ORUDIS SR Capsule Ref.[50303] Active ingredients: Ketoprofen

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2022  Publisher: sanofi-aventis australia pty ltd, 12-24 Talavera Road, Macquarie Park, NSW 2113, Toll Free Number (medical information): 1800 818 806, Email: medinfo.australia@sanofi.com

Product name and form

ORUDIS SR Ketoprofen.

Pharmaceutical Form

Orudis SR Capsules: modified release, hard gelatin capsule. Clear pink base & white opaque cap. Base and cap printed ‘ORUDIS SR 200’ and contains off-white to cream spherical pellets.

Qualitative and quantitative composition

Each Orudis SR capsule contains ketoprofen 200 mg.

For the full list of excipients, see Section 6.1 List of excipients.

Ketoprofen is DL-2-(3-benzoylphenyl) propionic acid. It is a white or off-white powder with melting point of about 93°C. MW: 254.3. Ketoprofen is very slightly soluble in water at 20°C, 2% soluble in dimethylformide and readily soluble in benzene, ethanol, chloroform, acetone and ethyl acetate at 20°C.

Chemical structure

CAS number: 22071-15-4

Active Ingredient Description
Ketoprofen

Ketoprofen is a non-steroidal anti-inflammatory drug. It has anti-inflammatory and analgesic actions.

List of Excipients

Orudis SR Capsules: Erythrosine, ethylcellulose, gelatin, non-pareil beads (PI 1014) (sucrose and maize starch), OPACODE monogramming ink S-1-20952 BLUE (PI 12300), shellac, colloidal anhydrous silica, sodium lauryl sulfate, purified talc and titanium dioxide.

Pack sizes and marketing

Orudis SR 200 mg Capsules are available in the following presentations: Blister pack of 4*, 28, 30* and 100* capsules.

* non-marketed pack sizes.

Marketing authorization holder

sanofi-aventis australia pty ltd, 12-24 Talavera Road, Macquarie Park, NSW 2113, Toll Free Number (medical information): 1800 818 806, Email: medinfo.australia@sanofi.com

Marketing authorization dates and numbers

21 October 1991

Drugs

Drug Countries
ORUDIS Australia, Spain, Finland, Italy, South Africa

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