Brufen
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
09-05-2024
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Active ingredient:
Ibuprofen
Available from:
Abbott Australasia Pty Ltd
Class:
Medicine Registered
Summary of Product characteristics
Brufen (ibuprofen)
400mg tablet; 100mg/5mL Syrup
31 July 2012
Page 1 of 13
Version 07
PRODUCT INFORMATION
BRUFEN
®
TABLETS AND SYRUP
NAME OF THE MEDICINE
Ibuprofen 400 mg tablet; 100mg/5mL Syrup
The structural formula for ibuprofen is shown below:
CAS Number: 15687-27-1
DESCRIPTION
Ibuprofen is a (±)-2-(_p_-isobutylphenyl) propionic acid.
Ibuprofen is a white crystalline
solid with a melting point of 74 - 77
o
C and is practically insoluble in water (<
0.1mg/mL) and readily soluble in organic solvents such
as ethanol and acetone.
PHARMACOLOGY
Ibuprofen
is a nonsteroidal anti-inflammatory agent that possesses analgesic
and
antipyretic activities. Its mode of action, like that
of other nonsteroidal anti-
inflammatory agents, is not completely understood,
but may be related to
prostaglandin synthetase inhibition.
Ibuprofen has shown
anti-inflammatory, analgesic and antipyretic activity in both
animal and human studies.
These properties provide symptomatic relief of
inflammation and pain in rheumatoid arthritis, osteoarthritis and allied conditions.
_PHARMACOKINETICS _
Absorption: Ibuprofen is well absorbed
after oral administration. Single doses of 200
mg taken on an
empty stomach by volunteers produced peak serum levels after
approximately 45 minutes. When taken after food, absorption
was slower, peak levels
appearing at 1.5 to 3 hours.
Bioavailability: The bioavailability of ibuprofen
from one "Brufen 400 mg" tablet is
equivalent to that from two "Brufen 200 mg" tablets, and 20
mL of a 2% Brufen
Syrup.
Brufen (ibuprofen)
400mg tablet; 100mg/5mL Syrup
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