Trimedat, tablets 200 mg 30 pcs

Spasmolytic agent.

ATX code: A03AA05

Pharmacological properties

Pharmacodynamics

Trimebutine, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Acting on peripheral δ-, μ- and k-receptors including those located directly on the smooth muscles throughout the gastrointestinal tract (GIT), it regulates motility without affecting the central nervous system. Thus, trimebutine restores normal physiological activity of intestinal muscles in various GI diseases associated with motility disorders.

Normalizing visceral sensitivity, trimebutine provides analgesic effect in abdominal pain syndrome.

Pharmacokinetics

Trimebutin is rapidly absorbed from the gastrointestinal tract after oral administration. Maximum concentration (C_max) in blood plasma is reached after 1-2 hours. Bioavailability is 4-6%. Volume of distribution (V_d) is 88 l. The degree of binding to plasma proteins is low – about 5%. Trimebutine penetrates through the placental barrier to a small extent. Trimebutine is biotransformed in the liver and excreted in the urine mainly as metabolites (about 70% during the first 24 hours). The elimination half-life (T_1/2) is about 12 hours.

Indications

Diarrhea, Irritable bowel syndrome, GI motility disorders, Colic, Constipation, GI spasms, Meteorism, Abdominal bloating, Reflux esophagitisSymptomatic treatment of pain, abdominal spasms and discomfort, bloating sensations (meteorism), Bowel motor disorders with changes in stool frequency (diarrhea or constipation), dyspepsia, heartburn, belching, nausea, vomiting, associated with functional diseases of the gastrointestinal tract and biliary tract (non-erosive form of gastroesophageal reflux disease; biliary stone disease; biliary tract dysfunction; irritable bowel syndrome; Oddi sphincter dysfunction, postcholecystectomy syndrome).

Postoperative paralytic intestinal obstruction.

Active ingredient

Trimebutin

Composition

One tablet contains:

The active substance: trimebutine maleate – 200 mg;

auxiliary substances: lactose monohydrate, potato starch, povidone, colloidal silicon dioxide (aerosil), magnesium stearate, talc.

How to take, the dosage

Inside. Adults and children from 12 years of age: 100-200 mg 3 times a day. For prevention of irritable bowel syndrome relapse after the conducted course of treatment during the remission period, it is recommended to continue taking the drug in dose of 300 mg per day for 12 weeks.

In children 3-5 years old: 25 mg 3 times a day. Children 5-12 years old: 50 mg 3 times a day.

Interaction

Drug interactions of Trimedat^® have not been described.

Special Instructions

The course of treatment of irritable bowel syndrome in the acute period of 600 mg per day for 4 weeks and continuation of treatment after the course at a dose of 300 mg per day for 12 weeks avoids a recurrence of the disease.

Synopsis

Round biconvex white tablets with a ridge on one side and an embossed symbol in the form of two drops on the other side (for 200 mg dosage).

Contraindications

Hypersensitivity to the ingredients of the drug.

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Children under 3 years of age (for this dosage form).

Pregnancy

Pregnancy precautions for use

The drug Trimedat^® should be used with caution during breastfeeding, since there is no data on its ability to penetrate into breast milk.

Side effects

Digestive system disorders: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation.

Nervous system disorders: drowsiness, fatigue, dizziness, headache, anxiety.

Allergic reactions: skin rash.

Other: menstrual irregularities, painful enlargement of the breasts, urinary retention.

Overdose

No cases of overdose of Trimedat® have been reported so far.

Treatment: cancellation of the drug, gastric lavage, administration of activated charcoal, symptomatic therapy. There are no specific antidotes.

Pregnancy use

The experimental studies did not reveal data on teratogenicity and embryotoxicity of the drug. Nevertheless, due to the lack of necessary clinical data, the use of Trimedat^® during pregnancy is contraindicated.

Trimedat^® is not recommended during lactation due to the lack of reliable clinical data confirming the safety of the drug during this period. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Similarities

Trimedat, Neobutin, Trimedat for children, Neobutin retard, Trimedat Forte