Composition
1 tablet contains:
Active ingredient: Â
trimebutine maleate 200 mg;
excipients:
lactose monohydrate 81.6 mg,
corn starch 32 mg,
colloidal silicon dioxide (aerosil) 3.2 mg,
magnesium stearate 3.2 mg
Pharmacological action
Pharmacotherapy group
Antispasmodic agent
ATX code: Â 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 motor skills 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
Suction and distribution. After oral use, trimebutine is rapidly absorbed from the gastrointestinal tract, the maximum concentration in blood plasma (Cmax) is reached in 1-2 hours. Bioavailability is 4-6%. Volume of distribution (Vd) – 88 liters. The degree of binding to plasma proteins is low – about 5%. Trimebutine only slightly penetrates the placental barrier.
Metabolism and elimination. Trimebutine is metabolized in the liver and excreted via the kidneys mainly in the form of metabolites (approximately 70% within the first 24 hours). The half-life (T 1/2) is about 12 hours.
Indications
Irritable bowel syndrome.
Postoperative paralytic intestinal obstruction.
Contraindications
Hypersensitivity to trimebutine maleate and other components of the drug.
Children under 3 years of age (for this dosage form). Pregnancy.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Side effects
From the digestive system: dry mouth, unpleasant taste sensations, diarrhea, dyspepsia, nausea, constipation.
Nervous system disorders: drowsiness, fatigue, dizziness, headache, restlessness, feeling hot or cold.
Allergic reactions: skin rash.
Other: menstrual disorders, painful breast enlargement, urinary retention.
Interaction
The drug interaction of Nebutin® is not described.
How to take, course of use and dosage
Inside, before meals.
Adults and children over 12 years of age: Â 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 aged 5-12 years: Â 50 mg 3 times a day.
Children aged 3-5 years: Â 25 mg 3 times a day.
Overdose
To date, no cases of trimebutine overdose have been reported.
Special instructions
A course of treatment for 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 relapse 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 psychomotor reaction and can be used in people of various professions, including those requiring increased attention and coordination of movements.
However, taking into account possible side effects that may affect these abilities (dizziness and others), caution should be exercised when driving vehicles and engaging in other potentially dangerous activities.
Form of production
Round biconvex tablets of white or almost white color with a risk.
Active ingredient
Trimebutin
Dosage form
Tablets
Description
For adults, Children over 3 years old
Indications
Irritable Bowel syndrome, Gastrointestinal Spasm, Gastrointestinal Motility disorders, Flatulence
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