Dinobutin (Gel) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

A03AA05 (Trimebutine)

Active Substance

Trimebutine (Rec.INN registered by WHO)

Dosage Forms

	Dinobutin	Oral gel 8.9 mg/1 g: tubes of 50 g or 100 g
		Oral gel (with strawberry flavor) 8.9 mg/1 g: tubes of 50 g or 100 g

Dosage Form, Packaging, and Composition

Oral gel opaque, homogeneous, white or almost white in color with white particles and a faint characteristic neutral odor; the presence of white inclusions and air bubbles is allowed.

Excipients: carbomer, sodium hydroxide, liquid maltitol, sucralose, sodium benzoate (E211), purified water.

50 g – aluminum tubes (1) with a dosing spoon* – cardboard packs.
100 g – aluminum tubes (1) with a dosing spoon* – cardboard packs.

* with markings corresponding to a capacity of 2.5 ml and 5 ml

Oral gelwith strawberry flavor opaque, homogeneous, white or almost white in color with white particles and a strawberry odor; the presence of white inclusions and air bubbles is allowed.

Excipients: carbomer, sodium hydroxide, liquid maltitol, sucralose, sodium benzoate (E211), purified water, strawberry flavor.

50 g – aluminum tubes (1) with a dosing spoon with markings corresponding to a capacity of 2.5 ml and 5 ml – cardboard packs.
100 g – aluminum tubes (1) with a dosing spoon with markings corresponding to a capacity of 2.5 ml and 5 ml – cardboard packs.

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders; synthetic anticholinergic agents, esters with a tertiary amino group

Pharmacological Action

Trimebutine, by influencing the enkephalinergic system of the intestine, regulates its peristalsis.

By acting on peripheral σ-, µ- and κ-opioid receptors, including those located directly on the smooth muscle throughout the gastrointestinal tract, 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

After oral administration, Trimebutine is rapidly absorbed from the gastrointestinal tract.

C_max in blood plasma is reached after 1-2 hours. Bioavailability is 4-6%. V_d is 88 L. Binding to plasma proteins is low – about 5%. Trimebutine slightly penetrates the placental barrier.

It is biotransformed in the liver and excreted in the urine mainly as metabolites (approximately 70% within the first 24 hours). T_1/2 is about 12 hours.

Indications

Symptomatic treatment of pain, spasms and discomfort in the abdominal area, flatulence, intestinal motility disorders with changes in stool frequency (diarrhea or constipation), dyspepsia, heartburn, belching, nausea, vomiting associated with functional diseases of the gastrointestinal tract and biliary tract (non-erosive form of gastroesophageal reflux disease, cholelithiasis, biliary tract dysfunction, irritable bowel syndrome, sphincter of Oddi dysfunction, postcholecystectomy syndrome).

Postoperative paralytic ileus.

ICD codes

Dosage Regimen

Administer orally. Use the provided dosing spoon for accurate measurement.

For adults and children over 12 years, take one 5 ml dose (approximately 200 mg of trimebutine maleate) three times daily.

For children from 5 to 12 years, take one 2.5 ml dose (approximately 100 mg of trimebutine maleate) three times daily.

For children from 3 to 5 years, take one 2.5 ml dose (approximately 100 mg of trimebutine maleate) twice daily.

For postoperative paralytic ileus, the typical adult dosage is one 5 ml dose three times daily

Adverse Reactions

Nervous system disorders: frequency unknown – drowsiness, feeling of tiredness, dizziness, headache, anxiety.

Gastrointestinal disorders: frequency unknown – dry mouth, unpleasant taste sensations, diarrhea, dyspepsia, nausea, constipation.

Skin and subcutaneous tissue disorders: frequency unknown – skin rash.

Renal and urinary disorders: frequency unknown – urinary retention.

Reproductive system and breast disorders: frequency unknown – menstrual cycle disorder, painful breast enlargement.

Contraindications

Hypersensitivity to trimebutine; pregnancy; pediatric age – depending on the dosage form.

Use in Pregnancy and Lactation

Contraindicated during pregnancy. If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the trimebutine drug leaflets regarding contraindications for the use of specific trimebutine dosage forms in children of different ages.

Special Precautions

The correspondence of the used dosage form to the indications for use must be strictly observed.

Effect on ability to drive vehicles and machinery

During the use of trimebutine, patients should exercise caution when driving vehicles and machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.