Neobutin, tablets 200 mg 30 pcs

Pharmacotherapeutic group

Spasmodic agent

ATC code: A03AA05

Pharmacological properties

Pharmacodynamics

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

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

Pharmacokinetics

Absorption and distribution. After oral administration, trimebutine is rapidly absorbed from the gastrointestinal tract, the maximum blood plasma concentration (Cmax) is reached after 1-2 hours. Bioavailability is 4-6%. Volume of distribution (Vd) is 88 l. The degree of binding to plasma proteins is low – about 5%. Trimebutine penetrates through the placental barrier to a small extent.

Metabolism and excretion. Trimebutin is metabolized in the liver and excreted through the kidneys mainly as metabolites (about 70% during the first 24 hours). The elimination half-life (T1/2) is about 12 hours.

Indications

Intestinal irritable bowel syndrome.

Postoperative paralytic intestinal obstruction.

Active ingredient

Composition

1 tablet contains:

the active ingredient:

Trimebutine maleate 200 mg;

excipients:

Lactose monohydrate 81.6 mg,

Corn starch 32 mg,

colloidal silica (aerosil) 3.2 mg,

magnesium stearate 3.2 mg.

How to take, the dosage

Ingestion, before meals.

Adults and children over 12 years of age: 100-200 mg 3 times daily.

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

Children aged 5-12 years: 50 mg 3 times daily.

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

Interaction

No drug interactions have been described for Neobutin®.

Special Instructions

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

Influence on ability to drive vehicles and mechanisms

The drug has no sedative effect, does not affect the speed of psychomotor reaction and can be used for persons of different professions, including those requiring increased attention and coordination of movements.

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

Contraindications

Hypersensitivity to trimebutyn malate and other ingredients of the drug.

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

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Side effects

Digestive system disorders: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation.

Nervous system disorders: drowsiness, fatigue, dizziness, headache, anxiety, feeling hot or cold.

Allergic reactions: skin rash.

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

Overdose

To date, no cases of trimebutine overdose have been reported.

Pregnancy use

Similarities