Tradename
Tritone
Generic Name
Trimebutine maleate
Category
Gastrointestinal System
Form
Various
Composition
Tablets
Active Ingredients
Trimebutine............100 or 200 mg
Excipients
Lactose, maize starch, microcrystalline cellulose, gelatine, magnesium stearate, talc

Powder for Suspension
Active Ingredients
Tritone..................480 mg/100 ml
Excipients
Citric acid monohydrate, sodium citrate dihydrate, methylparaben, strawberry essence, sucrose
Description
Intestinal motility regulator and antispasmodic
Properties/Actions
Pharmacology
Tritone
is an intestinal motility regulator and antispasmodic. It is a direct-acting smooth muscle relaxant, reducing spasms, therefore may decrease severe, acute abdominal pain associated with irritable bowel syndrome, especially if it is postprandial.
Tritone is a peripheral enkephalinergic receptor agonist and releases the enkephalins to act on digestive motility, which have an analgesic action.
Tritone stimulates the intestinal motility (by activating phase III of the migrating motor complex MMC) and inhibits spasms due to previous stimulation.

Pharmacokinetics
Peak plasma concentration in the blood is reached within 1 to 2 hours.
Elimination is rapid, principally through urine, with an average of 70% in 24 hours.

Indications
Tritone is indicated in:
  • Treatment and relief of symptoms associated with irritable bowel syndrome (spastic colon).
  • Treatment of pain associated with gastrointestinal and biliary tract disorders.
  • Postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.
  • Symptomatic treatment of pain associated with transit troubles, and intestinal discomfort associated with intestinal function.
Contraindications
Tritone is contraindicated in patients with hypersensitivity to trimebutine maleate or any other ingredients.
Drug Interactions
Side Effects/Adverse Effects
Very rare cutaneous reactions have been reported.
Pregnancy & Lactation
Safe use of trimebutine maleate during pregnancy and lactation has not yet been established. It is thus not recommended for use unless otherwise advised by the physician.
Dosage & Administration
The adult recommended dose is from 300-600 mg daily in divided doses before meals, according to the prescriber's instructions.
Tablets
  • 100 mg: 1-2 tablets to be taken three times daily before meals.
  • 200 mg: 1 tablet to be taken three times daily before meals.
Powder for Suspension
  • Oral suspension is to be reconstituted by adding the required amount of water to teh mark on the bottle and shake very well to reach the required measure corresponding to the bottle.
  • The dosage is usually 1 mg/kg/day in 3 divided doses. The measured dose depends on the weight of the child.
  • It is recommended to add the measured dose on the feeding bottle containing milk or water for the baby, or on a spoon to be given to a child.
  • Shake the bottle thoroughly before measuring.
Overdosage
Warnings
Notes
Storage
Store in a dry place, at a temperature not exceeding 30°C.
Packaging
Tablets: Box of 2 strips of 10 tablets each.
Suspension: Bottle of 125 ml after reconstitution.
Manufacturer
Global Napi Pharmaceuticals
Date Added/Updated
14th September 2012 1:56pm

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