PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

In inhalation toxicity studies (dog, monkey), no irritants of the nasal passages orrespiratory tract tissues were identified after intranasal administration of sumatriptan.Skin and Eye IrritancySumatriptan produced little or no irritant reaction when applied topically to the skin ofguinea pigs and was a non-irritant in the rabbit eye.Sumatriptan was shown to be devoid of detectable skin sensitizing potential in guineapigs subjected to a 12-day induction period (0.05 mL of a 10% solution, appliedepicutaneously) prior to challenge with sumatriptan.Dependence LiabilityThe physical dependence liability of sumatriptan was assessed in Cynomolgus monkeysat an oral dose of 5 mg/kg, the lowest tolerable dose causing mild to moderate CNSeffects.The behavioural changes observed upon withdrawal of sumatriptan were limited innumber, sporadic, unsustained and not observed in all animals. It would appear thatsumatriptan does not share with compounds such as opiates and benzodiazepines theability to cause physical dependence.October 21, 2014Page 39 of 58