CLOFENAC-50 ENTERIC COATED TABLET

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

DICLOFENAC SODIUM

MAH:

HOVID BERHAD

INN:

DICLOFENAC SODIUM

units_in_package:

100 Tablets

manufactured_by:

HOVID BERHAD

SPC

VICLO26-var (MY)
CLOFENAC 50 TABLET
809
DESCRIPTION
Round, yellowish brown enteric coated tablet with shallow convex
faces and bevel-edged.
COMPOSITION
Diclofenac sodium 50 mg per tablet
PHARMACODYNAMICS
Diclofenac sodium has analgesic, anti-inflammatory and anti-
pyretic properties. It is an inhibitor of prostaglandin synthetase
(cyclo-oxygenase).
PHARMACOKINETICS
•
ABSORPTION: Diclofenac is absorbed form the gastro-intestinal
tract but is subject to first-pass metabolism.
•
PROTEIN BINDING: At the therapeutic concentration, diclofenac
is more than 99% bound to plasma proteins.
•
EXCRETION: Diclofenac is excreted primarily in the form of
metabolites, mainly in the urine but also in the bile.
INDICATIONS
Diclofenac sodium is used for relief of pain and inflammation in
conditions such as rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis, acute gout and following some surgical procedures.
CONTRAINDICATIONS
•
Diclofenac sodium was considered unsafe in patients with
acute
porphyria
because
it
has
been
shown
to
be
porphyrinogenic in animals or _in vitro_ system.
•
Avoid giving to patients who are sensitive to aspirin.
•
Use in pregnant women should be avoided.
•
Severe cardiac failure
(see section WARNING and PRECAUTIONS)
WARNING
CARDIOVASCULAR EFFECTS
Treatment with NSAIDs including diclofenac, particularly at high
dose and in long term, may be associated with an increased risk
of serious cardiovascular thrombotic events (including myocardial
infarction and stroke).
Treatment with diclofenac is generally not recommended in patients
with established cardiovascular disease (congestive heart failure,
established ischemic heart disease, peripheral arterial disease) or
uncontrolled hypertension. If needed, patients with established
cardiovascular disease, uncontrolled hypertension, or significant
risk
factors
for
cardiovascular
disease
(e.g.
hypertension,
hyperlipidaemia, diabetes mellitus and smoking) should be treated
with diclofenac only after careful consideration and only at doses ≤
100mg d