LONITEN 2.5MG TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-11-2013
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Active ingredient:
MINOXIDIL
Available from:
PFIZER CANADA ULC
ATC code:
C02DC01
INN (International Name):
MINOXIDIL
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
MINOXIDIL 2.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
DIRECT VASODILATORS
Product summary:
Active ingredient group (AIG) number: 0114429002; AHFS:
Authorization status:
APPROVED
Authorization date:
1998-05-04
Summary of Product characteristics
_LONITEN (minoxidil tablets USP) Product Monograph _
_ Page 1 of 25 _
PRODUCT MONOGRAPH
PR
LONITEN
®
(Minoxidil Tablets USP)
2.5 mg and 10 mg
ANTIHYPERTENSIVE
®
TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
November 14, 2013
©
Pfizer Canada Inc. 2013
SUBMISSION CONTROL NO: 167423
_LONITEN (minoxidil tablets USP) Product Monograph _
_ Page 2 of 25 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
DETAILED PHARMACOLOGY
......................................
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