IN PEDIATRIC AGE

J Pediatr Gastroenterol Nutr. 2010 Apr; 50: 385-9.

Oral beclomethasone dipropionate in pediatric active ulcerative colitis: a comparison trial with mesalazine.

Romano C, Famiani A, Comito D, Rossi P, Raffa V, Fries W.

Although the use of beclomethasone in pediatric age is still strongly debated, this all-Italian study has shown how the administration for 4 weeks of this medicine can guarantee a more effective and faster remission of symptoms in patients with ulcerative colitis, than that obtainable with other drugs such as mesalamine

Method of use and dosage

CLIPPER ® 5 mg gastro-resistant tablets of beclomethasone dipropionate: the reference dosage is one tablet per day, taken in the morning for no more than 4 consecutive weeks.
CLIPPER ® rectal suspension of 3 mg beclomethasone dipropionate : it is recommended to apply an enema in the evening before going to bed for cycles of 3-4 weeks.
In any case, the correct dosage formulation and the appropriate dosage indications should be established by your doctor, after a "careful evaluation of the patient's physio-pathological picture.

CLIPPER ® warnings Beclomethasone dipropionate

CLIPPER ® should be taken with particular care and under strict medical supervision in patients with reduced liver and kidney function, given the lack of scientific documentation to evaluate the possible risks and side effects.
In the case of pre-existing or contextual intestinal infections, therapy with CLIPPER ® must be accompanied by therapy with an antibiotic that avoids the persistence of the pathogen.
The presence of headache, one of the side effects associated with beclomethasone therapy, could make the use of machinery and driving cars dangerous.

PREGNANCY AND BREASTFEEDING

The absence of clinical trials able to clarify the safety profile of beclomethasone on the health of the fetus when taken during pregnancy, strongly limits its use throughout pregnancy, with particular rigidity in the first trimester, and in the subsequent lactation period.

Interactions

The reduced systemic absorption of beclomethasone minimizes the risk of interactions with other active substances.
In fact, at the moment there are no known clinically significant interactions between CLIPPER ® and other drugs.

Contraindications CLIPPER ® Beclomethasone dipropionate

CLIPPER ® is contraindicated in case of ascertained hypersensitivity to its active ingredient or one of its excipients and during pregnancy and lactation.
Furthermore, its strong anti-inflammatory power limits its use in case of local tuberculous, fungal or viral infections and abscesses, obstructions or peritonitis.

Undesirable Effects - Side Effects

The low systemic absorption and the good tolerability of the active ingredient make CLIPPER ® a safe drug with no clinically significant side effects.
The main adverse reactions documented were affecting the gastrointestinal tract, with nausea, diarrhea and abdominal and nervous pains with headache.
In rare cases, allergic reactions and menstrual disturbances, always of modest entity, have been observed

Note

CLIPPER ® is a prescription drug.

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