Trimedat, pills 200mg, 30pcs

Composition

One tablet contains:

active ingredient: trimebutin maleate-200 mg;

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

Pharmacological action

Antispasmodic agent.

ATX code: A 03 AA 05

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 smooth muscles throughout the gastrointestinal tract (GIT), it regulates motility without affecting the central nervous system. Thus, trimebutine restores the normal physiological activity of the intestinal muscles in various diseases of the gastrointestinal tract associated with motor disorders.

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

Pharmacokinetics

After oral use, trimebutine is rapidly absorbed from the gastrointestinal tract. The maximum concentration (cmax) in blood plasma is reached after 1-2 hours. Bioavailability is 4-6%. Volume of distribution (V_d) – 88 liters. The degree of binding to plasma proteins is low – about 5%. Trimebutine only slightly penetrates the placental barrier. Trimebutine is biotransformed in the liver and is mainly excreted in the urine as metabolites (approximately 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 (flatulence), motor bowel 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; cholelithiasis; biliary tract dysfunction; irritable bowel syndrome Oddi sphincter dysfunction, postcholecystectomy syndrome).

Postoperative paralytic intestinal obstruction.

Use during pregnancy and lactation

Experimental studies have not revealed data on teratogenicity and embryotoxicity of the drug. However, due to the lack of necessary clinical data, the use of 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 using the drug during this period. If it is necessary to use the drug during lactation, stop breastfeeding.

Contraindications

Hypersensitivity to the components that make up the drug.

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

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

Pregnancy

Precautions for use

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

Side effects

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

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

Allergic reactions: skin rash.

Other: menstrual disorders, painful breast enlargement, urinary retention.

Interaction

The drug interaction of Trimedat® is not described.

How to take, course of use and dosage

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

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

Overdose

No cases of Trimedat overdose have been reported to date.

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

Description

Round biconvex tablets of white color with a risk on one side and an embossed symbol in the form of two drop-shaped elements on the other side (for a dosage of 200 mg).

Special instructions

A course of treatment for 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 relapse of the disease.

Form of production

Tablets 200 mg.

10 tablets in a contour cell package or in a contour cell package with perforation made of polyvinyl chloride film and aluminum foil printed varnished.

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

Storage conditions

In the original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf

life is 3 years.

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

Active ingredient

Trimebutin

Dosage form

Tablets

Description

Children over 12 years old, For adults

Indications

Reflux esophagitis, Irritable bowel syndrome, Flatulence, Diarrhea, Gastrointestinal spasm, Gastrointestinal motility disorders, Constipation