Mebeverini hydrochloridum

Pharmacotherapeutic group: synthetic anticholinergics, esters with a tertiary amino group ATC group: A03AA04 Mechanism of action and pharmacodynamic properties Mebeverine is a musculotropic antispasmodic with a direct effect on the smooth muscle of the gastrointestinal tract, without affecting normal intestinal motility. The precise mechanism of action of mebeverine is unknown. Several mechanisms may contribute to its local effect within the gastrointestinal tract, including reduction of ion channel permeability, blockade of noradrenaline reuptake, a local anaesthetic effect, and alterations in water absorption. Through these mechanisms, mebeverine exerts its antispasmodic activity, restoring intestinal motility without producing sustained relaxation of gastrointestinal smooth muscle cells (so-called hypotonia). Mebeverine does not cause the systemic adverse effects typical of anticholinergic agents. Clinical efficacy and safety The clinical efficacy and safety of various mebeverine formulations have been evaluated in more than 1,500 patients. Overall, clinical trials demonstrated significant improvement in the principal symptoms of irritable bowel syndrome (such as abdominal pain and stool parameters) compared with control or baseline groups. All formulations of mebeverine were generally safe and well tolerated at the recommended dosing regimen. Paediatric population Clinical studies with tablets or capsules have been conducted only in adults. Efficacy and safety data from clinical studies and post-marketing experience with mebeverine pamoate suspension in patients aged >3 years have shown that mebeverine is effective, safe, and well tolerated. Clinical studies with mebeverine suspension have demonstrated that mebeverine is effective in relieving the symptoms of irritable bowel syndrome in children. Additional open-label studies of mebeverine suspension against a baseline group confirmed the efficacy of this medicinal product. The dosing regimen for the tablet and capsule formulations was derived on the basis of the consistent safety and favourable tolerability of mebeverine.