OLFEN-100 SR DEPOCAPS

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

DICLOFENAC SODIUM

MAH:

MEPHARM (MALAYSIA) SDN BHD

INN:

DICLOFENAC SODIUM

units_in_package:

100Capsule Capsules

manufactured_by:

Acino Pharma AG

SPC

Olfen
®
-100
SR
_Depocaps_
®
_ _
_ _
_Antirheumatic _
_agent _
_with _
_anti-inflammatory _
_and _
_antipyretic _
_properties _
_ _
_ _
Composition
Each Olfen-100 SR Depocaps
®
contains:
Diclofenac sodium
100mg
(as sustained-release pellets)
Properties and actions
Olfen contains the sodium salt of diclofenac, a non-steroidal active
substance
having
pronounced
anti-rheumatic,
anti-inflammatory,
analgesic and anti-pyretic properties.
Inhibition
of
prostaglandin
biosynthesis,
which
has
been
demonstrated experimentally, is thought to be important for the
mechanism of action. Prostaglandins play an essential role in the
development of inflammation, pain and fever. The anti-inflammatory
and analgesic properties become clinically evident in the case of
rheumatic disorders in that the
symptoms, such as rest pain, pain
on motion, morning stiffness, swelling of the joints, are
significantly
improved and functional ability increases. In post- traumatic/post-
operative
inflammations,
diclofenac
causes
a
rapid reduction
in
spontaneous pain and pain on motion and reduces inflammatory
swelling and wound oedema.
For moderate and severe states of pain of a non-rheumatic type, as
well, the pronounced analgesic effect was demonstrated in clinical
trials. In cases of primary dysmenorrhoea, diclofenac can alleviate
pain and reduce the extent of bleeding.
Pharmacokinetics
After
oral
administration,
diclofenac
is
rapidly
and
completely
absorbed. The plasma concentrations are linearly dose-dependent.
Plasma protein binding amounts to more than 97%. Peak plasma
concentrations are attained 1-4 hours after taking the enteric-coated
Lactab tablets. The therapeutic plasma concentration range is 0.7-
2mcg/ml.
Diclofenac undergoes first pass metabolism. Elimination is about 2/3
renal and about 1/3 via the bile in metabolized form (about 90% of
the administered dose in 96 hours). The greater amounts of the
hydroxyl-glucuronide
and
sulphated
metabolites
are
biologically
inactive. Only about 1% is renally excreted in unchanged form.
The plasma