Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Essential Pharma, 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom
Docusatesodium is an anionic surfactant and used as a faecal softening agent. It is considered to ease constipation by increasing the penetration of fluid into the faeces thereby causing them to soften. Norgalax is usually effective in 5 to 20 minutes.
Norgalax has a local effect in the rectum. Minimal absorption cannot be ruled out even with a rectal application.
Non-clinical data reveal no special hazard for humans based on studies of acute toxicity, repeated dose toxicity and in-vitro genotoxicity. Docusate sodium has been shown to exhibit developmental toxicity in rodents at oral doses that are maternally toxic and sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. High oral doses given during lactation reduced pup weight and survival which was attributed to docusate and its metabolites present in the milk of the dams.
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