Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
Pharmacotherapeutic group: Topical products for joint and muscular pain, Capsaicin and similar agents
ATC code: M02AB01
Although the precise mechanism of action of capsaicin is not fully understood, current evidence suggests that capsaicin renders skin insensitive to pain by depleting and preventing reaccumulation of substance P in peripheral sensory neurons. Substance P is thought to be the principal chemomediator of pain impulses from the periphery to the Central Nervous System.
Absorption after topical application is unknown. Average consumption of dietary spice from capsicum fruit has been estimated as 2.5g/person/day in India and 5.0g/person/day in Thailand. Capsaicin content in capsicum fruit is approximately 1% therefore daily dietary intake of capsaicin may range from 0.5-1mg/kg/day for a 50kg person. Application of two tubes of Axsain Cream 0.075% (90g) each week results in a 9.6mg/day topical exposure. Assuming 100% absorption in a 50kg person, daily exposure would be 0.192mg/kg which is approximately one third to one quarter of the above mentioned dietary intake.
The available animal toxicity data relating to capsicum, capsicum extracts and capsaicin do not suggest that, in usual doses, they pose any significant toxicity hazard to man. Thus, in both single and repeat dosing studies which have been reported, capsicum extracts and capsicum are generally well tolerated at many times even the highest estimated human intakes. The safety of Axsain for use in human pregnancy has not been established since no formal reproduction studies have been performed on either animals or man. However, there is no reason to suspect from human or animal studies currently available that any adverse effects in humans are likely.
Studies reported in the published literature, which relate to potential genotoxic and carcinogenic action of capsaicin have produced inconclusive and conflicting data. However, it is unlikely that capsaicin, in the quantities absorbed transdermally from Axsain Cream, will pose any significant hazard to humans.
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