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.
Trimebutin, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. Acting on peripheral δ-, μ- and k-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.
Absorption and distribution: After oral administration, trimebutin is rapidly absorbed from the gastrointestinal tract, Cmax in the blood plasma is reached in 1-2 hours. Bioavailability is 4-6%. Vd - 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). T1 / 2 - about 12 hours
- irritable bowel syndrome - postoperative paralytic intestinal obstruction.
- 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 of the preparation.
Use during pregnancy and lactation
In experimental studies, no data were obtained on the teratogenicity and embryotoxicity of trimebutin. 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 during 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.
Dosage and administration
The drug is taken orally before meals. Adults and children over 12 years old are prescribed 100-200 mg 3 times / day. To prevent the recurrence 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 / day for 12 weeks. Children at the age of 5-12 years old are prescribed 50 mg 3 times / day, children aged 3-5 years old - 25 mg 3 times / day.
On the part of the digestive system: dry mouth, unpleasant taste, diarrhea, dyspepsia, nausea, constipation. Nervous system disorders: drowsiness, fatigue, dizziness, headache, anxiety, feeling hot or cold. Allergic reactions: skin rash. Other: menstrual disorders, painful enlargement of the mammary glands, urinary retention.
To date, cases of overdose of trimebutin have been reported.
Interaction with other drugs
Drug interactions drug Neobutine not described.
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. Impact on the ability to drive motor vehicles 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.