Neobutin Retard, 300 mg 60 pcs

Pharmacotherapeutic group: antispasmodic agent.

ATX 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 κ 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, trimebutin is rapidly absorbed from the gastrointestinal tract. The volume of distribution (Vd) is 88 liters. The degree of binding to plasma proteins is low – about 5%. Trimebutine penetrates through the placental barrier to a small extent.

Metabolism and excretion.

Trimebutine is biotransformed in the liver and excreted in the urine mainly as metabolites.

Indications

Active ingredient

Composition

1 tablet contains:

active ingredient: trimebutine maleate 300 mg;

excipients: lactose monohydrate, tartaric acid, hypromellose (hydroxypropyl methylcellulose), povidone K30, colloidal silicon dioxide (aerosil), magnesium stearate.

Hypromellose (hydroxypropyl methylcellulose), talc, Opaspray white M-1-7111 [titanium dioxide, denatured ethanol (methylated alcohol), hypromellose-2910, water], silicon defoamer.

How to take, the dosage

Ingestion, before meals.

Adults and children over 12 years of age take 300 mg twice daily.

The maximum daily dose is 600 mg.

Interaction

Special Instructions

The recommended course of treatment of irritable bowel syndrome in the acute period is 600 mg per day for 4 weeks.

Influence on driving and operating ability

The drug Neobutin® Retard has no sedative effect, does not affect psychomotor reactions and can be used in a variety of occupations, including those requiring increased attention and coordination of movements. However, given the possible side effects that may affect the above abilities (dizziness and others), caution should be exercised when driving motor vehicles and engaging in other potentially hazardous activities.

Synopsis

Contraindications

Hypersensitivity to the ingredients of the drug.

Children under 12 years of age.

Pregnancy.

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Side effects

Digestive system disorders: Dry mouth, unpleasant taste, diarrhea, dyspepsia, epigastric pain, nausea, constipation.

Nervous system disorders: sleepiness, fatigue, dizziness, headache, restlessness, weakness, feeling hot or cold.

Allergic reactions: cutaneous allergic reactions.

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

Overdose

Pregnancy use

Pregnancy Experimental studies have shown no data on teratogenicity and embryotoxicity of trimebutine. However, due to the lack of necessary clinical data, the use of trimebutine during pregnancy is contraindicated.

Breastfeeding period Trimebutine is not recommended during breastfeeding, due to a lack of reliable clinical data confirming the safety of trimebutine during this period. If it is necessary to use trimebutine during breastfeeding, breastfeeding should be stopped.

Similarities