International nonproprietary name: trimebutine (English) trimebutine).
On the Russian pharmaceutical market, the drug is produced by OJSC Valenta Pharmaceuticals.
The drug was initially registered in 2007 under the name "Trimedat" and was produced by a Russian company from a foreign-made finished dosage form (Dae Han New Pharm Co. Ltd, Korea).
In 2014, the drug was registered in Russia by Valenta Pharmaceuticals OJSC as "Trimedat Valens". At the moment, all stages of production, including the production of the finished dosage form, are Russian.
Like Trimedat, Trimedat Valenta is available in the form white tablets containing the active ingredient trimebutine maleate 100 mg And 200 mg .
There are some differences in the appearance of the tablets. The Korean tablets were marked with embossed alphabetic and geometric symbols, different for 100 and 200 mg dosages. Domestic-produced Trimedat is made in the form of round flat-cylindrical tablets with a chamfer and two intersecting marks on one side for a dosage of 100 mg, with a chamfer and a score on one side for a dosage of 200 mg.
Is different composition of excipients, included in the Trimedat and Trimedat Valenta tablets. In addition to lactose monohydrate, starch (corn and potato, respectively), colloidal silicon dioxide, magnesium stearate and talc, Russian-made tablets include povidone (improves the dissolution and bioavailability of medicinal substances).
Indications for use of Trimedat
In the instructions for the drug Trimedat Valens recommended for the treatment of irritable bowel syndrome and postoperative paralytic ileus.In the instructions for the previous version of the drug, which received permission for distribution in the Russian Federation ( Trimedat ), in addition to the purposes mentioned above, the following are indicated:
- motor disorders in functional diseases of the gastrointestinal tract
- gastroesophageal reflux disease (GERD)
- dyspeptic disorders in gastroduodenal diseases (abdominal pain, digestive disorders, nausea, vomiting)
- preparation for x-ray and endoscopic examinations of the gastrointestinal tract
Trimedat and gastrointestinal motility
Trimebutine regulates intestinal motility by influencing its enkephalinergic system. The drug has no effect on the central nervous system. Being an agonist of peripheral opiate receptors of various types (δ-, μ- and k-), located on neurons of the enteric nervous system and on smooth muscle cells throughout the gastrointestinal tract, it has a stimulating effect in hypokinetic conditions of the latter and acts as an antispasmodic in case of its excessive tone . Trimedat acts throughout the gastrointestinal tract. The figures below show changes in gastrointestinal motility parameters during treatment of GERD in children with Trimedat. To assess the nature of gastrointestinal motility, the method of peripheral electrogastroenterography (PEGEG) was used (). Not only was the basal indicators closer to normal, but also the postprandial response was restored.Note for fig. 1, 2: A - before meals, B - after meals
Rice. 1. Dynamics of relative electrical activity indicators (Pi/Ps) in children with gastroesophageal reflux before and after meals during treatment 
Rice. 2. Dynamics of rhythmicity coefficient indicators in children with gastroesophageal reflux before and after meals during treatment. *R<0,05
Trimebutine normalizes visceral sensitivity and thus has an analgesic effect in abdominal pain syndrome.
Trimebutin affects the humoral regulation of gastrointestinal motility, increasing the secretion of motilin and reducing the levels of gastrin, glucagon, pancreatic polypeptide, insulin and vasoactive intestinal peptide (Akopyan A.N., Belmer S.V., Vykhristyuk O.F. et al. with reference to Delvaux M., Wingate D. ).
Procedure for use and dosage of the drug Trimedat
Trimedat tablets are taken orally. Adults and children over 12 years of age are prescribed 100-200 mg 3 times a day.For the treatment of irritable bowel syndrome during an exacerbation, 600 mg of Trimedat per day is prescribed for 4 weeks. To prevent relapse of the disease, further administration of the drug at a dose of 300 mg per day for 12 weeks is recommended.
For children 3-5 years old, Trimedat is prescribed 25 mg 3 times a day, for children 5-12 years old - 50 mg 3 times a day.
Contraindications to the use of Trimedat
Hypersensitivity to trimebutine maleate and other components included in the drug.Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Children under 3 years of age - for dosage forms of Trimedat Valenta; children under 12 years of age - for dosage forms of Trimedat.
Pregnancy.
Use of Trimedat during pregnancy and lactation
Experimental studies have not revealed data on the teratogenicity and embryotoxicity of Trimedat. However, due to the lack of necessary clinical data, the use of the drug during pregnancy is contraindicated. It is also not recommended to prescribe Trimedat during lactation due to the lack of reliable clinical data confirming the safety of its use during this period. If it is necessary to use Trimedat during lactation, breastfeeding should be stopped.Side effects of Trimedat
During treatment with the drug, the following side effects may occur:- from the digestive system - dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea,
Trimedat belongs to the group of myotropic antispasmodics, the action of which is aimed at regulating gastrointestinal motility. The pharmacological effect is manifested in the restoration of gastrointestinal motility, which occurs as a result of relaxation of muscle tissue. The drug is effective throughout
length of the gastrointestinal tract, as a result of which intestinal peristalsis improves, destroyed
the activity of his muscles. The international nonproprietary name (INN) is trimebutine, the country of origin is Korea, the packaging is produced in Moscow by the Valenta company. The drug is not an antibiotic; the conditions for use (information about the composition, indications and contraindications) can be found in the annotation, Wikipedia, in the photos and pictures you can see what the packaging looks like.
Indications for use
- gastroesophageal reflux disease;
- disorders due to gastrointestinal diseases;
- dyspeptic disorders due to gastroduodenal diseases (indigestion, abdominal pain, vomiting, nausea);
- irritable bowel syndrome;
- postoperative paralytic intestinal obstruction, preparation for endoscopic and x-ray examinations of the gastrointestinal tract.
Trimedat is also prescribed for pancreatitis, flatulence, gastritis, biliary dyskinesia
ways, for diarrhea, high acidity, for diarrhea, for colitis, it is also recommended to take it for
constipation, nausea.
The drug is prescribed to a child for dyspeptic disorders caused by gastrointestinal motility disorders.
Composition, cost
The drug has two forms of release: tablets and suspension. The main active ingredient of the medicine is
trimebutine maleate, also contains the following auxiliary components: magnesium stearate, corn
starch, talc, colloidal silicon dioxide, lactose. Tablets are sold in cardboard boxes of 10, 20 and 30
cellular contour packages. How much does Trimedat cost? The cost depends on the number of tablets in the pack and varies between 165-405 rubles.
Trental analogues are cheaper
Is it possible to buy an analogue of the drug in pharmacies cheaper than what can be replaced? The medicine is cheaper
foreign and Russian analogues, one of them is motilak. Other analogues at the same or higher
cost: duspatalin, ganaton, meteospasmil, buscopan, duspatalin, dicetel, motilium, de-nol.
Instructions for use of trimedat for adults
The tablets must be swallowed and washed down with water; the dosage for children over 12 years of age and adults is 100-200 mg.
drug 3 r. per day. In order to prevent relapse of IBS after a full course of treatment during the period of remission, the medication should be continued, the dosage is 300 mg, the treatment period is 12 weeks. Dosage of suspensions - 2 tbsp. l. 3 r. in a day. How long is the treatment period, how many days? The duration of treatment in each specific case differs; in case of urticaria, the duration of treatment can take 2-6 weeks; the daily dosage can be increased to 450-600 mg.
For children dosage
Pills:
- Children aged 5-12 years - 50 mg 3 times. in a day;
- 3-5 years - 25 mg 3 times. in a day.
Suspensions:
- over 5 years - 2 tsp. 3 r. in a day;
- 1-5 years - 1 tsp. 3 r. in a day;
- 0.5-1 g - 1 tsp. 2 rubles per day;
- up to 0.5 g - 0.5 tsp. 2-3 r. in a day.
How to take it correctly for pancreatitis and flatulence?
How to take the drug for indications such as flatulence and pancreatitis? In such cases
complex therapy is used, since one dose often does not lead to the expected therapeutic effect, painful discomfort in the abdominal area is reduced only in some cases. Dosage
is selected individually depending on the severity of the condition and the age of the patient.
Should Trimedat be taken before or after meals?
How to take the drug correctly - before or after meals, instructions for use? Tablets recommended
drink within 15 – 30 minutes. before meals, at least within 20 minutes. after meal. It is recommended to take the medicine in
in a planned manner, throughout the entire course of treatment without interruptions. If you have symptoms of dyspepsia, you should take the tablets immediately, without focusing on meals.
Is it possible during pregnancy?
Is Trimedat prescribed during pregnancy, when can you drink it? The annotation states that during pregnancy from
Taking the drug should be avoided in the first three months, as well as during breastfeeding.
Trimedat reviews from doctors
What are the doctors' reviews? Feedback from experts is positive, which is due to certain factors; they base their opinion on the therapeutic effectiveness of the drug, the presence of contraindications, side effects and price. According to the listed characteristics, Trimedat is better than many similar medicines, so reviews about it are only positive. It helps in severe forms of the disease, has a convenient method of application, a person can buy it at any pharmacy.
Contraindications
The description of the medicine describes the conditions of use; it is not recommended to drink trimedate under the age of three; hypersensitivity to individual components is also a contraindication.
Side effects
The medication has no side effects with the exception of allergic reactions that may occur as a result of intolerance to individual components. There is no information on interactions with other drugs; diabetics should exercise caution since trimedate contains sugar. Taking two medications at the same time may increase their effect. An overdose can provoke increased side effects; if appropriate symptoms appear, therapy is carried out.
Trimedat and alcohol compatibility
Can it be taken simultaneously with alcohol? Compatibility with alcohol is not described, which means that their combination is allowed.
Regulator of gastrointestinal motility.
Drug: TRIMEDAT®
Active substance of the drug:
trimebutine
ATX encoding: A03AA05
KFG: A drug that regulates the motor function of the gastrointestinal tract
Registration number: LSR-005534/07
Registration date: 12/28/07
Owner reg. credential: Shchelkovo Vitamin Plant OJSC (Russia)
Trimedat release form, drug packaging and composition.
The tablets are white, round, biconvex, with a symbol in the form of two drop-shaped elements extruded on one side and a line on the other side.
1 tab.
trimebutine maleate
200 mg
Excipients: lactose, colloidal silicon dioxide, talc, corn starch, magnesium stearate.
10 pieces. — cellular contour packages (3) — cardboard packs.
The description of the drug is based on the officially approved instructions for use.
Pharmacological action of Trimedat
Regulator of gastrointestinal motility. Trimebutine, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Having an affinity for excitation and suppression receptors, it has a stimulating effect in hypokinetic conditions of intestinal smooth muscles and an antispasmodic effect in hyperkinetic conditions.
The drug acts throughout the gastrointestinal tract, reduces the pressure of the esophageal sphincter, promotes gastric emptying and increased intestinal motility, and also promotes the response of the smooth muscles of the colon to food irritants.
Trimebutine restores the normal physiological activity of the intestinal muscles in various gastrointestinal diseases associated with motility disorders.
Pharmacokinetics of the drug.
Suction
After oral administration, trimebutine is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved after 1-2 hours. Bioavailability is 4-6%.
Distribution
The degree of binding to plasma proteins is low - about 5%. Vd - 88 l. Trimebutine penetrates the placental barrier to a small extent.
Metabolism
Trimebutine is biotransformed in the liver.
Removal
Trimebutine is excreted in the urine mainly in the form of metabolites (approximately 70% during the first 24 hours). T1/2 - about 12 hours.
Indications for use:
Gastrointestinal motility disorders in the following diseases and conditions:
Gastroesophageal reflux disease;
Dyspeptic disorders in gastroduodenal diseases (abdominal pain, indigestion, nausea, vomiting);
Irritable bowel syndrome (manifested by pain, abdominal colic, intestinal cramps, flatulence, diarrhea and/or constipation);
Postoperative paralytic ileus;
Preparation for X-ray/endoscopic examination of the gastrointestinal tract;
Dyspeptic disorders in children.
Dosage and method of administration of the drug.
Adults and children over 12 years of age should take the drug orally at 100-200 mg 3 times a day.
Side effects of Trimedat:
Rarely: skin reactions.
Contraindications to the drug:
Children under 12 years of age (for this dosage form);
Hypersensitivity to the components of the drug.
Use during pregnancy and lactation.
The use of the drug Trimedat is contraindicated in the first trimester of pregnancy.
The use of the drug Trimedat is contraindicated during breastfeeding due to the lack of reliable clinical data confirming the safety of the drug.
Experimental studies have not revealed any evidence of teratogenicity or embryotoxicity of the drug.
Special instructions for the use of Trimedat.
No data provided.
Drug overdose:
To date, no cases of overdose of Trimedat have been reported.
Interaction of Trimedat with other drugs.
Data on drug interactions with Trimedat are not provided.
Terms of sale in pharmacies.
The drug is approved for use as a means of OTC.
Terms of storage conditions for the drug Trimedat.
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life: 3 years.
Trimedat (active ingredient trimebutine) is a domestic drug from the pharmaceutical company Valenta, the main pharmacological function of which is the regulation of gastrointestinal motility (GIT). It is used for various functional diseases of the digestive system, dyspeptic disorders, as well as for the recently widespread irritable bowel syndrome (its universal markers are abdominal pain and colic, intestinal spasms, increased gas formation, diarrhea or constipation). Trimedat acts throughout the digestive tract, including the bile ducts along with the gallbladder. In clinical practice, there are often cases of patients having diverse motor disorders of the gastrointestinal tract, with a predominance of various pathogenetic components. To identify a specific type of disorder, complex and not always accessible instrumental studies are required for a wide range of patients, such as: endoscopic manometry of the sphincter of Oddi, study of the motor function of the digestive tract with radioactive gold, etc. The lion's share of motor dysfunctions have a complex pathogenesis, so a gastroenterologist simply must have drugs in his arsenal that can have a beneficial effect on motor skills, regardless of what type of disorder occurs in this particular case. Trimedat is one such medicine. It eliminates both hypomotor and spastic dyskinesia of the intestines and biliary tract. Such universalism of trimedat makes it possible to influence the pathological process at its very initial stage and reduce the volume of necessary diagnostic interventions (as well as, of course, their cost).
The substance trimebutine was synthesized in France in 1969 and for many years was known under the trade name debridate.
In 2008, the Russian pharmaceutical company Valenta entered the market with its new brainchild - the drug trimedat, which was created on the basis of trimebutine. Trimedat interacts with peripheral opiate receptors, “scattered” throughout the gastrointestinal tract. They are located mainly in the nerve plexuses of the intestine. Among the opiate receptors, there are 3 subtypes: mu-, delta- and kappa. The first two are responsible for conducting excitation, and the last one is responsible for inhibition. Trimedat does not have an affinity for any one subtype of receptor, interacting with all of them at once. Being normokinetic, it has a dual regulatory effect. By binding to kappa receptors, trimedate suppresses motor activity, and by performing the same action in relation to mu and delta receptors, it stimulates it. Thus, trimedate, depending on the circumstances (read: the initial state of the motor function of the digestive tract), can act both as an antispasmodic and as a prokinetic. Trimedat affects the humoral regulation of the digestive organs, increasing the level of motilin (this hormone is one of the main regulators of gastrointestinal motility), reducing the level of gastrin, insulin, glucagon, pancreatic polypeptide, vasoactive intestinal peptide. As a result, the following clinically significant effects are modulated: gastric evacuation accelerates, motor function of the colon and visceral sensitivity change. The effectiveness of trimedat has been proven in a number of randomized studies. For example, in the treatment of irritable bowel syndrome, it was about 83%, which allows us to consider this drug as a universal regulator of the motor function of the gastrointestinal tract.
Pharmacology
Trimebutine, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Having an affinity for excitation and suppression receptors, it has a stimulating effect in hypokinetic conditions of intestinal smooth muscles and an antispasmodic effect in hyperkinetic conditions.
The drug acts throughout the gastrointestinal tract, reduces the pressure of the esophageal sphincter, promotes gastric emptying and increased intestinal motility, and also promotes the response of the smooth muscles of the colon to food irritants.
Trimebutine restores the normal physiological activity of the intestinal muscles in various gastrointestinal diseases associated with motility disorders.
Pharmacokinetics
Suction
After oral administration, trimebutine is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved after 1-2 hours. Bioavailability is 4-6%.
Distribution
The degree of binding to plasma proteins is low - about 5%. V d - 88 l. Trimebutine penetrates the placental barrier to a small extent.
Metabolism
Trimebutine is biotransformed in the liver.
Removal
Trimebutine is excreted in the urine mainly in the form of metabolites (approximately 70% during the first 24 hours). T 1/2 - about 12 hours.
Release form
Tablets are white, flat-cylindrical, with a symbol in the form of the letters “TM” extruded on one side, with three triangles located in a line above and below them; on the other side there are two intersecting risks.
Excipients: lactose, colloidal silicon dioxide, talc, corn starch, magnesium stearate.
10 pieces. - contour cellular packaging (1) - cardboard packs.
10 pieces. - contour cell packaging (2) - cardboard packs.
10 pieces. - contour cell packaging (3) - cardboard packs.
Dosage
For adults and children over 12 years of age, the drug is prescribed orally at 100-200 mg 3 times a day. To prevent relapse of irritable bowel syndrome after a course of treatment during the period of remission, it is recommended to continue taking the drug at a dose of 300 mg/day for 12 weeks.
Children aged 5-12 years are prescribed 50 mg 3 times/day, children aged 3-5 years - 25 mg 3 times/day.
Overdose
To date, no cases of overdose of Trimedat ® have been reported.Interaction
Drug interactions with Trimedat ® have not been described.
Side effects
Rarely: skin reactions.
Indications
- gastroesophageal reflux disease;
- motor disorders in functional gastrointestinal diseases;
- dyspeptic disorders due to gastroduodenal diseases (abdominal pain, indigestion, nausea, vomiting);
- irritable bowel syndrome, manifested by pain, abdominal colic, intestinal spasms, flatulence, diarrhea and/or constipation;
- postoperative paralytic ileus;
- preparation for x-ray/endoscopic examination of the gastrointestinal tract;
- dyspeptic disorders in children associated with gastrointestinal motility disorders.
Regulator of gastrointestinal motility. Trimebutine, which is contained in the drug, has a beneficial effect on the enkephalinergic system of the intestine and thereby regulates its peristalsis, has a stimulating effect in hypokinetic conditions of intestinal smooth muscles and an antispasmodic effect in hyperkinetic ones.
The drug acts throughout the gastrointestinal tract, reduces the pressure of the esophageal sphincter, helps the functioning of the stomach and enhances intestinal motility. Promotes the response of the smooth muscles of the colon to food irritants.
Trimedat instructions for use
Trade name: Trimedat.
Composition and release form
Trimedat tablets. Active substance: 1 tablet contains trimebutine maleate 100/200 mg.
Excipients: lactose; colloidal silicon dioxide, talc, corn starch, magnesium stearate.
100 mg tablets: white, flat-cylindrical, with an extruded symbol representing two letters TM on one side, above and below which there are three triangles in a line and two intersecting marks on the other side.
200 mg tablets: white, round, biconvex, with an embossed symbol in the form of two drop-shaped elements on one side and a line on the other side.
Both dosages come in packages of 10 tablets. (1 blister), 20 tablets. (2 blisters), 30 tablets. (3 blisters) in cardboard boxes.
Indications for use
Trimedat is used for gastroesophageal reflux disease, postoperative paralytic intestinal obstruction, for dyspeptic symptoms (nausea, vomiting, abdominal pain, etc.) for gastroduodenal diseases. The drug is also used for irritable bowel syndrome, in preparation for x-ray and endoscopic examinations, and for dyspeptic symptoms in children.
Gastrointestinal motility disorders in the following functional diseases and conditions:
- gastroesophageal reflux disease;
- dyspeptic disorders due to gastroduodenal diseases (abdominal pain, indigestion, nausea, vomiting);
- irritable bowel syndrome, manifested by pain, abdominal colic, intestinal spasms, flatulence, diarrhea and/or constipation;
- postoperative paralytic ileus;
- preparation for x-ray/endoscopic examination of the gastrointestinal tract;
- dyspeptic disorders in children associated with gastrointestinal motility disorders.
pharmachologic effect
Regulator of gastrointestinal motility. Trimebutine, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Having an affinity for excitation and suppression receptors, it has a stimulating effect in hypokinetic conditions of intestinal smooth muscles and an antispasmodic effect in hyperkinetic conditions.
The drug acts throughout the gastrointestinal tract, reduces the pressure of the esophageal sphincter, promotes gastric emptying and increased intestinal motility, and also promotes the response of the smooth muscles of the colon to food irritants.
Trimebutine restores the normal physiological activity of the intestinal muscles in various gastrointestinal diseases associated with motility disorders.
Pharmacokinetics
Suction
After oral administration, trimebutine is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved after 1-2 hours. Bioavailability is 4-6%.
Distribution
The degree of binding to plasma proteins is low - about 5%. V d - 88 l. Trimebutine penetrates the placental barrier to a small extent.
Metabolism
Trimebutine is biotransformed in the liver.
Removal
Trimebutine is excreted in the urine mainly in the form of metabolites (approximately 70% during the first 24 hours). T 1/2 - about 12 hours.
Dosage regimen
- For adults and children over 12 years of age, the drug is prescribed orally at 100-200 mg 3 times a day.
- Children aged 5-12 years - 50 mg 3 times a day.
- Children aged 3-5 years - 25 mg 3 times a day.
Side effect
The following undesirable effects were observed:
- allergic reactions;
- menstrual irregularities;
- hearing loss;
- the appearance of causeless anxiety.
Contraindications
- children under 3 years of age;
- hypersensitivity to the components of the drug.
Pregnancy and lactation
In experimental studies There was no evidence of teratogenicity or embryotoxicity of the drug.
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Best before date
Conditions for dispensing from pharmacies
The drug is approved for use as a means of OTC.
Trimedat price
TRIMEDAT TAB 200MG No. 30 - 250 rub.
TRIMEDATE 0.2 N30 TABLE - 257 rub.
Trimedat reviews
Once I was advised to use Trimedat as an antispasmodic. I bought it and didn’t regret it, it’s a hundred times better than No-Spa, because I noticed that after taking No-Spa I immediately felt dizzy, that is, it lowered my already low blood pressure even lower. This does not happen when taking Trimedat, it acts very quickly and relieves cramps in the stomach, pain in the intestines, pancreas, etc. The only negative is that 30 tablets cost 320 rubles.
It can also be used by children over 3 years old. The instructions for use say very little about side effects, only about skin reactions. I can say that when our family used Trimedat, it did not cause any side effects. The drug is excellent, it is also prescribed for irritable bowel syndrome, flatulence, diarrhea and constipation.