(For additional information
see "Trimebutine (United States: Not available): Patient drug information")
For abbreviations, symbols, and age group definitions used in Lexicomp (
show table)
Pharmacologic Category
-
Antispasmodic Agent, Gastrointestinal;
-
Opioid Agonist, Peripherally-Acting
Dosing: Adult
Irritable bowel syndrome
Irritable bowel syndrome (IBS): Oral: 200 mg 3 times/day.
Postoperative paralytic ileus
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.
Dosing: Pediatric
Children ≥12 years and Adolescents: Refer to adult dosing.
Adverse Reactions
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
Contraindications
Hypersensitivity to trimebutine or any component of the formulation
Warnings/Precautions
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).
Product Availability
Not available in the US
Generic Equivalent Available: US
May be product dependent
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Generic: 100 mg, 200 mg
Administration: Adult
Oral: Administer before meals.
Administration: Pediatric
Oral: Administer before meals.
Use: Labeled Indications
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
Metabolism/Transport Effects
None known.
Drug InteractionsNote: 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
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies. Use in pregnancy is not recommended per the manufacturer.
Dietary Considerations
Should be taken before meals.
Mechanism of Action
Spasmolytic agent with antiserotonergic activity and moderate opiate receptor affinity. Reduces abnormal motility; does not alter normal GI motility.
Pharmacokinetics (Adult Data Unless Noted)
Absorption: Rapid
Half-life elimination: ~10 to 12 hours
Time to peak, plasma: Within 1 hour
Excretion: Urine (primarily); feces (5% to 12%)
Brand Names: International
International Brand Names by CountryFor country code abbreviations (
show table)
-
(AR) Argentina: Biorgan | Biorgan ap | Colixane | Conjustron | Debridat | Debridat a.p. | Eumotil | Fenatrop | Fenatrop ap | Miopropan | Miopropan lp | Neotina | Normopax | Normopax 300 AP | Plidex | Plidex AP | Procinet Nf | Relopat | Sangalina | Tributina | Trimebutina | Trimebutina Vannier;
-
(BD) Bangladesh: Trimotil | Tritin;
-
(BF) Burkina Faso: Debutine;
-
(BG) Bulgaria: Tributin;
-
(CI) Côte d'Ivoire: Colospasmyl | Debridat | Debutine;
-
(CL) Chile: Debridat | Dolpic | Dolpic forte | Tidomel | Trim | Trimebutino;
-
(CN) China: Cerekinon | Diway | Nuo wei | Shu li qi neng | Shuang di | Trimebutine | Yuan sheng li wei;
-
(CO) Colombia: Antinime | Bi pasmin | Bumetin | Coltrim | Colypan | Debridat | Eumotrix | Fitraless | Isoflav | Kolantil | Kolontil | Lamotris | Lotrel | Muvett | Oclid | Synespas | Tributin | Trimebutina | Trimebutina maleato | Trimesher;
-
(DO) Dominican Republic: Debridat | Debridat ap | Debrium | Eutransil | Muvett | Polibutin;
-
(EC) Ecuador: Colypan | Debridat | Dolpic | Eutransil | Gaspat | Muvett | Trimebutina | Trimebutina MK;
-
(EG) Egypt: Debridat | G Regulator | Gast-reg | Tribudat | Trigenda | Tritone;
-
(ES) Spain: Polibutin;
-
(FR) France: Debricalm | Debridat | Modulon | Transacalm | Trimebutine | Trimebutine Actavis | Trimebutine Almus | Trimebutine Alter | Trimebutine arrow | Trimebutine biogaran | Trimebutine Cristers | Trimebutine evolugen | Trimebutine g gam | Trimebutine gerda | Trimebutine gnr | Trimebutine irex | Trimebutine Isomed | Trimebutine ivax | Trimebutine merck | Trimebutine Pfizer | Trimebutine Qualimed | Trimebutine Ratiopharm | Trimebutine Rpg | Trimebutine Sandoz | Trimebutine teva | Trimebutine zydus;
-
(GR) Greece: Ibutin;
-
(HK) Hong Kong: Cerekinon | Scd trimebutine | Tritin;
-
(IN) India: Trimspa;
-
(JP) Japan: Behm | Butikinon | Celvel | Cerekinon | Coolbutin | Gastlock | Isutinon iwaki | Isutinon teisan | Liement | Liement chemiphar | Malebutine | Mebucolon | Mebutit | Meptart | Movarol | Mustrick | Naruhiton | Nepten | Nichimalon | Pelkysil | Pilemain | Sakion | Sakion hexal | Sakion kayaku | Salnatin | Selumito | Supeslone | Tefmetin | Trasben | Trikinosin | Trishi ohara;
-
(KR) Korea, Republic of: Aerin ssuk | Anitine | Anytine | Anytinin | Bebutin | Benznal | Bimetin | Boryung trimebutine maleate | Butimerin | Celltrion trimebutine maleate | Cerekinon | Crobutin | Crobutine | Ctmetine | Elbutine | Embutin | Genuone trimebutine maleate | Hanabutin | Huniz trimebutine maleate | Ilyangbio trimebutine maleate | J butine | Jesbutine | Jintroi | Jintroy f | Juni | L butine | Mabin | Mabutan | Malbuthin | Maldive | Malebutine | Malix | Manpotin | Maributin | Mebulatin | Meburan | Mebut | Mebutin | Mekospasm | Meritin | Meriton Sr | Mirae trimebutine | Motric | Mributin | Mybutin | Mybutine | Neobutin sr | Newbutin sr | Pobutin | Polybutin | Polybutin s.r | Polybutine | Probutine | Recutin | Rimebutin | Rimex | Sambutin | Samchundang trimebutine | Sammetin | Sinbutin | Sinil trimebutine maleate | Spabutin | Talributine | Tambutine | Tarabutin | Tialbutin | Timebutin | Timetin | Tokarus | Toles | Tores | Torhes | Tri m | Tributin | Tributin sr | Tricool | Triel | Trien | Trima | Trimebutine | Trimebutine maleate hanall | Trimen | Trimetine | Trione | Trissak | Withus trimebutine maleate | Yumebutine;
-
(LB) Lebanon: Debritine | Debutine;
-
(LV) Latvia: Neobutin;
-
(MA) Morocco: Debridat | Inductan;
-
(MX) Mexico: Apocol | Cineprac | Crismotil | Debridat | Dolbutin | Espabion | Libertrim | Libertrim lp | Prescol | Scitin | Tempolib | Trimebutina;
-
(MY) Malaysia: Cerekinon | Debridat;
-
(NO) Norway: Debridat;
-
(PE) Peru: Colonix | Crolipsa | Debridat | Debridat ap | Muvett | Muvett sm | Neucinet s | Trimebutina genfar | Trimet;
-
(PK) Pakistan: Debridat | Tribate | Trimin;
-
(PL) Poland: Debretin | Debridat | Ircolon | Ircolon gastro | Tribux | Tribux bio;
-
(PT) Portugal: Debridat;
-
(PY) Paraguay: Distonil | Eumotrix | Eumotrix retard | Orudis | Trimebutina indufar | Trimebutina maleato | Ulcepina;
-
(RO) Romania: Colobutine | Colperin | Debridat | Ibutin | Trimebutin;
-
(RU) Russian Federation: Debridat | Neobutin | Neobutin retard | Trimebutine sz | Trimedat | Trimedat forte;
-
(SG) Singapore: Cerekinon | Debridat;
-
(TH) Thailand: Cerekinon | Debridat;
-
(TN) Tunisia: Colospasmyl | Debricol | Debridat | Transacalm | Trimebutine | Trimegam;
-
(TR) Turkey: Debridat | Debrutin fort | Gismotal | Tirebrant | Tribudat;
-
(TW) Taiwan: Trimetin;
-
(UA) Ukraine: Trimspa;
-
(UY) Uruguay: Aldar | Eumotil;
-
(VE) Venezuela, Bolivarian Republic of: Bumetin | Colypan | Dobracid | Muvett | Trimbet | Trimebutina | Trimebutina maleato;
-
(VN) Viet Nam: Agitritine | Butridat | Debutinat | Hasanbin | Iboten | Newbutin sr