Trimedat, tablets 100 mg 10 pcs

Trimebutine, acting on the encephalinergic 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.

Trimebutin thus restores normal physiological activity of the intestinal musculature 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

Symptomatic treatment of pain, abdominal cramps and discomfort, bloating sensations (flatulence), bowel motor disorders with altered stool frequency (diarrhea or constipation), dyspepsia, heartburn, belching, nausea, vomiting, associated with functional diseases of GIT and biliary tract (non-erosive form of gastroesophageal reflux disease; cholelithiasis; biliary dysfunction; irritable bowel syndrome; sphincter Oddi dysfunction, postcholecystectomy syndrome).

Postoperative paralytic ileus.

Active ingredient

Composition

One tablet contains:

the active ingredient:

trimebutine maleate – 100 mg;

excipients:

lactose monohydrate,

potato starch,

povidone,

How to take, the dosage

Ingestion.

Adults and children from 12 years of age: 100-200 mg 3 times a day. In order to prevent relapse of irritable bowel syndrome after the conducted course of treatment in 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

There are no data on drug interactions of Trimedat.

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 recurrence of the disease.

Impact on ability to drive, operate machinery

The drug does not have sedative action, does not affect psychomotor reaction time and can be used in various professions, including those requiring increased attention and coordination of movements.

Because of possible side effects that may affect the above abilities (dizziness and others), however, caution should be exercised when driving motor vehicles and engaging in other potentially hazardous activities.

Synopsis

Contraindications

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

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

Pregnancy.

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 for 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