Australian Approved Name (AAN): Poliglusam derived from Aspergillus niger
Common name/s and synonyms: Chitosan derived from Aspergillus niger
Superseded AAN: Chitosan
Maximum daily dose: 2g
Warnings and Restrictions: When for oral use:
(a) the maximum recommended daily dose of the medicine must not provide more than 2000 mg of Poliglusam derived from Aspergillus niger;
(b) the following warning statement (or words to the same effect) is required on the medicine label:
CHITO – Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication.; and
(c) if the medicine is a powdered dosage form, the following warning statement is also required on the medicine label:
DNTPOW – Do not take powder alone. Mix with food or fluid.
When used as an excipient, Poliglusam derived from Aspergillus niger is only permitted for use in topical medicines for dermal application.
Allowable purpose of the ingredient: Active. Excipient
TGA reference: International Non-Proprietary Name (modified)