Trimedat Forte, 300 mg 60 pcs

Antispasmodic agent

ATX code: A03A05

Pharmacodynamics

Trimebutine acts on the encephalinergic system of the intestine and regulates 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

Trimebutine is rapidly absorbed from the gastrointestinal tract after oral administration. The degree of binding to plasma proteins is about 5%. Trimebutine slightly penetrates through the placental barrier. Trimebutine is biotransformed in liver and excreted with urine mainly as metabolites.

In a study in healthy volunteers with a single administration of Trimedat® forte, the pharmacokinetic parameters of the active metabolite of trimebutine, 2-methylamino-2-phenylbutyl-3,4,5-trimethoxybenzoate (desmethyltrimebutine) were: maximum concentration (C_max) of 441.45±252.99 ng/mL; time to reach it (T_max) of 2.20±1.01 hours; mean retention time (MRT) of 17.12±3.14 hours; half-life (T_1/2) – 12.52±4.54 hours; volume of distribution (V_d) – 1279.72±1108.53 l, total clearance (CL_t) – 66.51±34.34 l/h.

Indications

Symptomatic treatment of pain, abdominal cramps and discomfort, bloating (flatulence), 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; cholelithiasis; biliary tract dysfunction; irritable bowel syndrome; sphincter Oddi dysfunction; postcholecystectomy syndrome).

Postoperative paralytic intestinal obstruction.

Active ingredient

Trimebutin

Composition

One tablet contains:

the active ingredient:

trimebutine maleate – 300 mg;

excipients:

Microcrystalline cellulose,

povidone (K 25),

hypromellose,

Magnesium stearate;

Shell composition: Opadray II 85F18422: partially hydrolyzed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc.

How to take, the dosage

Ingestion.

Adults and children over 12 years old take 1 tablet 2 times a day (12 hours apart).

The course of treatment of abdominal pain associated with functional diseases of the digestive tract and biliary tract is 28 days.

Interaction

Drug interaction of the drug Trimedat^® forte has not been described.

Special Instructions

In order to prevent a recurrence of irritable bowel syndrome after the course of treatment, it is recommended to continue taking a dose of 300 mg per day for 12 weeks during the period of remission.

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Synopsis

Circular biconvex film-coated white tablets with an embossed symbol in the form of two drop-shaped elements on one side. On the cross section the core is white or almost white.

Contraindications

Hypersensitivity to the ingredients of the drug.

Pregnancy.

Children under 12 years of age (for this dosage form).

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.

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

Overdose

No cases of overdose of Trimedat® forte 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

There are no data on teratogenicity and embryotoxicity of the drug in experimental studies. Nevertheless, due to the lack of necessary clinical data, the use of Trimedat^® forte during pregnancy is contraindicated. </It is not recommended to prescribe Trimedat^® forte 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

Neobutin, Trimedat for children, Neobutin retard, Trimedat Forte