P Â - Caution when used during pregnancy
L Â - Caution when used during lactationÂ
|Â SeeÂ TERMINOLOGY & ABBREVIATIONS|
|ATC Classification||A03AA05 - trimebutine; Belongs to the class of synthetic anticholinergics, esters with tertiary amino group. Used in the treatment of functional bowel disorders.|
|Indication(s)||Gastroenterology:Â Polymorphous symptoms of the gastrointestinal tract, grouped under the irritable bowel syndrome entity or functional digestive disorders, in particular abdominal pain and cramps; spasms, flatulence, diarrhoea and/or constipation.|
|Dosage &Â Administration||
The adult recommended dose is up to 600 mg daily in divided doses. It is administered as one 200 mg tablet three times daily before meals.Â
Tablet:Â Adults:Â 1-2 tablets 3 times daily.
In the event of overdose, symptomatic treatment should be instigated.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
Trimebutine maleate is contraindicated in patients with known hypersensitivity to trimebutine maleate or any of the excipients.
|Warning & Precautions||
Although teratological studies have not shown any drug related adverse effects on theÂ course and outcome of pregnancy in laboratory animals by both oral and parenteralÂ routes, the use of Trimebutine maleateÂ in pregnant women is notÂ recommended.Â
Children: Not recommended for use in children under 12 years of age.
Suspension:Â In the event of diabetes, take into account the sucrose content (5 mL contains sucrose 3 g).
Caution for usage
Oral Suspension: Instructions for Use:Â Fill the bottle to the mark with nonsparkling water. Shake vigorously until thoroughly mixed. Shake the bottle each time before use. The reconstituted oral suspension cannot be stored at room temperature (between 15Â°C and 25Â°C, do not refrigerate or freeze) for >4 weeks after reconstitution.
|Adverse Drug Reactions||
In clinical studies, adverse effects of mild to moderate nature occurred in 7% of the patients treated with Trimebutine maleate (MODULONÂ®). No single side effect occurred in more than 1.8% of the patients and some of these might have been related to the patientâ€™s condition rather than the medication. The commonly reported adverse effects are as follows: a) Gastrointestinal: Dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea and constipation were reported in total of 3.1% of the patient population; b) CNS: Drowsiness, fatigue, dizziness, hot/cold sensations and headaches were reported in 3.3%; c) Allergic reactions: Rash in 0.4% of the patients; and d) Miscellaneous effects: Menstrual problems, painful enlargement of breast, anxiety, urine retention and slight deafness were also infrequently reported.
Animal studies have shown that trimebutine maleate increases the duration of d-tubocurarine-induced curarization. No other drug interactions have been observed during clinical trials or otherwise reported.
|Use inÂ PregnancyÂ & Lactation||
Use in pregnancy:Â Studies in animals have not revealed any teratogenic effect.
|Storage||Store below 25Â°C.|
|Pharmacology||Trimebutine maleate is a musculotropic antispasmodic (A: Gastrointestinal tract and metabolism).
Pharmacodynamics:Â Film-Coated Tablet:Â Through its action on the enkephalinergic system of the gut. Trimebutine is a regulator of digestive motility. Acting as an enkephalinergic agonist on excitatory and inhibitory receptors, it exerts a stimulating action on hypokinetic and a spasmolytic effect on hyperkinetic digestive muscle. Trimebutine restores a physiologic motility in functional digestive diseases related to mobility disorders.
Oral Suspension:Â Gastrointestinal motility modifier. Peripheral enkephalinergic agonist. Trimebutine stimulates intestinal motility (triggering phase III waves propagated by the migrating motor complex) and inhibits it in the event of prior stimulation.
Pharmacokinetics:Â Oral Suspension:Â Peak blood levels obtained after 1-2 hrs.Â Rapid elimination, mainly in the urine: On average 70% in 24 hrs.