Pharmacodynamics
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.
The clinical efficacy and safety of various dosage forms of mebeverine have been studied in more than 1,500 patients. Significant reductions in the predominant symptoms of irritable bowel syndrome (eg, abdominal pain, stool characteristics) have generally 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.
Children. Clinical studies of tablets or capsules have only been conducted in adults. Clinical efficacy and safety data from clinical trials, as well as post-marketing experience with the use of mebeverine pamoate suspension in patients aged 3 years and older, have demonstrated that mebeverine is an effective safe preparation, well tolerated.
Clinical studies of mebeverine suspension have shown that it is effective in relieving the symptoms of irritable bowel syndrome in children. Further open-label studies of mebeverine suspensions confirmed the efficacy of the preparation.
The dosage regimen of tablets or capsules is calculated based on the safety and tolerability of mebeverine.
Pharmacokinetics
Absorption. Mebeverine is rapidly and completely absorbed after oral administration in tablet form. Due to the prolonged release of the preparation from the capsule, it can be taken 2 times a day.
Distribution. With repeated use of Duspatalin, significant cumulation does not occur.
Metabolism. Meverine hydrochloride is mainly metabolized by esterases, which, at the first stage of metabolism, break down ester bonds to form veratric acid and mebeverine alcohol. In blood plasma, demethylcarboxylic acid (DMCA) is the main metabolite. T1 / 2 of DMCC in equilibrium state - 5.77 hours 97%.
Excretion. Mebeverine 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 in the form of the corresponding carboxyl or DMCA.
Children. Pharmacokinetic studies in children have not been conducted.
Adults and children over the age of 10:
For oral administration. drink tablets or capsules with a sufficient amount of water (at least 100 ml). it is not recommended to chew due to the fact that the tablets have an unpleasant taste, and the capsule coating is intended to provide a prolonged release mechanism.
Adults and children over the age of 10 take 1 tablet 3 times a day about 20 minutes before meals or 1 capsule 2 times a day (morning and evening).
The duration of use is not limited. If one or more doses are missed, the patient should take the next dose as previously prescribed. The missed dose should not be taken in addition to the regular dose.
Special populations. Dosing studies in elderly patients, patients with impaired renal and / or hepatic function have not been conducted. Based on existing post-marketing data, no specific risk for the elderly has been identified in patients with impaired renal and / or liver function. There is no need for dose adjustment for the above patient groups.
Hypersensitivity to the active substance or any of the inactive components of the preparation.
The following adverse reactions have been reported, occurring spontaneously during post-marketing use. the frequency cannot be accurately determined from the available data.
Allergic reactions were observed mainly from the skin.
Skin and subcutaneous tissue disorders: urticaria, angioedema, facial edema and rash.
From the immune system: hypersensitivity (anaphylactic reactions).
Use during pregnancy and lactation. there are only very limited data on the use of mebeverine in pregnant women. studies of reproductive toxicity in animals are insufficient. duspatalin is not recommended for use during pregnancy.
It is not known whether mebeverine or its metabolites passes into breast milk. The excretion of mebeverine into the breast milk of animals has not been studied. Duspatalin should not be used during breastfeeding.
There is no clinical data on the effect on male or female fertility; however, animal studies have not shown any harmful effects of Duspatalin.
Children. Duspatalin capsules should not be used in children under 3 years of age due to the lack of clinical data for this age category. Also, Duspatalin capsules should not be used in children aged 3 to 10 years due to the high content of the active substance.
The ability to influence the reaction rate when driving or working with other mechanisms. Studies of the effect on the ability to drive and operate machinery have not been conducted. The pharmacodynamic and pharmacokinetic profile, as well as post-marketing experience, do not indicate any harmful effect on the ability to drive a car and work with mechanisms.
Interaction studies with alcohol have been conducted. in vitro and in vivo studies in animals have shown the absence of any interaction between duspatalin and ethanol.
In case of an overdose, excitation of the central nervous system can theoretically be observed. in cases of mebeverine overdose, the symptoms were absent or they were mild and quickly disappeared. the observed overdose symptoms were of neurological or cardiovascular origin. the specific antidote is unknown. symptomatic treatment is recommended. gastric lavage is recommended only in case of intoxication with numerous preparations, which is diagnosed within 1 hour from the moment of taking the preparations. measures to reduce absorption are not necessary.
In its original packaging at a temperature not exceeding 25 ° C. do not store at temperatures below 5 ° C.