DEPIXOL Film-coated tablet Ref.[8628] Active ingredients: Flupentixol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, UK

Pharmacodynamic properties

Pharmacotherapeutic group: Neuroleptics (antipsychotics)
ATC code: N05AF01

Flupentixol is a neuroleptic of the thioxanthene series.

The antipsychotic effect of neuroleptics is believed to be related to their dopamine receptor blocking effect. The thioxanthenes have high affinity for D1 and D2 receptors.

Pharmacokinetic properties

Oral administration to volunteers (8 mg single dose and 1.5 mg/day) and patients (5-60 mg/day) resulted in serum drug concentration curves with a maximum around four hours after administration. Mean biological half-life was about 35 hours in patients. No difference was seen in patients between half-lives estimated after single-dose administration and those estimated after repeated administration. Mean oral bioavailability of flupentixol varied between 40% and 55%.

Preclinical safety data

Reproductive toxicity

In fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats. Animal reproduction studies in mice, rats and rabbits have not shown evidence of teratogenic effects. Embryotoxic effects in terms of increased post implantation loss/increased absorption rates or occasional abortions were seen in rats and rabbits at doses associated with maternal toxicity.

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