Tritin

Tritin

trimebutine

Manufacturer:

Samjin

Distributor:

Yu Chun
/
SB Pharma
Full Prescribing Info
Contents
Trimebutine maleate.
Description
Each tablet contains: Trimebutine maleate 100 mg.
Excipient/Inactive Ingredients: Lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, magnesium stearate.
Indications/Uses
For the treatment and relief of symptoms associated with the irritable bowel syndrome (spastic colon). In postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.
Dosage/Direction for Use
The adult recommended dose is up to 600mg daily in divided doses. It is administered as 200mg three times daily before meals.
Overdosage
No evidence of overdosage have been reported to date. However, if overdosage should occur following oral administration of trimebutine maleate, gastric lavage is recommended. Treatment should be made according to the symptoms observed.
Contraindications
The drug is contraindicated in patients with known hypersensitivity to trimebutine or any of the excipients.
Warnings
Use in Pregnancy: Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy in laboratory animals by both oral and parenteral routes, the use of trimebutine maleate in pregnant women is not recommended.
Use in Children: Not recommended for use in children under 12 years of age.
Use In Pregnancy & Lactation
Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy in laboratory animals by both oral and parenteral routes, the use of trimebutine maleate in pregnant women is not recommended.
Adverse Reactions
In clinical studies, adverse effects of mild to moderate nature occurred in 7% of the patients treated with trimebutine maleate. No single side effect occurred in more than 1.8% of the patients and some of these might have been related to the patient's condition rather than the medication. The commonly reported adverse effects are as follows: Gastrointestinal: Dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea and constipation were reported in a total of 3.1% of the patient population.
Central Nervous System: Drowsiness, fatigue, dizziness, hot/cold sensations and headaches were reported in 3.3%.
Allergic: rash in 0.4% of the patients.
Miscellaneous: Menstrual problems, painful enlargement of breast, anxiety, urine retention and slight deafness were also infrequently reported.
Drug Interactions
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.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A03AA05 - trimebutine ; Belongs to the class of synthetic anticholinergics, esters with tertiary amino group. Used in the treatment of functional bowel disorders.
Presentation/Packing
Form
Tritin tab 100 mg
Packing/Price
100's
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