Neobutin - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Trimebutin, acting on the enkephalinergic system of the intestine, is the regulator of its peristalsis. Acting on peripheral δ-, μ- and κ-receptors, including those located directly on the smooth muscles throughout the gastrointestinal tract (GIT), it regulates the motor function without affecting the the central nervous system. In this way, trimebutin restores the normal physiological activity of the musculature of the intestine in various gastrointestinal disorders associated with motor disorders.

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

Pharmacokinetics:

Absorption and distribution. After oral administration trimebutin quickly absorbed from the gastrointestinal tract, the maximum concentration in the blood plasma (Cmah) is achieved 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%. Trimebutin to a small extent penetrates through the placental barrier.

Metabolism and excretion. Trimebutin is destabilized in the liver and excreted through the kidneys mainly in the form of metabolites (approximately 70% within the first 24 hours).

Half-life (T_1/2) - about 12 hours.

Indications:

Adults and children from 3 years.

Symptomatic treatment of pain, cramps and discomfort in the abdominal area, sensations of bloating (flatulence), motor bowel disorders with a change in stool frequency (diarrhea or constipation),dyspepsia, heartburn, belching, nausea, vomiting associated with functional diseases of the gastrointestinal tract and biliary ducts (non-erosive form of gastroesophageal reflux disease, cholelithiasis, biliary tract dysfunction, irritable bowel syndrome, Oddi sphincter dysfunction, postcholecystectomy syndrome). Postoperative paralytic intestinal obstruction.

Contraindications:

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

Children under 3 years (for this dosage form).

Pregnancy.

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Pregnancy and lactation:

Pregnancy. In the experimental studies, there was no evidence of teratogenicity and embryotoxicity of trimebutin. Nevertheless, in connection with the lack of necessary clinical data, the use of trimebutin during pregnancy is contraindicated.

Breastfeeding period. It is not recommended to apply trimebutin in the period of breastfeeding, due to the lack of reliable clinical data confirming the safety of the drug during this period.If trimebutin is needed during breastfeeding, breastfeeding should be discontinued.

Dosing and Administration:Inside, before eating.

Adults and children over 12 years of age: on 100-200 mg 3 times a day.

To prevent the recurrence of irritable bowel syndrome after the 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: 50 mg 3 times a day.

Children aged 3-5 years: 25 mg 3 times a day.

Side effects:

From the digestive system: dry mouth, unpleasant taste sensations, diarrhea, indigestion, nausea, constipation.

From the nervous system: drowsiness, fatigue, dizziness, headache, anxiety, a feeling of heat or cold.

Allergic reactions: skin rash.

Other: violations of menstrual nikla, painful enlargement of the mammary glands, retention of urine.

Overdose:Until now, no cases of thymebumin overdose have been reported.

Interaction:

Drug Interactions of the drug® not described.

Special instructions:

The course of treatment of irritable bowel syndrome in an acute period in a dose of 600 mg inday for four weeks and the continuation of treatment after a course of 300 mg per day for 12 weeks allows to avoid recurrence of the disease.

Effect on the ability to drive transp. cf. and fur:The drug does not have a sedative effect, does not affect the speed of the psychomotor reaction and can be used in people of various professions, including those requiring increased attention and coordination of movements. However, considering possible side effects that may affect these abilities (goalsenvironment and others), followsto be cautious when driving and practicing other potentially hazardous activities.

Form release / dosage:Tablets of 100 mg and 200 mg.

Packaging:

For 10, 15, 20, 30 tablets in a contour cell pack of film polyvinylchloride and aluminum foil printed lacquered.

For 1, 2, 3 contour squares, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:LP-003098

Date of registration:20.07.2015 / 01.12.2016

Expiration Date:20.07.2020

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp19.06.2018

Illustrated instructions

Instructions

Neobutin® (Neobutine)