NU-NAPROX EC TABLET (ENTERIC-COATED)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

NAPROXEN

Disponível em:

NU-PHARM INC

Código ATC:

M01AE02

DCI (Denominação Comum Internacional):

NAPROXEN

Dosagem:

375MG

Forma farmacêutica:

TABLET (ENTERIC-COATED)

Composição:

NAPROXEN 375MG

Via de administração:

ORAL

Unidades em pacote:

60/100/500

Tipo de prescrição:

Prescription

Área terapêutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0109634004; AHFS:

Status de autorização:

CANCELLED (UNRETURNED ANNUAL)

Data de autorização:

2018-03-28

Características técnicas

PRODUCT MONOGRAPH
NU-NAPROX EC
NAPROXEN TABLETS
125 MG, 250 MG, 375 MG AND 500 MG
NU-NAPROX SR
NAPROXEN SUSTAINED-RELEASE TABLETS
750 MG
NU-NAPROX EC
NAPROXEN ENTERIC-COATED TABLETS
250 MG, 375 MG AND 500 MG
ANTI-INFLAMMATORY AGENT WITH ANALGESIC AND ANTIPYRETIC PROPERTIES
NU-PHARM INC.
DATE OF REVISION:
50 MURAL STREET, UNITS 1 & 2
October 20, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 133520
1
PRODUCT MONOGRAPH
NU-NAPROX
Naproxen Tablets
125 mg, 250 mg, 375 mg and 500 mg
NU-NAPROX SR
Naproxen Sustained-Release Tablets
750 mg
NU-NAPROX EC
Naproxen Enteric-Coated Tablets
250 mg, 375 mg and 500 mg
THERAPEUTIC CLASSIFICATION
Anti-inflammatory Agent with Analgesic and Antipyretic Properties
ACTIONS AND CLINICAL PHARMACOLOGY
Naproxen has demonstrated anti-inflammatory, analgesic and antipyretic
properties in classical
animal test systems. In patients with rheumatoid arthritis the
anti-inflammatory action has been
shown by a reduction in joint swelling, pain, and duration of morning
stiffness, and by enhanced
grip strength and increased mobility. It exhibits an anti-inflammatory
effect even in
adrenalectomized animals and therefore its action is not mediated
through the pituitary-adrenal
axis. It is not a corticosteroid.
During clinical trials, naproxen has been found to be less likely to
cause gastrointestinal bleeding
in doses usually used than is acetylsalicylic acid.
Clinical trials in man have shown the clinical activity of 500 mg of
naproxen daily to be similar to
that of 3.6 grams of acetylsalicylic acid daily.
2
From clinical trials it appears that enteric-coated naproxen has
reduced potential for severe
complaints when compared to standard naproxen.
Pharmacokinetics
Naproxen is rapidly and completely absorbed from the gastrointestinal
tract. After administration
of naproxen, peak plasma levels of naproxen anion are attained in 2 to
4 hours, with steady-state
conditions normally achieved after 4-5 doses. Plasma naproxen levels
and areas under plasma
concentration vs. time curves increased linearly with dose