Irritable bowel syndrome (IBS): Oral: 200 mg 3 times/day.
Postoperative paralytic ileus: Oral: 200 mg 3 times/day.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥12 years and Adolescents: Refer to adult dosing.
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Modulon: 200 mg [DSC]
Generic: 100 mg, 200 mg
Not available in the US
Oral: Administer before meals.
Oral: Administer before meals.
Note: Not approved in the US
Irritable bowel syndrome: Treatment and relief of symptoms associated with irritable bowel syndrome (IBS) (spastic colon).
Ileus: Treatment of postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Mood change (7%), dizziness (≤3%), drowsiness (≤3%), fatigue (≤3%), feeling hot (≤3%), sensation of cold (≤3%), taste disorder (≤3%)
Gastrointestinal: Constipation (≤3%), diarrhea (≤3%), dyspepsia (≤3%), epigastric distress (≤3%), nausea (≤3%), xerostomia (≤3%)
Frequency not defined:
Central nervous system: Anxiety, headache
Endocrine & metabolic: Gynecomastia, menstrual disease
Genitourinary: Breast hypertrophy, mastalgia, urinary retention
Otic: Auditory impairment
<1%, postmarketing, and/or case reports: Skin rash
Hypersensitivity to trimebutine or any component of the formulation
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Neuromuscular-Blocking Agents (Nondepolarizing): Trimebutine may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification
Adverse events were not observed in animal reproduction studies. Use in pregnancy is not recommended per the manufacturer.
Should be taken before meals.
Spasmolytic agent with antiserotonergic activity and moderate opiate receptor affinity. Reduces abnormal motility; does not alter normal GI motility.
Absorption: Rapid
Half-life elimination: ~10 to 12 hours
Time to peak, plasma: Within 1 hour
Excretion: Urine (primarily); feces (5% to 12%)
