Neobutine pills 100mg №10

Antispasmodic

Mechanism of action

Trimebutin, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Acting on peripheral δ-, μ- and κ-receptors, incl. being directly in the smooth muscles throughout the gastrointestinal tract, regulates motility without affecting the central nervous system. Thus, trimebutin restores the normal physiological activity of the muscles of the intestine in various diseases of the gastrointestinal tract associated with impaired motility.

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

Pharmacokinetics

Suction and distribution

After ingestion, trimebutin is rapidly absorbed from the gastrointestinal tract, C_max in blood plasma is achieved in 1-2 hours. Bioavailability is 4-6%. V_d - 88 l. The degree of binding to plasma proteins is low - about 5%. Trimebutin to a small extent penetrates the placental barrier.

Metabolism and excretion

Trimebutin is metabolized in the liver and excreted through the kidneys mainly in the form of metabolites (approximately 70% during the first 24 hours). T_1/2 - about 12 hours

Indications

- irritable bowel syndrome;

- postoperative paralytic intestinal obstruction.

Dosage and administration

The drug is taken orally before meals.

Adults and children over 12 years old appoint 100-200 mg 3 times / day.

To prevent the recurrence of irritable bowel syndrome after the course of treatment in remission, it is recommended to continue taking the drug at a dose of 300 mg / day for 12 weeks.

Children aged 5-12 years appoint 50 mg 3 times / day, children aged 3-5 years - 25 mg 3 times / day.

Side effect

Gastrointestinal: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation.

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.

Contraindications

- children's age up to 3 years (for this dosage form);

- pregnancy;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

- Hypersensitivity to trimebutine maleate and other components that make up the drug.

Use during pregnancy and lactation

AT experimental studies no data on the teratogenicity and embryotoxicity of trimebutin were obtained. However, due to the lack of necessary clinical data, the use of the drug Neobutine^® during pregnancy is contraindicated.

Do not use the drug Neobutine^® in the period of breastfeeding due to the lack of reliable clinical data confirming the safety of the drug during this period.If necessary, the use of trimebutin during breastfeeding, breastfeeding should be discontinued.

Use in children

Use of the drug is contraindicated in children under 3 years of age (for this dosage form).

Special notes

The course of treatment of irritable bowel syndrome in the acute period at a dose of 600 mg / day for 4 weeks and continued treatment after the course at a dose of 300 mg / day for 12 weeks avoids the relapse of the disease.

Influence on ability to drive motor transport and control mechanisms

The drug does not have a sedative effect, does not affect the speed of psychomotor reactions and can be used in people of various professions, including 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 doing other potentially dangerous activities.

Overdosage

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

Drug interaction

Drug interaction drug Neobutine^® not described.

Terms and conditions of storage

The drug should be stored in a dry, dark place and out of reach of children at a temperature not exceeding 25 ° C. Shelf life - 2 years.

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