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trimebutine maleate toxicology acute toxicity

Time:2015/9/30 7:22:25

The acute toxicity of trimebutine maleate estimated by various routes of administration gave the following results (LD50 in mg/kg ± S.E.)


ORAL >5000 >5000 2500 ± 800

I.P. 500 ± 46 550 ± 55 ---*

I.V. 43 ± 3 16 ± 3 ---*

*i.p. and i.v. studies in the rabbit were not performed Death was produced by respiratory arrest within 1 minute, 15 minutes and 24 hours after i.v., i.p. or oral dosing, respectively.

The acute i.v. toxicity was studied in anaesthetized dogs with the monitoring of cardiovascular and respiratory functions. At dose levels in the range of 1 to 20 mg/kg,

dose related reductions in respiratory rate and arterial blood pressure were observed.

Death due to respiratory arrest occurred at 49 mg/kg. Cardiac function persisted for almost three minutes after respiratory arrest; therefore, the death occurred due to the

respiratory arrest and not due to effect on the cardiovascular system. 

trimebutine maleate subacute toxicity

Trimebutine maleate was injected intravenously for four weeks to rats and beagle dogs at doses of 4, 8 and 16 mg/kg/day or 4, 7 and 12.5 mg/kg/day, respectively.In rats, no specific organ toxicity was observed. In the high dose group, however, there was a high mortality rate since half of the animals died during the study. Death occurred

always within 15 seconds of dosing and the animals exhibited signs of acute CNS involvement. Postmortem examination showed a slight weight increase of spleen and

adrenals in males at 16 mg/kg/day. The injection sites were of normal appearance. 

In dogs, transient, reversible signs of CNS effects were apparent at 7 and 12.5 mg/kg/day. An overall weight loss was observed in the high dose females while weight gain was

decreased in males at 7 and 12.5 mg/kg/day. The injection sites of treated and control animals were comparable.