Land: Kanada
Sprache: Englisch
Quelle: Health Canada
NAPROXEN
PHARMASCIENCE INC
M01AE02
NAPROXEN
500MG
SUPPOSITORY
NAPROXEN 500MG
RECTAL
10/30
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0109634003; AHFS:
APPROVED
2010-06-03
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 Lesen Sie das vollständige Dokument