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

Irritable bowel syndrome.

Postoperative paralytic ileus.

Pharmacological effect

Pharmacotherapeutic group

Antispasmodic

ATX code: A03AA05

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 gastrointestinal diseases associated with motility disorders.

By normalizing visceral sensitivity, trimebutine provides an analgesic effect for abdominal pain syndrome.

Pharmacokinetics

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

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

Special instructions

A 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 helps to avoid relapse of the disease.

Impact on the ability to drive vehicles and machinery

The drug does not have a sedative effect, does not affect the speed of the psychomotor reaction and can be used by people of various professions, including those requiring increased attention and coordination of movements.

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

Active ingredient

Trimebutine

Composition

1 tablet contains:

active ingredient:

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.

Pregnancy

Pregnancy. Experimental studies have not revealed data on the teratogenicity and embryotoxicity of trimebutine. However, due to the lack of necessary clinical data, the use of trimebutine during pregnancy is contraindicated.

Breastfeeding period. It is not recommended to use trimebutine during breastfeeding due to the lack of reliable clinical data confirming the safety of the drug during this period.

If it is necessary to use trimebutine during breastfeeding, breastfeeding should be discontinued.

Contraindications

Hypersensitivity to trimebutine maleate and other components included in 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, diarrhea, dyspepsia, nausea, constipation.

From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety, feeling hot or cold.

Allergic reactions: skin rash.

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

Interaction

Drug interactions with Neobutin® have not been described.

Overdose

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

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

3 years.
Do not use after the expiration date stated on the package.

Manufacturer

Alium JSC, Russia