DISLEP Solution for injection / infusion Ref.[51152] Active ingredients: Levosulpiride

When levosulpiride is administered orally at a dose of 50 mg, the plasma peak is reached within 3 hours and averages 94.183 ng/ml. The elimination half-life calculated after administration of 50 mg i.v. of levosulpiride is 4.305 hours.

The elimination of the drug occurs mainly via the urine.

The acute toxicity values expressed as LD₅₀ after oral administration in mice, rats and rabbits were respectively equal to 2450 mg/kg, 2600 mg/kg and greater than 1500 mg/kg. The values of LD₅₀ via i.p. in mice are equal to 210 mg/kg, in rats via i.p. and i.v. 270 mg/kg and 53 mg/kg respectively, in rabbits via i.v. 42 mg/Kg. Subacute toxicity tests were conducted by administering the active ingredient daily for 12-13 weeksin rats,rabbits and dogs. No toxic symptoms were observed at doses of 25 mg/kg s.c. and 300 mg/Kg p.o. in rats, at doses of 250 mg/kg p.o. and 12.5 mg/kg i.m. in rabbits and at doses of 50 and 100 mg/kg p.o. in dogs.

Chronic toxicity tests, after administration of the drug for 180-190 days, at doses of 100 mg/kg p.o. and 20 mg/kg s.c. in rats, of 10 mg/kg i.m. in rabbits and 20 mg/kg p.o. in dogs, were well tolerated.

Studies performed on rats and mice, by administering the drug at a higher dosage than that expected for humans, have shown that levosulpiride does not possess carcinogenic properties.

Studies performed on rats and rabbits have shown that the drug is not teratogenic. In vitro tests have excluded that the drug possesses mutagenic properties.