APO PIROXICAM CAP 20MG CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PIROXICAM

Disponible depuis:

APOTEX INC

Code ATC:

M01AC01

DCI (Dénomination commune internationale):

PIROXICAM

Dosage:

20MG

forme pharmaceutique:

CAPSULE

Composition:

PIROXICAM 20MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0114612001; AHFS:

Statut de autorisation:

MARKETED

Date de l'autorisation:

1986-12-31

Résumé des caractéristiques du produit

_APO-PIROXICAM (Piroxicam capsules) _
_ _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-PIROXICAM
Piroxicam Capsules
Capsules, 10 mg and 20 mg, For Oral Use
Apotex Standard
Nonsteroidal Anti-inflammatory Drug (NSAID)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Authorization:
MAR 03, 1986
Date of Revision:
MAY 16, 2023
Submission Control No: 271164
_APO-PIROXICAM (Piroxicam capsules) _
_ _
_Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNING AND PRECAUTIONS BOX
05/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
05/2023
7 WARNINGS AND PRECAUTIONS, Skin
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
........................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics (< 16 years of age):
......................................................................................
4
1.2
Geriatrics (> 65 years of age):
......................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
......................................................................
5
4
DOSAGE AND ADMINISTRATION
...................................................................................
6
4.1
Dosing Considerations
.................................................................................................
6
4.2
Recommended