PMS-NAPROXEN SUPPOSITORY

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

NAPROXEN

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

M01AE02

DCI (Dénomination commune internationale):

NAPROXEN

Dosage:

500MG

forme pharmaceutique:

SUPPOSITORY

Composition:

NAPROXEN 500MG

Mode d'administration:

RECTAL

Unités en paquet:

10/30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0109634003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2010-06-03

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PMS-NAPROXEN
(Naproxen Tablets, U.S.P.)
(Naproxen Suppositories, B.P.)
125, 250, 375 and 500 mg TABLETS
500 mg SUPPOSITORIES
ANTI-INFLAMMATORY AGENT WITH ANALGESIC & ANTIPYRETIC PROPERTIES
PHARMASCIENCE INC.
Date of Revision:
6111 Royalmount Ave., Suite 100
June 8, 2010
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Submission Control No: 139182
_Pms-NAPROXEN Product Monograph_
Page 2 of 22
PRODUCT MONOGRAPH
PMS-NAPROXEN
(Naproxen Tablets, U.S.P.)
(Naproxen Suppositories, B.P.)
125, 250, 375 and 500 mg Tablets
500 mg Suppositories.
THERAPEUTIC CLASSIFICATION
Anti-inflammatory agent with analgesic and antipyretic properties.
ACTION 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.
Naproxen absorbs virtually completely from the upper gastro-intestinal
tract. The rate of
absorption is relatively slow. The time to reach peak plasma
concentration following rectal
administration of Naproxen 500 mg suppository is similar to that for
the oral tablet, occurring 2
to 3 hours after dosing.
The mean biological half-life for Naproxen suppository ranges from
16.8 to 17.5 hours. The
AUC 0 --> ∞ is similar to that of Naproxen tablet.
_Pms-NAPROXEN Product Monograph_
Page 3 of 22
At therapeutic levels, Naproxen is 99% protein bound. Elimination
o