Neobutin 200 mg 30 tablets

Indications

Symptomatic treatment of pain, spasms, and discomfort in the abdominal area, feelings of bloating (flatulence), motor disorders of the intestine with changes in stool frequency (diarrhea or constipation), dyspepsia, heartburn, belching, nausea, vomiting, related to functional diseases of the gastrointestinal tract and biliary pathways (non-erosive form of gastroesophageal reflux disease, cholelithiasis, dysfunction of the bile ducts, irritable bowel syndrome, dysfunction of the sphincter of Oddi, post-cholecystectomy syndrome).
Postoperative paralytic intestinal obstruction.

Method of administration and doses

Orally.
Adults and children over 12 years: 100–200 mg 3 times a day.
To prevent recurrence of irritable bowel syndrome after treatment during the remission period, it is recommended to continue taking the medication at a dose of 300 mg per day for 12 weeks.
Children aged 5–12 years: 50 mg 3 times a day. Children aged 3–5 years: 25 mg 3 times a day.

Section: Composition

1 tablet contains:
active ingredient: trimebutine maleate 200 mg; excipients: lactose monohydrate, corn starch, colloidal silicon dioxide (aerosil), magnesium stearate.

Description of the dosage form

Round biconvex tablets of white or almost white color with a score.

Contraindications

Increased sensitivity 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.

Special instructions

The treatment course for irritable bowel syndrome during the acute period at a dose of 600 mg per day for four weeks, followed by continued treatment after the course at a dose of 300 mg per day for 12 weeks, helps to prevent disease recurrence.

Section: Side effects

From the digestive system: dry mouth, unpleasant taste sensations, diarrhea, dyspepsia, nausea, constipation.
From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety, feeling of heat or cold.
Allergic reactions: skin rash.
Others: menstrual cycle disturbances, painful enlargement of the mammary glands, urinary retention.

Overdose

To date, there have been no reports of cases of trimetazidine overdose.

Interaction

The drug interaction of Neobutin® is not described.

Section: Pharmacodynamics

Trimebutine, acting on the enkephalinergic system of the intestine, is a regulator of its peristalsis. By acting on peripheral μ-, δ-, and κ-receptors, including those located directly on the smooth muscle throughout the gastrointestinal tract (GIT), it regulates motility without affecting the central nervous system.
Thus, trimebutine restores the normal physiological activity of the intestinal musculature in various gastrointestinal diseases associated with motility disorders.
By normalizing visceral sensitivity, trimebutine provides an analgesic effect in abdominal pain syndrome.

Pharmacokinetics
Absorption and distribution.
After oral administration, trimetazidine is rapidly absorbed in the gastrointestinal tract, with the maximum concentration in plasma (Cmax) reached within 1–2 hours. The bioavailability is 4–6%. The volume of distribution (Vd) is 88 L. The degree of binding to plasma proteins is low – about 5%. Trimetazidine penetrates the placental barrier to a minor extent.
Metabolism and excretion.
Trimetazidine is metabolized in the liver and excreted through the kidneys predominantly as metabolites (approximately 70% within the first 24 hours). The half-life (T1/2) is about 12 hours.