Consumer medicine information

1 Name of Medicine

Framycetin sulfate, gramicidin and dexamethasone (as sodium metasulfobenzoate).

2 Qualitative and Quantitative Composition

Each mL contains framycetin sulfate 5 mg, gramicidin 50 microgram and dexamethasone (as sodium metasulfobenzoate) 500 microgram.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sofradex is a clear bright colourless aqueous solution.

4 Clinical Particulars

4.9 Overdose

Long-term intensive topical use may lead to systemic effects.
For information on the management of overdose, contact the Poisons Information Centre, telephone number 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Framycetin sulfate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFRASUL.gif Molecular weight: 712.72.
Gramicidin. See Table 1.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SOFRAD01.gif https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGRAMIC.gif Dexamethasone sodium metasulfobenzoate.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDESOME.gif Molecular weight: 598.6.
CAS number. Framycetin sulphate - 4146-30-9.
Gramicidin - 1405-97-6.
Dexamethasone sodium metasulfobenzoate - 3936-02-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SOFRADST.gif