General Information
Revision date
2015-08-21
Product name
None identified
Chemical name
Mixture - contains a sodium salt of ethacrynic acid, which is a unsaturated ketone
CAS No.
6500-81-8
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture product packaged in final form for patient of the substance or
Icons in SDS
Company Information
company name
Par Sterile Products
e-mail address of the competent person responsible for the Safety Data Sheet
drugsafety@parpharm.com
GHS Information
Signal word
None
Section 2
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labeling listed below is for bulk Ethacrynate Sodium Injection. Globally Harmonized Not classified System [GHS] SECTION 2 - HAZARDS IDENTIFICATION …continued
Hazard statements
None required None required
Signal word
None required
Precautionary statements
None required
2.3 Other hazards
Contains ethacrynate sodium, which is used as a diuretic at doses ranging from 50 to 200 mg. Excessive diuresis may cause fluid and electrolyte imbalances, which may cause symptoms such as thirst, weakness, dizziness, confusion, muscle cramps, and nausea. Hearing loss has been also been reported with clinical use. Note This mixture does not meet criteria for classification under GHS as implemented by Regulation EC No 1272/2008 (EU CLP) and Hazard Communication Standard No. 1910.1200 (US OSHA). Nevertheless, it should be handled with caution as it is pharmacologically active.
