APO-DICLOFENAC SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DICLOFENAC SODIUM

Disponible des:

APOTEX INC

Codi ATC:

M02AA15

Designació comuna internacional (DCI):

DICLOFENAC

Dosis:

1.5%

formulario farmacéutico:

SOLUTION

Composición:

DICLOFENAC SODIUM 1.5%

Vía de administración:

TOPICAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0114417007; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2010-07-15

Fitxa tècnica

1
PRODUCT MONOGRAPH
PR
APO-DICLOFENAC
(1.5% W/W DICLOFENAC SODIUM SOLUTION)
TOPICAL ANTI-INFLAMMATORY – ANALGESIC
APOTEX INC. DATE OF REVISION:
JANUARY 9, 2018
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
CONTROL NO.:
212374
2
PR
APO-DICLOFENAC
(1.5% W/W DICLOFENAC SODIUM SOLUTION)
PHARMACOLOGIC/THERAPEUTIC CLASSIFICATION
TOPICAL ANTI-INFLAMMATORY – ANALGESIC
ACTIONS AND CLINICAL PHARMACOLOGY
Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) of
the arylacanoic
acid group, with analgesic and anti-inflammatory properties. The mode
of action of
diclofenac sodium is not fully known, but it is considered to be
primarily through its
inhibitory
effects
on
prostaglandin
synthesis
by
interfering
with
the
action
of
prostaglandin synthetase/cyclo-oxygenase, isoforms 1 and 2 (COX-1 and
COX-2). It does
not act through the pituitary-adrenal axis. Diclofenac sodium does not
alter the course of
the underlying disease in patients with osteoarthritis; it has been
found to relieve pain,
reduce swelling and tenderness, and increase mobility.
CLINICAL TRIALS
Randomized clinical trials with APO-DICLOFENAC have NOT been designed
to detect
differences in cardiovascular adverse events in a chronic setting.
However, large population-based observational studies, meta-analyses
and systematic
reviews suggest that diclofenac use is associated with an increased
risk of cardiovascular
thrombotic events, including myocardial infarction and ischemic
stroke. Results of some
studies suggest that the cardiovascular risk is related to the dose
and duration of
diclofenac exposure and is greater in patients with risk factors for
cardiovascular disease.
STUDY 1
In an 84-day (12-week), double-blind, vehicle-controlled clinical
trial in patients with
osteoarthritis
of
the
knee,
the
efficacy
of
diclofenac
sodium
topical
solution
was
demonstrated by three primary variables—pain and physical function,
as measured with
the WOMAC LK3.1 Osteoarthritis Index—plus Patient Global Assessment.
Efficacy was
confirmed
by
the
secondary
variable,