CLIPPER ® 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 CLIPPER ® Beclometasone dipropionate
CLIPPER ® is useful in the treatment of inflammatory bowel disorders such as mild to moderate ulcerative colitis.
Mechanism of action CLIPPER ® Beclometasone dipropionate
CLIPPER ® is a steroidal anti-inflammatory drug based on beclometasone dipropionate, a potent corticosteroid that, taken orally, passes the gastric barrier unharmed 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 inflammatory process activation, and more precisely to inhibit the enzyme phospholipase A2, necessary for the synthesis of inflammation mediators belonging to the category of metabolites of arachidonic acid such as prostaglandins, prostacyclines and leukotrienes.
Furthermore the same active ingredient 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 not able to vary the normal blood parameters.
Studies carried out and clinical efficacy
1. UTILITY OF BECLOMETASONE IN CLINICAL PRACTICE
Beclomethasone dipropionate is one of the oral anti-inflammatory steroid drugs used in clinical practice for the treatment of inflammatory diseases of the intestinal tract. This multicenter study showed 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 DEPROPIONATED IN THE ULCERATIVE COLITIS
This study conducted on 64 patients suffering from ulcerative colitis, showed how oral treatment with beclomethasone dipropionate could be useful in improving symptoms in patients not responding to mesalazine. The possibility of being able to opt for another drug other than mesalazine but just as effective, allows the doctor to be able to act even in the most difficult cases.
3. BECLOMETASONE PROVIDED IN PEDIATRIC AGE
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 remission of the symptomatology in patients suffering from more effective and faster ulcerative colitis, compared to that obtainable with other drugs such as mesalazine
Method of use and dosage
CLIPPER ® 5 mg gastro-resistant tablets of beclomethasone dipropionate: the reference dosage is one tablet a day, taken in the morning for not more than 4 continuous weeks.
CLIPPER ® rectal suspension of 3 mg of beclomethasone dipropionate : it is recommended to apply an enema in the evening before going to bed for 3-4 week cycles.
In any case, the correct formulation of the dosage and the appropriate dosage instructions should be established by your doctor, after a careful evaluation of the patient's physiopathological situation.
Warnings CLIPPER ® Beclometasone dipropionate
Intake of CLIPPER ® should be carried out with particular care and under strict medical supervision in patients suffering from reduced liver and kidney function, given the lack of scientific documentation to evaluate possible risks and side effects.
In the case of pre-existing or contextual intestinal infections, therapy with CLIPPER ® must be accompanied by an antibiotic that avoids the persistence of the pathogen.
The presence of headache, among the side effects associated with beclomethasone therapy, could make the use of machinery and driving vehicles 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 the pregnancy, with particular rigidity in the first trimester, and in the subsequent period of breastfeeding.
Interactions
The reduced systemic absorption of beclomethasone minimizes the risk of interactions with other active ingredients.
At present, clinically significant interactions between CLIPPER ® and other drugs are not known.
Contraindications CLIPPER ® Beclometasone dipropionate
CLIPPER ® is contraindicated in case of hypersensitivity to its active ingredient or one of its excipients and during the period of pregnancy and lactation.
In addition, the strong anti-inflammatory power limits its use in case of tuberculous, fungal or viral local infections and abscesses, obstructions or peritonitis.
Undesirable effects - Side effects
The low systemic absorption and the good tolerability of the active principle make CLIPPER ® a safe drug with no clinically significant side effects.
The main adverse reactions documented were at the gastrointestinal tract, with nausea, diarrhea and abdominal and nervous pain with headache.
In rare cases allergic reactions and menstrual disorders have been observed, always of modest entity
Note
CLIPPER ® is a medicine that can be sold under prescription.
