Adults and children aged 10 and over: symptomatic treatment of abdominal pain and spasms, bowel disorders and discomfort in the bowel area in irritable bowel syndrome; the treatment of gastrointestinal spasm secondary origin, caused by organic disease.
active substance: mebeverine hydrochloride.
1 capsule contains 200 mg of mebeverine hydrochloride.
Duspatalin excipients: magnesium stearate, methacrylate copolymer dispersion, talc, hypromellose, polyacrylate dispersion, glycerol triacetate.
Hard gelatin capsule (size No. 1): titanium dioxide (E 171), gelatin.
Duspatalin Dosage form
Sustained-release capsules, solid.
Basic physical and chemical properties: opaque white hard gelatin capsules of size No. 1 with the corresponding marking 245, contain granules from white to almost white.
Drugs used for functional gastrointestinal disorders. Synthetic anticholinergics, esterified tertiary amines. Mebeverine.
ATX code A03A A04.
Mechanism of action and pharmacodynamic effects.
Mebeverine is a myotropic antispasmodic with a selective effect on the smooth muscles of the digestive tract. It eliminates spasms without inhibiting normal intestinal motility. Since this action is not mediated by the autonomic nervous system, there are no typical anticholinergic side effects.
Clinical efficacy and safety.
The clinical efficacy and safety of various dosage forms of mebeverine have been studied in more than 1,500 patients. Significant amelioration of the predominant symptoms of irritable bowel syndrome (such as abdominal pain, stool features) has usually been observed in reference and pivotal-controlled clinical trials.
All dosage forms of mebeverine were generally safe and well tolerated at the recommended dosage regimen.
Clinical studies of the use of tablets or capsules have been conducted only with the participation of adults. Clinical efficacy and safety data obtained from clinical studies, as well as from post-marketing experience with the use of mebeverine pamoate suspension in patients aged 3 years and older, have shown that mebeverine is an effective and safe drug, well tolerated.
Clinical studies of mebeverine suspension have shown that the drug is effective in relieving the symptoms of irritable bowel syndrome in children. Further open-label studies of mebeverine suspensions confirmed the efficacy of the drug.
The dosage regimen of the drug in the form of tablets or capsules is determined based on the safety and tolerability of mebeverine.
Mebeverine is rapidly and completely absorbed after oral administration in tablet form. Due to the extended release of the drug from the capsule, it can be taken twice a day.
With repeated use of the drug Duspatalin®, no significant cumulation occurs.
Meverine hydrochloride is mainly metabolized by esterases, which, at the first stage of metabolism, cleave ester bonds to form veratric acid and mebeverine alcohol. In plasma, demethylcarboxylic acid (DMCA) is the main metabolite. The half-life of DMCC in equilibrium is 5.77 hours. With repeated use of capsules (200 mg 2 times a day), Cmax for DMCA was 804 ng / ml, and tmax was about 3:00. The relative bioavailability of the sustained-release capsules was found to be optimal with an average ratio of 97%.
Mebeverin is not excreted unchanged, it is completely metabolized, and metabolites are excreted almost completely. Veratric acid is excreted in the urine. Mebeverine alcohol is also excreted by the kidneys, partly as the corresponding carboxylic acid (CA) and partly as demethylcarboxylic acid (DMCA).
Pharmacokinetic studies in children have not been conducted.
Adults and children over the age of 10:
symptomatic treatment of abdominal pain and cramps, bowel disorders and bowel discomfort in irritable bowel syndrome;
treatment of gastrointestinal spasms of secondary genesis caused by organic diseases.
Hypersensitivity to the active substance or to any of the excipients of the drug indicated in the “Composition” section.
Interaction with other medicinal products and other forms of interaction
Interaction studies were not conducted, except for interactions with alcohol. In vitro and in vivo studies on animals have shown the absence of any interaction between Duspatalin® and ethanol.