Question
Posted on: September 5 2019Propylene glycol as solvent for nipa esters in Aqua Conservans, used in syrups?
Answer
The following limits, expressed in terms of maximum daily dose of propylene glycol , are considered to be safe and with no noticeable effects whatever the duration and the route of administration, with the exception of inhalation. Special attention will have to be taken to avoid hyperosmolality, CNS, cardiovascular, and/or respiratory effects during bolus parenteral administration.
|
Age group |
neonates up to 28 days (or 44 weeks post menstrual age for pre- terms) |
1 month (29 days) up to 4 years |
5 years up to 17 years and adults |
|
Safety limits |
1 mg/kg |
50 mg/kg |
500 mg/kg |
As a general remark, it should be kept in mind that higher doses may be administered, when justified on a case by case basis in order to support the safety of the proposed formulation.