Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Laboratoires THEA, 12 Rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, FRANCE
Pharmacotherapeutic group: Anriglaucoma preparations and miotics; Beta-blocking agents
ATC code: S01ED01
Timolol can be characterised by three pharmacological properties:
Timolol maleate eye gel reduces intra-ocular pressure, whether or not this is associated with glaucoma.
An effect is seen around 20 minutes following instillation, reaches a maximum in 1 to 2 hours and is still present after 24 hours.
There is no effect on pupil diameter or visual acuity.
TIOPEX 1 mg/g eye gel is a preservative free formulation.
Negligible systemic exposure has been observed in patients treated with TIOPEX 1 mg/g given once daily. Data from a recent comparative pharmacokinetic study (LLOQ=0.146 ng/ml) have shown that the plasma level is generally below the LOQ.
None of the mutagenesis studies carried out in vivo and in vitro on timolol have produced any evidence of mutagenic potential. Cancerogenic potential in timolol has been shown in animals, at exposure levels much higher than those observed in clinical practice during treatment with TIOPEX 1 mg/g.
Reprotoxicity studies have not shown any teratogenic effect in mice, rats and rabbits. In rats, a delay in ossification was observed at levels of exposure much higher than those observed in clinical practice during treatment with TIOPEX 1 mg/g. No effects on fertility were observed in rats.
In rabbits, a single or repeated instillation of TIOPEX 1 mg/g for 28 days did not cause any local or systemic intolerance, nor local anaesthetic effect.
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