Trimedat, tablets 200 mg, 30 pcs.

One tablet contains:

active substance: trimebutin maleate - 200 mg;

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

An antispasmodic.

ATX Code: A03AA05

Pharmacological properties

Pharmacodynamics

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

By normalizing visceral sensitivity, trimebutin provides an analgesic effect in abdominal pain.

Pharmacokinetics

After oral administration, trimebutin is rapidly absorbed from the digestive tract. The maximum concentration (C _max ) in blood plasma is reached after 1-2 hours. Bioavailability is 4-6%. Distribution volume (V _d ) - 88 l. The degree of binding to plasma proteins is low - about 5%. Trimebutin to a small extent penetrates the placental barrier. Trimebutin is biotransformed in the liver and excreted in the urine mainly in the form of metabolites (approximately 70% during the first 24 hours). The half-life (T _1/2 ) is about 12 hours.

Postoperative paralytic intestinal obstruction.

In experimental studies, no data were found on teratogenicity and embryotoxicity of the drug. However, due to the lack of necessary clinical data, the use of the drug Trimedat ^® during pregnancy is contraindicated.

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

Hypersensitivity to the components that make up the drug.

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Children's age up to 3 years (for this dosage form).

Pregnancy

Precautions for use

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

From the digestive system: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation.

From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety.

Allergic reactions: skin rash.

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

The drug interaction of the drug Trimedat ^{® is} not described.

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

Treatment: drug withdrawal, gastric lavage, administration of activated carbon, symptomatic therapy. There are no specific antidotes.

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

Influence on the ability to drive vehicles, mechanisms

The drug does not have a sedative effect, does not affect the speed of the psychomotor reaction and can be used in people of various professions, including those requiring increased attention and coordination of movements. However, given the possible side effects that may affect these abilities (dizziness and others), care should be taken when driving and engaging in other potentially dangerous activities.

200 mg tablets

On 10 tablets in a blister strip packaging or in a blister strip packaging with perforation from a film of polyvinyl chloride and varnished aluminum foil.

3 or 9 contour packs (for a dosage of 200 mg), together with instructions for use, are placed in a pack of cardboard.

3 years.

Do not use after the expiration date indicated on the package.