Trimedat tab. 100mg # 10

Dosage form

White round flat-cylindrical tablets with a bevel and two intersecting marks on one side

Structure

One tablet contains:

active substance: trimebutin maleate - 100 mg

excipients: lactose monohydrate - 70 mg, potato starch - 20 mg, povidone - 4 mg, colloidal silicon dioxide (Aerosil) - 2 mg, magnesium stearate - 2 mg, talc - 2 mg.

pharmachologic effect

Trimebutin, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis.

Acting on peripheral 5-, p- and k receptors, including those located directly on smooth muscles throughout the gastrointestinal tract (GIT), it regulates motility without affecting the central nervous system.

Thus, trimebutin restores the normal physiological activity of the intestinal musculature in various gastrointestinal diseases associated with motility disorders.

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

Pharmacokinetics

After oral administration, trimebutin is rapidly absorbed from the gastrointestinal tract.

The maximum concentration (Cmax) in blood plasma is reached after 1-2 hours. Bioavailability is 4-6%.

The volume of distribution (Vd) - 88 liters.

The degree of binding to plasma proteins is low - about 5%.

Trimebutine slightly crosses the placental barrier.

Trimebutine is biotransformed in the liver and excreted in the urine mainly as metabolites (approximately 70% during the first 24 hours).

The half-life (T1 / 2) is about 12 hours.

Side effects

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.

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

Selling features

Available without a prescription

Special conditions

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 allows you to avoid recurrence of the disease.

Influence on the ability to drive vehicles and 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 can affect these abilities (dizziness and others), care should be taken when driving vehicles and engaging in other potentially hazardous activities.

Indications

Irritable Bowel Syndrome.

Postoperative paralytic intestinal obstruction.

Contraindications

Hypersensitivity to trimebutin maleate and other components that make up the drug.

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Children under 3 years old - for this dosage form.

Pregnancy.

Pregnancy and lactation:

Experimental studies have not revealed data on the teratogenicity and embryotoxicity of the drug.

However, due to the lack of the necessary clinical data, the use of Trimedat® Valenta during pregnancy is contraindicated.

It is not recommended to prescribe Trimedat® Valenta during lactation, due to the lack of reliable clinical data confirming the safety of the drug during this period.

If necessary, use of the drug during lactation should stop breastfeeding.

Drug interactions

Drug inter

Name ENG

TRIMEDAT

Clinical and pharmacological group

A drug that regulates the motor function of the gastrointestinal tract

ATX code

Trimebutine

Dosage

100mg

Structure

active substance: trimebutin maleate - 100 mg.

excipients: lactose monohydrate - 70 mg, potato starch - 20 mg, povidone - 4 mg, colloidal silicon dioxide (aerosil) - 2 mg, magnesium stearate - 2 mg, talc - 2 mg.

Indications

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 cramps, intestinal cramps, flatulence, diarrhea, and / or constipation)

postoperative paralytic intestinal obstruction

preparation for X-ray / endoscopic examination of the gastrointestinal tract

dyspeptic disorders in children associated with impaired gastrointestinal motility.

Contraindications

hypersensitivity to drug components

children under 3 years old

pregnancy and lactation.

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 3 years

INN / Active ingredient

trimebutine maleate

Specifications

Category

Preparations for the gastrointestinal tract

Scope of the drug

Gastrointestinal tract

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

ten

Scope of application

Gastroenterology

Minimum age from

3 years old

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Valenta Pharmaceuticals

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antispasmodic

Anatomical and therapeutic characteristics

A03AA05 Trimebutin

Dosage form

Pills

The target audience

Children

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

trimebutine maleate 100 mg

Package weight, g

45

Mode of application

:

Inside.

Adults and children from 12 years old: 100-200 mg 3 times a day.

To prevent recurrence of irritable bowel syndrome after the course of treatment during the period of remission, it is recommended to continue taking the drug at a dose of 300 mg per day for 12 weeks. < br> Children 3-5 years old: 25 mg 3 times a day.

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

Information on technical characteristics, delivery set, country of manufacture